Brexit Changes to the Regulatory Process for the Life Sciences Industry

15 Jan, 2020

The Impact of Brexit on the Life Sciences Industry

Brexit – Changes to Marketing Authorization (MA)

Some of the biggest process changes involve the marketing authorization (MA) application. For example, where they don’t already have presence, it will become necessary to set up a marketing authorization holder (MAH) in the EU or European Economic Area (EEA), a legal requirement. Furthermore, the MA dossier must be assessed by a Reference Member State (RMS) that is not UK, which means in future the UK’s health authority, the MHRA, will not be able to evaluate an application for EU or EEA markets, nor act as an RMS or concerned member state (CMS). The UK will in essence be a “third-country” with a significant loss in EU procedural licence influences for pharma and medical device products.

MHRA – Loss of MHRA expertise that could be detrimental for scientific approval for the EU as the MHRA led 20% of scientific evaluations of new medicines in the EMA.
Potential Delays for UK Patients – countries such as Switzerland that possess a bilateral agreement with EU have a delay of approximately 157 days later than EU countries.

Regulatory Labeling, Package Inserts & Leaflets Post Brexit

The impact of Brexit extends to the naming of local representatives in the product information, since these individuals must be based in the EU or EEA. If the representative was UK-based in the past, amendments must be completed and implemented before Brexit.

The MHRA is also seeking to reduce the workload on companies by announcing that the UK will continue to accept batch testing carried out in certain countries on the whitelist – EU and EEA countries as well as those with which the EU have an agreement. The same approach will be applied to the certification by a Qualified Person (QP) responsible for ensuring the batch meets compliance requirements before releasing the batches. However, for products manufactured in a third country and directly imported into the UK, companies will need to ensure a UK-based QP certifies batch testing and that there is full compliance with good manufacturing practice guidelines.

Key Changes Regarding Qualified Person for Pharmacovigilance (QPPV)

[/fusion_title][fusion_imageframe image_id=”5067|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=”Brexit Changes Regarding Qualified Person for Pharmacovigilance QPPV – Celegence – Life Science” 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/Brexit-Changes-Regarding-Qualified-Person-for-Pharmacovigilance-QPPV-Celegence-Life-Science.jpg[/fusion_imageframe][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=””]Despite these steps to limit the work companies face with Brexit, there are several key changes, particularly with regards to pharmacovigilance and quality oversight of products. After Brexit, companies will no longer be able to have their EU Qualified Person for Pharmacovigilance (QPPV) in the UK. Additionally, assuming a no-deal situation, they will be required to have an equivalent UK QPPV for UK authorized products, and that person will be responsible for establishing and maintaining the UK pharmacovigilance system master file.[/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=””]

Life Science Companies & Hard Brexit

While negotiations between the UK and EU on a withdrawal plan continue, life sciences companies should prepare for the worst-case scenario – a hard Brexit. Having plans in place will help to ensure continuity of operations and smooth relations between UK and EU-based manufacturers and MAHs. Above all, the focus must remain on the patient – ensuring continued supply of medicines and meeting the health needs of the UK population.

Generic marketing authorizations granted before 30 March 2019 that are based on the reference product in UK will remain valid. Furthermore, bioequivalence studies with UK reference product may only be used in generic applications if an MA is granted before the above date.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” 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=””]Get Brexit Ready Now[/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 expert team at Celegence provide comprehensive regulatory services for the life sciences industry and can help you navigate current and future labeling challenges as they relate to the aftermath of Brexit. Make sure you and your business are Brexit ready and get in touch today.[/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_size=”” 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” 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″][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_size=”0″ 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” 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=”no”][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_size=”0″ 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” 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=”no”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

[fusion_fontawesome icon=”fa-info-circle fas” size=”35px” flip=”” rotate=”” spin=”no” alignment=”left” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” margin_top=”” margin_right=”10px” margin_bottom=”” margin_left=”” circle=”no” iconcolor=”#2da9e0″ circlecolor=”” circlebordercolor=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_fontawesome] For more information, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical regulatory labeling services.

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Medical Devices: Low-Risk Device Challenges MDR

08 Jan, 2020

Medical Devices in the EU: Low-Risk Device Challenges

EU MDR Classification Made Simple

There are ‘extra requirements’ for devices that fall into any of the following categories; sterile, reusable surgical or has a measuring function.

Understanding Conformity Assessment for Class 1 Medical Devices

[/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 only available Conformity Assessment route for self-certified class I devices is to create and maintain technical documentation in compliance with Annex II & III. For class I (other requirements Is, Im, Ir), a limited QMS should be in place to ensure production controls are in place, as is detailed in Annex XI-Part A, or you may choose Annex IX – Chapter I, depending on which route suits your needs.[/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=””]General Safety Performance Requirements Considerations for 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=””]Once determined, you should ensure that your products meet the relevant ‘General Safety Performance Requirements’ (GSPRs) listed in Annex I of the MDR and IVDR. The benefits of using the device must outweigh risks and achieve the claimed performance. This must be proven with supporting clinical evidence or investigation, chemical, physical and biological properties. The ‘General Safety Performance Requirements’ (GSPR’s), are based on the previous Essential Requirements laid out in the MDD 93/42/EEC and AIMD 90/385/EEC, however, they are now much more prescriptive (thankfully). You will now see specific requirements for products containing nano particles. Also requirements for usability have been called out in much more detail, focusing on protecting the ‘layperson’ and addressing specific use risks. Historically this has been a problematic area, causing much confusion to manufacturers about what is required for legacy devices and the best way to address the requirement.[/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=””]The regulation also calls out very specific requirements on what needs to be contained on the label. For instance,‘Unique Device Identification’ (UDI) is a new requirement, which is causing manufacturers many problems as new software, systems and processes are required and to accommodate this. There are also many new requirements in the labelling section of Annex I, whereby you are now required to identify your product as a ‘Medical Device’. New requirements relating to information on your Instructions for use e.g. bearing a notice to the user and/or patient that serious incidents should be reported to the manufacturer and competent authority. While the concept of serious incident reporting/vigilance reporting is not new, it was not previously required to inform users or patients in the IFU that such incidents should be reported. Patient reporting of adverse events would likely be new to manufacturers and may require new procedures and investigation practices. However, for class (I & IIa) devices, it is not mandatory to supply Instructions For Use, with your product, as long as the device can be used safely without.[/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=””]

Other Key Challenges For Low Risk Medical Devices

For true Class I Devices you do not have an obligation to tell the Competent Authority (CA) each time there is a change to the product, although this should be documented in your technical documentation, with a solid QMS process that is super sensitive to changes. The Competent Authority (CAs) do not currently have mechanisms to check product changes or to deal with the queries.[/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=””]

Registration in the European Database on Medical Devices (EUDAMED)

It is the manufacturer’s responsibility to register a medical device. You will get assigned a basic UDI-DI. Until EUDAMED is fully functional, manufacturers and EU representatives must notify the competent authority (CA) and register the device.[/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=””]

How You Can Comply With the New EU MDR

Article 2 – Definitions (ensure your product fits the definition of a medical device)
Article 10 – General obligations of manufacturers
Article 15 – Person responsible for regulatory Compliance
Article 19 – EU Declaration of Conformity
Article 20 – CE marking of Conformity
Article 25 – Identification within the supply chain
Article 27 – Unique Device Identification System
Article 29 – Registration of Devices
Article 31 – Registration of manufacturers, authorised representatives and importers
Article 51 – Classification of devices
Article 52 – Conformity Assessment Procedures
Article 61 – Clinical Evaluation
Article 62 – Clinical Investigations
Article 83 – Post Market Surveillance system of the manufacturer
Article 85 – Post Market Surveillance Report
Article 87 – Vigilance

The annexes provide detailed information as to how you should meet the articles, which is the law:

Annex I – General Safety and Performance Requirements (GSPR’s)
Annex II – Technical Documentation
Annex III – Technical Documentation on Post Market Surveillance
Annex IV – EU Declaration of Conformity
Annex V – CE Marking of Conformity
Annex VI – Information to be submitted upon registration of devices and Economic Operators, core data elements relating to UDI
Annex VIII – Classification, the applicable annex based on Conformity Assessment
Annex XIV – Clinical Evaluation and Post market Clinical Follow-Up
Annex XV & XVI

MDR Changes – Costly and Time Consuming

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]There is no doubt that the changes we are facing in industry with the introduction of MDR are huge, complex, time-consuming and costly. Transitioning to the MDR might seem overwhelming and many companies don’t know where to start or get lost along the way. Therefore, you need to be well informed about how best to strategize effectively. By engaging with Celegence, your organization can leverage our quality and regulatory expertise to solve complex challenges.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” 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=””]The Celegence team can provide complete end-to-end solutions for medical device compliance. We can help to perform gap analysis of your existing documentation and close any gaps that we may find. Our team can supply simple templates and design regulatory and QMS strategies that help you gain CE approval, deal with any classification/conformity assessment dilemmas you may have, help to assess changes, and help steer you in the right direction to ensure that you remain compliant. We believe in “Right First Time” approach when it comes to technical documentation and clinical reporting. We will share our years of knowledge and know-how, deliver an advantageous set of services related to matching people’s needs to expertise and deliver services on time, ensuring your continued route to 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=”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” 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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 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Post-Market Clinical Follow-up (PMCF) Requirements under the EU MDR

24 Apr, 2019

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padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”7549|full” max_width=”” sticky_max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align_medium=”none” align_small=”none” align=”none” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Post-Market Clinical Follow-up (PMCF) Requirements under the EU MDR – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2019/04/Post-Market-Clinical-Follow-up-PMCF-Requirements-under-the-EU-MDR-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” 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=””]Post-Market Clinical Follow-up (PMCF) Requirements under the EU MDR[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The following is the third in the series of blogs related to the recent updates to EU MDR. Read the 1st post about understanding medical device equivalence vs demonstration of equivalence. You can view the 2nd post about the new European Union MDR: impact on technical file.[/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_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=””]

Under the new EU Medical Device Regulation (MDR), manufacturers are required to plan pro-actively to gather, record and analyse performance and safety data throughout the lifecycle of medical devices placed on the market. This systematic approach to gathering feedback is intended to demonstrate the products continued performance in accordance with its intended use and identify any early safety signals that may arise. The PMS data set on a periodic basis is fed into the Quality Management System with focused areas in Risk Management and Clinical Evaluation

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” 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 MDR calls for a more defined and strategic post-market surveillance (PMS) system which is an integral part of the company’s Quality Management System and now requires more than simple complaint monitoring. The EU MDR has much more explicit requirements regarding PMS systems, including the need to now include PMS and PMCF plans or justifications and Product Safety Update Reports (PSUR) within the Technical Documentation. These reports are required to be reviewed periodically by the Notified Body and will feature PMS outcomes; the timeframes are subject to the classification of device. For higher class devices, the PSURs are required to be submitted annually. This is just one of many key changes the MDR introduces, as lifecycle management is a key theme throughout the revised legislation.[/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=”20px” 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=””]Post Market Clinical Follow-up (PMCF)[/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 Post Market Clinical Follow-up (PMCF) is one element of PMS activities which can confirm the clinical performance and safety of the device and ensure continued acceptability of risk. Compared to other PMS activities, PMCFs are much more formal in nature and proactive with pre-approved outcomes or acceptance criteria. The focus is typically on certain area of performance or safety which is driven from risk management, CER or even other PMS data. A PMCF is often required where there is limited clinical data for a legacy device and becomes especially relevant when there are long term data gaps or unanswered questions associated to the use, certain indications, or novel features of a new device. As the name suggests, the activities occur after the product is CE marked and therefore the PMCF supplements the existing pre-market clinical and non-clinical data. The PMCF is required to be carefully planned with factors such as statistical rationales in areas such as patient numbers, device usage, follow-up period, outcomes and criteria in order to support the key objectives.[/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 PMCF can take the form of a clinical study, an appropriate registry, a customer survey, feedback from key opinion leaders, or even a planned follow-up with patients using the device. Due to the variety in types of PMCF and the need to tailor each one specifically to each device, understanding the right approach is a big challenge for manufacturers.

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In order to design a successful PMCF plan, it is very important to select appropriate end points that bridge any gaps in clinical evidence and ensure that the safety and effectiveness of the device are being measured effectively to demonstrate a favourable benefit-risk profile of the medical device throughout its expected lifetime. The PMCF is a requirement for those devices where the safety and performance require further evaluation to support the pre-market data.

Whether each indication of the device is supported by adequate clinical evidence or not;
If the device involves some innovation in terms of design, materials, substance, medical condition, disease being treated or principal of operation;
If the product is a high-risk device based on its nature, the medical condition it is being used for, the intended population, invasiveness or clinical procedures by which it is used;
If the product is involved use in a high-risk anatomical location;
If the product is intended for use in high risk population, then is there sufficient clinical evidence to support the use of this product in the specific population etc.
If the device is novel or has novel features or high-risk substances

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” 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=””]Apart from the factors mentioned above, a number of other points need to be considered while determining the need for a PMCF for a particular device, especially for legacy devices that have been on the market for some time but have limited clinical data or can no longer leverage equivalent device data due to the enhanced MDR requirements in this area. Under the new EU MDR, a thorough and detailed examination of all the available clinical evidence needs to be performed as part of the clinical evaluation gap assessment for existing devices in order to decide if a PMCF is warranted for a given device. If there are gaps in clinical data, a PMCF may become required in order to be successful in the MDR transition and therefore this should be identified immediately to prevent the loss of CE certification due to lack of clinical data. The MDR requires that every medical device considers the need to perform a PMCF; where not required due to sufficient clinical evidence, the rationale is required to be documented within the Technical Documentation.[/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″ 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=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius=”” box_shadow=”no” dimension_box_shadow=”” 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_image_id=”” 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=”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=””]

Complete end-to-end solutions for PMCF by Celegence

The Celegence team can provide complete end-to-end solutions for PMCF; from determining its necessity for a particular device based on the available data to the type of study that is required for PMCF as per the EU MDR. We can also provide a detailed and comprehensive justification if a PMCF is not warranted based on the available clinical data. Our focus is to work with you to develop enhanced proactive systems and implement a strong, risk-based approach. We achieve this by developing and implementing checklists, tools and templates that are easy to understand and use. Our activities center around improvement of manufacturers’ existing PMS systems as well as inputs on whether a PMCF is required. Finally, we can support in designing and facilitating the actual PMCF studies when required. Our team is comprised of subject matter experts who will determine the aim, objectives and set the end points, as well as statisticians to determine the appropriate trial model, the sample size, and interim monitoring. By leveraging Celegence, manufacturers can achieve execution of PMCF activities and the follow-up less time consuming and costly.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” 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=””]Celegence can provide you with subject matter experts, including both regulatory professionals, statisticians and medical doctors with relevant device expertise to complete this work for you or supplement your internal team as needed. [/fusion_title][/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=”4%” 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=”” 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=”#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=”” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

[fusion_fontawesome icon=”fa-info-circle fas” size=”35px” flip=”” rotate=”” spin=”no” alignment=”left” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” margin_top=”” margin_right=”10px” margin_bottom=”” margin_left=”” circle=”no” iconcolor=”#2da9e0″ circlecolor=”” circlebordercolor=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_fontawesome] For more information reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities

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The New European Union MDR: Impact on Technical Files

21 Sep, 2018

The following is the second in the series of blogs related to the recent updates to EU MDR. Read the 1st post about understanding medical device equivalence vs demonstration of equivalence. You can view the 3rd post about post the new post market clinical follow up requirements for EU MDR.

[/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_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 new EU MDR requires technical documentation to include a substantially larger amount of information on all aspects of the medical device. In some areas, such as risk management, manufacturers will need to first implement new and more detailed systems and processes before much of the newly required information can even be identified and collected. This poses a risk to all device companies for compliance readiness – companies that have a product portfolio focused on lower risk devices as well as companies that focus on higher risk devices.

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Celegence can provide expertise on implementing processes for medical device design and development, manufacturing, and post-market surveillance for technical file compliance with the new MDR regulation, as well as provide experienced resources to create and remediate product technical files.[/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=”yes” 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=””]Device Description and Product Specifications[/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 new MDR requires the product’s technical documentation to include more information within the section that covers the Device Description and Product Specifications. The new requirements for this section include information on the composition of the complete device (as opposed to just the significant components), transparency of all operating principles of the device, detailed profiling of the intended users of the device, and additional considerations to be answered that profile the risk classification of the device.

Regarding the intended users of the device, the new MDR now requires that the technical file include precise identification of the intended patient population, the medical conditions relevant to the use of the device, as well as acknowledgement of specific patient selection criteria.

This section of the technical file will also need to include an official written justification for the decisions made on the risk profile of the device and the classification rule(s) applied to the device, as well a description of all raw materials incorporated into key functional elements of the device (not just components of the device that affect biocompatibility).

Manufacturers must also include in this section of the technical file a written rationale for the qualification of the product as a device.

The technical documentation that covers the device design and manufacturing information is also impacted by the new MDR regulations. The design information for the device must now describe the complete design process used, as well as the design controls that are in place for the device’s development. The manufacturing section of the technical file must now include complete information on all manufacturing processes used, as well as their validation. Manufacturers must also identify all suppliers and sub-contractors involved with the design and manufacturing of the device, not just “critical” suppliers and sub-contractors.

The section(s) within the technical file that cover the device’s pre-clinical verification and validation information are also impacted by the new MDR regulation. The focus of this information is still on device’s safety and performance, but there is substantially greater detail in the information required. This section must now include a critical analysis of all verifications and validation tests and results, as well as the complete testing protocols. The new MDR regulation also requires some mandatory pre-clinical data, which includes all of the following:

[/fusion_text][fusion_checklist icon=”fa-angle-right fas” iconcolor=”#2da9e0″ circle=”no” circlecolor=”” size=”” divider=”” divider_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””][fusion_li_item icon=””]Physical, chemical and microbiological characterization[/fusion_li_item][fusion_li_item icon=””]

Electrical safety and electromagnetic compatibility

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Software verification and validation

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Stability and shelf life

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Performance and safety testing

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Proof that the device conforms to the general safety and performance requirements when connected to any indicated other device(s)

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The technical documentation on clinical evidence for the device will also require more information to comply with the new MDR regulation. This section must now directly include the clinical evaluation plan and the post-market clinical follow-up plan and report… references to this documentation being contained elsewhere will no longer suffice. Additionally, the clinical evidence section must now include proof on the manufacturer’s processes for effective communication with competent authorities, notified bodies, economic operators and users, as well as procedures to fulfill all the manufacturers’ obligations.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” 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=””]Celegence can provide you with subject matter experts, including both regulatory professionals and medical doctors with relevant device expertise to complete this work for you or supplement your internal team as needed. [/fusion_title][/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=”20px” padding_bottom=”” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”#f6f8f8″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ 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[/fusion_text][/fusion_builder_column_inner][/fusion_builder_row_inner][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Medical Devices: Substantial Equivalence vs. Demonstration of Equivalence

25 Jul, 2018

[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=”4809|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=”” 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/2016/04/Medical-Devices-Regulation-Celegence-EU.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=””]Medical Devices: Substantial Equivalence vs. Demonstration of Equivalence[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The following is the first in the series of blogs related to the recent updates to EU MDR. Read the 2nd post about the new EU MDR rules and their impact on technical files. You can view the 3rd post about post the new post market clinical follow up 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_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=””]How to Demonstrate Equivalence Between Medical Devices – 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=””]

Recent updates to the European Union Medical Device Regulations (MDR) brings about a very important topic for the medical device industry – how to adequately demonstrate equivalence between the device under evaluation and a similar, currently marketed device.

CE Marking Process for Medical Devices – EU MDR

The below tables summarize the differences in the way the FDA and the European Commission evaluate the clinical, technical and biological characteristics when comparing the device under evaluation and the proposed equivalent device.

For many companies, it is a challenge just to find adequate regulatory resources to compile this exhaustive list of medical device characteristics for both the device under evaluation and the proposed equivalent device. An adequate demonstration of medical device equivalency that meets the requirements of the regulations and passes review by your notified body or the FDA will require a substantial investment of both time and specialized expertise.

Celegence can provide you with subject matter experts, including both regulatory professionals and medical doctors, with relevant device expertise to complete this work for you or to supplement your internal team as needed.

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Medical Device Equivalence Comparisons – Criteria

[/fusion_title][fusion_table fusion_table_type=”2″ fusion_table_rows=”3″ 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=””]

	Clinical Characteristics	Technical Characteristics	Biological Characteristics
U.S. FDA 510k Application Substantial Equivalence	Multiple equivalent devices may be used to come to a cumulative conclusion Same intended use Risk-based comparison of indications for use – disease or condition 1 Risk-based comparison of indications for use – patient population or anatomical site1	Differences in technological characteristics are acceptable Differences in technological characteristics must not raise different questions of safety and effectiveness that pose a significant safety or effectiveness concern for the device under evaluation	Differences in material or substances are acceptable Differences in contact of human tissues or body fluids are acceptable Similar biocompatibility performance testing is required Differences in materials or substances and contact profile are evaluated by the affect it may have on known 2 safety or effectiveness aspects
European Union CE Mark Technical File Demonstration of Equivalence	Multiple equivalent devices may be used to come to a cumulative conclusion Only a single device may be used to demonstrate equivalence Same intended purpose Same clinical condition Same body site Similar patient population Performances not significantly different	Similar design Same conditions for use Similar specifications and properties Similar deployment methods Similar principles of operation Similar critical performance requirements	Same materials or substances Same contact of human tissues or body fluids

Clinical Characteristics

Technical Characteristics

Biological Characteristics

U.S. FDA

510k Application

Substantial Equivalence

Multiple equivalent devices may be used to come to a cumulative conclusion
Same intended use
Risk-based comparison of indications for use – disease or condition 1
Risk-based comparison of indications for use – patient population or anatomical site1

Differences in technological characteristics are acceptable
Differences in technological characteristics must not raise
different questions of safety and effectiveness that pose a
significant safety or effectiveness concern for the device under evaluation

Differences in material or substances are acceptable
Differences in contact of human tissues or body fluids are acceptable
Similar biocompatibility performance testing is required
Differences in materials or substances and contact profile are evaluated by the affect it may have on
known 2 safety or effectiveness aspects

European Union

CE Mark Technical File

Demonstration of Equivalence

Multiple equivalent devices may be used to come to a cumulative conclusion
Only a single device may be used to demonstrate equivalence
Same intended purpose
Same clinical condition
Same body site
Similar patient population
Performances not significantly different

Similar design
Same conditions for use
Similar specifications and properties
Similar deployment methods
Similar principles of operation
Similar critical performance requirements

Same materials or substances
Same contact of human tissues or body fluids

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Medical Device Equivalence Comparisons – Content

	Clinical Content	Technical Content	Biological Content
U.S. FDA 510k Application Substantial Equivalence	Regulatory classification Indications for use Environment of use Patient population	Comparative drawings or pictures at a system level Principles of operation Description of technology used, design, features Identification of significant design specifications, presented in comparative tabulations Performance specifications, presented comparatively Compliance with standards Compatibility with other devices If available, Instructions for Use or Manuals Descriptive information alone may be sufficient	Materials information for patient contacting Materials information for potentially patient contacting materials Biocompatibility assessment and profile Biocompatibility testing result and compliance to standards
European Union CE Mark Technical File Demonstration of Equivalence	Clinical condition including severity and stage of disease, medical indication, intended purpose Anatomical body site User population – age, gender, anatomy, physiology Clinical performances – expected clinical effect, intended purpose, duration of use Clinical literature and concise summaries of literature including methods, results, and conclusions Evaluation of the methodological quality and scientific validity of clinical literature Current knowledge/ the state of the art Type of device-body interaction Description of relevant clinical, biological and technical characteristics that affect clinical properties of the device Any differences in intended purpose – indications, contraindications, precautions, target patient groups, target users, mode of application, duration of use/ number of re-applications Whether the comparison carried out covers all products/ models/ sizes/ settings/accessories and the entire intended purpose of the device under evaluation, or only certain aspects Conclusions on device equivalency including conformity to each of the relevant essential requirements Explanations of differences in devices If equivalence is concluded, confirmation that the differences are not expected to affect the clinical performance and clinical safety of the device under evaluation; description of any limitations and gaps Identification of differences and evaluation of expected influence on clinical performance and clinical safety, and reasons for assumptions made The relevance of each dataset from an equivalent device The level of access to technical and clinical data from the proposed equivalent device	Manufacturer Name, models, sizes, settings, components Relationship to the device under evaluation Regulatory status Justification and validity of parameters and models for non-clinical determination of characteristics Specifications and properties (type and intensity of energy, tensile strength, viscosity, surface characteristics, wavelength, surface texture, porosity, particle size, nanotechnology, specific mass, atomic inclusions, etc.) Deployment methods Principles of operation and the means by which the device achieves the therapeutic result Critical performance requirements Conditions of use Field safety corrective actions Product labels and Instructions for Use Comparative drawings or pictures at a system level and for components / elements with body contact Identification of pre-clinical studies Original full text versions of pre-market study reports assessing parameters of interest, including summaries, methods, results, and conclusions Evaluation of the methodological quality of the study and the scientific validity of the information If measurements are possible, supporting non-clinical information and testing of clinically relevant specifications and properties measured both devices, presented comparatively All information listed above must also be provided for software and accessories	Materials and substances with body contact, and their role and nature, and their risk analysis information Type of body contact Biological safety testing information (e.g. ISO 10993) Manufacturing information for special treatments Sourcing and manufacturing procedures Analytical methods chosen for material characterization Histopathological studies on host response in vivo in the intended application and duration of contact For animal tests, species identification and justification for the choice of the test and its predictive value Abrasion, if relevant, and host response to particles A justification explaining the situation should be provided for any difference in biological characteristics

Clinical Content

Technical Content

Biological Content

U.S. FDA

510k Application

Substantial Equivalence

Regulatory classification
Indications for use
Environment of use
Patient population

Comparative drawings or pictures at a system level
Principles of operation
Description of technology used, design, features
Identification of significant design specifications, presented in comparative tabulations
Performance specifications, presented comparatively
Compliance with standards
Compatibility with other devices
If available, Instructions for Use or Manuals
Descriptive information alone may be sufficient

Materials information for patient contacting
Materials information for potentially patient contacting materials
Biocompatibility assessment and profile
Biocompatibility testing result and compliance to standards

European Union

CE Mark Technical File

Demonstration of Equivalence

Clinical condition including severity and stage of disease, medical indication, intended purpose
Anatomical body site
User population – age, gender, anatomy, physiology
Clinical performances – expected clinical effect, intended purpose, duration of use
Clinical literature and concise summaries of literature including methods, results, and conclusions
Evaluation of the methodological quality and scientific validity of clinical literature
Current knowledge/ the state of the art
Type of device-body interaction
Description of relevant clinical, biological and technical characteristics that affect clinical properties of the device
Any differences in intended purpose – indications, contraindications, precautions, target patient groups, target users, mode of application, duration of use/ number of re-applications
Whether the comparison carried out covers all products/ models/ sizes/ settings/accessories and the entire intended purpose of the device under evaluation, or only certain aspects
Conclusions on device equivalency including conformity to each of the relevant essential requirements
Explanations of differences in devices
If equivalence is concluded, confirmation that the differences are not expected to affect the clinical performance and clinical safety of the device under evaluation; description of any limitations and gaps
Identification of differences and evaluation of expected influence on clinical performance and clinical safety, and reasons for assumptions made
The relevance of each dataset from an equivalent device
The level of access to technical and clinical data from the proposed equivalent device

Manufacturer
Name, models, sizes, settings, components
Relationship to the device under evaluation
Regulatory status
Justification and validity of parameters and models for non-clinical determination of characteristics
Specifications and properties (type and intensity of energy, tensile strength, viscosity, surface characteristics, wavelength, surface texture, porosity, particle size, nanotechnology, specific mass, atomic inclusions, etc.)
Deployment methods
Principles of operation and the means by which the device achieves the therapeutic result
Critical performance requirements
Conditions of use
Field safety corrective actions
Product labels and Instructions for Use
Comparative drawings or pictures at a system level and for components / elements with body contact
Identification of pre-clinical studies
Original full text versions of pre-market study reports assessing parameters of interest, including summaries, methods, results, and conclusions
Evaluation of the methodological quality of the study and the scientific validity of the information
If measurements are possible, supporting non-clinical information and testing of clinically relevant specifications and properties measured both devices, presented comparatively
All information listed above must also be provided for software and accessories

Materials and substances with body contact, and their role and nature, and their risk analysis information
Type of body contact
Biological safety testing information (e.g. ISO 10993)
Manufacturing information for special treatments
Sourcing and manufacturing procedures
Analytical methods chosen for material characterization Histopathological studies on host response in vivo in the intended application and duration of contact
For animal tests, species identification and justification for the choice of the test and its predictive value
Abrasion, if relevant, and host response to particles
A justification explaining the situation should be provided for any difference in biological characteristics

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1 The comparison is risk-based and there is flexibility in a finding of “similarity”. When changes between the indications for use raise a new safety or effectiveness issue or have the potential to significantly increase a safety or effectiveness concern, equivalence is not supported.

2 The flexibility in differences of materials or biological contact profile is dependent on FDA’s conclusions on what constitutes a significant difference to safety or effectiveness, based off industry meta-data (all relevant pre-market and post-market data).

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