Components of an Effective Post-Market Surveillance for Medical Devices

02 Jul, 2020

PMS Requirements – MDD Compared to MDR

Manufacturers are now required to update their PMS system proactively in a comprehensive and systematic fashion in accordance with EU MDR. This allows the manufacturers to set in place an interactive corrective action or preventive action process which is proportionate to the device type and update clinical evaluation documents.

It is important to note that the requirements for PMS should be directly proportional to the risk associated with the device based on its intended use.

[/fusion_text][fusion_imageframe image_id=”5756|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=”Requirements of Post Market Surveillance – PMS – Medical Devices” 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/2020/07/Requirements-of-Post-Market-Surveillance-PMS-Medical-Devices.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 Post Market Surveillance (PMS)[/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 necessary to consider the product technology in relation to the manufacturer and the marketplace while developing a PMS, as there tends to be a large amount of data informing about the reasonable risks associated with the device when the device technology has been in place over a prolonged period of time. For manufacturers of new technology, there may be limited understanding of the patient population and complexities of the device state. Requirements of PMS can be met by:

State-of-the-art market experience data for similar devices may be adequate to support clinical evaluation requirements for low risk devices with a long history of use
Quantified clinical data pertaining to safety and performance of the device from peer-reviewed literature in order to support the clinical evaluation requirements
Increased monitoring ensuring early detection of risks which were not foreseen in the development phase
Post-market clinical follow-up (PMCF) may also be warranted to capture adequate real-world clinical use of the device

The analysis and review of PMS data is to be performed regularly by manufacturers as part of the risk management process. Information for risk management can be gathered from patients, physicians, healthcare facilities, regulatory authorities, professional societies, researchers and internal personnel.

[/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 combination of ‘proactive’ and ‘reactive’ PMS activities form the basis of the device’s PMS plan, which is provided as a part of the assessment for CE mark certification. Proactive PMS anticipates and curtails events before they occur, gaining real-time performance data of the device. Examples include, customer surveys, post CE mark clinical trials (including PMCF), expert user groups, and manufacturer sponsored device tracking/implant registries. Reactive PMS is a passive form of data collection activities when manufacturers respond after an event has occurred. It could range from complaints to serious injury. Examples include, customer complaints, service reports, failure analysis, literature review, and non-manufacturer sponsored trials or regional/national device registries.[/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=””]Quality Management System[/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=””]Based on the classification of a device, a quality management system (QMS) should cover all procedures and processes relating to aspects of design, manufacturing, supply management, risk management, complaint handling, clinical data, storage, distribution, and product labeling.

Manufacturers of all medical devices must document and prove to the notified bodies that they meet the requirements of Article 10 (General obligations of manufacturers) and Annex IX (Conformity assessment based on QMS and technical documentation) of the new EU Medical Device Regulations (EU MDR). Additional ways to meet QMS requirements include compliance with the requirements enlisted in Annexes X (Conformity assessment based on type examination) and XI (Conformity assessment based on product conformity verification).[/fusion_text][fusion_imageframe image_id=”5757|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=”Quality Management System for Medical Devices – Effective Post Market Surveillance (PMS)” 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/2020/07/Quality-Management-System-for-Medical-Devices-Effective-Post-Market-Surveillance-PMS.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=””]Pre-Production QMS[/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 considered best practice to setup a pre-production QMS, 18-24 months prior to commercialization and distribution of the device. This helps manufacturers continuously update and improve the system while they proceed internal validation procedures and market launch. In order to ensure ongoing compliance with quality system procedures, manufacturers must be encouraged to perform internal audits evaluating QMS at least once a year.[/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=””]Vigilance System in PMS[/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=””]ISO 13485 applies to all medical devices on the market and therefore PMS plans must be formulated in context to a proactive PMS.
Vigilance is an output of the quality management system and is therefore beneficial to plan post-market clinical data gathering activities during the technical documentation of a device.

Therefore, establishing a vigilance system in the post-production phase to report authorities of serious device-related incidents (reactive in nature) could effectively facilitate the detection of previously unknown adverse product information. This assessment can prove useful to prevent future recurrence of incidents that might have otherwise led to death or serious deterioration in health.[/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=””]Vigilance Guidance Document[/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 Medical Device Vigilance System (MDVS) is intended to facilitate a direct, timely, and harmonized implementation of Field Safety Corrective Actions (FSCA) and FSN (Field Safety Notice) across the Member States where the device is in use.

The latest update in MDVS guidelines introduces manufacturer incident report (MIR) which details adverse event terminology/coding harmonized via the International Medical Device Regulators Forum (IMDRF) and the use of unique device identification (UDI), while introducing a single registration number (SRN), keeping in focus the future Eudamed.

Notified bodies provide support by assessment of vigilance procedures, performing audit procedures, and assessing the impact of vigilance issues on certification. Additionally, user input and feedback is vital for vigilance. Users report suspecting incidents with user interaction and cooperation is necessary for the implementation of FSCA.[/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=””]Translating Clinical Data Beyond PMS Activities[/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 data can help in identifying residual risks of devices. Additionally, gathering robust long-term clinical data can present itself as a successful marketing tool improving economic value of the device and ultimately support product liability claims, if required. The current emphasis on PMCF requirements by EU MDR in obtaining continued clinical data stands to benefit both patients and manufacturers. A PMCF study or plan is expected to be a part of the PMS plan and in the clinical evaluation. Adequate rationale is to be provided as to why a PMCF is not applicable for a medical device.[/fusion_text][fusion_imageframe image_id=”5759|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=”Effective Post-Market Surveillance – Medical Devices Conclusions – 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/2020/07/Effective-Post-Market-Surveillance-Medical-Devices-Conclusions-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=””]

Effective Post-Market Surveillance for Medical Devices – Conclusions

For more information on how we can help you create a PMS or a PMCF Plan to comply with the European Union (EU), reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities.

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Remote Medical Audits During COVID-19

02 Jun, 2020

This blog identifies how to use remote medical audits effectively and aims to help manufacturers turn massive challenges into meaningful change during these trying times. Against this backdrop, remote inspections are a new concept for most of us, and manufacturers are unsure of its objectivity, trustworthiness, credibility and effectiveness. However, we presume it to be an effective way to keep your certification program moving along, as was originally planned before the Coronavirus/ COVID-19 pandemic.

To learn more about the EU MDR changes you can view some of the previous posts in the series:

[/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=””]Overview of Remote Medical Audits[/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=””]

What is a remote audit? When are remote audits allowed? How does a notified body decide whether a remote audit is permitted or not? What documents are reviewed at a remote audit? How do manufacturers prepare for a remote audit? What tools should be used? When is an on-site follow-up audit required? This blog anticipates to address all these queries, to help you prepare. It is always worthwhile to check with your notified body on their modus operandi.

[/fusion_text][fusion_imageframe image_id=”5651|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=”What is a Remote Medical Audit – Celegence Medical Device Consultants” 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/2020/06/What-is-a-Remote-Medical-Audit-Celegence-Medical-Device-Consultants.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=””]

What Is A Remote Medical Audit?

Firstly, what is a remote audit? A remote audit is the same as an on-site audit, but the auditor engages with you via technology. It is important to keep in mind that the remote audit is not to be viewed as an inferior method for performing on-site audits. Even more so than in the case of an on-site audit, it still covers documentation and record review, tours of your premises, interviews with workers and presentation of findings by using a range of technology platforms including:

Live web streaming technology such as Webex, Skype, MS Teams, GotoWebinar
Live streaming paired with mobile technology such as a smartphone or tablet with video capabilities (e.g. WhatsApp, Skype or Facetime)
Live streaming paired with technology and video headsets

If remote audits can be undertaken, it limits certification constraints as the audit program is enabled per the initial audit schedule. Remote inspections may even be cost-effective, as there are no additional expenses, such as travelling, accommodation expenses to be added. Although, be mindful, that it may be expensive in the long run if a follow-up audit is required, but this may be necessary to maintain current certification.

Most surveillance audits
Portions of recertification audits
NB Transfer Audits
Review of Covid-19–related devices

The following may not be suitable for remote audits; initial Stage II audits (unless it’s COVID-19–related), scope expansions, adding new sites, new processes and unannounced inspections etc.[/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=””]Preparing for Remote Medical Audits[/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=””]Typically, your notified body will work with you on a risk-based approach. Whereby, usually a pre-audit questionnaire will be issued to the manufacturer, this will be completed and then sent back to the notified body. The Scheme Manager will review the completed documentation while taking into consideration the audit history, being mindful of the significant changes that were intended to be considered at the next audit.

Some substantial questions that needs to be addressed include;

Will the Quality Management System (QMS) be fully functional?
Will the client operate some kind of smartphone/camera application (WhatsApp, Facetime, Skype), allowing live audio/visual access to the manufacturing areas?

After assessing all of the above pointers, the Scheme Manager should contact the manufacturer and discuss the recommendation. If agreed upon by the manufacturer, the remote audit may progress.

Notified bodies may offer different approaches based on the factors above;

Full remote audit
Full remote audit with an on-site follow-up verification
Partial remote audit plus an on-site follow-up
Rescheduled on-site audit
Certification suspension

You need to check with your NB to see which of these approaches they do offer.[/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=””]Remote Audit Plan[/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=””]As with any audit, you will receive your audit plan from the assigned reviewer. They will most probably provide you with a list of documents as part of this plan, that may encompass the quality manual, an index of all QMS procedures, complaint records, corrective and preventive actions (CAPA’s) etc. The notified body should work with you on this, taking into consideration specific requirements and your technology infrastructure, to ensure a successful audit.

Post confirmation, the date will be scheduled, the audit team leader will start the audit planning process. This includes identifying and settling on the technology approach to be used during the 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=””]Tools Needed for Remote Medical Audits[/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=””]

Typically, manufacturers should have a video conferencing tool; this would be something like Cisco Webex, Microsoft Teams, Skype. Whichever you choose, just ensure that the security settings are adequate to meet your needs. A successful remote audit relies on proper connectivity (i.e. voice and video) to ensure stable communication between the auditor and the auditee.

Once your connection is up and running, audit evidence will be collected via interview, review of documentation and records (via screen sharing) and observation of processes and activities (via video-sharing, if possible). It is recommended that you have a collaboration area, such as a google drive, one drive, dropbox whereby you can share documents with the auditor as required. Evidence collected will be documented, reviewed and reported to support the audit findings and conclusions – the only difference is it will be done using remote techniques. It is recommended that you have adequately tried these methods, before the audit date, ensuring that connectivity, logging on, etc., all work as anticipated.

Follow-up Audits

A follow-up audit is scheduled for recertification which mandates follow-up verification activities. It may be for a scope expansion,e.g., the addition of new sites, a new process or new devices (excluding COVID-19–specific devices).

Audit Reporting

In addition to a standard on-site audit report, remote audit reports will also include details about the remote auditing methods applied. There should not be any significant differences in the way that you receive your audit report.

[/fusion_text][fusion_imageframe image_id=”5652|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=”What is a Remote Medical Audit – Celegence Medical Device Consultants” 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/2020/06/Remote-Medical-Audits-in-the-Future-Celegence-Medical-Devices-Consultants.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=””]Remote Medical Audit 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=””]

While we navigate the uncertainty imposed by the pandemic with new ways of living, inclusive of aspects like working from home, social distancing, and severe travel restrictions being imposed, we have to adapt the best we can. But speed is of the essence while organizations globally are experiencing workforce disruption at an unprecedented scale and speed. We are optimistic that with the key insights provided in this blog setting up, hosting and being part of a remote audit is one thing less that you and your business have to worry about. Remote audits may become a permanent fixture of our future, but for now, they are here, and we have to embrace them and work closely with our notified body to try to keep disruption to a minimum.

[/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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animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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

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Addressing the Regulatory Challenges with Software as a Medical Device in EU MDR

14 May, 2020

Guidance on Qualification and Classification of Software as a Medical Device in Regulation (EU) 2017/745

“any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of, or converting that energy.”

The term Software as a medical device is defined by the MDCG as a set of instructions that processes input data (data provided through the use of a human data-input device) and creates output data (data produced by software) and are therefore deemed to be an active device as per the MDR guidelines. Medical device software is intended to drive/influence the use of a (hardware) medical device, used alone, or in combination, for a purpose as specified in the guidance document.

Your organization may benefit from the EU MDR consulting services offered by Celegence for a seamless transition to the new requirements with effective business outcomes.[/fusion_text][fusion_imageframe image_id=”5610|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 Device Software – Qualifying Parameters for MDSW under EU MDR – Celegence Consultants” 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=””]https://www.celegence.com/wp-content/uploads/2020/05/Medical-Device-Software-Qualifying-Parameters-for-MDSW-under-EU-MDR-Celegence-Consultants.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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Qualifying 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=””]The guideline lays out qualification criteria to clarify what type of software may subject to the regulations. The guideline states that the “Software must have a medical purpose on its own to be qualified as an MDSW.”

Firstly, the manufacturer’s product must fulfill the definition of a “medical device”, “software”, or in vitro diagnostic medical device according to Article 2(1) of Regulation (EU) 2017/745 – MDR and/or Article 2(2) of Regulation (EU) 2017/746 – IVDR. The intended purpose of the software described by the manufacturer is relevant to qualifying the software as a device and further addressing its classification.

Implementation rules 3.3 and 3.5 described in the Regulation (EU) 2017/745 – MDR or Regulation (EU) 2017/746 – IVDR also respectively apply when the software is intended as an accessory to a medical device and does not meet the definition of a medical device or an in vitro diagnostic medical device.

The qualifying factors of software as a medical device is independent of the risk of harm to users (both patients and professionals) within a healthcare setup.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]

Qualifying Parameters for Medical Device Software (MDSW)

Software that directly controls a medical device (hardware), providing immediate decision-triggering information intended to be used by healthcare professionals or patients (e.g. blood glucose meter software).
Software that provides support for healthcare professionals (e.g. ECG interpretation software).
Software intended to process, analyze, create, or modify medical information when the software is governed by a medical intended purpose (e.g. searching image for findings that support a clinical hypothesis as to the diagnosis or evolution of therapy)
Independent software, by having its intended medical purpose

Software may be qualified as MDSW regardless of its location (e.g. operating in the cloud, on a computer, on a mobile phone, or as an additional functionality on a hardware medical device). With the transformational impact of technology shaping the medical device sector, Celegence’s expert team can provide regulatory guidance and supplement information on whether your device qualifies as a MDSW.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]

Decision Tree To Assist the Qualification of Software as MDSW

[/fusion_title][fusion_imageframe image_id=”5614|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=”Qualification of Software as MDSW Criteria – 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=””]https://www.celegence.com/wp-content/uploads/2020/05/Qualification-of-Software-as-MDSW-Criteria-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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Rules for Classifying MDSW and Their Implementation[/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 regards to software medical devices, changes to classification have been a leading cause for concern. In classifying software as a medical device, Rules 9, 10, 11, 12, 13, 15, and 22 of Annex VIII EU-MDR 2017/745 are to be applied. Nearly all software medical devices are likely to be class IIa, or even class III (the highest risk category), where previously the majority have been class I. This potential up-classification can be attributed to the wide-phrasing of Rule 11 which was newly added to Annex VIII of the EU MDR.

This rule was issued with guidance from the International Medical Device Regulators Forum (IMDRF). The drafting of Rule 11 assigns a significant proportion of software medical devices to the higher classes and manufacturers have taken a cautionary approach to this rule. The implication of such strict wording has led to increase in class contingent irrespective of the probable innocuous function of the device itself. For e.g., in cases were the software performs a relatively simple function, but if the resulting decision of the device itself could impact the well-being of the patient, the device is awarded the highest risk category. This may place additional strain on the manufacturer to place the device on market.

The Medical Device Coordination Group (MDCG) Guidance on Qualification and Classification of Software, appears to soften the impact of Rule 11, providing greater clarity with regards to classification of software medical devices. It particularly describes and categorizes the significance of the information provided by an active device to the patient management in combination with patient condition by dividing them into three sub-rules.

For further details on classification rules, please refer to:
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Protecting Medical Device Software[/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=””]Rapidly improving technology has made Software medical devices increasingly prevalent in the healthcare sector. Securing data being stored or processed by MDSW’s has become a valid concern for manufacturers not only in the development phase but also during the product maintenance.

Susceptibility to malware is a scaling concern as the software component in several MSDW’s becomes more complex. Manufacturers must be prepared to assess security risks, detect compromise, and recover from any data breach incidents.

Designing patent protection and copyright registrations are some of the primary measures that can be taken to protect MDSW’s. Additionally, cybersecurity measures based on cryptography, digital signatures, and frequent integrity checks, may help protect system programs and data against unauthorized manipulation.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Conclusions Regarding Software as a Medical Device and 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=””]

In conclusion, increased use of software as medical devices has undeniably improved several aspects of patient care and management. However, security breach of MSDW’s has presented itself as a justifiable risk and this may present as a challenge to the manufacturer and regulatory agencies to ensure adherence to conformity assessments.

The qualification criteria and classification rules detailed in the EU regulation – 2017/745 – MDR and 2017/746 – IVDR addresses gaps between standalone and incorporated software devices. The requirements help manufacturers and agencies navigate through a well laid out system while the stringent guidelines also drive manufacturers to adopt continued data protection measures.

Ensuring precise classification, adequate clinical evidence, and appropriate risk mitigation procedures play key roles in addressing and improving patient safety and device performance to successfully place a device on the market.

[/fusion_text][fusion_imageframe image_id=”5611|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=”Regulatory Compliance MDSW EU MDR – Medical 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=””]https://www.celegence.com/wp-content/uploads/2020/05/Regulatory-Compliance-MDSW-EU-MDR-Medical-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=”4″ font_size=”” animated_font_size=”” 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=”” margin_top_small=”” margin_bottom_small=””]

Key Takeaways For Software as a Medical Device Manufacturers

Software must adhere to the definition of a medical device under the MDR
To classify a software, key questions pertaining to the devices intended use and purpose must be answered
Implementation rules of Annex VIII help address the applicability of software:
- Implementation Rule 3.3, states that ‘Software, which drives or influences the use of a device, shall fall within the same class as the device’ and ‘If software is independent of any other device, it shall be classified in its own right’
- Implementing rule 3.5 states ‘If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device’s intended purpose, the strictest rule and sub-rule resulting in higher classification will apply’
Up-classification of MSDW’s will require approval from notified body prior to marketing in the EU

While you integrate modern product development methodology to compete with fast-paced innovation, partner with Celegence to ensure regulatory compliance of your MDSW to successfully place the device on the market.

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

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Implications of COVID-19 on the Medical Device and Diagnostics Industry

22 Apr, 2020

[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=”5554|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=”Implications of COVID-19 on the Medical Device and Diagnostics Industry” 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=””]https://www.celegence.com/wp-content/uploads/2020/04/Implications-of-COVID-19-on-the-Medical-Device-and-Diagnostics-Industry.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=”” 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=”” margin_top_small=”” margin_bottom_small=””]COVID-19 Impact on the Medical Device and Diagnostics Industry[/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 SARS-CoV-2 pandemic and the unprecedented nature of this health crisis poses significant strain to the global life sciences industry. Amid uncertainty, both governing and regulatory bodies are working nonstop to ensure guidelines are set in place to aid the medical device industry in reacting to this crisis.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Deferral of EU MDR Enforcement Due To COVID-19[/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 order to prioritize the health sector’s fight against COVID-19, and as detailed in our MDR Timelines update, the European Commission released a proposal on April 3rd, 2020 that it would defer the enforcement of the EU Medical Devices Regulation (MDR) for a year effective from May 26th, 2020. As for the In Vitro Diagnostic Regulation (IVDR), which will be applicable from May 26th, 2022, the Commission stated that the respective stakeholders will have to implement the new IVDR within the fixed transition timelines.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]

European Commission Statement Re EU MDR and Coronavirus

The official statement released by the Commission stated:

“As the coronavirus crisis increases demands for certain vital medical devices, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation.”

The Commission further stated that with a view to avoid disruption of the device market at such a critical time, the year-long delay will not alter the substance of MDR. Moreover, the delay will “not impose new obligations on the concerned parties. It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, a one-year deferral as regards the date of application of certain provisions of that Regulation.”

[/fusion_text][fusion_imageframe image_id=”5555|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=”Recommendation EU 202 403 – Celegence – COVID-19″ 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=””]https://www.celegence.com/wp-content/uploads/2020/04/Recommendation-EU-202-403-Celegence-COVID-19.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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Recommendation (EU) 2020/403[/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 European Commission published Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures to ensure that the industry can quickly respond to the increased demand of medical devices generated by the public health crisis, which addressed the shortage of Personal Protective Equipment (PPE) necessary in the context of the COVID-19 outbreak.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]What Does Recommendation (EU) 2020/403 Suggest?[/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 context of the current COVID-19 outbreak, the guidance document enables supply chains by allowing more devices, including Personal Protective Equipment (PPE) to be placed on the market quickly. It addresses the way in which economic operators have redesigned manufacturing lines and/or diversified supplier base in order to keep up with the increasing demands thereby reducing the risks of first responders and medical professionals.

The document suggests:

The directives address the COVID-19 outbreak as a public health crisis. Therefore, on a duly justified request Member States may authorize placing individual devices on the market within the territory of the Member State concerned, for which the conformity assessment procedures haven´t been carried out yet.
The Commission has agreed with the European Standardization Organizations that several standards are made fully available by the national standardisation bodies allowing manufacturers to download these without cost from the online catalogues of the national standardization bodies.
Additionally, the recommendations by the Commission is accompanied by a guidance document on conformity assessment procedures for PPE (such as surgical masks, exploration gloves and gowns).
The recommendation discusses the off label use of a medical device and states that when necessary to use an existing medical device for a purpose or in a way different from that intended by the manufacturer, risks and benefits to the patient are to be carefully assessed.
The following factors may be included in the assessment of the off-label use of the devices:
- Documented risk assessment in device use
- Suitable precautions to minimize risks
- Reviewing risk assessment at suitable periods
- Consideration of ethical and legal implications
- Obtaining necessary approval from competent authorities when required
Derogations allow national authorities to place certain devices on the market even if the conformity assessment procedures have not been carried out yet.
In cases of assessing the need for a derogation, the national competent authority in a Member State may consider factors such as:
- The degree of criticality of the use of the device for the protection of health
- Availability of suitable substitutes
- Documentation of compliance with a harmonized standard or other specific technical solutions ensuring fulfilment of the applicable essential requirements laid down in the relevant Directive
- Review of reports of tests performed by competent bodies
- Indications from vigilance and/or market surveillance
The recommendation mentioned that the derogation should be temporary and the period of validity limited to what is strictly required for rendering the device compliant with the legislation or, if earlier, when suitable substitutes can be expected or the critical needs will no longer be present.
The guideline also stated that clinical investigations that may have started prior to May 26, 2021 in accordance with the MDDs can be continued. However, serious adverse events need to be reported in accordance with MDR.
The Council has also rejected the proposal of the EC to change the date of obligation to place UDI (unique device identification) carriers on the label and packaging of devices.

Facilities can approach authorities for remote surveillance and recertification procedures. Manufacturers with good conformity will be approved for remote audits. Facilities that may require an on-site visit to verify the implementation of corrective actions or have a high number of nonconformities may not substitute their surveillance or recertification audit with a remote 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=”” 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=”” margin_top_small=”” margin_bottom_small=””]

Remote Audit Requirements for Facilities

Facilities requesting for remote audits must adhere to requirements such as:

Communication technologies and tools to be available while adhering to data privacy and security norms
Required documentation such as audit plans, audit report, Nonconformity Grading and Exchange (NGE) form, etc. to be prepared
Notified bodies to clearly document that “the audit was performed remotely” and record any aspect of the remote audit that may have not yielded confidence which an on-site audit would have
The remote surveillance will primarily focus on activities that can be verified remotely, and elements that cannot be verified will be listed in the audit report as deviations to the plan and added to the next on-site audit

Successful remote audits will be issued with validity for 6 months and will be followed by an on-site audit within six months. A successful verification of the recertification process may lead to a certificate with a maximum validity period of 3 years calculated from the expiry date of the prior certificate. In cases where the verification process was unsuccessful, the certification shall be suspended.

[/fusion_text][fusion_imageframe image_id=”5556|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=”Additional Guidance Contained in the IAF – COVID-19″ 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=””]https://www.celegence.com/wp-content/uploads/2020/04/Additional-Guidance-Contained-in-the-IAF-COVID-19.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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Additional Guidance Contained in the IAF[/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 guidance also suggests that notified bodies may consider additional guidance contained in the IAF (International Accreditation Forum) documents while accounting for existing recent audit results with exception of any guidance which contradicts this transmittal.

The guidance ultimately states the notified bodies should consider extraordinary measures on a case-by-case basis to ensure the continual supply of medical devices during the pandemic restrictions.

Considering co-decision to be a normal lengthy procedure to reach conciliation, there may be a possibility for EU to indicate enforcement discretion to ensure devices reach patients after May 26, 2020.

Collectively, the notified bodies, manufacturers, and regulatory agencies continue to co-ordinate to maximize efficiency, while implementing the requirements of the MDR amidst the distress as the world navigates through the evolving pandemic.[/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]Celegence can provide you with subject-matter experts, including both regulatory professionals and medical doctors with the relevant device expertise to help you through the MDR process during the COVID-19 pandemic. Our team of MDR experts would love to partner with you in delivering regulatory compliance end-to-end. For more information, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities

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IMDRF & Summary of Recent Changes to Clinical Evaluation Guidance

16 Apr, 2020

This article aims to help manufacturers understand how the International Medical Device Regulators Forum (IMDRF) can assist you in designing compliant regulatory strategies, and how to access the extensive catalogue of guidance documents. The following is the eighth blog in the series related to the recent and impending updates to EU MDR 2017/745. In this blog, we will provide useful insights on some key topics and latest updates from the IMDRF.

To learn more about the EU MDR changes you can view some of the previous posts in the series:

[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Who are the IMDRF?[/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 International Medical Device Regulators Forum or IMDRF is a voluntary group of medical device regulators from around the world who came together to build on the influential foundational work created by the Global Harmonisation Task Force on Medical Devices (GHTF), with an aim to accelerate international medical device regulatory harmonisation and convergence.

The group was founded in October 2011 by representatives from Australia, Brazil, Canada, China, EU, Japan, and the US as well as World Health Organisation (WHO) representatives. The purpose of this group is to provide a forum for members to deliberate and provide state of the art (SOTA) guidance on strategies, policies, and direction. The group works with other stakeholders such as industry Subject Matter Experts (SMEs), academia, healthcare professionals, and consumer and patient groups. The IMDRF sets up working groups that are responsible for collaborating on a variety of topics and developing technical documentation for the industry. A list of the current/closed work items is available 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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Differences Between IMDRF and GHTF[/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=””]GHTF was also a voluntary group of representatives of global regulatory authorities from the US, EU, Canada, Japan and Australia that were divided into three regions, Europe, Asia-Pacific and North America. It was disbanded in late 2012, and the IMDRF appropriated the work undertaken by GHTF. Although they share the same goal of harmonising the regulatory landscape across the world, the difference lies in the constitution of the working groups − GHTF was primarily made up of regulators and industry, while IMDRF involves many other key stakeholders, and works much more collaboratively than GHTF. Among others, the five key study groups of IMDRF focus on: Regulatory Systems, Vigilance, Quality Systems, Auditing Practices, and Clinical Practices.[/fusion_text][fusion_imageframe image_id=”5537|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=”Who Are the IMDRF – Celegence – Medical Device Regulators” 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=””]https://www.celegence.com/wp-content/uploads/2020/04/Who-Are-the-IMDRF-Celegence-Medical-Device-Regulators.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=”” 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=”” margin_top_small=”” margin_bottom_small=””]IMDRF – Recent Decisions and Work Items[/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 IMDRF publishes documents that are open to members of the public to review and provide comments on the text. A date for the completion of the consultation period is printed on the consultation document, along with an email address to share comments addressed to the group. Should you want to add comments to any of the consultation documents issued, you will need to complete the comments template, that you can find on the IMDRF website. Some of the recent consultation documents published by IMDRF are ‘Competence and Training Requirements for Regulatory Assessors’, ‘Principles of IVD classification’ and ‘Regulatory Authority Assessment Method for Recognition and Surveillance of MD Conformity Assessment Bodies’. The documents are easy to follow and assist in interpreting the regulatory requirements with ease.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Clinical Evaluation Working Group of IMDRF – Final Guidance[/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 Evaluation Working Group of IMDRF issued a final guidance relating to clinical investigations, clinical evaluation, and key definitions relating to clinical evidence in October 2019 (IMDRF MDCE WG/N56FINAL:2019). This document supersedes the guidance document published by GHTF (GHTF/SG5/N2R8:2007). Together with the MEDDEV 2.7/1 rev 4 guidelines, the IMDRF guidance document provides detailed and easy to follow guidance on how to fulfil the requirements stipulated in MDR 2017/745.
Some key topics from the Clinical Evaluation guidance document are discussed below.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Key Topics from the Clinical Evaluation Guidance Document[/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=””]

Overview of Clinical Evaluation

The structure of the document walks you through the basics, covering topics such as “what is a clinical evaluation”, “why is a clinical evaluation important”, and “what is the clinical evaluation process”. It has detailed flow charts outlining “the stages of a clinical evaluation”. Software as a Medical Device and In-vitro Diagnostic Devices (IVDs) are specifically addressed. The document also provides guidance on how to effectively build literature searching strategies, how to use other clinical data, such as clinical investigations. It advises how to appraise/analyse the clinical data correctly and what should be detailed in the CER report. A list of considerations for comparability of devices and a suggested format for a Literature Search Report are provided as Appendices to the Guidance Document.

Frequency of Updates to the Clinical Evaluation Report (CER)

The IMDRF document states that the CER should be updated periodically. This frequency should be laid out in the clinical evaluation plan if you look at other guidance documents, e.g. MEDDEV 2.7.1 Rev4. It is expected that the CER should be ‘actively’ updated at least annually for high risk or new devices, and every 2 to 5 years for lower risk, well-established devices. A justification for the frequency of updates will be required. For all risk classifications of devices, the CER will need to be updated whenever new information from the Post Market Surveillance (PMS) affects the evaluation or its conclusions, the data from the risk management system should link into the CER making it an iterative process feeding back to the labelling, if necessary.

Qualifications of Report Authors and Evaluators

Section 5.0 General principals provide information relating specific requirements for the expertise and experience of CER authors and evaluators, “the clinical evaluation should be conducted by a suitably qualified individual or individuals. A manufacturer must be able to justify the choice of the evaluator(s) through reference to qualifications and documented experience” typically this would include a relevant higher education degree and five years’ related professional experience, or ten years’ professional experience if a degree is not considered a prerequisite for the task. Deviations from these requirements should be documented and duly justified. All evaluators must now make a declaration of interest, that should be appended to the final clinical evaluation report.

Equivalence

The criteria (clinical, technological, biological) are unchanged, but more information on how this should be documented and factors which could affect the demonstration of equivalence are provided. In particular, requires that design differences and their impacts on clinical safety and performance be described in detail, that comparative drawings and diagrams should be provided, and that each device with which equivalence is claimed must meet all three equivalence criteria. It may be necessary to undertake further testing to support equivalence.

The Scientific Validity of Data

Section 6.1 Identifies the datasets that are the most important in contributing to the demonstration of the overall performance of the medical device and, particular performance characteristics. It outlines why they are considered to be pivotal, and how they demonstrate the performance of the medical device collectively (e.g. consistency of results, statistical significance, the clinical significance of effects) with greater emphasis on demonstrating the scientific validity of data, including statistical considerations. Manufacturers need to address factors which can affect the scientific validity of different types of datasets. Besides, clarifying and explaining critical details throughout the document for each stage of the clinical evaluation process: factors which could affect the completeness, objectivity or weight of data should be described, including literature search and retrieval methods, identify the datasets that are considered to be the most important in contributing to the demonstration of the overall performance of the medical device and, where useful, particular performance characteristics.

Access to Data for Equivalent Devices

MEDDDEV 2.7.1 rev4 also requires that the Notified Body challenge the manufacturer’s access to data on the equivalent device(s) (Appendix A12.2.3); this is considered a transition point for the Regulation, which will require a manufacturer to have a contract in place allowing access to data for competitor devices with which equivalence is claimed.

Risk-benefit Analysis

The evaluation and quantification of benefits and risks and the assessment of the overall risk-benefit profile. The value of post-market data, and factors which could affect the statistical validity of the evaluation of this data, are addressed in some detail. The guidance eludes to the fact that the overall goal of the analysis stage is to make a benefit/risk determination if the appraised data sets available for a medical device collectively demonstrate the safety, clinical performance and effectiveness of the device in relation to its intended use.

Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF)

Throughout this guidance, it repeatedly states the links between clinical evaluations, PMS is reinforced. To ensure that post-market activities, manufacturers are expected to implement and maintain surveillance programs that routinely monitor the safety, clinical performance and effectiveness of the medical device as part of their Quality Management System. For more info see the PMCF Requirements for EU MDR.[/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_imageframe image_id=”5538|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=”IMDRF Changes EU MDR – Celegence – Medical Device Regulators” 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=””]https://www.celegence.com/wp-content/uploads/2020/04/IMDRF-Changes-EU-MDR-Celegence-Medical-Device-Regulators.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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Changes to IMDRF Clinical Evaluation Guidance – 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=””]The IMDRF website provides a repository of technical information to help manufacturers build effective regulatory strategies. The resources have been compiled by regulators and industry experts and serve to provide useful pragmatic guidance documents that help to interpret the regulations/directives. These documents should be used in combination with other guidance documents, e.g. MEDDEVs. They are designed to complement one another. When developing regulatory strategies, manufacturers should always consult the IMDRF website and check for the latest updates.[/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” 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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]Celegence can provide you with subject-matter experts, including both regulatory professionals and medical doctors with the relevant device expertise to complete this type of work for you or supplement your internal teams as needed. Our team of MDR experts would love to partner with you in delivering regulatory compliance end-to-end. For more information, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities

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Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs)

01 Apr, 2020

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Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs)

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” 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=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Welcome to the seventh post in our series of blogs related to some of the key challenges encountered by medical device manufacturers due to the recent updates to EU MDR. In this post we will focus on the Clinical Evaluation Reports (CER) and Plans (CEP). As of the latest regulatory changes, there is an increased emphasis on the detailed and transparent documentation of clinical data to ensure a thorough evaluation process. This includes stricter scrutiny on the sources and relevance of all kinds of clinical evidence as well as non-clinical or preclinical evidence used to support clinical documentation specially CEP and CER.

This post will focus on the EU MDR and Clinical Evaluation Reports (CER). Read our other posts about understanding:

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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” marquee_direction=”left” marquee_speed=”15000″ 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=”” title_link=”off” link_url=”” link_target=”_self” 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″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Overview of EU MDR and Clinical Evaluation Reports (CER)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” 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=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Production and distribution of medical devices in Europe is strictly governed by EU MDR regulations. It aims to ensure high standards of quality and safety for medical devices, replacing the previous Medical Device Directive (MDD) and the Directive on Active Implantable Medical Devices.

Key aspects of the EU MDR include:

Stricter Clinical Evaluation Requirements: Devices must undergo rigorous clinical evaluations to ensure safety and performance.
Enhanced Traceability: The regulation mandates a unique device identification (UDI) system to improve traceability.
Post-Market Surveillance: Manufacturers are required to continuously monitor the performance and safety of their devices once they are on the market.
Transparency and Documentation: Increased transparency through the European database on medical devices (Eudamed) and detailed technical documentation requirements.

These regulations are crucial for maintaining patient safety and fostering innovation in the medical device industry. A Clinical Evaluation Report (CER) is one of the crucial documents required under the EU MDR. It involves the assessment and analysis of clinical data related to a medical device to verify its clinical safety and performance. The CER must be continuously updated with new clinical data as it becomes available, ensuring ongoing compliance with the EU MDR.[/fusion_text][fusion_imageframe image_id=”20868|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Regulatory Challenges Medical Device Manufacturers” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ 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/2020/04/Regulatory-Challenges-Medical-Device-Manufacturers.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” marquee_direction=”left” marquee_speed=”15000″ 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=”” title_link=”off” link_url=”” link_target=”_self” 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″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Regulatory Challenges for Medical Device Manufacturers[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” 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=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Medical device manufacturers face several regulatory challenges that can impact their operations and market access. They, like all businesses, expend their limited resources very carefully, making it difficult to invest equally in all products.

Evolving Regulations: Regulatory frameworks, such as the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), are continuously evolving. Keeping up with these changes requires significant resources and constant monitoring.
Clinical Evidence Requirements: Manufacturers must provide robust clinical evidence to demonstrate the medical device safety and efficacy. This often involves extensive clinical trials and data collection, which can be time-consuming and costly.
Global Compliance: Different countries have varying regulatory requirements. Navigating these diverse regulations can be complex, especially for companies operating in multiple markets. For instance, the Medical Device Single Audit Program (MDSAP) aims to streamline audits across several countries, but it still requires thorough preparation.
Cybersecurity: With the increasing integration of digital technologies in medical devices, ensuring cybersecurity has become a critical regulatory requirement. Manufacturers must protect patient data and device functionality from cyber threats.
Supply Chain Management: Ensuring that all components and materials used in medical devices comply with regulatory standards is a significant challenge. This involves rigorous supplier audits and quality control measures.
Post-Market Surveillance: Manufacturers are required to continuously monitor the performance of their devices once they are on the market as part of post-market surveillance requirements. Reporting of adverse events and implementation of corrective actions is also required under new provisions.

Addressing these challenges requires a proactive approach, including investing in regulatory expertise, adopting advanced technologies for data management, and maintaining robust quality management systems (QMS). Streamlining these processes is essential for medical device manufacturers to ensure efficiency and compliance.

EU MDR Checklist mostly includes

General Administrative Information
Applicable Legislation
General Safety and Performance Requirements (GSPRs)
Clinical Evaluation
Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
Summary of Safety and Clinical Performance (SSCP)

The EU Commission has also introduced additional guidance documents to help manufacturers navigate the new requirements, including templates for clinical evaluation plans and reports that align with MEDDEV 2.7.1 Rev 4. These guidelines and checklist items are essential for ensuring compliance with the EU MDR and maintaining market access in the European Union.[/fusion_text][fusion_imageframe image_id=”20867|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Notified Bodies Requirements Medical Devices – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ 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/2020/04/Notified-Bodies-Requirements-Medical-Devices-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” marquee_direction=”left” marquee_speed=”15000″ 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=”” title_link=”off” link_url=”” link_target=”_self” 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″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Notified Body Requirements for Medical Devices[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” 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=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Notified bodies play a crucial role in the conformity assessment of medical devices before they can be placed on the market in the EU. They are designated by an EU Member State or other countries under specific agreements. They must meet stringent requirements related to organizational aspects, quality management, resources, and processes.

They assess whether medical devices comply with the MDR or IVDR which includes examining the technical design, testing the products, reviewing compliance documentation. Auditing manufacturer quality management system and performing products checks. Due to the difference in the type and risk of devices the process of audit becomes very complex. However irrespective of differences in price sales complexity of the products they still have to go through similar stringent rules for certification. The involvement of a notified body depends on the classification of the medical device. For example, Class I devices that are sterile, have a measuring function, or are reusable surgical instruments, as well as Class IIa, IIb, and III devices, require a notified body[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ 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=”” title_link=”off” link_url=”” link_target=”_self” 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″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Clinical Evaluation Report[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” 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=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]A Clinical Evaluation Report (CER) is a comprehensive document that summarizes the clinical evaluation process for a medical device. It is essential for demonstrating the safety and performance of the device, particularly for regulatory approval in the EU under the Medical Devices Regulation EU 2017/745 (MDR).

These documents are mandatory mostly and are essential for manufacturers to obtain the CE certification. A Notified body shall audit all the CER except the class I products which are self-certified. The first important part of creating a CER is to prepare a CEP, which details the plan on how the evidence will be presented from which sources will they be obtained for the subject devices. Next step is to identify any clinical gaps in the clinical evidence for the subject device. Once done the quality appraisal and scientific validity of the clinical data is evaluated which is the third step. And the last but not least important part of CER is the evaluation of evidence that the device complies with GSPR.

Major important sections of CER are:

Scope and Plan: Define the scope of the clinical evaluation and create a detailed plan outlining the objectives, methodology, and timelines
Identification of Data: Gather relevant clinical data from various sources, including clinical investigations, scientific literature, and post-market surveillance (PMS) data.
Appraisal of Data: Assess the quality and relevance of the collected data. This involves evaluating the scientific validity and applicability of the data to the device in question.
Analysis of Data: Analyze the clinical data to determine the device’s safety and performance. This includes assessing the benefit-risk profile, identifying residual risks, and addressing any uncertainties or unanswered questions.
Compilation of the Report: Summarize the findings in a structured report. The CER should include:
- General information about the device and manufacturer
- Description of the device’s intended purpose and technical characteristics
- Summary of clinical data and its appraisal
- Analysis demonstrating conformity with relevant safety and performance requirements
Continuous Updates: The CER is a living document that should be regularly updated with new clinical data especially from post market surveillance activities.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ 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=”” title_link=”off” link_url=”” link_target=”_self” 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″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Navigating Regulatory Challenges with Expert Assistance[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” 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=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Navigating regulatory challenges can be complex, but expert assistance can significantly streamline the process. Celegence offers tailored consulting services to help manufacturers navigate the complex regulatory landscape. Our experts provide strategic advice and hands-on support to optimize the clinical evaluation process. With the help of our experts, you can easily navigate through complex regulations, ensure global compliance and make sure your product meets all necessary standards for international markets.[/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 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margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Clinical Evaluation Reports (CER) Specialists

Our medical writing specialists in Clinical Evaluation process can provide invaluable support to medical by ensuring compliance with regulatory requirements and streamlining the CER preparation process. Our regulatory experts have in-depth knowledge of regulatory guidelines, such as the EU Medical Device Regulation (MDR) and FDA requirements and we ensure that the CER meets all necessary standards as per market standards. By leveraging the expertise of our CER specialists, manufacturers can ensure their clinical evaluation reports are thorough, compliant, and ready for regulatory submission.

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FDA Medical Device Registrations – 510(k) Submissions

25 Mar, 2020

Based on the changes being made to the product, there are different types of 510(k) submissions that a manufacturer can choose. These are Traditional 510(k), Special 510(k) and Abbreviated 510(k) pathways, each associated with different review timelines. Manufacturers qualifying for a Special 510(k) are at an advantage owing to the 30-day submission processing in comparison to the 90-day submission processing timeline for a Traditional and Abbreviated 510(k).

Celegence can help you identify if your medical device qualifies for a Special 510(k) and you can benefit from the reduced processing time for your 510(k).[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Different Types of 510(k) Submissions[/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=””]Based on the changes being made to the product, there are different types of 510(k) submissions that a manufacturer can choose. These are Traditional 510(k), Special 510(k) and Abbreviated 510(k) pathways, each associated with different review timelines. Manufacturers qualifying for a Special 510(k) are at an advantage owing to the 30-day submission processing in comparison to the 90-day submission processing timeline for a Traditional and Abbreviated 510(k).

Celegence can help you identify if your medical device qualifies for a Special 510(k) and you can benefit from the reduced processing time for your 510(k).[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]The Special 510(k) Pathway – Medical Device Submissions[/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 Special 510(k) pathway was previously limited to review of changes to a cleared device that did not impact its intended use or alter the device’s fundamental scientific technology. In a newly published FDA guidance, FDA has revamped this approach to make this pathway more inclusive by allowing for certain intended use changes and technological changes with well-established qualification methods to be reviewed under a Special 510(k).

Manufacturers can submit their device modifications as a Special 510(k) if they meet the following minimum requirements:

The proposed change is submitted by the manufacturer legally authorized to market the existing device meaning the modification must be made to manufacturer’s own device
Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change; and
All performance data necessary to support substantial equivalence (SE) can be reviewed in a summary or risk analysis format.

The FDA guidance document “The Special 510(k) Program” issued September 13, 2019 provides information and examples of types of intended use and technological changes that may be eligible for this pathway.[/fusion_text][fusion_imageframe image_id=”5468|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=”Not All Device Modifications Require a 510(k) Submission – 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=””]https://www.celegence.com/wp-content/uploads/2020/03/Not-All-Device-Modifications-Require-a-510k-Submission-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=”” 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=”” margin_top_small=”” margin_bottom_small=””]

Not All Device Modifications Require a 510(k) Submission

It is important to understand that not all modifications to a device require a 510(k) submission (21 CFR 807.81 (a)(3)). A risk-based approach is necessary to determine if the change triggers a 510(k) to FDA. This determination is made in consultation with FDA guidances ‘Deciding When to Submit a 510(k) for a Change to an Existing Device’ and ‘Deciding When to Submit a 510(k) for a Software Change to an Existing Device’. After this decision is made, the eligibility for a Special 510(k) can be determined based on the performance testing (if any) that are needed to qualify the change. The specific considerations for this determination is provided as a flowchart in the guidance document.

The first consideration in determining eligibility is whether the change is being made to manufacturer’s own device. The Agency is relying on previous detailed review of the same product and the robustness of the manufacturer’s design control processes through this question.

The next consideration is whether performance data is needed to evaluate the change. Some changes may be based on scientific rationale in which case the Special 510(k) needs to be accompanied with a clear rationale explaining why performance data was not deemed necessary.

In cases where the design control process leads to need for additional verification or validation testing, the next consideration is whether a well-established method exists for evaluation of the change.

The well-established methods include:

The submitter’s methods, protocols, and acceptance criteria used to support the previously cleared 510(k) that can be applied to the subject 510(k);
Methods found in an FDA-recognized voluntary consensus standard or FDA guidance document;
Qualified medical device development tools (MDDTs); or
Widely available and accepted methods published in the public domain, scientific literature, or found acceptable by FDA through the submitter’s own 510(k)-clearance, a granted De Novo classification request, or premarket application (PMA) approval.

Note that not all devices have product specific guidance documents or applicable consensus standards. In such cases, use of same test methodology as described in a previous 510(k) or other pre-market applications is a suitable alternative.

The final consideration is whether the data generated can be reviewed in a summary or risk analysis format. Submission of complete test reports defeats the purpose of a Special 510(k) and may lead to conversion of the submission to a Traditional 510(k). The results from verification and validation need to be provided in a summary format or risk analysis format. This information should be sufficient to establish SE to the predicate device.

The specific instances where FDA believes a Special 510(k) is not appropriate is also described in the guidance document. This includes situations where FDA would need to review complete test reports in order to determine SE.

Convert A Special 510(k) to a Traditional 510(k)

[/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=””]FDA can convert the Special 510(k) to a Traditional 510(k) if SE determination cannot be made through information submitted in a Special 510(k). Such decisions have FDA management concurrence and are typically conveyed to the submitted during Refuse To Accept (RTA) review process. This type of conversion results in delays as the content of the Traditional 510(k) varies from a Special 510(k) and this data gap needs to be fixed for a complete review. Therefore, in cases where there are deviations from well-established methods and the manufacturer is unsure about use of Special 510(k) pathway, a Pre-Submission meeting with FDA can be considered to ensure success of the regulatory strategy.[/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=”” 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=”” 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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=”5469|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=”FDA Guidance Interpretation Specialists – 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=””]https://www.celegence.com/wp-content/uploads/2020/03/FDA-Guidance-Interpretation-Specialists-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=”” 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=”” margin_top_small=”” margin_bottom_small=””]FDA Guidance Interpretation Specialists[/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 provides regulatory strategy consulting and can help you navigate the complexities of FDA guidance interpretation and FDA interactions. Reach out to us at info@celegence.com or contact us online for more information.[/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″ 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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=”” 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Medical Devices with Ancillary Medicinal Substances (Combination Products)

11 Mar, 2020

In this post we’ll detail the changes the new EU MDR will have on medical devices with ancillary medicinal substances (combination products).[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Defining the Correct Regulatory Pathway for 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=””]It can be challenging to determine the classification of your product under EU MDR 2017/745. To correctly understand if your product falls under the medicinal product directive or medical device regulation, you first need to evaluate the (PMOA) Primary Mode of Action.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Defining A Medical Device – 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=””]

A ‘medical device’ is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

Defining A Medicinal Product – EU MDR

[/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=””]A medicinal product example could be wound treatment product for delivery of an antimicrobial product whereby the PMOA is either (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or to making a medical diagnosis. For example, a wound dressing with an antimicrobial coating or a heparin-coated catheter are medical devices per the definition in Article 2 of the EU MDR 2017/745.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Devices With An Ancillary Medicinal Substance – 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=””]

Devices which incorporate an ancillary medicinal substance or combination products, such as drug-eluting stents or metered-dose inhalers, contain a medical device component which acts as the delivery system of the integral drug element. To be considered a device-drug and fall under the EU MDR, the PMOA should be achieved by the device part with the substance having an ancillary action. EU MDR Article 1 Subject Matter and Scope subpoint (8) states:

“Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation”.

EU Medical Device Regulation (MDR) 2017/745
EU In Vitro Diagnostics Regulation (IVDR) 2017/746
MEDDEV guidelines

Medicinal Products Directive:

Regulation 726/2004: Establishment of European Medicines Agency (EMA)Directive 2001/83/EC Medicinal products for human use
Amended Directives 2002/98/EC; 2004/24/EC and 2004/27/EC.

[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Documentation Requirements[/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 combination products, the documentation should be compiled in accordance with the relevant regulation either IVDR Annex II or MDR Annex II. For the drug section, requirements set out in Notice to Applicants Volume 2B are applicable. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/b/update_200805/ctd_05-2008_en.pdf eCTD format.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Guidance Documents from The European Medicines Agency (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=””]The European Medicines Agency (EMA), which oversees the European Union’s pharmaceutical market, published draft guidelines on Medical Devices Regulation (MDR) in 2019 for manufacturers of combination products with drug and medical device elements. The guidelines address Article 117 of the MDR, which will establish new compliance obligations for drug-device combination products. It is expected that the final text will be issued ahead of the May 2020 MDR deadline. https://www.ema.europa.eu/en/quality-requirements-drug-device-combinations

Guidance from the EMA relating to the procedural aspects as well as format and data requirements to facilitate the consultation procedure to the European Medicines Agency (EMA) by notified bodies can be found here: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-recommendation-procedural-aspects-dossier-requirements-consultation-ema-notified-body-ancillary_en.pdf (updated Jan 2020)

MEDDEV Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative https://ec.europa.eu/docsroom/documents/10328/attachments/1/translations is a helpful document, but this will need to be updated to incorporate the MDR requirements, as this is currently written to address MDD93/42/EEC requirements.[/fusion_text][fusion_imageframe image_id=”5444|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 Ancillary Medicinal Substances (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=””]https://www.celegence.com/wp-content/uploads/2020/03/Medical-Devices-with-Ancillary-Medicinal-Substances-Combination-Products-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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Consultation Procedure for Devices With an Ancillary Medicinal Substance[/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 consultation process for devices which incorporate an ancillary medicinal substance has not changed dramatically under the new regulation. Depending on the type of ancillary medicinal substances, a consultation with either the European Medicinal Component Authority (CA) or with the European Medicines Agency (EMA) is required.

Role of Notified Body

It usually is at the discretion of the notified body to choose who they feel is best suited to review based on previous experience and where the product will be sold. The consultation will include aspects of quality and safety of the drug substance alone, and also the usefulness of the drug into the device (clinical risk/benefit) of the ancillary medicinal substance. However, the notified body must consult the European Medicines Agency in the case of ancillary human blood derivative or medicinal products that fall within the scope of the Annex to Reg. (EC) No 726/2004.

The notified body will give due consideration to the opinion of the European Medicines Agency when making its decision. It will not deliver the certificate if the Agency’s scientific opinion is unfavourable. As part of this process, there will typically be a pre-submission meeting held, allowing the manufacturer and the notified body to meet with the CA or the EMA to have an opportunity to discuss the regulatory pathway. Scientific advice cannot be given during this meeting. Usually, the notified body should request this pre-submission meeting at least six months before the intended submission date. Once the review has taken place, the CA/EMA will issue a decision to the notified body. The consultation process should take no longer than 210 days, from receipt of a completed/valid application. However, should the information be missing or inadequate, then the clock is stopped until the required data is provided.

The recently published EMA document[2] discusses the requirements of Article 117 of the EU MDR 2017/745, and details requirements for Notified Body involvement of a medicinal product that incorporates a drug-device combination product. Article 117 of the has introduced amendments to Annex I section 3.2 (12) of (MPD) Medicinal Products Directive 2001/83/EC concerning the documents need to be submitted to the CA assessing Marketing Authorisation Applications (MAAs) for medicinal products incorporating a device as an integral part. These products are covered by the second subparagraph of Article 1(8) and the second subparagraph of Article 1(9) of the MDR.

The amended provisions of point 12 of Section 3.2 of Annex I to Directive 2001/83/EC, require applicants for Marketing Authorisation Applications (MAAs) of medicinal products incorporating as an integral part a device, to submit the results of the assessment of the device part with the relevant GSPRs set out in Annex I to the MDR. If the application dossier does not contain these results and where the conformity assessment of the device, if used separately, requires the involvement of a notified body, the applicant is required to provide an opinion on the conformity of the device with the relevant general safety and performance requirements (GSPRs) issued by a notified body. You should ensure that your notified body is appropriately accredited to render such opinions.

Obtaining marketing authorisation for devices which incorporate an ancillary medicinal substance is costly, time-consuming and can be challenging, especially if you are not familiar with the new requirements.

Most medical device companies are now familiar with the requirements of the new regulations; however, pharmaceutical regulatory teams may likely find themselves in uncharted waters. The planning stage is crucial to meet the deadlines in time and efficiently manage compliance timelines and expectations. Therefore, partnering with a specialist that understands the requirements is essential to minimise the regulatory risk, and ensure speed to market.

[/fusion_text][fusion_imageframe image_id=”5445|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 Ancillary Medicinal Substances (Combination Products) – EU MDR Specialists” 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=””]https://www.celegence.com/wp-content/uploads/2020/03/Medical-Devices-with-Ancillary-Medicinal-Substances-Combination-Products-EU-MDR-Specialists.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=”” 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=”” margin_top_small=”” margin_bottom_small=””]EU MDR Compliance Specialists[/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 can assist in navigating the medical device regulations and determining the way ahead for your device. Get in touch, speak to our experts – we can offer a partnership approach while helping you gain the necessary regulatory approvals.

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EU MDR Checklist – Key Timelines & Impact on Medical Device Companies

13 Feb, 2020

EU MDR Checklist Download – Get Actionable Technical Documentation Requirements

EU to Propose 1-year MDR Delay due to Coronavirus

Update Posted: 3rd April 2020
Medical device companies have been working to meet the implementation of the new MDR, scheduled for May 26, 2020. The European Commission is putting together a plan calling on the European Parliament and the Council in early April 2020 to postpone implementation of the current Medical Device Regulation (EU MDR) by one year considering the coronavirus pandemic. This measure is to reduce the burdens on the healthcare systems.

A one-year delay in the implementation of MDR will mark a significant shift in the EU strategy. This will ease the pressure from notified body authorities and the medical device industry and allow them to fully concentrate on urgent priorities related to the coronavirus crisis.

Despite the probable delay in MDR and IVDR implementations, most medical device manufacturers still have a lot to do in order to be ready when the transition does happen. The delay of date of application effects manufacturers of medical devices, notified bodies designated under current directives & old directives. Depending on where you are at with MDR remediation, our team can help you keep the momentum going. Celegence can provide gap analysis and cost-effective resourcing to ensure that you and your business are compliant with all of the EU MDR requirements.

Download the EU MDR checklist and let the spreadsheet identify gaps in your processes that need to be addressed to achieve MDR certification.[/fusion_alert][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=”” 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=”” margin_top_small=”” margin_bottom_small=””]What are the Deadlines for Transition to the European 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=””]

In May 2017 the new European MDR started a 3-year transition period. The key deadlines for the new EU MDR are:

May 2020 – completion deadline for the MDR
May 2022 – EC compliance certificates issued before May 27, 2017, expire
May 2024 – Available for all EC certificates issued five years from the date of issue/renewal, or four years from the application date of the MDR (May 27, 2020), whichever comes first
May 2025 – Can no longer sell or distribute devices certified under the MDD

[/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=”3″ font_size=”” animated_font_size=”” 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=”” margin_top_small=”” margin_bottom_small=””]Factors Medical Device Companies Need to Consider for New 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=””]If you are preparing to improve your device design early, you should consider taking the MDR certification approach. Keep in mind that notified body resources are currently overstretched. With only a handful currently designated, you want to start implementing your device portfolio strategy now, particularly if you have certificates that are due to expire.

A comprehensive quality system and the technical documentation needed for conformity assessment 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=”3″ font_size=”” animated_font_size=”” 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=”” margin_top_small=”” margin_bottom_small=””]Impact on MDD-certified Devices Already in the Distribution Chain after May 2020[/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 launched on the EU market in compliance with MDD / AIMDD before May 2017 will remain valid until expiration or until May 2024. Note the downsides associated with doing so, if you intend to follow a stockpiling devices approach as a bridge strategy to obtain MDR certification.

Notified bodies can no longer accept notifications of “substantial” design changes and approve them. This means the device cannot undergo substantial (and perhaps necessary) design changes, including labeling/packaging changes, manufacturing process improvements, or the addition of new features and functionality.
The devices will need to continue to comply with state-of-the-art criteria, including general specifications and recognised standards provided by the EU.
New MDR post market surveillance (PMS) requirements need to be implemented along with post market clinical follow-up (PMCF) requirements or justification as to why PMCF is not required.
Registration for all economic operators must still be completed; furthermore, quality arrangements between the supplier and the Authorized Representative (AR), the importer, and the distributors will need to be in place.
The MDR will also affect devices not intended for medical purposes, as they are now included in MDR Annex XVI. Products previously deemed questionable or outside the reach of the MDD are now or fall under a new classification as medical devices.
The new classification rules represent a step towards aligning the classifications of the EU and the US. Under the revised classification rules included in MDR Annex VIII, you need to assess whether any of your devices have moved to a higher classification.

[/fusion_text][fusion_imageframe image_id=”5357|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=”EU MDR Checklist – Guide to EU MDR Compliance – 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=””]https://www.celegence.com/wp-content/uploads/2020/02/EU-MDR-Checklist-Guide-to-EU-MDR-Compliance-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=”” 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=”” margin_top_small=”” margin_bottom_small=””]EU MDR Checklist: 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=””]Our regulatory experts have worked through the regulations, picking up the most minute compliance points and developing them into a 23-page checklist of actionable technical documentation requirements that you can use to ensure that you are meeting all EU device manufacturing mandates.

This checklist aims to provide a tool for manufacturers to use when assembling the technical documentation as part of CE marking requirements as set out in EU MDR 2017/745.

General administrative information
Applicable legislation & Device identification
General safety & performance requirements (GSPRs)
Clinical Evaluation (typically MEDDEV 2.7.1)
Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF)
Summary of Safety and Clinical Performance (SSCP)

Your company’s regulatory affairs, quality assurance & legal counsel team, will benefit from the checklist. Make sure you are compliant and sign up to receive the checklist today!

[/fusion_text][fusion_imageframe image_id=”5361|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=”New EU MDR – Compliance Experts – 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=””]https://www.celegence.com/wp-content/uploads/2020/02/New-EU-MDR-Compliance-Experts-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=”” 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=”” margin_top_small=”” margin_bottom_small=””]

Helping You With The New EU MDR Challenges

Celegence has a wealth of knowledge to help you navigate through the complex regulatory challenges that the new EU MDR bring. We can assist you throughout the entire process to ensure that you and your business are compliant with all of the EU MDR requirements.

[/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=”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=””]

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Selecting and Working With Your Notified Body for Entering European Market

23 Jan, 2020

Notified Bodies (NBs) in 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=””]Selecting the right Notified Body (NB) can be challenging. Which NB is right for your organization and what has changed with the introduction of the new EU MDR? Many small to mid-sized medical device companies are attempting to address these questions as they develop their MDR compliance strategies. In this article we will outline some of the criteria to use when selecting a Notified Body and how best to work with them within the European market.[/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=”” 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=”” 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=”” margin_top_small=”” margin_bottom_small=””]What Is A Notified Body?[/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=””]An NB is a public or private organisation designated by a competent authority of a member state of the European Union to carry out specific conformity assessment tasks specified in the European regulations. Until now, NBs have assumed more of a consultative role to help manufacturers meet CE marking requirements. Now, under the new MDR and IVDR, these organizations will serve as enforcers of the new regulations evaluating all applicable medical 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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Identification Criteria for 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=””]A critical point to consider when identifying a potential NB is whether it has been designated for the services needed for your device portfolio. Not all NBs can certify compliance with all conformity assessment procedures, nor are all device types necessarily covered. The first place that you need to look before choosing a NB is the New Approach Notified and Designated Organisations (NANDO) website, which is published and maintained by the European Commission. This is an electronic register that allows users to search for information related to notified bodies, including their location, the regulations that they are designated to, and conditions they may operate under, as well as exclusions, if any.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Notified Bodies Designated by the EU MDR 2017/745[/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 table below lists the notified bodies designated by the EU MDR 2017/745, along with their scope. It is essential to check for exceptions to the designations/scope; some NBs have indicated that they have been selectively including or excluding scope codes.[/fusion_text][fusion_table fusion_table_type=”2″ fusion_table_rows=”10″ fusion_table_columns=”4″ hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Notified Bodies Designated by the EU MDR 2017/745
Number	Notified Body Number	Name	Country
1	NB 0086	BSI Assurance UK Ltd	United Kingdom
2	NB 2797	BSI Group The Netherlands. B.V	Netherlands
3	NB 1912	DARE!! Service B.V.	Netherlands
4	NB 0344	DEKRA Certification B.V.	Netherlands
5	NB 0124	DEKRA Certification GmbH	Germany
6	NB 0051	IMQ INSTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.	Italy
7	NB 0197	TÜV Rheinland LGA Products GmbH	Germany
8	NB 0123	TÜV SÜD Product Service GmbH Zertifizierstellen	Germany
9	NB 0482	MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH	Germany

[/fusion_table][/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=”3″ font_size=”” animated_font_size=”” 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=”” margin_top_small=”” margin_bottom_small=””]Selecting A Notified Body[/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=””]At this point, it’s worth contacting and engaging in discussions with the respective NBs. Some are not taking on new clients and it may be useful to have this clarified at the outset. The next step is to arrange a face-to-face meeting, where you can ask all the questions that you may have. Manufacturers need to decide on the conformity assessment procedure they wish to follow to CE Mark their devices. Manufacturers should not wait until the last minute to select a notified body, as this process is quite lengthy.[/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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Increased Demand on Notified Bodies With the Introduction of 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=””]

Article 120 of the EU MDR 2017/745 does allow CE certificates issued by NBs before the 26th May 2017 to remain valid until their expiry date or at the latest until May 26, 2022. However, CE Certificates issued after May 26, 2017 will remain valid until their expiry date or until 26th May 2024.

With the introduction of MDR, there is much heavier scrutiny from the competent authority. The regulation has many specific requirements, creating an increase in NB workloads and decrease in NB availability. Prior to the introduction of MDR, 55 NBs accredited to audit medical devices under MDD 93/42/EEC, and 22 certified to audit IVDs under IVDD 98/79/EC, were listed on the NANDO database. The list that intended to apply for designation under MDR has shrunk significantly.

[/fusion_text][fusion_imageframe image_id=”5105|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=”Scarcity of Notified Bodies in EU – Celegence Life Science Regulation” 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=””]https://www.celegence.com/wp-content/uploads/2020/01/Scarcity-of-Notified-Bodies-in-EU-Celegence-Life-Science-Regulation.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=”” 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=”” margin_top_small=”” margin_bottom_small=””]

A Scarcity of Notified Bodies

A significant number of NBs exited the market because of the scarcity of skilled evaluators, which has created a significant bottleneck. According to – “Notified Bodies Members’ Intention to Apply to be Designated against MDR and/or IVD”– a document published by Team NB – it is intended that 23 of the larger NBs would apply for MDR designation. It is anticipated that higher risk classes will encounter delays in product approvals and slower device entry-to-market. Additionally, with notified bodies now required to review more significant volumes of data, the timelines for approvals/rejections have lengthened, increasing overall costs. In fact, this may result in long delays before the review process can even commence.

Impact of Brexit on Notified Bodies

Annex XII MDR lists specific requirements relating to Certificates issued by a NB. Under MDD, not all notified bodies explicitly listed product codes on CE certificates (other than Class III certificates); they permitted freedom, by defining a technology. Other notified bodies allowed matrix certificates, which contained the critical product parameters. Consequently, new products that fell within the scope of a matrix certificate and had specifications that fell within specifically defined parameters were automatically covered by the same CE certificate. However, MDR Annex XII, chapter II, states that each Certificate should contain unambiguous identification of the device. Other minimum content of the certificates are specified. Understanding how the NB will address these requirements are essential areas to be discussed when you have the initial face-to-face meeting with your potential NB.

[/fusion_text][fusion_imageframe image_id=”5113|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=”Notified Bodies EU MDR Service – Celegence Life Sciences Solutions” 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=””]https://www.celegence.com/wp-content/uploads/2020/01/Notified-Bodies-Regulatory-Challenges-Celegence-NB-in-EU.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=”” 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=”” margin_top_small=”” margin_bottom_small=””]Importance of Choosing the Right Notified Body[/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=””]

Device manufacturers planning to market their products in the EU should carefully identify the capabilities of the notified bodies under consideration before entering into a contractual relationship with such an organisation. Your chosen notified body must assess your company’s current and planned designs, technical documentation, and quality management system. You should assess your requirements as a medical device manufacturer, and whether the expertise and experience that your chosen NB holds and are willing to share is right for you. It is also important that from the beginning you have clarity on and fully understand what they deem as ‘significant change’ and that they have clear policies on handling product changes. Carefully choosing the right NB can save you time and money and increase your chances for successful marketing.

Selecting, swapping, and engaging with your NB are critical aspects for your business. Engaging with the right partner that holds the relevant expertise and passion for driving innovation forward is imperative for business growth. The potential threat of the lack of NB availability and the resultant delays is the industry not being able to supply medical devices to the patient/user, and the danger of stifling innovation; a situation best avoided!

Helping You With Notified Bodies and Regulatory Challenges

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