[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”0″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”7260|full” max_width=”” sticky_max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align_medium=”none” align_small=”none” align=”none” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Why Software as a Medical Device (SaMD) is Prioritized in the EU MDR – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2021/02/Clinical-Evaluation-Report-Introduction-to-Clinical-Reports.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Introduction to Clinical Reports: What Are They, When/Where Are They Used, and Why?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

The current European medical device regulatory framework set its precedence in the early 1990s when the rules relating to the safety and performance of medical devices were first harmonized in the European Union (EU). These guidelines were summarized in the European Commission’s Directive 93/42/EEC and later amended by Directive 2007/47/EC. The European Union – Medical Device Regulations (EU MDR) have promoted a more uniformed approach towards conformity assessment procedures of the directives within the EU.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

What Is Clinical Evaluation?

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Clinical evidence is collected throughout the life cycle of a medical device and is an ongoing process. It is first performed during the development of a medical device to identify data that needs to be generated for market access and is updated regularly thereafter per regulations. Continued clinical evaluation is necessary as it ensures the safety and performance of the device throughout the lifetime that the medical device is on the market through comprehensive data review. Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise, and analyze clinical data pertaining to a medical device. Its core objective is to analyze whether there is sufficient clinical evidence to confirm compliance with relevant general safety and performance requirements (GSPRs) when using the device according to the manufacturer’s instructions for use. CERs are not a new requirement, however, under the EU MDR, the acceptability of content has changed – highlighting key requirements on transparency and traceability with an increased level of scrutiny over clinical evidence and levels of examination.

Specific requirements of the evaluation include appropriateness to the intended purpose of the device, benefits and risks pertaining to their nature, probability, extent, duration, and frequency. Key issues for a successful clinical evaluation methodology include the proper determination of the benefit/risk profile in the intended target groups and medical indications, and the demonstration of acceptability of that profile based on current knowledge/the state of the art in the respective medical field. This process is the device manufacturer’s responsibility, and the clinical evaluation plan and report form the documentation presenting the technical and clinical evidence summary of the device.[/fusion_text][fusion_imageframe image_id=”7267|full” max_width=”” sticky_max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align_medium=”none” align_small=”none” align=”none” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Medical Devices with Software Components – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2021/02/Clinical-Evaluation-Medical-Device-Life-Sciences-Regulation-Consultantion.jpg[/fusion_imageframe][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]When is a Clinical Evaluation Undertaken?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Clinical evaluation is conducted throughout the life cycle of a medical device as an ongoing process. To gain market access, it is first performed during the development of a medical device for an initial CE mark and then updated regularly as per mandated standards.

When a clinical evaluation is undertaken for the development a new medical device – premarket research and development processes guide the evaluation process. Manufacturers conduct gap searches to identify any gaps in the current data, determine if equivalence is to be claimed, and to define the requirements for demonstrating safety and performance of the device. Therefore, as the initial clinical evaluation identifies the questions to be answered by a clinical investigation, the clinical evaluation process should generally commence in advance of any clinical investigation.

Whereas, when a clinical evaluation is undertaken for an initial CE mark and subsequent placement of the device on the market, the purpose is to identify aspects that need to be addressed systematically during post-market surveillance (PMS), e.g., estimating the requirement of a post market clinical follow-up (PMCF) study. These aspects include an estimation of the residual risks and uncertainties, or any unanswered questions (such as rare complications, uncertainties regarding long-term performance, safety under wide-spread use). Additionally, the evaluation process aims at documenting sufficient clinical evidence to demonstrate conformity with the GSPRs covering clinical performance and clinical safety.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]How is Clinical Evaluation Performed?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The clinical evaluation is based on a comprehensive analysis of available pre-and post-market clinical data relevant to the intended purpose of the device in scope.

There are 4 stages in performing a clinical evaluation, described below in detail:

Stage 0: Defining the scope and planning the clinical evaluation.
Stage 1: Identifying pertinent data.
Stage 2: Appraisal of data sets for scientific validity, weightage, and relevance.
Stage 3: Analyze the data, whereby conclusions are reached about:

• compliance with GSPRs on performance and safety, and the benefit/risk profile of the device.
• the contents of information material supplied by the manufacturer.
• residual risks and uncertainties required to be addressed during PMS.

Stage 4: Finalize the clinical evaluation report.

The clinical evaluation report summarizes and draws together the evaluation of all the relevant clinical data documented or referenced in other parts of the technical documentation constituting evidence for the conformity assessment.[/fusion_text][fusion_imageframe image_id=”7268|full” max_width=”” sticky_max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align_medium=”none” align_small=”none” align=”none” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Software as Medical Device – Regulatory Bodies – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2021/02/The-Four-Stages-of-CER-Clinical-Evaluation-Report-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Defining the Scope of a CER[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Prior to beginning the clinical evaluation, the manufacturer must define the scope of the device based on the clinical perspective, nature, and history of the device thereby setting up the basis for further steps, such as identification of pertinent data. Following this, the manufacturer should submit, as part of their documentation of the quality management system, a clinical evaluation plan for review by the Notified Body. The plan outlines the strategies and procedures used in the clinical evaluation of the device and presents potential key factors determining the safety and performance of the device. This includes the scientific rationale for the design and mechanism of action of the device, taking into account the SOTA.

Per MDR 2017/745 Annex XIV Part A, a thorough CEP shall include at the minimum:

• an identification of the general safety and performance requirements that require support from relevant clinical data.
• a specification of the intended purpose of the device.
• a clear specification of the intended target groups with clear indications and contra-indications.
• a detailed description of the intended clinical benefits to patients with relevant and specified clinical outcome parameters.
• a specification of the methods to be used for the examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of the residual risks and side-effects.
• an indicative list and specification of the parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device.
• an indication of how benefit-risk issues relating to specific components such as use of pharmaceutical, non- viable animal or human tissues, are to be addressed.
• a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of this Annex with an indication of milestones and a description of potential acceptance criteria.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Identifying Pertinent Data for a Clinical Evaluation Report[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]There are often three key sources of data that can be included for devices:

1. Studies published in medical journals.
2. Unpublished, internal data.
3. Complaint/post-market surveillance data.

Identifying high-quality data resulting from a well-controlled clinical trial process contributes as a valuable source for demonstrating safety and performance of the device and are key factors in drafting a CER.

To identify such pertinent data, a well-defined, systematic, and transparent literature search must be created. Literature search databases for identifying data must be chosen. The most commonly searched databases include: PubMed, Embase, Cochrane, and Google Scholar. Each database has its respective strengths and weaknesses and should be used based on the type of the device. An inclusion/exclusion criterion should be set to generate relevant data sets, limit the scope of the report, and to keep it manageable.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Analyzing the CER Data[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]It is mandatory to analyze and present the study results in terms of their quality, safety, and performance. There are two ways in which data can be presented in a CER:

1. Text-based summaries of individual studies – it allows for comprehensive discussion of all studies included. However, the disadvantage here is that drawing conclusions from presenting numerical endpoints is inherently difficult.
2. Visual summaries of pooled data – its advantageous in presenting individual endpoints through graphs, figures, tables etc. However, this method may be susceptible to errors, and thus, a quality check or aid from a statistician is recommended.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Finalizing the CER[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Once the data is collected, appraised, and analyzed, the results are contextualized in terms of the wider picture of the device. The final CER should address any risks identified from the internal and external data sets and concludes with the mitigations provided.

The conclusion of the CER should demonstrate that the performance and safety of the device as claimed have been established; and the risks associated with the use of the device are acceptable when weighed against the benefits to the patient. Thereby, the CER concludes that the clinical evidence demonstrates conformity with the relevant GSPRs.

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Clinical Evaluation Report (CER) Specialists[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Celegence has a wealth of knowledge to help you navigate through the complex regulatory challenges brought forth by the EU MDR. From consultative services to end-to-end writing capabilities, our expert team can support you in all aspects of your Clinical Evaluation.

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radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” 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[fusion_fontawesome icon=”fa-info-circle fas” size=”35px” flip=”” rotate=”” spin=”no” alignment=”left” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” margin_top=”” margin_right=”10px” margin_bottom=”” margin_left=”” circle=”no” iconcolor=”#2da9e0″ circlecolor=”” circlebordercolor=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_fontawesome]

For more information about how we can help with CER writing, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.

[/fusion_text][/fusion_builder_column_inner][/fusion_builder_row_inner][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ 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padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6778|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Why Software as a Medical Device (SaMD) is Prioritized in the EU MDR – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2021/01/Why-Software-as-a-Medical-Device-SaMD-is-Prioritized-in-the-EU-MDR-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Software as a Medical Device SaMD at a Glance[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Software as a Medical Device (SaMD) is the fastest evolving type of medical device on the market. With a rise in interconnected and ‘smart’ devices, they are rapidly growing in global presence. There is a wide range of intended uses for these devices, including measuring blood pressure, monitoring respiratory issues, and circulatory problems, all without the patient being confined to a hospital bed. This trend will only escalate, as many legacy devices will soon be upgraded to more advanced versions with software as an active part in their design. According to a recent Business Wire report, there is expected to be a Compound Annual Growth Rate (CAGR) of over 20% in SaMD device sales over the next seven years. Since there is demand, there certainly will be greater resources allocated to research and development for SaMDs.

The regulations for SaMD products have been a point of emphasis for industry experts, manufacturers, and notified bodies alike. Celegence has previously expanded on the topic, examining the parameters and classifications while highlighting the key take-a-ways for these device manufacturers. You can read the regulatory challenges for SaMD here.[/fusion_text][fusion_imageframe image_id=”6781|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Medical Devices with Software Components – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2021/01/Medical-Devices-with-Software-Components-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Industry Prevalence of Software as a Medical Device (SaMD)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Medical devices with software components are rapidly trending upwards in terms of prevalence. This is no secret to the European Commission and FDA respectively, as technological capabilities tend to have a compounding effect in terms of uses. Agile development involving verification and validation testing, followed by continuous real-world data collection and learning human factors has led software components to provide continual loop data to healthcare providers thereby improving treatment decision making. Further, advancements in SaMDs promote the independence of patients fighting long term ailments and illnesses.

Additionally, software is becoming abundantly used as add-ons for legacy devices. Having the ability to adapt many proven devices with software is just another reason why the European Commission has decided to update many of the regulations. In what has been the most large-scale update of medical device regulations in decades, it is no secret why the EU MDR has prioritized software in its regulations.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Reclassifications that are Reflective of SaMD Trends[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Much of the classification guidance for software has to do with its intended purpose. This area of regulation desperately needed more in-depth directives. The sheer amount of new intended purposes has far exceeded the volume of regulatory updates from the EU. Not only have intended purposes expanded greatly, but also the ability to assist in the decision-making process mandates further directives from regulatory authorities in this space. For example, software that supplies information to assist in making decisions regarding diagnostic or therapeutic purposes will now be Class IIa. There is one important exception to this rule though, i.e..if the pending decision has the potential to cause death or an extreme irreversible health issue of the patient will be classified as Class III.

Another area that saw proportional expansions to their regulations, is the elevated risk of the software due to rise in software capabilities and functionality. To this point, Class IIb will include devices that could cause serious deterioration of the patient’s health but are not irreversible. Devices that simply monitor the anatomical processes of a patient will be Class IIa but will be classified as IIb if the process being monitored could result in immediate danger to the patient of the measurements stray too far.

One last area of interest for the industry is SaMD devices that involve a transfer of energy between the device and the patient. These types of devices have developed extremely quickly, but even so, their complete medicinal potential has certainly not been realized. As such, Rule 9 of the regulation governs devices that are intended to exchange or administer energy, which will be Class IIa. Further, these devices will be classified as IIb if the process by which the energy is transferred is potentially hazardous. Additionally, Rule 10 of the same Annex states that devices that are intended to “monitor and diagnose” will be class IIa if energy is absorbed by the body from the device. Devices such as these would be upgraded to class IIb if the device monitors a parameter that could be potentially life threatening (central nervous system, respiratory issues, and cardiac activity).

For complete guidance on SAMD, explore here.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Challenges with SaMD

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]While the feedback loop for SaMDs drives innovation and faster product iteration, the industry also faces a fundamental challenge on examining how to develop a product for a fast-changing, ever-evolving “internet of everything” world while demonstrating continued patient safety, clinical efficacy, and adhering to regulatory compliance?

One of the best ways for companies to address this includes continued notified body and IRB involvement for high-risk devices while enabling a faster feedback loop including, risk-based software segregation, development of the software involving formative human factors coupled with real-world performance analytics, and an effective clinical validation and quality management system.[/fusion_text][fusion_imageframe image_id=”6782|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Software as Medical Device – Regulatory Bodies – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2021/01/Software-as-Medical-Device-Regulatory-Bodies-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Industry Perspective from Celegence Medical Device Regulatory Consultant[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Software as medical device products seem to have exponential growth in terms of connectivity and capabilities. As one development can lead to three of four more device advancements, and so on, and so forth. Thus, it is no secret that regulatory bodies are planning on enacting regulatory frameworks that allow for clear and straightforward guidance in the coming years as new and more advanced devices come to the market.

From everything I’ve heard from individuals at cutting edge, and major device manufacturers, is that the key trend is connectivity, and their diagnostic implications. Additionally, a major driver in SaMD development is the rise of smartwatches. Not only are they generally affordable, they offer a convenient, and even stylish tool to monitor a variety of health metrics. While medical uses were not likely to have been the impetus for smartwatch developments, they have effectively altered medical device capabilities forever.

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Summary – SaMD and the EU MDR

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The changes that are being ushered in now with regards to Software as a Medical Device, and the rate of ongoing technological advancement, means that SaMD is not just going to be a regulatory concern for the short term but more than likely for the long term. Medical device manufactures need to be aware of their requirements and obligations with regards to SaMD and we are happy to provide our clients with that expertise.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” box_shadow=”yes” box_shadow_vertical=”5%” box_shadow_horizontal=”5%” box_shadow_blur=”28″ box_shadow_spread=”2″ box_shadow_color=”#f1f6f8″ box_shadow_style=”” padding_top=”” padding_right=”0px” padding_bottom=”” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”#f6f8f8″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

[fusion_fontawesome icon=”fa-info-circle fas” size=”35px” flip=”” rotate=”” spin=”no” alignment=”left” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” margin_top=”” margin_right=”10px” margin_bottom=”” margin_left=”” circle=”no” iconcolor=”#2da9e0″ circlecolor=”” circlebordercolor=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_fontawesome]

Manufacturers of SaMD should seek regulatory advice and operational support to ensure that essential documentation and clinical evidence for your product portfolio complies under the new MDR. To discuss how our team can strategically partner with yours, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.

[/fusion_text][/fusion_builder_column_inner][/fusion_builder_row_inner][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”0″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6754|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Clinical Evaluations for Unique Product Types Under the EU MDR Q&A – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2021/01/Clinical-Evaluations-for-Unique-Product-Types-Under-the-EU-MDR-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Clinical Evaluations for Unique Product Types Under the EU MDR – Q & A[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Celegence, a Global Regulatory Affairs Services & Technology company for the Life Sciences Industry, partnered with Regulatory Affairs Professionals Society (RAPS) in November to offer a webcast titled “Clinical Evaluations for Unique Product Types Under the EU MDR”.

If you were not able to attend this webinar, here is a link where you can view the on-demand version. We are here to help answer any other questions that you may have related to the webinar, or about how you may be able to benefit from our MDR compliance services or technology, we are happy to assist. Contact us to find out how we can help you optimize your RA/QA strategy.

This post contains the Q&A session from the webinar – giving you the answers to the most common questions that were asked about Clinical Evaluations under the EU MDR.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A full transcript of the Q&A session is available to download and to read below. 

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Q: Does the PSUR need to be included in the CER?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: No, the PSUR (Periodic Safety Update Report) is a separate document. Of course, it incorporates maybe some data that comes from the CER, but it is not directly linked to the CER because for implantable devices, the notified bodies will review the PSURs on an annual basis. This means you do need to update the full CER. Thus, it will be a separate document – it might be reviewed in combination with the PSUR, but it should not be included within the CER itself.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Q: How do we know if our clinical data will be considered sufficient?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A: For legacy devices, MDCG 2020-6 helps to find the answer. Manufacturers always approach their notified bodies to know if there are any guidance documents coming up. They also ask, what sufficient clinical data is? And, how many patients do I need to ask? For which there is not one simple solution. It depends on the risk factor of the device, and market history of your device. In the end, for the EU MDR, you need to have sufficient data for all indications to demonstrate safety and performance over the expected lifetime.

Let’s say if you have an implant that is in the patient’s body for the rest of the patient’s life, at some point, if you give this to a younger, less than 30-year-old patient, you would need to have 50 years of data for that. So, is this feasible? No, and would it also be feasible to have a premarket clinical study that lasts 10 years? No, of course not. But, let’s say you have an implantable device that is in the body for 12 months, of course then you can have sufficient clinical data in this case, which would cover the whole implant lifetime of the device. The basic message here is that it is not that simple. It also depends on the quantity of the indication. If you have an osteoarthritis of the hip, this is a very broad indication, and it is not an easy question to answer, as some other devices only have 40 or 50 devices sold per year. It really depends – look at your indications, look at your proposed lifetime, look at the data sources you might be able to access, especially the PMCF setting, and do not forget the PMCF is a lifelong requirement for the device. And of course, at some point you will be able to close the gap to get sufficient data.

Just emphasizing those points – the requirement from the GSPR is for the risks to be reduced as far as possible. So, look closely at your risk management and your PMCF activities to determine if you have a PMCF plan that is going to justify and detail an approach, or provide justification on why it is not necessary. It will bear a lot of influence also from the state-of-the-art, because this will be increasingly compared to that of your competitors, so you should be aware of what your competition is doing as well.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Q: For existing devices, how do you structure the Post Market Data analysis so that we do not need to generate new clinical data?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: If you have sufficient data for your device, then you probably would not need it. Post Market surveillance requires that for as long as the device is on the market, and as long as a device is implanted, you have to follow up with the post market surveillance vigilance system. There are some options here for legacy devices to go with the MDCG 2020 – 6, the clinical data for similar devices from the state of the art, then of course, you need to close the gap on your own device. The term clinical data is a very broad term, and again, it depends on the risk of your device. If you have a class 2A instrument that has no direct impact on the patient, at some point you probably will have sufficient clinical data that could be considered. But, for implantable devices, it is nearly impossible to not have any kind of specific PMCF activity to get more clinical data.

Post Market data should be considered as well as part of the spectrum. Aside from cost considerations, this kind of spectrum goes from lower levels of commitment to higher levels of commitment. This can look something like a literature review on product returns, customer surveys, and consumer focus groups. Moving on up, you have retrospective patient reviews and record reviews. Finally, you would go on to registry studies and then finally clinical investigations that may be randomized.

You have a broad variety of different modalities to use. A legal manufacturer needs to determine how comfortable they are with their indications and claims, and with the cost aspects as well to determine how far in that spectrum they are ready to wade, and bear the risk of what they have not committed to. So, you need to find a comfortable place in that spectrum where you can be ready for an MDR audit.

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Q: What are the specific requirements for clinical investigations being conducted outside of the EU?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A: It depends between pre-market and post-market investigations. Of course, you can always – if you already marketed a device outside of the European Union – conduct a post market study there. You might be able to use this for the initial CE Mark in Europe.

Then if you plan to do a new study, always take into consideration the requirements of ANNEX 15 of the MDR, and every clinical study, regardless of what part of the world it is conducted, should follow the ethical and scientific standards. So ISO 1551 needs to be considered.

When it comes to the transferability of the data that MEDDEV 2.7.1 Rev 4 talked about, is the transferability of clinical data outside of the European Union to the European population. The MDR does not really require this, but your notified body might challenge you on it. If you have the same device being used for a completely different patient population, maybe a younger patient population, then you can try to conduct a study in a second world country. If you are trying to transfer that kind of data into the European Union for a completely different patient population, the notified bodies could challenge you on that – saying that you have a lot of data on the patient population with an average age of 40 years old, but now you are applying with a different indication for the European Union, even if it is the same device. So, if the data is transferable, it is no problem to use for European Union data, but as I said, talk to your study investigator to determine if it is transferable from a clinical perspective.[/fusion_text][fusion_imageframe image_id=”6750|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Should the EUDRA vigilance administered by the EMA be one of the databases to consider for the clinical evaluations of DDCs” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2021/01/Should-the-EUDRA-vigilance-administered-by-the-EMA-be-one-of-the-databases-to-consider-for-the-clinical-evaluations-of-DDCs.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Q: Should the EUDRA vigilance administered by the EMA be one of the databases to consider for the clinical evaluations of DDCs?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A: The straight answer is no, because EUDRA vigilance is talking about the drug entity of the medicinal product. Technically, from a device point of view, considering the risks which have been arising from medicinal products, it can be considered as a part of the clinical evaluation. With that said, EUDRA vigilance is not a viable source because notified body opinion reports are completely based on devices, and the device interactions with the medicinal product. You are supposed to be taking into account the device and its interactions in the drug-device combination. The straight answer is no, please do not take any of the information from EUDRA vigilance.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Q: Does PSUR in this context mean pharmacovigilance of the combination products submitted to the EMA?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: No. Periodic safety update reports are completely based on the risk classification. Class 3 devices and implants require an annual submission of the PSUR reports. Class 2B requires annual submissions, and 2A requires submission once every two years. This is the summary of information that you are drawing from risk management, clinical evaluation, and post market surveillance. But in case you are trying to work out the risk classification, implants will have a direct implication from PSUR to article 18 with the implant card and article 32 with the SSCP (summary safety clinical performance). Technically, the PSUR is a summary of the information from the clinical evaluation from post market surveillance or any of the other product performance studies. So, this should not include pharmacovigilance or any of the medicinal products, but for any of the intricate risks that are associated with the device, the drug interactions should be proactively considered.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Q: For DDCs using platform technologies, there could be a large volume of clinical trial data. How do we decide which trials to include in the CER?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A: I would suggest that the clinical investigation section of the CER be organized by clinical indication, and that the evidence supporting the clinical indication be presented together. In addition, some clinical indications do not support a specific indicated use, which you may be worried about. There are two ways to go then, in the event that you have strong evidence from the remaining clinical investigations, you may just decide that you can drop the study, and only list the pivotal studies. On the other hand, if you have a limited number of studies and you need the evidence to show support for the overall clinical safety and efficacy, put it in a general section, which may precede your specific indication. Whether that is an approach that your notified body approves, remains to be seen, and that will depend entirely upon your notified body and your relationship with them.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Q: If you have conducted several clinical investigations for an integral device, does it still require a PMCF study?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: The PMCF is a scaled down version of a clinical investigation. A clinical investigation, otherwise referred to as a clinical trial, is a segment within the clinical evaluation. So technically, if we have some problems that can not be answered in a holistic approach, a clinical investigation has to be addressed in a single PMCF study. This is particularly in terms of high-risk products. It is not possible to answer all of the questions that are related to the bar compatibility, shelf life, the performance, and the efficacy. In those areas, if there is a question, it is always advisable that the notified body will be looking for objective evidence – what is the proactive approach the manufacturer is taking, identifying CAPA investigations, and singling out a PMCF study. So, it is not possible to conclude if either one study is enough, or if 10 studies are required. If there is a substantial number of clinical investigations conducted on a product, we still will be forgetting some of the other corners. So, when the product is performing in the market, you will come across some live information, like issues with the device failure, device incompatibility side effects, or any other areas which have to be considered as a single study in the Post Market Clinical Follow-up. If the MDR does not say a PMCF has to be conducted once every 5 years, or once every 10 years, there should be a proactive approach for manufacturers to conduct. Otherwise, PMCF sources the information for clinical evaluation and post market surveillance. Which are taken once again in PSUR & SSCP segments. Please make sure the PMCF is a tradition of your product trend analysis.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Q: Which GSPRs are relevant to include in the clinical evaluation for a DDC?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: In a direct sense, if you can segregate or categorize the entire general safety performance requirements, you have three essential chapters. Chapter one is the general requirements, which is GSPR one all the way to nine, and they are mandatory. All of the manufacturers have to comply. So, if you go to chapter 2, it talks about the design and manufacturer. Then chapter 3 includes information that has been provided along with the device.

We need to categorically understand that from one, all the way to nine, in most of the situations, you need to talk about the risk-benefit analysis. So, for a drug device combination, we need to understand which of these segments can be demonstrated from the risk management point of view. Straight to the point here – GSPR 12.1, and 12.2 focus on medicinal product directives 2001 / 83 EC. For those medicinal products and the devices, how are they integrated? Are the DDCs integral DDCs? Or non-integral DDCs?

You need to make a decision about how the drug is interacting with the device. Also, the interaction of the device with any of the other components, which may be medicinal products or others, needs to be defined in the terms of risk management. Please focus on GSPR 12.1, and 12.2 towards labeling, ten, four, and five. The labeling of the device component will be overruled by the medicinal product regulations, so technically, even if you are going to mention single-use, or any other kind of labeling, they only pertain to the device. So, you need to be cautious about assessing the risk. Take a proactive approach towards labeling as per ten, four, and five. Going across, the other mandatory information you are providing in your IFU is from GSPR 23, which are the essential bits. Focus on GSPR 1 to 9, 12.1, 12.2, 10.4.5, and towards 23.

[/fusion_text][fusion_imageframe image_id=”6749|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Clinical Evaluations for Unique Product Types Under the EU MDR – Celegence – Q2″ link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2021/01/Clinical-Evaluations-for-Unique-Product-Types-Under-the-EU-MDR-Celegence-Q2.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Q: For software that is an accessory to a medical device, what kind of clinical evidence is required?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: It depends on what the software is doing. If the software has its own intended purpose, or if the software is playing a relevant part, or, if the software is making a relevant decision, then you need to have clinical data specifically for that intended use. So, depending on the risk class of the software, that would decide the amount and quality of clinical data you would need, but again, it really depends on what the manufacturer’s definition is for what the software is doing.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Q: How do we know what type of PMCF study we need to conduct?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: Starting from the end of the spectrum – that is the least commitment to the greatest – it goes literature reviews, proactive product returns, surveys, consumer focus groups, retrospective patient record reviews, registry studies, and finally clinical study. You have to get a feeling for the amount of risk the legal manufacturer is willing to carry into the future to balance that with the costs of the time and money to collect this data. While some manufacturers will have deep pockets, they will be able to proceed further into the spectrum, while others will understand that they have relatively little resources, high costs, and little time before their certifications expire. They might have to even delay their MDR audits until they are able to complete one or more of these investigations, so you need to get a feel for your resources, the levels of risk that you deal with, and the clinical indications that you are addressing.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Q: Can you elaborate on how to deal with Legacy devices with a lack of clinical data?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: As a legal manufacturer, you need to consider the list that goes from literature review to clinical investigation. You must take into consideration the risk level of the device, and then develop a sense for the cost in terms of time and expenses, and then balance that with the available resources for the manufacturer. Then, to address the clinical gaps, there is a MDCG guidance on this – 2020.6. It is not unreasonable to suggest to your notified body that an investigation may be a considerable expense, requiring the legal manufacturer to complete it over several years. I believe the most important thing a notified body wants to see –  is that you have a plan to address the gaps, and a defined approach as you proceed through the negotiations.

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Q: In many instances, indications for use remains silent on patient groups that are regarded as sensitive populations by MEDDEV 2.12 / 2. Will these practices be allowed after the date of effectivity for the MDR?

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A: This is one area that falls into the area of best practices. I cannot really say how the regulation will be enforced and in what way, but my sense is that this is an area long ignored by regulatory obligation. There are two relevant risk trajectories to be considered – first, the legal manufacturers remain silent on use in Paediatric and elderly patients, and they decline to prepare themselves accordingly. In such cases, it would be difficult for the person in the audit to bear the risk to be asked this at any time. If it does not occur during the first audit, this could occur during subsequent audits. So, this is not really a safe trajectory. The alternative is for a manufacturer that remains silent on the indications for sensitive populations to prepare for the post market clinical follow up plan. As we document investigations that would have been done in a paediatric and elderly population, such documents would provide the basis for claiming that the legal manufacturer that is addressing what has been this area of regulatory obligation. I mean with sensitive populations, it really depends on what the device is doing, what is the type of the device. So, at some point, the manufacturer needs to address this in their PMCF study, and do not forget with MDR manufacturers, they now clearly need to find a target population. If the manufacturer defines the target population with no age limitations, the notified bodies will challenge manufacturers on if they are able to confirm safety and performance for all the different age populations from your claim on the label.

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radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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For more information on how we can help you with EU MDR reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities.

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padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6621|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Clinical Evaluations for Unique Product Types Under EU MDR – Dr. Matthias Fink” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/12/Clinical-Evaluations-for-Unique-Product-Types-Under-EU-MDR-Dr.-Matthias-Fink.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Clinical Evaluations for Unique Product Types Under the EU MDR – Webinar[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Dr. Matthias Fink is board-certified orthopaedic and trauma surgeon with over 17 years of experience in orthopaedic, trauma, and reconstructive surgery, with extensive training in cardiovascular and thoracic surgery. He is the Global Team Leader for the Ortho, Trauma, and Dentistry Team within the Clinical Centre of Excellence for TÜV SÜD, and the Team Manager of the Clinical Focus Team in North America.

Manufacturers of medical devices must carry out a clinical evaluation of their products in order to be allowed to market them in Europe. To do this, the manufacturer must use clinical data to confirm that the medical device is safe and functions as intended. The manufacturer then assesses whether the risks of use are in a reasonable proportion to the expected benefits. During our webinar titled “Clinical Evaluations for Unique Product Types Under the EU MDR”, Dr. Matthias Fink spoke specifically about the MDCG guidance documents, equivalence demonstration, and different articles of the MDR for clinical evaluation plans.

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Why should you read the transcript / watch this video?

• To understand the strategies and approaches to consider for specific product types
• To get an overview of the updates on regulations and guidance documents

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A full transcript of Dr. Mattias Fink’s presentation is available to download (and to read below) and just press play to watch the clip now. 

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” 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display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Introduction[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” 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Good Morning. I would like to step back a little, to give a more high-level overview. We already have a lot of MDCG documents published, and there will be more guidelines coming. There’s still discussions on the interpretation of certain paragraphs of the MDR. So, what I am going to talk about today is our current interpretation.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]MDR Guidance Documents[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]I just mentioned them, but I want to highlight the MDCG guidance documents. A lot of them are already published, and a couple more are still to come. We are still waiting for the PSUR guidance and templates for the post-market setting. This is the guidance document everyone is very anxiously waiting for. We have a couple of guidance documents already published, which are related to clinical evaluation and specially, to the unique clinical devices. One is, MDCG 2019 – 11, on the classification of software as Medical device, as well as 2020 – 1 on clinical evaluation of medical device software. For software, it is a big change because it was not really considered in the previous directives. So, this is a big step forward for software manufacturers and for manufacturers who have software as an integral part of the medical device.

I always recommend reading those guidance documents. They are not legally binding as they are guidance documents, so they are not regulation & not the law. But in Europe, the authorities of different member states require notified bodies to follow these guidance documents. The notified bodies are going to challenge you on the requirements as set out in those guidance documents. I really encourage everyone to be familiar with the guidance documents because you might receive some challenges on those aspects from your Notified body.

Two guidance documents everyone really was waiting for are MDCG 2020 – 5 and – 6 on equivalence approaches, and on sufficient clinical data for legacy devices. I am going to touch on this little bit later on. There is a MDCG guidance on transitional provisions for consultations (DDC). I am also going to quickly talk about consultations for drug device combinations and what is required from a clinical perspective for combinations. And the last one on this list, is MDCG 2020-13 on the Clinical Evaluation Assessment Report Template, which basically is the unique template that every notified body is expected to follow. That template is what every notified body has to use for our assessments of clinical evaluation reports that we are going to receive from the manufacturers of certain devices. I am only mentioning ‘consultation’ according to article 54 regarding the mandatory legal consultations with the expert panel. Some of those CEAR reports will be publicly available – at least for the expert panels and for the common authorities.

This is why we have to align with the template every notified body is expected to use, and this template is publicly available. So, the notified body will probably implement them into their own documents. I encourage everyone to please make a note of that template because whenever you ask the question, why is my notified body asking me this in relation to a clinical evaluation? This is probably coming from that template because this is the information that the notified body needs to assess during the review.[/fusion_text][fusion_imageframe image_id=”6623|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”MEDDEV 271 REV 4.0 – MDR Medical Devices – Matthias Fink – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/12/MEDDEV-271-REV-4.0-MDR-Medical-Devices-Matthias-Fink-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Annex XIV, Part A: Clinical Evaluation Plan[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]So, going into that further – it was introduced with the MEDDEV 271 REV 4.0 that talked about scope & planning. Now, with the MDR Annex XIV, we clearly have the requirements for all medical devices, and this is regardless if it is a new device or a legacy device, which is to have a clinical evaluation plan that will cover the whole life cycle of the device. A couple of things that are highlighted here, are also newly-introduced with the MDR. With the MDD – of course, you are required to have your labeling define the indication and contraindication, but there was no real requirement of a predetermined target group. So now, the manufacturer is required to define this target population, and then of course, to ensure the life cycle of that device has sufficient data for the whole target population.

Another interesting and new aspect is the clinical benefit to patients, with relevant and specified clinical outcome parameters. MDR article 2 defines clinical benefits as the positive effects that the device has on the patient. It’s not necessarily the intended use, for example, if you have the intended use being a hip prosthesis, you will probably say it’s intended use was replacing the hip joint. This is not necessarily the benefit for the patient. In this case it would likely be restoring mobility or reducing pain.

There are a lot of different things that need to be considered, and that the manufacturer has to define in the clinical evaluation plan. They must also provide the specific outcome parameters like the radiological scores if it is a bone implant, or if any kind of patient scores are needed to confirm the benefits to patients. The last topic is the clinical development plan – the MDR clearly requires the clinical development plan to be part of the clinical evaluation plan. The clinical development plan is much more relevant for the review by the notified body for a new medical device, but it also has to be addressed in the clinical evaluation plan for a legacy device. For legacy devices, it probably could be the summary of the clinical evaluation plan – which steps the manufacturer took, or what actions they took before obtaining the CE mark.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]MDR Article 61[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]For Class 3 devices and implantable devices as a general rule – clinical investigations will be expected. That is roughly the same as the MDD. But of course, we all know there were a lot of possible exceptions where a manufacturer obtains a CE Mark without having a pre-market clinical investigation. One big factor, which a lot of notified bodies have seen in the past with the MDD, was the equivalence approach. This is still possible with the MDR, but it has become much more stringent. Everything I am talking about right now also applies to any kind of drug device combinations. If the drug device combination product in the past relied on clinical data from the equivalent device, then the same is going to apply here as well.

Legacy devices are any device that is already marketed under the directives of either MDD or AIMDD. Then we have article 61.6b – which is a list of exempted devices that are not required to have clinical data, including dental implants, sutures, plates, and screws. If they have sufficient data, and it can be demonstrated, then a premarket investigation is not required.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Equivalence Demonstration[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Talking about equivalence, MDCG 2020-5 provides us with more clarification on the definition of equivalence. Those of you who are familiar with the MEDDEV REV 4.0 – these characteristics are similar to the extent that there would be no clinically significant difference in the clinical performance and safety of the device. The differences between your device and the proposed equivalent device though, can only be to the extent that it will not have any clinically significant difference. But what does clinically significant mean? It depends on the device. Of course equivalence has to be based on proper scientific justification, and has to be based on preclinical data. Just a descriptive demonstration of equivalence that is pictures of the two devices next to each other, and comparing the wording, is not sufficient.

The most important topic that the manufacturer has to demonstrate are the sufficient levels of access to the data for devices to which the manufacturer is claiming equivalence. This has to be done by a contract between manufacturer A and manufacturer B in this case.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]MDCG 2020 – 5 Equivalence[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

This contract is required for all implantable, and all class 3 devices. If it is coming from the same manufacturer, then they should have sufficient access to their own technical documentation. They must be able to demonstrate this in a detailed way, for which the MDCG 2020-5 document has a nice table at the end that should be used. It is very important that the equivalence demonstration focuses on the differences. In the past, we have seen manufacturers focusing more on demonstrating all the similarities of the devices, when really they should focus on explaining those differences between the two devices.

If the manufacturer finds equivalence of one of his own devices, this can be already CE marked under MDD or AIMDD. If the manufacturer finds equivalence to a different manufacturer then he needs to have that contract in place that allows the manufacturer continuous access to the technical documentation. This proposed equivalent device needs to be MDR certified.

Two points to know – there is a very low number of MDR certified devices currently on the market, and not many manufacturers are giving their competitors full access to their technical documentation. This is going to make the equivalence path very narrow compared to the MDD.

If it is a non-implantable class 2a or 2b device, it is a little bit less restrictive. But, the manufacturer still needs to demonstrate a sufficient level of access to the data relating to the equivalent device, maybe with comparative bench testing, or something like that.

[/fusion_text][fusion_imageframe image_id=”6624|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”MDR Applications for Legacy Devices – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/12/MDR-Applications-for-Legacy-Devices-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]MDCG 2020 – 6 Clinical Data for Legacy Devices[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Currently, I would say 95% of the MDR applications that we are seeing at TUV SUD are legacy devices, and I am pretty sure that is very similar to other notified bodies as well. These legacy devices are already MDD or AIMDD certified, and of course, some of these devices now have higher classifications. The problem is that some of those devices probably did not come under such high scrutiny in the past by their notified body, so the manufacturer might have identified some data gaps. Which we have seen specially for devices going from 2A to 2B.

And of course, it is not the intention of the MDR to make a lot of medical devices obsolete that are currently approved and widely used, just because they might have some gaps in clinical data. So, this is why we have the MDCG 2020 – 6 guidance document, which is meant to help manufacturers keep legacy devices on the market as long as they fulfil certain requirements.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]MDCG 2020-6 Well Established Technology (WET)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]We now have a definition in the MDCG document on well-established technology. They must have a relatively simple, or common and stable design. The device group must have well-known safety and risk benefits, with no major safety issues in the past. Not every device that is a legacy device is automatically a well established technology. For example, on this slide – spinal disc replacement devices for spinal disc diseases – which have a fairly long history. I believe they started in the 80s, but they have had a lot of problems with respect to different designs. There is not one common design and there were many recalls, so those devices have fulfilled one or two of those criteria, but are still not considered as a well-established technology. For those devices which are considered a well established technology, and for which there is not sufficient data on the market, then MDCG 2020 – 6 basically allows for those types of devices to use clinical data on a lower evidence level. For example – the state of the art data required to keep devices on the market under the MDR, but then of course with the equivalence demonstration, the manufacturer needs to close this gap with the clinical data in the post market clinical follow-up.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Combination Products[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]One important thing for drug device combinations products, is whether the integral part is a medicinal product, or if it is a medical device. In the end, the manufacturer has to decide on its own.

The 2001/83/EC regulation for medicinal products is much more stringent, and a much more complex medical device regulation. If you are going to apply as a medical device combination product then the notified body is going to check your application process for the classification of that device. Some things have changed with the MDR, the initial applications of all legacy devices have to undergo a re-consultation depending on the previous consultation report from the commanding authority. It might be only a short consultation, but that will be decided by the authorities.

With the MDD, there were certain devices that were not required to have a consultation if the medicinal product is not a liable actor upon the body, but this is now removed with the MDR. So, for the MDR, all medical devices which in some form incorporate the medicinal product, must undergo the consultation. So, this is one of the largest differences.

For the clinical data, there is no real difference between a medical device that incorporates a medicinal substance or not, because the manufacturer needs to have the clinical data needed to demonstrate the safety and performance of the device. When it comes to equivalence, as an example, for an antibacterial coated and an uncoated version of your product, it would not be possible to claim equivalence between the coated and uncoated versions.[/fusion_text][fusion_imageframe image_id=”6625|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”MDCG 2020-12 – Consultation Procedure Drug Device – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/12/MDCG-2020-12-Consultation-Procedure-Drug-Device-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Documentation Package for Consultation[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

MDCG 2020-12 provides the information regarding the consultation procedure. Please be aware that the consultation time for the authorities for those drug device combination products is 210 days.

Notified bodies are not allowed to continue with the certification process before the consultation reports and opinions are provided by the authority. So, you have to factor that into your process if you have a device that contains a medicinal product as an integral part. Be aware that the certification process will be much longer just because of this long period of time that is reserved for the consultation process with your authority.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Software as a Medical Device[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]I have not seen a lot of active software as a medical device related products, but there are two definitions you have to differentiate. Either as a software, only to be used as a medical device, or as a software which has an intended purpose of its own. For example, a medical device software smart watch app, which is intended to send alarm notifications to the user and/or health practitioner when it recognizes irregular heartbeats for the purpose of detecting cardiac arrhythmia. Then of course, the software will have its own intended purpose. According to MDCG 2020-1, it depends if it is a standalone software or not.

If it is a software that is related to the example here that we just talked about, with the medical device in this case being a smartwatch, then of course the clinical evaluation needs to consider the software + device itself. If it is a standalone software, then the manufacturer needs to have the clinical data for the software alone. In case the software is driving or influencing the use of a medical device with no independent intended purpose or independent claimed clinical benefit, then no clinical data or clinical evaluation report for the software itself is required[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Conclusions[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

This was a very quick run through of the requirements under the MDR for clinical data. As I said, there is no real difference between those devices, and the basic requirements of article 61 are valid for all the devices. Something very important though, is that the equivalence demonstration that we have seen in the past, will no longer be valid for most devices. There is a way for legacy devices to stay on the market, and that is with MDCG 2020-6, with any kind of data gaps identified by the manufacturer being addressed in the PMCF. With that, I thank you for your time today!

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” box_shadow=”yes” box_shadow_vertical=”5%” box_shadow_horizontal=”5%” 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filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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For more information on how we can help you with EU MDR reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities.

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[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”0″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6509|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Clinical Evaluations for Unique Product Types Under EU MDR – Dr Pratibha Mishra – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/12/Clinical-Evaluations-for-Unique-Product-Types-Under-EU-MDR-Dr-Pratibha-Mishra-Celegence.png[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Clinical Evaluations for Unique Product Types Under the EU MDR – Webinar[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Dr. Pratibha Mishra is the associate manager of Medical Device Services for Celegence where she leads a team of qualified medical writers. Her team has successfully conducted clinical evaluations for complex devices including software as a medical device (SaMD) products, as well as drug-device combination products. She is experienced in developing MDR compliant templates for a variety of documents, including CER, CEP, PMCF Plan, PMCF Report, and has drafted responses to notified body observations related to clinical evaluations.

The EU MDR (EU 2017/745) date of application, May 26th of 2021, is quickly approaching, meaning expanded requirements for clinical evaluations. The implementation of the EU MDR will result in expanded Clinical Evaluation requirements for all EU marketed devices. There must be special attention paid to unique products as the MDR’s regulatory framework is contingent on the type of product. Combination products, legacy devices, and software as a medical device (SaMD) products will all be subject to increased regulations. During our webinar titled “Clinical Evaluations for Unique Product Types Under the EU MDR”, Dr. Pratibha Mishra gave an in-depth overview of the CE requirements for EU MDR compliance, strategies, and the approaches to consider for specific product types.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Why should you watch this video?

• To gain an understanding of regulatory strategy for medical device software and drug device combination products
• Learn how to strategically plan your process for Clinical Evaluations
• To understand the essential aspects of Clinical Evaluation Reports

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A full transcript of Dr. Pratibha Mishra’s presentation is available to download (and to read below) and just press play to watch the clip now. 

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Introduction[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Good evening. I am glad to be here to speak about the clinical evaluation of medical devices and the output of the process – the clinical evaluation report – or the CER. I will also cover important points to consider when performing clinical evaluation of unique product types, like drug device combination products and medical device software. Before we move on, just a little bit about me. I am an associate manager for the medical device services team here at Celegence. I have a master’s degree in oral medicine & Maxillofacial radiology and have a background of working in hospitals as well as academia. I have written and reviewed several regulatory documents for medical devices of all classes, and in a wide range of therapeutic areas. Here at Celegence, I lead a team of highly qualified medical writers and we have expertise in the technical evaluation of complex devices, including medical device software and drug device combination products.[/fusion_text][fusion_imageframe image_id=”6513|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Article 61 Part A – Clinical Evaluations – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/12/Article-61-Part-A-Clinical-Evaluations-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Clinical Evaluation and the Product Life Cycle[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Clinical evaluations are addressed in Article 61-part A, and it has several mentions throughout the regulation. It is well understood to be an important process in the device life cycle. It is very closely related to other pre and post market activities that take place during the life cycle of a medical device. Findings from a CER, for example, will feed into the ISO 14971 risk management process. Clinical evaluation will also inform the decision of whether post-market clinical follow up (PMCF) activities are required for your device, what type of activities can be planned, or if one is planned already, it will serve as an input for the CER.

The MDCG 2027 guidance provides templates for the PMCF plan and report, and it states quite clearly that the impact of the PMCF on the CER needs to be considered. The Post Market Surveillance Plan also will have to consider the findings of the CER, and the CER will in turn evaluate the findings from the PMS report in terms of device safety.

Furthermore, the MDR also requires creation and maintenance of additional documentation like the Summary of Safety & Clinical Performance (SSCP) and the Periodic Safety & Update Report (PSUR), which along with the vigilance reports, have to be uploaded to the EUDAMED database. The SSCP and PSUR – these new documents are also interlinked with the CER in terms of information that is captured in these documents.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Clinical Evaluation – Stakeholders[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Clinical evaluation requires inputs from several cross-functional experts: the marketing team for example, will provide information on similar devices, the clinical research team for planned, ongoing, or completed clinical investigations, regulatory experts for the guidelines and standards that are applicable for the device under evaluation, and the risk teams for potential and residual risks associated with the device. All these stakeholders need to be involved in the planning, creation, and maintenance of a CER.

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Clinical Evaluation – Process and Procedure[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Clinical Evaluation Planning (CEP) Stage 0: Before clinical evaluation is undertaken, a plan is created, which is stage 0 of the process. The plan is intended to outline the scope and the pathway for the clinical evaluation to be followed, and it serves as a basis for subsequent steps. The MEDDEV Rev 4.0 guideline provides the checklist with considerations for a CEP, which is a very useful document to refer to in the planning stage.

Clinical Evaluation Process Stage 1 – 3: The next three stages – stage 1, 2, and 3, involve identifying the relevant sources of data, appraising the quality and suitability of the data with respect to safety and performance of the device under evaluation, and the analysis of evidence gathered from these data sources.

Clinical Evaluation Report (CER) Stage 4: Stage 4 will involve the creation of the final report by deriving conclusions from the data that has been analyzed so far, and demonstrating compliance to the General Safety and Performance Requirements (GSPR) from Annex. 1 of the MDR related to device safety, performance, and the benefit risk profile when used as intended.

This is not the end of the process though, after submission of the CER to the notified body, there may be observations from the reviewers, which need to be addressed. The CER also is a live document that needs periodic updates. The frequency of these updates will be dictated by the risk category of the device and the post-market experience. For example, identification of a new risk from the PMS data may instigate an update of a CER.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Clinical Evaluation – Data Sources[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

The content that goes into a CER is heterogeneous, the sources of input data may be internal – that is data the manufacturer generates during the life cycle of the product, or data from external sources. The internal data may include verification and validation testing, other performance and safety-related preclinical studies that have been conducted by the compatibility evaluation, and external sources of data can be from a clinical trial registry. Additionally, this includes published literature that can be found from literature databases, or adverse event databases that are maintained by regulatory authorities of different countries. Depending upon the region where the device is marketed, these databases can serve as a source of information on safety alerts, recalls, or other information that is reported for the device or similar devices.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Clinical Evaluation Report – Essential Aspects[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Essential aspects to be included in every CER for compliance with MDR requirements:

State-of-the-Art (SoTA): The CER is required to include a review of current technical capabilities, or accepted clinical factors, with respect to the device, the procedure, or patient management. In our experience here at Celegence, we have found that quantitative, or at least a comprehensive qualitative assessment of the benefits and risks of the device in comparison to other alternatives, is focused on during the notified body reviews of a CER.

Clinical Data: For clinical data, the extent of clinical data that needs to be presented depends on the novelty and the complexity of a device. Once again, MEDDEV Rev 4.0 is a helpful guide to know what kind of data can serve as evidence, and how to appraise this data. The approach that we follow is to critically analyze the evidence in terms of how it links to the state-of-the-art (SoTA) and to meet specific predetermined safety and performance objectives. We have seen that the clinical evidence the notified body expects in a CER, is expected to support each indication of a device, or each indication of all the devices, if there is more than one device under evaluation.

Non-Clinical/Pre-Clinical Data: Non-Clinical/Pre-Clinical Data – like the usability and human factor evaluation studies are also important sources of information to substantiate performance, and can also be leveraged. Once again, validation to standards or other performance bench testing needs to be linked to the actual clinical performance or the State of the Art (SoTA) requirements from the particular device, or device family, when the data is being analyzed. This is something that notified body observations tend to highlight, which is the gap between information presented and its meaning, in terms of demonstrating safety and performance.

Post Market Surveillance: We know that reliance on the active post market data is no longer sufficient. Post market data needs to be proactively collected and that is very important under MDR. PMCF activities are indicated when more clinical evidence is required and as mentioned before, data collected from the PMCF will feed into the CER and the conformity assessment that is done as part of the CER.

Equivalence: This is a very important topic – the MDCG 2025 guidance should serve as a basis for clinical evaluation if the equivalence pathway is to be followed. Dr. Fink will talk about equivalence under MDR in his presentation later on. So I would just like to say that based on our experience with notified body observations, it is very important to select the right device as the equivalent device if this pathway is chosen. All of this data ultimately is required for the analysis and substantiation of the benefit risk ratio in the favor of the device.

Benefit-Risk Analysis: All the data that we have collated needs to be analyzed to highlight the type, magnitude, and duration of benefits that are offered to the patient or the user. What is the medical necessity that the device serves, and whether the benefit risk ratio is substantiated by evidence that is precise and falsifiable.[/fusion_text][fusion_imageframe image_id=”6515|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Clinical Evaluations – Medical Device Software – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/12/Clinical-Evaluations-Medical-Device-Software-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Classification of Medical Device Software[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]It is now critical to evaluate the benefit risk profile of the software in its own right. The classification of the software as a device or accessory, is independent of its location, or how it is interconnected with the hardware. It depends on the risk associated with its involvement in the medical decision-making process. It is a factor of the significance of information that is provided by the software, and its role in the diagnosis or therapy, as well as the seriousness or criticality of the medical condition.

When conducting clinical evaluation for medical device software, in addition to traditional evidence that is gathered from literature, it is also a useful approach to include survey based studies for substantiating performance. Also, demonstration of equivalence where possible, as per MEDDEV REV 4.0 and MDCG 2025 guidance, can be considered with similar products in the market.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Medical Device Software – Clinical Evaluation[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The clinical evidence to be presented in the CER – will depend on the intended use of the software. The software could have an independent intended use and clinical benefits. It could also have an intended use and clinical benefits that drives or influences another medical device that serves a medical purpose, or the software may have no intended purpose of its own and it may just be an accessory or a component of another medical device. For example, when establishing state-of-the-art (SoTA) in the CER for a software, it can be based on the review of literature for establishing clinical validation, a competitive assessment with other devices with the same intended use, or other software that works on the same base algorithm. For technical validation, it can be demonstrated by validation studies that are conducted for software architecture design for IEC 62304, and the main operating function, which is IEC 62366. This is data that the manufacturer will already have from the pre-market activities that were performed for the particular software. This can be leveraged into the clinical evaluation for these kinds of devices.

The risk evaluation, among other things, should include a review of cyber security vulnerability databases of different agencies such as the European Union Agency for Cyber Security (ENISA). There are several databases similar to ENISA that can be a good source of information for risks related to cybersecurity, and the assessment of the benefits offered by the device software is irrespective of its categorization. This is different from the risks that are involved based on its involvement in the medical decision-making, which is what needs to be highlighted in a clinical evaluation report.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Combination Products and Novel Technologies with Medicinal Products[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A combination product will consist of a pharmaceutical product and a medical device. These products may be integral or non-integral among other types. MDR has introduced new requirements for notified body involvement in the regulatory approval process for integral medical devices under Article 117. The market authorization dossier for such products, which is submitted to the competent authorities, is now expected to include an assessment of the conformity to GSPRs for the device component of such products.

A clinical evaluation report can be a document that demonstrates conformity to GSPRs to fulfil the requirement that article 117 has raised for such products. The demonstration of clinical evidence for these products has become much more significant under MDR than previous directives. The CER – it should be noted – is a separate process. It cannot replace the investigational studies that are conducted for the drug entity. However, often they do not consider evaluation of the safety or performance of the medical device component as its key endpoint.

For a new device under development, this is an important consideration to be made now under the new regulations in the clinical development plan stage, one can include such studies or include key device measures to focus on the device component when a clinical investigation is being planned. For cases where the device is already on the market, PMCF studies can be useful. The PMCF is focused on the safety and performance aspect of the device component which can help gather technical evidence for a DDC product.[/fusion_text][fusion_imageframe image_id=”6516|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Combination Products – Clinical Evidence – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/12/Combination-Products-Clinical-Evidence-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Combination Products – Clinical Evidence[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]When talking about clinical evaluations for drug device combination products, the state-of-the-art (SoTA) in the CER can be based on a description of the technical platform or device families that these devices work on. And once again, provide a competitive assessment from literature with other alternative delivery systems and their benefits and risks to the patient or users. In addition, it has to be highlighted in the CER – what the direct benefits are from such devices, from its intended use, as well as indirect benefits such as the ease of use, or quality of life that is offered by using such products as compared to alternatives. These benefits need to be weighed against risks such as those arising from, among other things, interactions of the drug and device components.

It must be kept in mind though that the final decision of the safety and performance of these kinds of devices still rests with the competent authority. If there are safety concerns, for example, the stability of the drug component or the integration of the two components, if that is under the question, then the notified body opinion report that has been provided under Article 117 may be overruled by the competent authorities decision.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Conclusions[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A well-planned regulatory strategy needs to be in place for medical device software and drug device combination products just like any other medical device. It should be in place as early as possible in the life cycle of the clinical evaluation plan. Beginning early in the life cycle will help to ascertain the amount of clinical evidence that’s available, and if there is a need for PMCF activity. The CER that will follow this plan will serve as an important document to demonstrate safety and performance, and for a favorable benefit risk ratio of the device when used in the field, which is critical, and is what the notified bodies are looking for in their review.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ 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padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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For more information on how we can help you with EU MDR reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities.

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[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ 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padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6470|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Economic Operators and Conclusions – EUDAMED Webinar – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/11/Economic-Operators-and-Conclusions-EUDAMED-Webinar-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]How to Start Preparing Your RA QA Team for The EUDAMED Database – Economic Operators & Conclusion[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]John Bradsher is a RAPS Global Certified expert in Regulatory Affairs and Quality Assurance of Medical Devices for Celegence. He has a background in the EU MDR that is both broad and deep: at a medium-sized manufacturer of vascular devices, he managed the program for MDR compliance, and in other assignments he managed the development of clinical evaluation documents for a global manufacturer. He has cleared several 510(k)s and has worked on products in EU classes I-III in his 27 years of project management.

With the European Commission delaying the implementation of EUDAMED, medical device companies now have an opportunity to be proactive. According to the EC, this new IT system aims to improve “transparency and coordination of information” for devices within the European marketplace.

During our webinar titled “How to Start Preparing your RA/QA Team for the EUDAMED Database”, John spoke specifically about which areas of EUDAMED require relevant changes by your staff, which areas will necessitate a regulatory partner, and helped attendees gain a broader understanding of the requirement timeline.

The following is the fourth in the series of blogs related to the “Celegence EUMDR Webinar – How to Start Preparing Your RA QA Team for The EUDAMED Database”. Read the 1st post about understanding EUDAMED overview and electronic systems. You can view the 2nd post about UDI and product types of immediate concern. You can view the 3rd post about SaMD, Brexit and market surveillance.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Why should you watch this video?

• Comprehend the necessary interactions between legal manufacturers and their economic operators
• Learn more about the required responsibilities of Authorized Representative (AR) and Person responsible for Regulatory Compliance (PRRC)

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A full transcript of Dr. John Bradsher’s talk is available to download (and to read below) and just press play to watch the clip now. 

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Responsibilities of Economic Operators – EUDAMED

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We will now move on to the responsibilities of economic operators, and we will start with the supply chain. At this time, legal manufacturers are compelled to identify distributors and importers in their supply chains to establish the responsibilities with each of them. They are also compelled to identify authorized representatives along with importers and distributors to create provisions, and to ensure traceability for both the upstream and downstream provisions.

This includes EO’s that have received devices, and EO’s that have supplied devices within their supply chain to the competent authorities for 10 years after the last device was placed on the market. This obligation actually changes to 15 years, in the instance that you’re marketing an implantable device. The legal manufacturer, and its economic operators, must cooperate with distributors and importers to achieve an appropriate level of traceability.

The completion of the registration requirement for your economic operators is expected by the date of application in May of 2021. We now know that the EUDAMED registration module for economic operators will be available in late 2020, which allows us about five months for the completion of this requirement.

[/fusion_text][fusion_imageframe image_id=”6471|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Legal Manufacturers – EUDAMED Webinar – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/11/Legal-Manufacturers-EUDAMED-Webinar-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Requirements for Manufacturers[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]For manufacturers, many of these requirements may look familiar if you have been marketing in the EU on MDD certificates, and for many of these, you would regard them as essential components for quality management. Specifically, legal manufacturers are expected to establish and document a system for risk management.

They are compelled to make provisions, keep copies of technical documentation, declarations of conformity, and make the certificates available to the competent authorities for at least 10 years after the last device is placed on the market. With that obligation changing to 15 years – in the case that you market implantable devices – manufacturers are expected to establish documents, implement, maintain, update and continuously improve quality management systems that are proportionate to their risk class.

Legal manufacturers are expected to plan, establish, document, implement, maintain, and update a post market surveillance system based on a post market surveillance plan and it will include your technical documentation. They are expected to establish a method for reporting incidents and Field Safety Corrective Actions, as described in the relevant articles. At this time, if they have not already done so, legal manufacturers should consider taking out liability insurance.

More on that topic, in the EU under the MDR, legal manufacturers will be sharing legal responsibility for liability with authorized representatives. Likewise, it makes sense for authorized representatives to consider – if they have not already done so – taking out liability insurance. For these requirements, it is expected that you complete them by the date that you have designated for your QMS audit.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Requirements for the Authorized Representative (AR)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Moving on to the requirements for your authorized representative. These are fewer, but nonetheless important. Legal manufacturers are expected to essentially designate their ARs, as well as to agree upon a mandate of their responsibilities with their authorized representatives.

They are expected to ensure the authorized representatives have permanent access to all documentation required to fulfill their tasks. They also must define the modalities in their agreement between the manufacturer and both the incoming & outgoing authorized representatives (in the event of a changeover for authorized representation).

Suffice it to say, these have all been a specific focus in a lot of discussions, particularly the availability of permanent access to documentation since legal manufacturers regard this as intellectual property and proprietary under many circumstances.

Many legal manufacturers are currently negotiating with their notified bodies about whether they can provide access to redacted copies, or copies of technical documentation that would be sufficient to fulfill all the required tasks, but would not give a technical documentation availability to the full suite of intellectual property from the manufacturer.

This is the time for you to be considering the agreements that you’re going to be making with your authorized representative.[/fusion_text][fusion_imageframe image_id=”6472|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Person Responsible for Regulatory Compliance – PRRC – EU MDR – EUDAMED – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/11/Person-Responsible-for-Regulatory-Compliance-PRRC-EU-MDR-EUDAMED-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Requirements of the Person Responsible for Regulatory Compliance (PRRC)

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Now, the person responsible for regulatory compliance is a new role identified by the EU MDR. It is the responsibility of large and medium manufacturers to appoint a person in their organization as the person responsible for regulatory compliance, and they must have demonstrated expertise. It essentially comes down to education and training.

Manufacturers that are smaller, including small and micro manufacturers, have the option to use an outside resource to designate a person responsible for regulatory compliance. On that note, please be aware that changes in your person responsible for regulatory compliance will be regarded as a significant change by your notified body.

As such, you may want to think carefully about the benefits and risks of having a third party nominee for your PRRC, especially if it means you’re going to have that person changing over the course of the next many years. Each personnel change will be processed with a significant change now. This requirement for your PRRC’s registration is expected to be completed by the date of applicability on May 26th of next year.

We now know that the registration elements will be available in late 2020. So, we will have months to do this in advance of deadlines. You should expect to be done with this step of registration for your authorized representatives, and your person responsible for regulatory compliance, by the day that you have determined with your notified body for your manufacturers MDR certification audit.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]EUDAMED Database Conclusions[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]This brings us full circle. We’ve had time to discuss many topics today, and as time permits, we’ll have a few minutes now to talk about a couple of the modules that we didn’t discuss, including article 57, the electronic system on certificates, and article 73, the electronic system on clinical performance investigation.

As we discussed previously, this first article is the electronic system on certificates. That is article 57, and article 52 in the IVDR, which describes the requirements. That is where you’re going to find your certificates for your declarations of conformity and summaries of safety and clinical performance. There will also be a part of that module that will contain the current list of designated notified bodies and how they are designated for each regulation.

That brings us to the electronic system on clinical and performance investigation. This is where the two regulations diverge a little, in regards to the MDR, it’s called clinical investigations, and in the IVDR, they are called performance investigations. These are under article 73 of the MDR, and article 68 under the IVDR. Nonetheless, this is the module where you are going to log on to get a single identification number, if you’re performing either clinical, or performance investigations in the EU.

That is going to be a go-to resource for those of you in that situation. These two modules are not expected to be available by the date of applicability. We currently are keeping a close eye on when they may be made available, as there are certainly many development projects that are ongoing, and will be depending upon this type of functionality.

Celegence can be a very useful resource for you to continue to stay up to date, and to help navigate through this path as you are moving forward in the next many months towards compliance.

So, this brings us full circle. Today we discussed many topics including EUDAMED and UDI. Thank you![/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” 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radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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For more information on how we can help you EU MDR reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.

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[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”0″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6430|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”SAMD, Brexit and Market Surveillance – EUDAMED Webinar – John Bradsher” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/11/SAMD-Brexit-and-Market-Surveillance-EUDAMED-Webinar-John-Bradsher.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]SaMD, Brexit & Market Surveillance – EUDAMED Database Webinar with John Bradsher[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]John Bradsher is a RAPS Global Certified expert in Regulatory Affairs and Quality Assurance of Medical Devices for Celegence. He has a background in the EU MDR that is both broad and deep: at a medium-sized manufacturer of vascular devices, he managed the program for MDR compliance, and in other assignments he managed the development of clinical evaluation documents for a global manufacturer. He has cleared several 510(k)s and has worked on products in EU classes I-III in his 27 years of project management.

With the European Commission delaying the implementation of EUDAMED, medical device companies now have an opportunity to be proactive. According to the EC, this new IT system aims to improve “transparency and coordination of information” for devices within the European marketplace.

During our webinar titled “How to Start Preparing your RA/QA Team for the EUDAMED Database”, John spoke specifically about which areas of EUDAMED require relevant changes by your staff, which areas will necessitate a regulatory partner, and helped attendees gain a broader understanding of the requirement timeline.

The following is the third in the series of blogs related to the “Celegence EUMDR Webinar – How to Start Preparing Your RA QA Team for The EUDAMED Database”. Read the 1st post about understanding EUDAMED and electronic systems. You can view the 2nd post about UDI and product types of immediate concern.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Why should you watch this video?

• To gain an understanding of the UDI requirement for Software as a Medical Device (SaMD)
• To learn more about the requirement for marketing in the UK Post-Brexit
• To understand the EUDAMED requirements for vigilance and post-market surveillance

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A full transcript of Dr. John Bradsher’s talk is available to download (and to read below) and just press play to watch the clip now. 

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Product Types: Software as a Medical Device (SaMD)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]There are few product types that deserve special attention today, considering BUDI requirements, and I would like to talk about software as a medical device. As indicated here, the only software that is subject to UDI requirements are those that are commercially available on their own, or they constitute a standalone device.

If the software is an integral component of your device, such instances would be free from the UDI requirements. As indicated here, a new UDI is required in instances when you have a modification that changes the original performance, the software, or the interpretation of the data. It can also be required when you have either, any change that could result in misidentification of your device, or an ambiguity in its traceability.

Graphically, it is shown here, showing what could trigger a new UDI, which includes changes in your BUDI-DI, changes that impact performance and safety, or your interpretation of the data. Also, this includes changes to your trade name or other proper names, your version or model number, warnings or contraindications, and changes to the interface language.

Minor software changes, like bug fixes, would not rise to the level of requiring a new BUDI assignment, even though they would require a new product identifier of the UDI type (UDI-PI). However, if such a change rises to the level that it requires a security patch, or an enhancement to the operating efficiency of the software, it would be reverted to the UDI, triggering a major change, which would also be necessary to submit in a significant change note.[/fusion_text][fusion_imageframe image_id=”6432|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Software as Medical Device – EUDAMED – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/11/Software-as-Medical-Device-EUDAMED-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Marketing in the UK Post-Brexit[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Many of you will be interested in marketing in the UK post-Brexit, and as we get closer to the end of 2020, it looks more likely that we may be dealing with a hard Brexit at the end of the year. As we discussed previously the MHRA has been providing guidance on this subject.

One of the things that will be introduced, is a new Conformity Assessment Mark, called the UKCA Mark. This will be a homolog, if you will, of the EU CE Mark for conforming devices. This will be necessary for those of you interested in marketing in the UK for all devices, after the midpoint of 2023, which is June 30th.

To obtain and to apply such a CE Mark, you are required to have a UK approved notified body, and an audit, in order to get the certificate and to fix the UKCA Mark on your labeling and device.

The MHRA has provided an allowance for those of you that may need a bit of time to comply with this requirement. Specifically, they are allowing manufacturers with current EU certificates that are either issued under the directive or the regulation – that is MDD and IVD, AIMDD, MDR or IVDR certificates – to remain valid in the UK, up to the mid-year point of 2023. So, we will have some time to comply with this regulation before it takes effect.

However, for new products that are going to be introduced to the UK after the end of 2020, these will now require separate audits and conformity assessments, except for products that are in class I self-declared groups.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]EUDAMED Module: Vigilance and Post-Market Surveillance System (Article 92, MDR; Article 87, IVDR)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Moving on to the remaining EUDAMED requirements, we have vigilance and post-market surveillance. This is your article 92 from the MDR obligation, and that correlates with the article 87 in the IVDR. This is where you will find reports of serious incidents and Field Safety Corrective Actions (FSCA) as described in articles 87, and 89. This is a good moment for us to remember that we are going to be on a shorter reporting time regime in the coming years. Specifically, we are currently at 30 days under the current MedDEV 2.1-2 guideline, and we will be moving to a 15-day reporting time for incidents and serious events effective on May 26th of 2021.

This includes legacy devices, and we should also note that the Field Safety Corrective Actions (FSCA) be reported without undue delay. This is also the module where you will find reports of trends and non-serious incidents, or expected undesirable side effects that could have a significant impact on the benefit risk analysis for devices.[/fusion_text][fusion_imageframe image_id=”6433|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”EUDAMED – EU Commission and Brexit – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/11/EUDAMED-EU-Commission-and-Brexit-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Final Module of EUDAMED: The System on Market Surveillance (Article 100, MDR; Article 95, IVDR)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

This brings us to the final module on EUDAMED, the system on Market Surveillance. This is the article 100 obligation, correlated to article 95 from the EU in-vitro diagnostic regulation. I regard this as the final module in the respect of the article numbers. However, it is expected to be one of the earliest available functional modules for manufacturers.

This is where you will find final inspection reports on economic operators in the supply chain, information on devices with an unacceptable profile risk to health and safety, information on noncompliant products, and information on preventative health measures. This will be a module accessed primarily by notified bodies, competent authorities, and the EU commission, but not the public. The only possible exception, would be information that is intended to promote public health protection.

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” box_shadow=”yes” box_shadow_vertical=”5%” box_shadow_horizontal=”5%” 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filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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For more information on how we can help you EU MDR reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.

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[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”0″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6394|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”UDI and Product Types of Immediate Concern – EUDAMED Webinar – John Bradsher – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/11/UDI-and-Product-Types-of-Immediate-Concern-EUDAMED-Webinar-John-Bradsher-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]UDI & Product Types of Immediate Concern – EUDAMED Database Webinar with John Bradsher[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]John Bradsher is a RAPS Global Certified expert in Regulatory Affairs and Quality Assurance of Medical Devices for Celegence. He has a background in the EU MDR that is both broad and deep: at a medium-sized manufacturer of vascular devices, he managed the program for MDR compliance, and in other assignments he managed the development of clinical evaluation documents for a global manufacturer. He has cleared several 510(k)s and has worked on products in EU classes I-III in his 27 years of project management.

With the European Commission delaying the implementation of EUDAMED, medical device companies now have an opportunity to be proactive. According to the EC, this new IT system aims to improve “transparency and coordination of information” for devices within the European marketplace.

During our webinar titled “How to Start Preparing your RA/QA Team for the EUDAMED Database”, John spoke specifically about which areas of EUDAMED require relevant changes by your staff, which areas will necessitate a regulatory partner, and helped attendees gain a broader understanding of the requirement timeline.

The following is the second in the series of blogs related to the “Celegence EUMDR Webinar – How to Start Preparing Your RA QA Team for The EUDAMED Database”. Read the 1st post about understanding EUDAMED – overview and electronic systems.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Why should you watch this video?

• To gain an understanding of the UDI of various Therapeutic Areas and Product Types
• Learn more about the UDI Timeline

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A full transcript of Dr. John Bradsher’s talk is available to download (and to read below) and just press play to watch the clip now. 

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″]
[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Unique Device Identification (UDI), Definitions (Annex Vi)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Now, moving along to registration. This is the article 29 obligation from the MDR, and the article 26 from the IVDR. The BUDI is a data element that has gotten a lot of attention and has created some anxiety along the way, and without getting into too much detail, the BUDI, like the UDI, is a package of attributes and data. Both will have places that they will be used in common, for instance, the regulatory submissions shown here, each will have unique places where the information is displayed. So for instance, your BUDI will be found on declarations of conformity and on summaries of safety and clinical performance. While a UDI is the type of data you find on primary product labels, implant cards and vigilance communication.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]One Module of EUDAMED will be the database for UDIs (Article 27/24)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Graphically, we have a UDI which is broken up into two parts, it essentially contains the UDI-DI: the device identifier, and the UDI-PI: the product identifier, and these will be provided for reporting serious incidents and Field Safety Corrective Actions (FSCA), which will be provided to patients receiving implants under the MDR.

The economic operators in your supply chain are going to be obliged to maintain electronic records of the BUDI for class III and implantable devices, as well as devices that will be detailed in any implementing act yet to be published. This is an obligation of the economic operators that is reflected as well. With health institutions throughout the EU, they will also be compelled to maintain BUDI records for all class III and implantables, as well as devices detailed in the implementing act. There is an element of the unknown here in the respect that member states, as stakeholders, may encourage or require healthcare institutions to maintain records of BUDIs for all devices.

This is an area to watch closely because it would be an increase in the amount of effort necessary to be compliant with regulations for registration. We are waiting to see where the various different jurisdictions land on this, and I encourage you to stay in touch with Celegence, who will help keep you notified and help you navigate through the unknown with respect to this type of jurisdiction specific requirement that may be emerging over the next many months.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

MHRA Requirements for Products in the UK

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Now for those of you interested in marketing in the UK, including Britain, Scotland and Northern Ireland, the MHRA has issued requirements for products of all classes to be registered with the UK as well, and this is going to be necessary for those who don’t have an alternate means of completing it by the end of the year 2020. The grace periods for class III and class II devices have already passed, and the period for the class I devices will pass at the end of December. This legal requirement to register will not affect you if you have an existing relationship with an authorized representative within the UK. Be aware, however, that this is guidance that is based on the concept of a hard Brexit at the end of December of 2020, and as December 31st approaches, things may change as there may be a trade agreement. The MHRA may provide additional further guidance, suffice it to say, this is an area that is being closely watched as well, and as such, Celegence can help keep you up to date on the requirements as they become public.[/fusion_text][fusion_imageframe image_id=”6395|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”MHRA Requirements for Products in the UK – EUDAMED” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/11/MHRA-Requirements-for-Products-in-the-UK-EUDAMED.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Product Types of Immediate Concern[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]I would like to move on to product types of immediate concern. Specifically, products that will be marketed on directive certificates after the date of applicability in the EU will be regarded as legacy devices. The MDR does not specifically require BUDIs on legacy devices, but the EU commission has essentially detailed a two-part work around.

First, registration will be necessary according to the article 29 requirements, but it will be possible to complete that registration in the absence of a BUDI using other attribute data and including your UDI. Moving forward with that approach, legal manufacturers will bear a certain amount of risk. In that respect, if there is a Field Safety Corrective Action (FSCA) that occurs with such a legacy device, and it has not been registered by its BUDI, the effective device must be then immediately registered now for the reporting of the serious incident or FSCA.

To me, it looks like the European commission is preparing an on-demand system to handle such events, even before the registration system is available on a broader basis for legacy devices.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″]
[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]UDI Timeline[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]In contrast to what we just discussed, we will now consider the requirements for devices placed initially on the regulation certificates that are under the MDR, or IVDR. What we see here in this slide is the concept of the end of the window of opportunity to have your BUDIs displayed on your packaging, on your labeling, and other higher levels of packaging. This occurs in the even numbered years, as shown above the register for MDR compliant devices in a reducing risk format, and it occurs in odd numbered years below the register for in-vitro diagnostic regulation regulated devices.

The current dates of applicability for the MDR are May of 2021, and May of 2022 for the IVDR. Since those are only a single year separated, we have this resulting alternation, and the dates that the BUDI requirements will be met for each of the affected risk classes for devices.

There are many reasons why, that as a legal manufacturer, you may choose to be active much earlier than these deadlines when assigning your BUDIs. Specifically, the application to the notified body for conformity assessment is contingent upon completing of assignments of your various products to BUDI groups. Many legal manufacturers are currently active in grouping their devices into various BUDI groups.[/fusion_text][fusion_imageframe image_id=”6396|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”UDI Timelines EUDAMED – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/11/UDI-Timelines-EUDAMED-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Recommendations for UDI Timeline[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]There are many reasons why, that as a legal manufacturer, you may choose to be active much earlier than these deadlines when assigning your BUDIs. Specifically, the application to the notified body for conformity assessment is contingent upon completing of assignments of your various products to BUDI groups. Many legal manufacturers are currently active in grouping their devices into various BUDI groups.

This is done so that they can proceed with the necessary negotiation with their notified body in order to determine how many technical files will be needed to be audited for each group of devices. These early moving determinants are the type of thing that many legal manufacturers are currently active with. Do not be swayed to believe that you can wait until these deadlines are near to get started on this type of activity.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” box_shadow=”yes” box_shadow_vertical=”5%” box_shadow_horizontal=”5%” box_shadow_blur=”28″ box_shadow_spread=”2″ box_shadow_color=”#f1f6f8″ box_shadow_style=”” padding_top=”” padding_right=”0px” padding_bottom=”” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”#f6f8f8″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

[fusion_fontawesome icon=”fa-info-circle fas” size=”35px” flip=”” rotate=”” spin=”no” alignment=”left” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” margin_top=”” margin_right=”10px” margin_bottom=”” margin_left=”” circle=”no” iconcolor=”#2da9e0″ circlecolor=”” circlebordercolor=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_fontawesome]

For more information on how we can help you EU MDR reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.

[/fusion_text][/fusion_builder_column_inner][/fusion_builder_row_inner][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”0″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6372|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”How to Prepare RA QA Team for Eudamed Database – John Bradsher – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/11/How-to-Prepare-RA-QA-Team-for-Eudamed-Database-John-Bradsher-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]How to Start Preparing Your RA QA Team for The EUDAMED Database – John Bradsher’s Presentation – Overview & Electronic Systems[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]John Bradsher is a RAPS Global Certified expert in Regulatory Affairs and Quality Assurance of Medical Devices for Celegence. He has a background in the EU MDR that is both broad and deep: at a medium-sized manufacturer of vascular devices, he managed the program for MDR compliance, and in other assignments he managed the development of clinical evaluation documents for a global manufacturer. He has cleared several 510(k)s and has worked on products in EU classes I-III in his 27 years of project management.

With the European Commission delaying the implementation of EUDAMED, medical device companies now have an opportunity to be proactive. According to the EC, this new IT system aims to improve “transparency and coordination of information” for devices within the European marketplace.

During our webinar titled “How to Start Preparing your RA/QA Team for the EUDAMED Database”, John spoke specifically about which areas of EUDAMED require relevant changes by your staff, which areas will necessitate a regulatory partner, and helped attendees gain a broader understanding of the requirement timeline.

The following is the first in the series of blogs related to the “Celegence EUMDR Webinar – How to Start Preparing Your RA QA Team for The EUDAMED Database”.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Why should you watch this video?

• For explanations of various modules of EUDAMED
• To gain an understanding of the overview of the functionalities of EUDAMED

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A full transcript of Dr. John Bradsher’s talk is available to download (and to read below) and just press play to watch the clip now. 

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Thank you, Dylan, for that introduction, my name is John Bradsher and I will walk you through the requirements and the availability of EUDAMED over the next 40 minutes.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]EUDAMED Modules[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Today we will discuss modules – detailed in articles – 27, 29, 31, 92 and 100. We will briefly discuss EUDAMED modules that are detailed in articles 57 and 73. These are the EU MDR article designations, and where I can, I will provide the correlated in-vitro diagnostic regulation article designations as well.

Many of you may be familiar with the notice of full functionality at EUDAMED, which is not expected until quarter four of 2022, a full two years off, and that is dependent upon a successful audit in maybe the year 2022. There also could be things that put it off to an even later benchmark. One of the questions that we will then address today, is how you as manufacturers are expected to comply with various deadlines that take effect well before that date of full functionality of EUDAMED.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]EUDAMED Overview[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

This slide gives us an overview of some of the functionalities of EUDAMED. Not all of which will have an immediate effect on that date of applicability.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Electronic System on Certificates – Article 57 EU MDR[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]First, the electronic system on certificates. This is the article 57 obligation from the MDR, correlated to article 52 from the in-vitro diagnostic regulations. This is the module that will contain declarations of conformity, summaries of safety and clinical performance, and your listing of designated notified bodies. This will have content that is intended to be public facing, including your summaries of safety and clinical performance, as well as other content that is not intended to be facing the public.[/fusion_text][fusion_imageframe image_id=”6370|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Article 57 EUMDR – RA QA Team Preparation for EUDAMED Database – John Bradsher – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/11/Article-57-EUMDR-RA-QA-Team-Preparation-for-EUDAMED-Database-John-Bradsher-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Electronic System on Vigilance[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Next, is the electronic system on vigilance. This is the article 92 obligation correlated to article 87 in the in-vitro diagnostic regulation, it will contain your post-market surveillance update reports, reports of Field Safety Corrective Actions (FSCA), and serious incidents. This module will also have a mix of public facing and non-public facing information.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Electronic System on Market Surveillance[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Moving on, we have the electronic system on market surveillance. This is your article 100 obligation, correlated to the article 95 from the in-vitro diagnostic regulation. This is where you will find your final inspection reports for all economic operators in the supply chain, information on non-compliant products, and information on products that have unacceptable risks to health and safety.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Electronic System on Clinical Investigations[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Moving along to the final position, we have the electronic system on clinical investigations. This is the article 73 obligation, and it is correlated with article 69 in the in-vitro diagnostic regulation, where it is called the electronics on performance investigations. This is a module that the legal manufacturer will use if performing clinical or performance investigations in the EU, and this module will generate single identification numbers for clinical investigations. Most of the information that is on this module will not be available to the public.

Now, if we move to the right, we have considered most of these document oriented elements, and to the left, we also have registration requirements, which are shown here. This is a group of modules that will include the registration of economic operators, which is article 31 in the MDR article, and article 28 in the IVDR. It will also include the registration of devices, which is article 29 in EU MDR, and article 26 in the IVDR, as well as the BUDI database, which is article 27 in the MDR, and article 24 in the IVDR.

[/fusion_text][fusion_imageframe image_id=”6371|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Eudamed Compliance Dates EU MDR – John Bradsher – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/11/Eudamed-Compliance-Dates-EU-MDR-John-Bradsher-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Timelines for EUDAMED Compliance

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These modules for registration are said to be slated for availability in late 2020, which should give us about five months in advance for compliance with registration requirements for EUDAMED in advance of that date of applicability in May of 2021.

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video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” box_shadow=”yes” box_shadow_vertical=”5%” box_shadow_horizontal=”5%” box_shadow_blur=”28″ box_shadow_spread=”2″ box_shadow_color=”#f1f6f8″ box_shadow_style=”” padding_top=”” padding_right=”0px” padding_bottom=”” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”#f6f8f8″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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For more information on how we can help you EU MDR reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.

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padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6349|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”MDR Article 117- A New Implication for Drug-device Combination Products – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/MDR-Article-117-A-New-Implication-for-Drug-device-Combination-Products-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]MDR Article 117: Implications for Drug-device Combination Products[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Drug Device Combinations (DDCs) have become more and more prevalent as a method of administration for medicinal products. Over the past several years, there has been a substantial increase in the number of scientific advice requests and marketing authorization applications for products that incorporate drug and device components, or drug-device combinations. In essence, it reflects the potential for devices to decrease the burden on patients and providers. Notably, this includes products with automated functions that help patients manage self-administration of medicines.

Drug Device Combinations such as pre-filled syringes or pre-filled pens are considered to “have the potential to make treatments safer, more effective, or more convenient or acceptable to patients.” However, they must fulfill a significant set of additional requirements. The US and EU have profoundly different systems for determining assessment routes for drug (or biologic) and device combinations.[/fusion_text][fusion_imageframe image_id=”6350|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Assessment groups for drug (or biological) and device combinations – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Assessment-groups-for-drug-or-biological-and-device-combinations-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Combination Products Definitions[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]In the US, these products are termed as “combination products,” and the lead division is selected based on the primary mode of action. For relevant aspects of the product, other divisions are chosen. However, in the EU, the process is slightly different as the term “combination product” is not recognized officially. Although the products are still assessed based on the primary mode of action, there is also the determination of two primary assessment formats: either medicinal product or medical device.

The EU regulates DDC Products as a medicinal product or as a medical device. Hence, there is no consistent definition given in the EU for such products. The European Medicines Agency (EMA) provides the most meaningful definition describing the combination and is stated as:

“The medical device may be supplied as an integral component of the medicinal product (e.g. pre-filled syringe, auto-injector), or separately (copackaged; e.g. oral syringe, pen-injector), as a non-integral combination with the medicinal product, or independently marketed (in cases where the device meets the requirements for the necessary delivery system stated in the Summary of Product Characteristics (SmPC) for the medicinal product).”

A single integral DDC is described as follows:

“If a medical device used to administer a medicinal product is placed on the market in such a way that the device and medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable.”

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]The Existing System for CE Marking Combination Products[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

The Medicinal Product Directive (MPD) mandates evidence of CE marking but does not detail the requirements for non-CE marked devices. According to Article 1 Subpart 3 of the MPD, devices in which ‘the device and medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable’ were governed by the MPD. Additionally, the essential requirements of Annex I in the MDD was applicable to establish safety and performance of the device.

[/fusion_text][fusion_imageframe image_id=”6352|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Medicinal Product Directive MPD – MDR Article 117 – Implications for Drug-device Combination Products” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Medicinal-Product-Directive-MPD-MDR-Article-117-Implications-for-Drug-device-Combination-Products.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

The New System for CE Marking Combination Products – Article 117

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The EMA, which oversees the European Union’s pharmaceutical market, has begun rolling out guidance and clarifications regarding Medical Devices Regulation (MDR) compliance issues for manufacturers of combination products with drug and medical device components. As per the EMA guideline, manufacturers of drug-device combination products will have to meet MDR Article 117 regulatory requirements. The EMA notes that Article 117 of the Regulation requires Notified Body (NB) involvement for European market authorization of a medicinal product that incorporates an integral medical device, or drug-device combination product.

Article 117 of the new EU MDR amends Annex I of the Medicinal Product Directive (MPD) 2001/83/EC, point 12 of Section 3.2. This states that:

“(12) Where, a product is governed by this Directive, the marketing authorization dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer’s EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.

If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question.”

The change mainly applies to integrated, non-reusable products where the drug element is the primary mode of action. Fundamentally, the device element of a medicinal product – when integral (classified either as Class I [i.e. sterile], Class IIa, Class IIb or Class III), non-reusable and intended exclusively for use in the given combination – needs to conform to the Annex I (MDR) GSPR and without the requirement to be regulated as a CE-medical device. Integral devices classified as Class I devices (i.e. non-sterile) are not subject to an NB opinion.

Although a short article, it introduces a new requirement for NB involvement in medicinal products with an integral medical device. Marketing such products as a ‘medicinal product’ would require manufacturers to seek a Notified Body Opinion (NBOp). The NB will access and confirm if the device is compliant with the relevant General Safety and Performance Requirements (GSPR) and issues an NBOp report to the manufacturer. The NBO report is expected to be submitted to the EMA in the Market Authorisation Application (MAA) by the manufacturer. This will be assessed by the Competent Authority and the final approval of the product will remain with the EMA.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Amendment of the MPD and its Impact on the MAA[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]With the changes implemented by the EU MDR, the MAA must include either a:

1. CE certificate issued by a NB for the medical device component, or
2. Notified Body Opinion (NBO) on the conformity of the device

Scenario 1 would require manufacturers of the medical devices to obtain CE marking with the aid of an appropriate conformity assessment process applicable to the device. The CE certificate would then need to be submitted to the MAA.

Scenario 2 where a CE mark has not been issued to the device component on its own, the manufacturer must reach out to an NB and seek their opinion on the conformity of the device, and provide the NBO report in the MAA.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Role of Notified Bodies in MMA Submission[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

• To provide an NBO, the NBs will require access to the Technical Documentation of the manufacturer that provides sufficient evidence/scientific data to support product claims.
• Applicable to initial MMA submissions as well as submissions of “substantial design changes to the device component” (including “addition or full replacement of the device”)
• Technical documentation expectations by the NB are detailed in the Annex II of the MDR.
• Information that the NB would require to support a conformity assessment for medical devices includes:
  • Risk Management Documentation
  • Safety and Performance Data including clinical data
  • Functionality Testing (accuracy of dosage, performance of device)
  • Instructions for Use/Training for Users
  • Usability/Human Factor Testing
  • Compatibility Testing
  • Sterilization Validation
  • Sterility Test Data
  • Packaging Validation Testing

[/fusion_text][fusion_imageframe image_id=”6351|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Information a Notified Body Needs for a Medical Device Conformity Assessment – EU MDR” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Information-a-Notified-Body-Needs-for-a-Medical-Device-Conformity-Assessment-EU-MDR.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Challenges Faced by Notified Bodies[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

• With the increase in requirements of the MDR, the number of NBs and their scope will decrease
• The available number of NBs qualified to assess DDCs may be lower than expected and this can turn out to be challenging for pharmaceutical manufacturers
• The expectations regarding the presentation of data showing compliance with the GSPRs are not yet well defined
• The assessment report of the NB concluding the requested opinion should be designed in a way that the medicine’s competent authority can rely on it for the final marketing authorization (MA). Hence representatives of the NB and the EMA should discuss the expectations and requirements in advance to ensure a consistent procedure

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• Identify a NB intending to be EU MDR designated for your specific technology
• Assess which GSPRs are applicable to your products
• Obtain scientific data that demonstrates conformance to the applicable GSPRs
• Assemble Technical Documents to support the medical device components

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Summary – MDR Article 117 and Implications for Drug-device Combination Products[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

• For manufacturers who intend to qualify drug-device combination products, it is vital that their marketing authorization dossiers include the results of the conformity assessment or the CE Mark issued by the NB for device components. Furthermore, for device components that lack CE Marking, manufacturers will have to submit opinions from NBs regarding conformity of those components to the MDR requirements.
• A product’s device and medicinal components must form a “single integral product”, the product must be intended for use only in the drug-device combination; and the product must not be reusable. Only if these parameters are applicable, the product will have to comply with the requirements of MDR Article 117.
• For new marketing authorization applicants to establish that the device component of a drug-device combination product meets the MDR requirements established in Annex I of the Regulation, will require a DoC or CE Mark. If not, they must provide opinions from NBs supporting conformity to MDR Annex I rules.

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box_shadow_blur=”28″ box_shadow_spread=”2″ box_shadow_color=”#f1f6f8″ box_shadow_style=”” padding_top=”” padding_right=”0px” padding_bottom=”” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”#f6f8f8″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ 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Manufacturers of combination products should seek regulatory advice and operational support from the expert Celegence team to ensure that essential documentation and clinical evidence for your product portfolio complies under the new MDR. To discuss how our team can strategically partner with yours, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.

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