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

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

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

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

Why should you watch this video?

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

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

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

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

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

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

MHRA Requirements for Products in the UK

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

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

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

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

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

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

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

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

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

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

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

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

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

Why should you watch this video?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Timelines for EUDAMED Compliance

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

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

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

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

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

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

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

A single integral DDC is described as follows:

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

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

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

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

The New System for CE Marking Combination Products – Article 117

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

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

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

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

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

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

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

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

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

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

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

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

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Next Steps for Manufacturers to Implement Article 117[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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

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

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

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” box_shadow=”yes” box_shadow_vertical=”5%” box_shadow_horizontal=”5%” box_shadow_blur=”28″ box_shadow_spread=”2″ box_shadow_color=”#f1f6f8″ box_shadow_style=”” padding_top=”” padding_right=”0px” padding_bottom=”” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”#f6f8f8″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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

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

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

[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”0″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6329|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Implications of MDR for Medical Devices Incorporating Artificial Intelligence and Machine Learning – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Implications-of-MDR-for-Medical-Devices-Incorporating-Artificial-Intelligence-and-Machine-Learning-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Implications of MDR for Medical Devices Incorporating Artificial Intelligence and Machine Learning[/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=””]Artificial intelligence (AI) and machine learning (ML) in medical devices is an important part of the healthcare industry with the potential to improve patient care, as well as administrative processes by automating tasks and achieving faster results. According to the latest report by PwC, AI will contribute an additional $15.7 trillion to the world economy by 2030, with the greatest impact being in the field of healthcare. Real-world applications of AI and ML in medical devices include imaging systems used for diagnostic information, smart electrocardiograms estimating the probability of a heart attack, and AI-assisted stethoscopes that patients can use at home.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Defining Artificial Intelligence and Machine Learning[/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=””]Artificial Intelligence can be broadly defined as the:

“science and engineering of making intelligent machines, especially intelligent computer programs using models based on statistical analysis of data, expert systems that primarily rely on if-then statements, and machine learning.”

Machine Learning is an:

“artificial intelligence technique that can be used to design and train software algorithms to learn from and act on data, essentially creating adaptive algorithms that have the potential to continuously optimize device performance in real-time to improve patient outcomes.”

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Current Regulatory Space in AI/ML 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=””]AI in medical devices is a relatively new technology that is constantly evolving, and therefore, is an uncharted territory that presents challenges for regulatory bodies. The EU directives and regulations (e.g. MDD, MDR), and the harmonised standards (e.g. EN IEC 62304) do not have concrete guidelines on medical devices which incorporate AI and ML. The existing general regulatory requirements for such devices include:

• Demonstration of safety and performance of the medical device
• The devices must be validated against the intended purpose and stakeholder requirements and verified against the specifications (including MDR Annex I 17.2)
• They must ensure that the software has been developed in a way that ensures repeatability, reliability, and performance (including MDR Annex I 17.1), including describing the methods used for verification
• If the clinical evaluation is based on a comparator device, this device must be sufficiently technical equivalent, which explicitly includes the evaluation of the software algorithms (MDR Annex XIV, Part A, paragraph 3)
• Before development, manufacturers must determine and ensure the competence of the people involved (ISO 13485:2016 7.3.2 f)

[/fusion_text][fusion_imageframe image_id=”6331|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=”Artificial Intelligence – Medical Machine Learning – Software as a Medical Device – EU MDR – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Artificial-Intelligence-Medical-Machine-Learning-Software-as-a-Medical-Device-EU-MDR-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Artificial Intelligence/Machine Learning (AI/ML)- Software as a Medical Device (SaMD)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The greatest benefits of AI/ML in software resides in its ability to learn from real-world use and experience, and its capability to improve its performance. The ability for AI/ML software to learn from real-world feedback (training) and improve its performance (adaptation) makes these technologies uniquely situated among software as a medical device (SaMD).[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]FDA’s Proposed Regulatory Framework for AI/ML SaMD[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]In the spring of 2019, the FDA released a proposed regulatory framework for AI/ML-based Software as Medical Device (SaMD) as a first step to regulate such devices. The aim being a potential approach to mandate premarket review for AI/ML-driven software modifications. The proposal discusses its experience in the premarket approval of “locked” algorithms. However, “adaptive” AI/ML-based SaMD with the ability to continuously learn and adapt to real-world data have not been able to be regulated using the traditional pathways. Suggestions were made that a new total product lifecycle (TPLC) regulatory approach is required to keep up with the pace of these highly iterative, autonomous devices while continually providing an effective and safe regulatory framework.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Risk Categorization for Medical Devices[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The proposal also translates risk categories by using the International Medical Device Regulators Forum (IMDRF) SaMD risk categorization framework, which combines the seriousness of the medical condition, and the significance of the information provided by the AI/ML-based SaMD to the healthcare decision. The risk-based approach to categorize SaMD is based on intended use. The four categories, ranging from lowest (I) to highest risk (IV), reflect the risk associated with the clinical situation and device use.[/fusion_text][fusion_imageframe image_id=”6334|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=”Risk Categorization – International Medical Device Regulatators Forum – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Risk-Categorization-International-Medical-Device-Regulatators-Forum-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Types of AI/ML-based SaMD Modifications[/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 proposal anticipates that modifications to devices incorporating AI/ML may involve algorithm architecture modifications and re-training with new data sets. The types of modifications fall into three broad categories:

• Performance – clinical and analytical performance
• Inputs used by the algorithm and their clinical association to the SaMD output
• Intended use – The intended use of the device for the state of the healthcare condition

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Total Product Lifecycle Regulatory Approach[/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 proposal addresses the necessity of a TPLC approach by assessing the quality of a manufacturer’s software development, testing, and performance monitoring of the device. This approach enables the continual evaluation and monitoring of a software product from its premarket development to post-market performance.

[/fusion_text][fusion_imageframe image_id=”6332|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=”Total Product Lifecycle Regulatory Approach – AI and Machine Learning Medical Devices – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Total-Product-Lifecycle-Regulatory-Approach-AI-and-Machine-Learning-Medical-Devices-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

FDA Total Product Lifecycle Regulatory Approach

[/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 FDA’s proposed TPLC approach is based on the following general principles that balance the benefits and risks, and provide access to safe and effective AI/ML based SaMD:

• Establish clear expectations on quality systems and good ML practices (GMLP)
• Conduct premarket review for those SaMD that require a premarket submission to demonstrate reasonable assurance of safety and effectiveness, and establish clear expectations for manufacturers of AI/ML-based SaMD to continually manage patient risks throughout the lifecycle
• Expect manufacturers to monitor the AI/ML device and incorporate a risk management approach, and other approaches outlined in “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.” This will entail guidance in development, validation, and execution of the algorithm changes (SaMD Pre-Specifications and Algorithm Change Protocol)
• Enable increased transparency to users and the FDA using post-market real-world performance reporting for maintaining continued assurance of safety and effectiveness

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Conclusions – Medical Devices with Artificial Intelligence and Machine Learning

[/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 future for AI/ML based medical devices is exciting and requires a shift in perspective to maximize the safety and efficacy of AI/ML in health care. It currently poses significant challenges for manufacturers and regulatory agencies, therefore requiring collaboration between them to develop integrated systems and a novel streamlined approach in regularizing such advanced tools.

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” box_shadow=”yes” box_shadow_vertical=”5%” box_shadow_horizontal=”5%” box_shadow_blur=”28″ box_shadow_spread=”2″ box_shadow_color=”#f1f6f8″ box_shadow_style=”” padding_top=”” padding_right=”0px” padding_bottom=”” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”#f6f8f8″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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

Celegence experts can provide you with an overview on the principles and pathways of bringing AI/ML based medical device into the market. For further information on assessing required premarket approvals of your medical device reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.

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padding_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=”no”][fusion_imageframe image_id=”6143|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=”RAPS Webinar Transcript – Q&A – Taking Advantage of the EU MDR Delay – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/RAPS-Webinar-Transcript-QA-Taking-Advantage-of-the-EU-MDR-Delay-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]How to Proactively Take Advantage of the EU MDR Extension[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Celegence, a Global Regulatory Affairs Services & Technology company for the Life Sciences Industry, partnered with Regulatory Affairs Professionals Society (RAPS) in July to offer a webcast “Taking Advantage of the EU MDR Delay in Uncertain Times – Optimizing Your Medical Device RA/QA Strategy”.

By replaying this webinar, you will have an opportunity to develop a comprehensive, and advanced understanding of the potential strategic solutions for EU MDR compliance, regardless of where you are in the transition process.

Additionally, you will also learn how to proactively take advantage of the extension for both MDD renewal and EU MDR implementation to effectively manage every facet of the regulatory change. This post contains the Q&A session from the webinar – giving you the answers to the most common questions that were asked about the EU MDR.

If you were not able to attend this webinar, here’s a link where you can view the on-demand version. We are here to help address any other questions that you may have related to the webinar, or questions about how you may be able to benefit from our MDR compliance services or technology, we are happy to assist. Contact us to find out how we can help you optimize your RA/QA strategy.[/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=”” 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”][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_size=”0″ 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=”no”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q. What are the top 2 MDR non-conformances and how do we respond?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A: If you have a designated Notified Body that is already sending your MDR submissions, and with the date of application being one year later, you must have your QMS system in the right place. The non-conformances coming in with MDR submissions are – Queries are coming in from companies and notified bodies to make sure MDR is followed, UDI, labeling questions, Strategy for Regulatory compliance (which has to be part of QMS system,) Person responsible for regulatory compliance (PRRC), Vigilance, GSPR & risk documentation which comes under PMCF activities. The top two MDR non-conformances that we see are Clinical Evaluation and PMCF activity & study, these two account for 30-50% of all the non-conformances.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: When exactly are the PMS reports, PSURs and SSCPs due with respect to the new DoA?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: They are due at the time of submission. With the date of application, these activities must be implemented for your remaining MDD certificates.

[/fusion_text][fusion_imageframe image_id=”6145|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”EU MDR Delay – Surveillance Requirements” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/EU-MDR-Delay-Surveillance-Requirements.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: How will the MDR change have affected critical suppliers?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: Critical suppliers, in general, are part of the quality system surveillance which must be implemented by the manufacturer. Now, there are aspects of higher scrutiny such as Economic Operators, which are particularly important for critical suppliers and the overall supply chain. Other than that, the main principle of the surveillance of critical suppliers did not change as part of 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_size=”” 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”][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_size=”0″ 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=”no”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: What are some best practices and tips for virtual audits?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A: Some best practices for virtual audits include ensuring the IT files are prepared multiple days in advance, as well as having shared folders that are available to auditors during the audit process. Make sure to organize all chats and other forms of communication with your different teams as part of your audit process. Preparation is one of the most important aspects, not only on the technical side, but also for the documents to be reviewed and discussed. Scheduling is also critical, especially for larger manufacturers where 2 or 3 auditors are conducting the audit. The availability of the involved people needs to be aligned accordingly, and preparation of the presided schedule is important. Fixing the time zone challenges is particularly important. However, we must understand that one of the major obstacles for MDR transition currently is that we are not allowed to do initial MDR audits in a remote setup.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: Can you please elaborate the applicability of Article 120? Can the manufacturer use MDCG 2020-3 after May 2021 but can use NBOG 2014-3 before May 2021, correct?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: Article 120 applies to remaining MDD certificates after the date of application. Also, after the date of application, the relevant guidance is from MDCG papers. Whatever you do under MDD so far, remains the same as it was on the date of application.

[/fusion_text][fusion_imageframe image_id=”6146|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Article 120 of EU MDR – MDD – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Article-120-of-EU-MDR-MDD-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: Is the PRRC the person who must sign the DoC or can this be someone else at the manufacturer’s, like the managing director?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A: The regulatory responsible person needs to have some background and relevant experience in the regulatory field, which is defined in the MDR. With that said, signing the DoC is an essential responsibility of the manufacturer. It needs to be a person that is directly employed by the legal manufacturer. This can be someone from the manufacturer in a position of management, but your PRRC must be in place for multiple other 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=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: Will notified bodies audit clinical trials?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: Notified Bodies will not specifically audit clinical trials, but they will make assessments based on clinical activities, so they may be implemented differently. Notified bodies’ concept is to have clinical audits. These can be combined with other auditing activities, where Notified Bodies can look at other processes, planning, and reporting in the clinical area. In general, the clinical aspects need to be a part of the conformity assessment by the notified bodies.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: How does new regulation affect clinical evaluation standards of surgical devices with broad intended uses?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A: For surgical devices, you are going to have more clinical investigation work as part of the new EU MDR regulations, and to maintain compliance with ISO 14155. The main difference is the amount of clinical information you will need to have for your clinical evaluation reports for your surgical devices with broad intended uses.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: Where in the technical document, do you recommend adding the post market surveillance data/report and PSUR? create a new section?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A: In the MDD technical file, there is a section for post market studies. Now, there is no specific place within the technical document to add PMS data, but if you identify the specific section where you need to add the data/report, you can link it to the relevant technical document. This will then make it easier to update, rather than attempting to update the entire large document.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Q: How can companies keep track of guidance from commission and take it into consideration for implementation?

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A: The regulatory intelligence team within the company typically keeps up with all the new regulations that are posted, and they provide the regulatory team with guidance on these changes, on a weekly/monthly basis. Much of these changes are related to gap assessment, compliance with new regulations, and EU Commission documentation changes etc[/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_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 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 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 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]

Do you need additional EU MDR assistance? Our team is ready to help! Reach out to us via email info@celegence.com, contact us online or read more about our medical device capabilities.

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[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”0″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6117|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=”RAPS Webinar Transcript – Virtual Audits Q and A – Dr Sophie Vaillot and Dr Royth von Hahn” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/RAPS-Webinar-Transcript-Virtual-Audits-Q-and-A-Dr-Sophie-Vaillot-and-Dr-Royth-von-Hahn.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]What Are Some Best Practices in Handling Virtual Audits?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Dr. Sophie Vaillot is the Head of Global Regulatory Affairs at Nobel Biocare Systems who is responsible for the overall regulatory compliance including regulatory strategy planning and execution – FDA pre-submission meetings, 510(k), CE marking and global market access as well as life cycle management activities. Dr. Royth von Hahn is the Global Head of TUV SUD‘s Business Unit “Medical and Health Services (MHS)” who is responsible for a network of around 600 experts and a portfolio of lifecycle services for medical devices, from product design to risk management and approval.

The EU commission is calling for authorities to allow notified bodies to conduct virtual audits of medical devices and in vitro diagnostics during the COVID-19 pandemic. Effectively handling the virtual audits in compliance with the EU MDR is still a challenge for many organizations. During our webinar discussion titled “Taking Advantage of the EU MDR Delay in Uncertain Times: Optimizing Your Medical Device RA/QA Strategy”, Dr. Sophie & Dr. Royth spoke specifically about some of the best practices in handling the virtual audits.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Why should you watch this video?

• This video provides tips and techniques for effective virtual audits in compliance with EU MDR which can support ongoing operations and improve audit effectiveness during unusual times
• Notified Body perspective: Virtual audit preparation & considerations
• Understand the beneficial tactics you can use in a virtual audit
• Understand the regulatory guidelines for virtual audits and how you can have the best virtual audit experience. Explore how Covid-19 will change the processes of audits moving forward.

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A full transcript of the Q&A is available to download (and to read below) and just press play to watch the clip now. 

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″]
[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Dr. Sophie Vaillot on Best Practices for Virtual Audits – 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=””]Well, maybe I can just share some insights because we have actually gone through several virtual audits very recently. And the answer is something that I can relate to right to right now due to my web camera not working (laughing), but it is making sure that all the IT portions of the Audit are taken care of. That is, knowing which system you’re going to use, making sure that you can test it with the auditors, and doing all of this a couple of days before the audit to make sure there are no issues. What we have found to be very helpful is making sure we have shared folders which are available to the auditors. And also that we prepare as much information as we can ahead of time so it doesn’t take ages to download or retrieve. This is also so the information can be easily accessible with clear organization, like for the chat communication of the different teams. Virtual Audits are not much different I would say, compared to a regular audit in terms of preparations, but the I.T. side and managing the availability of all the different participants can be a bit more challenging. So far, it has worked well from all sides, and the NBs have provided us with some good feedback about how it was organized. So, now Dr. Royth might have some perspective from the notified bodies point of view.[/fusion_text][fusion_imageframe image_id=”6118|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=”Virtual Audits EU MDR – Dr Sophie Vaillot – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Virtual-Audits-EU-MDR-Dr-Sophie-Vaillot-Celegence.jpg[/fusion_imageframe][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″]
[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Dr. Royth von Hahn on Best Practices for Virtual Audits – 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=””]Yeah, I share the same experience here. Preparation is one of the most important things, not only for the technical side, also for the documents that are to be reviewed or discussed. It definitely makes sense to prepare that in advance. It is also important to have a good understanding of the scheduling, especially for larger manufacturers, who typically have teams of two or three auditors doing things in parallel. So, availability of the right people needs to be lined up in preparation for the precise scheduling, and it is even more important if you have time zone challenges. For most aspects of virtual audits, we do not see much difference, especially if there is a well-established system already in place. There are limitations of course, when it comes to production, especially like clean room audits, or various specific aspects of production where it is limited what we can do remotely. But other than that, so far it has been quite smooth with the remote audits we have performed. However, it’s important to understand that one of the major obstacles for the MDR transition currently, is that we are not allowed to do initial MDR audits in a remote setup. That, at least from our perspective, is the biggest obstacle in really managing the transition into the MDR. Since we cannot rely on previous assessments, and we have to do everything on site for the initial audit, this basically where the current MDR projects get to a full stop.[/fusion_text][fusion_imageframe image_id=”6119|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=”Virtual Audits – Dr Royth von Hahn – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Virtual-Audits-Dr-Royth-von-Hahn-Celegence.jpg[/fusion_imageframe][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” box_shadow=”yes” box_shadow_vertical=”5%” box_shadow_horizontal=”5%” box_shadow_blur=”28″ box_shadow_spread=”2″ box_shadow_color=”#f1f6f8″ box_shadow_style=”” padding_top=”” padding_right=”0px” padding_bottom=”” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”#f6f8f8″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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

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[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”0″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6097|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=”RAPS Webinar Transcript – MRD Non Conformance – Dr. Greg Ship – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/RAPS-Webinar-Transcript-MRD-Non-Conformance-Dr.-Greg-Ship-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Dr. Greg Shipp’s Q&A on MDR Non Conformance

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

Dr. Greg Shipp is the Director, Global Medical Devices/Clinical Evaluation Group at Bausch Health Companies Inc. who provides leadership to the Clinical Evaluation Group, including authoritative opinions and answers to medical-based questions concerning the clinical evaluation of medical devices for submission of clinical/regulatory documents to global regulatory authorities.

Effectively handling non-conformances in compliance with the new EU MDR is the biggest challenge for many medical device organizations. During our webinar titled “Taking Advantage of the EU MDR Delay in Uncertain Times: Optimizing Your Medical Device RA/QA Strategy”, Dr. Greg Shipp spoke specifically about the top 2 MDR non-conformances and how medical device organisations should respond to them.

It is very important for medical device organizations to determine the underlying causes of the non-conformances and take preventive action to eliminate the cause of potential nonconformities. In the Medical Devices Industry, these non-conformances can lead to serious problems, therefore, the way of handling such problems is important. Here are a few tips for dealing with them, or being proactive to mitigate them.

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

This video outlines two leading non-conformances that are seen in MDR submissions, in particular Clinical Evaluation Reports, and how the manufacturers should respond to them in compliance with the EU MDR.

• PMCF activities and studies
• Clinical evaluation and clinical evaluation reports

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A full transcript of Dr.Greg Shipp’s Q&A is available to download (and to read below) and just press play to watch the clip now. 

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″]
[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]It’s interesting, we all found out that the date of application was actually going to be a year later, so I thought we’re going to have all this extra time to do things, get things together, and we do. But we also thought we are going to be able to go on vacation with all this extra time, right?

The truth is that we’re working harder than we have, and getting that extra year is not really something that is going to decrease the workload, if anything, it’s increased. If you have a designated notified body and you’re already sending in MDR submissions, and with the date of application being a year later, one thought was that you didn’t have to have your QMS systems up to the right level. But if you are submitting MDR submissions, you have got to have your QMS system right, or you cannot submit and actually get approval.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Practical Items About Non-Conformance[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

I just wanted to mention some practical things about non-conformances that are coming in from MDR submissions. Queries are coming in, and there is a lot of work to do because of these queries. I think the notified bodies and the companies are actually learning things, and right now, their notified bodies are really making sure that the MDR is being followed. So now, we have got a limited data set of 30 to 50 companies or so, from regulatory consultant groups, the industry, and notified bodies. And I want to concentrate on the first two leading issues that we see, which account for 30 to 50 percent of all the non-conformances.

The issues other than that, say, issues three through ten, are things like:

• UDI
• Labeling questions
• The strategy for regulatory compliance (which has to be part of the QMS system)
• The person responsible for regulatory compliance
• Vigilance
• CSPRs
• Risk documentation defining the residual risks which come into your PMCF activities.

So, the first two leading non-conformances are, not surprisingly, number two being clinical evaluation and clinical evaluation reports, and number one being PMCF activities and studies. So, we will deal with clinical evaluation first. One of the main things coming in as queries is being able to show that your claims are supported by clinical evidence. That has to be shown throughout the CER, and must show that the clinical evidence is measurable and objective. There is now a MDCG (Medical Device Coordinated Group) document, number five and number six, that actually go into clinical evaluation equivalents, and they also go into how those are going to be looked at by the notified body.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Post Market Clinical Followup (PMCF)[/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=””]Defining the rationale and the reason that you were actually doing the activity that you are talking about, are you going to do a survey? Are you going to do a retrospective data analysis? Are you going to do a prospective analysis? Are you going to do a prospective clinical study? You need to be able to speak on, and be clear about, what you’re doing and why you’re doing it.  Things are based on the classification of the device and how many clinical studies you’ve already done. And by building that argument, you are able to support your PMCF activities.

Timelines for the PMCF – You have got to really justify what you are putting down as the ongoing reports that you need to do, as this is an ongoing process and the PMCF has to be measurable. So, if you are doing a survey, then you have got to define really what information you are getting and why it is significant for the device. And of course, with data analysis and studies, you have got to have a protocol which is as strong as a scientific protocol. There is also an MDCG for the PMCF, both 07 and 08, which go into great detail about how to actually use the information.[/fusion_text][fusion_imageframe image_id=”6099|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=”Dr. Greg Shipp – Importance Document Alignment EU MDR – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Dr.-Greg-Shipp-Importance-Document-Alignment-EU-MDR-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Importance of Document Alignment[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

There are some quick queries that have arisen with clinical evaluation. It is extremely important to align your documents to make sure that they all say the same thing in terms of intended use indications. That means everything, the risk analysis, design risk analysis, the CER, the IFU, and the risk management documentation, have to all say the same thing and be totally aligned with each other. That is something that has come up.

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The Quandary Between CEP and CER

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As you guys know, the CEP now has a part that is the (CDP) Clinical Data Plan. Basically, that is something where you start with exploratory studies, all the way through to the pivotal studies. And that has to be defined in a way where you’re documenting exactly which studies are doing what, and defining clearly what that plan is.

There is an interesting thing, a quandary sometimes between the CEP and the CER. That quandary is that you need to have the CEP written before the clinical pivotal trials are done. And with the CER, it may be a year and a half later until you write that. So, things may happen between that time. You may change the indications, you may change the number of devices, and certainly the device family, where the CEP did not have that. So basically, our thought is that you do not want to change the CEP because it is the plan moving forward, but there will be changes and you need to document those in the CER stating why you made those changes.

The CER is a standalone, and you have to have standards, and nonclinical testing that is documented there. You really have to do precise GSPRs with clinical evidence for the GSPRs, and why you feel like you are compliant with them, as well as for the timing of the next CER.

[/fusion_text][fusion_imageframe image_id=”6100|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=”Dr. Greg Shipp – Items to Consider for Non Conformance EU MDR – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Dr.-Greg-Shipp-Items-to-Consider-for-Non-Conformance-EU-MDR-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Final Items to Consider re Non-conformance

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One thing that’s really important is that no matter what clinical and medical affairs, or sales, says, do not put the word ‘novel,’ or talk about ‘pediatric population’ if it is not important. Those things can potentially force you to go in the PMCF for a study or something, which really you did not need to go to. So you have really got to watch the words you use.

And then, in terms of the clinical investigations, if you have old studies that are from back in 1995, for example, they may not be compliant with 14155. So that is just something to think about. How are you going to handle that? There are going to be gaps, and you have got to think about justifications and rationales for why that is OK.

There are also new MDCGs that just came out. I won’t talk about the clinical performance, but that is in MDCG 09 and 10, and then one that just came out in MDCG 13, which shows what the notified bodies are going to be looking at in terms of clinical evaluations. That is my presentation of the non-conformances.

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radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” 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For more information on how we can help you EU MDR reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities.

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[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”0″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6084|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”EU MDR Delay RAPs – Dr Royth Von Hahn’s Presentation – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/RAPS-Webinar-Transcript-EU-MDR-Delay-Presentation-Dr-Royth-von-Hahns-Celegence-1.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Dr Royth von Hahn’s Presentation on the EU MDR Extension

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Dr. Royth von Hahn is the Global Head of TUV SUD’s Business Unit “Medical and Health Services (MHS)”. He is responsible for a network of around 850 experts and a portfolio of lifecycle services for medical devices, from product design to risk management and approval.

Despite all the uncertainty with harmonized standards and how the EU MDR actually will be enforced by Notified Bodies and regulators, manufacturers should fully understand the new regulation to prepare for the changes ahead. This includes working closely with their Notified Bodies for consistency in interpretation. Selecting the right Notified Body (NB) can be challenging. Which NB is right for your organization and what has changed with the introduction of the new EU MDR? Many small to mid-sized medical device companies are attempting to address these questions as they develop their MDR compliance strategies. During our webinar titled “Taking Advantage of the EU MDR Delay in Uncertain Times: Optimizing Your Medical Device RA/QA Strategy”,Dr. Royth spoke specifically about the additional year from the perspective of notified bodies, and what steps you should take for the transition into the MDR.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Why should you watch this video?

• Learn how to strategically plan for upcoming audits based on common NB findings and pitfalls.
• Grasp how to use the time to work with NBs, Economic Operators, and implement all recently published MDCG Guidance.

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

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″]
[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_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=””]Here you can see a brief overview of what I am doing at TUV. We are globally responsible for the medical and health service business, and we have been dealing with the MDR for quite a long time now, preparing for that transition. Today, I will give you a brief overview of mainly three items. One is with respect to this additional year from the perspective from a notified body. How to use this time, and what steps you should take to really make use of this additional year of MDD for the transition into the MDR. Then I will turn to two other major aspects where we already can see that the preparation of the industry is not yet adequate to meet the needs. One is the post market activities you are supposed to do, and the next one is the economic operators.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Transition Planning from MDD to MDR Depending on Product Portfolio[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Now, I’ll start with the transition planning from MDD to MDR. This is really something where you need to look at your product portfolio and do an evaluation of your priorities. We have this new date of application in place. So, you have some time for additional changes on the existing certificates and you may also have time to renew some of your certificates. But you need to keep in mind that the timeframe is limited. So, it is unlikely, especially in the high-risk classes, that you will be able to complete a conformity assessment under MDD for a completely new product.

The other aspect Sophie mentioned already, and that is the capacity of the notified bodies being limited, especially with those who are already designated for the MDR. So, they are trying to focus all their resources on the MDR transition. In case you have projects you still want to pursue under MDD, make sure you line those up, and you make a clear roadmap together with your notified body, so that they can line up their resources to be prepared for submissions. Also, keep in mind that the final review stages at the notified bodies take a couple of weeks.

So, the latest submission dates for new MDD related files, change notifications, renewals, or some transfers, will be sometime this year depending on your notified body. But there will be a deadline for applying under MDD that is earlier than the date of application, of course. Then also make sure you align your own resources to these timelines, because usually there are some questions that go back and forth that you have to answer, and you have to have your people in place to respond quickly to really conclude the conformity assessment.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Structure of the 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=””]Then I would like to go briefly over to the post market surveillance and vigilance requirements under the MDR. This is specifically important because this chapter and this part of the MDR does not only apply if you are certified under MDR already. Even if you continue to use the grace period for your existing and ongoing MDD certificates, you are supposed to execute the post market surveillance, according to the MDR. So regardless, if you have formally transferred to the MDR or not be, please be aware. Maintaining the MDD certification after the date of application is also something that is happening under the MDR, the deed ends and does not exist beyond the date of application. So that specific chapter is applicable also for the MDD certificates.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Major Elements of Post Market Surveillance (PMS)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Now, if we look at the major elements of the post market surveillance (PMS), here you see a brief overview of what you’re supposed to do with the post market clinical follow-up. The reports, the plans, the periodic safety update reports, are a whole bunch of things you are supposed to do under MDR postmarking surveillance.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Periodic Safety Update Report (PSUR)[/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=””]Looking a little bit into the structure here, one central element is the periodic safety update report. That is something where you need to look at the conclusion of the benefit risk determination, and how that would be modified or changed with the information you are gathering from the market. That’s where the main findings of the PMCF report have to end up. Then you also have to consider things like the sales volume of the devices and the estimate of the population using the devices involved in usage frequency. That’s to make a link to the risk management where you have certain probabilities to find, and for checking that the assumptions you’ve taken in your risk management are actually valid.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″]
[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Article 83, 84: PMS and Annex II + III, XIV, B: PBCF[/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=””]On the other hand, here you see how these different activities are embedded in each other. This is for the planning stage where you have the clinical evaluation plan, and within that, you have the PMS plan. And as a part of that, you have the post market clinical follow-up plan. All these things need to be laid out in your system. These processes have to be established in your quality system so that you have a systematic approach on how this planning is done, and later, can execute it.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Annex XIV, Part B: PMCF – Report[/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=””]Once you come to the reporting part, here we have the post market clinical follow up report, so that it meets to match whatever you have planned before.

It is part of the clinical evaluation report that is regularly updated. And all of that is part of the technical documentation, including the risk management and some copies of the instructions for use. So, all these documents and processes are linked to each other and it is important that you implement that structure in this way. In the end, that means with the PMCF report and the clinical evaluation report, you have to update the technical documentation.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Processes, Plans (P), Reports (R), Summary (S)[/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=””]Here you see an overview for how the plans of the different aspects refer, or relate, to the reports or the summaries given. You can see again that the summary of the safety and clinical performance is the central part where you aggregate all the information on the post market surveillance process. And again, make sure that this is in place even for existing MDD certificates of products.[/fusion_text][fusion_imageframe image_id=”6051|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Economic Operators in European Market – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Economic-Operators-in-European-Market-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Economic Operators[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

So now the second aspect I want to highlight here are the economic operators. Before we go into the different roles here, it’s important to understand that these terminologies are used for the European market, which is ‘placing on the market’ and ‘making available.’

• Placing on the market – Placing on the market is the first transfer of the device from a manufacturing stage into the European Union.
• Making available –  is really the distribution to the end user of the device, whoever that is.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Economic Operator Activities & Obligations[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Now looking at the economic operator activities and the obligation, we started with a manufacturer – if the manufacturer is on European territory, more precisely, the territory of the European Union, then the manufacturer places those devices on the market by themselves.

But if not, they will have to have an authorized representative for doing that. And if the devices are shipped from outside the European Union into the European Union, that is done by a so-called importer. So, in that case, the importer takes on the role of placing the devices on the market. There is another role that can be the same entity, but does not have to be, and that is the distributor. The distributor, according to our definition, makes the devices available on the market. With these roles, there are different obligations they are following and different things to consider here. So here, you see the overview of what the economic operators from the authorised representative, the importer, and the distributor are supposed to do, and for what parts of the device information they are responsible for.

Now, what is really important and a significant change to the previous set up under MDD, where you had this European representative in a slightly different matter, is that there are legal responsibilities on each of these economic operators. The distributor is obliged to verify the CE marking and the declaration of conformity (DoC), the instructions for use, and the UDI. The importer needs to verify it again, this is the CE marking, the DoC, labeling, and the UDI, and these are  legal requirements.

Authorised Representative – also, the authorised representative is legally responsible for the product on the market in Europe. So that is important also for your business relationship with these economic operators.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Person Responsible for Regulatory Compliance

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One of the things we also have to consider here, is that Authorized representative is supposed to have a person in place that is responsible for regulatory compliance. The way the different tasks are split between the manufacturer itself, and the European representative, you can see here. The basic check of the device, and the conformity before the release of the device, is on the manufacturer, as well as the technical documentation and issuing the declaration of conformity. But the European representative is supposed to carry out the post market surveillance, the vigilance reporting, and the device statements for international performance studies. Additionally, it’s important to mention that the technical documentation has to be available with the EU representative at any time. That’s also a change to the previous set up under MDD, where the E.U. representatives would just have to make access to the technical documentation available. Here, the technical documentation needs to be available with the European representative, so, that also means your European representative will have access to the technical documentation in full.

[/fusion_text][fusion_imageframe image_id=”6052|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Person Responsible Regulatory Compliance under EU MDR – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/10/Person-Responsible-Regulatory-Compliance-under-EU-MDR-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Conclusions

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In conclusion, regarding your planning of the remaining year, coordinate resource planning with your notified body, and prioritize your projects strategically because the resources will be limited. Prepare postmarket activities for the complete product portfolio, MDD and MDR, because the respective MDR requirements also apply for maintained MDD certificates. Establish the PMS in your systems and your documentation. Make sure that all the updates and reporting is in place for all the post market activities. Take a close look at the setup of your economic operators and their legal obligations. Make sure that the economic operators you have in place are ready and prepared to take on the roles and responsibilities they have under MDR. And then lastly, ensure each of the European economic operators is clear about their obligations and duties, including legal responsibility. And with that, I would conclude my brief overview of what to consider in this additional year before the date of application of MDR. Thank you very much!

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

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

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[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ 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padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”6007|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=”RAPS Webinar Transcript – EU MDR Delay Presentation – Dr Sophie Vaillot -Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/09/RAPS-Webinar-Transcript-EU-MDR-Delay-Presentation-Dr-Sophie-Vaillot-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Dr Vaillot’s Presentation on the EU MDR Extension

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Dr. Sophie Vaillot is the Head of Global Regulatory Affairs at Nobel Biocare Systems who is responsible for the overall regulatory compliance including regulatory strategy planning and execution – FDA pre-submission meetings, 510(k), CE marking, and global market access, as well as lifecycle management activities.

The EU commission at the end of the March postponed the date of application for medical device companies due to the uncertain COVID 19 situation. Implementing the specific requirements in compliance with EU MDR is still a big challenge for medical device manufacturers. During our RAPS webinar discussion titled “Taking Advantage of the EU MDR Delay in Uncertain Times: Optimizing Your Medical Device RA/QA Strategy”, Dr. Sophie Vaillot spoke specifically about MDR Overview, Timelines & MDR Delay – Impact and how to use it.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Why should you watch this video?

• This video (and transcript) will provide you with an understanding of what the EU-MDR extension means for your organization, and how the extra time should be leveraged for both new and legacy devices.
• You will be able to strategically plan for interactions with specific extra-EU situations: Switzerland and Turkey.

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

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″]
[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Well, thank you, everyone, for attending this webinar. I am very excited to be here today and to discuss the MDR and more specifically, this new date of application, and how the industry can benefit from it.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]MDR – A Long Journey[/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=””]Before getting into the specifics of this additional year and the impact of this delay, I’d like to just take a quick step back, maybe for those who were not part of the regulatory world just 10 years ago, to have a quick look at the MDR journey, which is actually a long one. It started more than 10 years ago, with the public consultation from the EU commission to update the medical device directive.

So that led to multiple versions of a new regulation, with multiple versions going back and forth between the different legal entities of the European Union (EU), before getting to a compromised text, which was finally adopted and published in May 2017. The date of application at that time, was to be three years later in May 2020. So, the text has already been amended and changed from the original text through corrigendum, and with some delegated and implementing acts.

So, why such a long journey? Well, first, because of the complexity of the legislative process in Europe. They must work with different notified bodies, which need to approve and agree on the text and requirements. And because the MDR is so complex, the text brings several new requirements and concepts into regulation.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]MDR 2017 / 745 at a Glance[/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=””]Some of these new concepts are coming from work that was previously done at the international level. First through the GHTF work, and then through the IMDRF directive, which can be seen in the introduction of the UDI of different requirements around the technical file, and strengthening the PMS requirements as well. So, the MDR brings lots of new concepts and specific requirements. I am not going to go into detail here because Royth is going to mention them later on.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]DOA of MDR 2017/745 Pushed by 1 Year – MDR 2017/745 New Timelines[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]So, what happened just recently at the end of March, just short of two months before the date of application, the EU commission actually shared that they were working on a proposal to postpone the date of application. This is something that had already been brought to their attention by the industry, through Trade Associations, and was supported by regulators, and actually some of them, maybe unofficially, supported them. But that’s not something that the EU commission was willing to pursue given the COVID situation. They realized that given the new circumstances, challenging environment, and the need for notified bodies, regulators and the EU commission had to focus on COVID19 related medical devices and identities, and there was a need to postpone the date of application.

So, again, that’s kind of a complex legislative process that had to be implemented, where all defendants, the three legal entities, had to act to agree on the proposal. The EU commission was able to run that pretty smoothly, and over a month later after the initial communication, at the end of April, the regulation amending the MDR was actually published with immediate effect. Which then resulted in the postponement of the date of application, with the date now being May 26th, 2021. So, as we are going to see (in the graph) changes later on this year, there are some timeline’s that are not impacted by this amendment to the regulation.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]MDR 2017/745 – 1 Additional Year? For Whom, for What?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]What is important to keep in mind is that this additional year is not a gift to the industry. Firstly, it is providing more time for the regulators and the notified bodies to complete the designation process. Hopefully, MDR designated notified bodies will be able to process the authority & the industry requests. It is more time for the notified bodies to continue working on the rollout and the certificate conversion. It’s more time as well for the EU Commission to continue drafting and publishing the pending publications. There are actually several MDCG guidances which are still pending, and are due between now, and the end of the year. It is also more time to continue working on the EUDAMED implementation, and making sure that the new timelines of EUDAMED for 2022 are met.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″]
[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

The Industry’s Readiness

[/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=””]Even if it is not a gift to the industry, that does not mean that the industry is not going to be able to benefit from it. Based on a recent survey that was published by Greenlight Guru, it seems that a large portion of the industry is welcoming of an additional year. But a vast majority of the industry members stated they were not MDR ready, and were not confident that they would pass an MDR audit. About half of them are still saying that they do not have the budget to be able to implement MDR compliance.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Take Time to Carefully Assess your Situation!

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]So, for everyone, this is time that can be used to actually address these weaknesses, so the first thing to do is to take the time to carefully assess your current situation. And then again, that is going to be dependent on your own organization, and where you are in the MDR implementation process. For example, is your MDD certificate already renewed? Is your NB already MDR designated?

If so, have you already started to plan your audits? Do you have a schedule for the coming months? And do you know the different timelines that you need to meet? If your NB is not yet MDR designated, do you have an idea of when that will be the case? Then you can start working on that to plan the different steps that need to be completed.

Do you have all the MDCG guidelines? Which ones are coming in, and which ones are going to be impacting your products or your processes? Did you take the time to formally train your different employees and keep track of these training sessions? Because this is actually something that is often requested by NBs.[/fusion_text][fusion_imageframe image_id=”5964|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”EU MDR 2017745 – One Year Delay – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/09/EU-MDR-2017745-One-Year-Delay-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

MDR 2017/745 – 1 Additional Year? But Keep in Mind

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]It is an additional year, but keep in mind as well that some other deadlines are not changing. The date of application is one year later, but the so-called ‘grace period’ is still ending in 2024, which means that is the last date to be able to place MDD CE marked medical devices on the EU market.

The date of application is changing, but not article 120 of your MDD certificate that has already been extended. This gives you more time to ask for a renewal of the MDD certificates, but some notified bodies have stopped actually accepting these renewals based on the upcoming date of application. So, you would need to check with your notified body about what your current position is, and that is something that you can benefit from.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Extra Time for MDD Legacy Devices

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]There are a few things that you can still do regarding your MDD legacy devices.

Planned to exit the EU market for some parts of the Portfolio? – The first thing is that I know some of the industry members are actually planning to exit the EU market for some of their medical devices. When that is done, you don’t want to invest into MDR compliance for those devices, which makes sense from a business standpoint. This gives you some extra time to continue placing them on the market and maximizing the life of all of these products.

Considering making any changes to legacy devices? –This additional year until the date of application also allows more time to continue working with your NB to understand how they would accept changes made to these products, and to these devices already CE marked. Additionally, how they would apply either the guidance on the significant changes, or NBOG one of substantial changes. So that requires, again, a discussion with your notified body and how that can be applied. But that is just one option that you have and some extra time to work on that.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Extra Time for PMS Activities – Collecting Data

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]So, an additional year is also extra time to be fully ready for the MDR and specifically for some specific new requirements which have been introduced regarding the PMS activities that you need to have. So, you may not need it right now, but you are going to need it in a year or so. So, this is some more time to make sure that you have the right channels to collect that information, and that you have the right level of information. I would say specifically in these new environments where clinical practice may change, you may need to adapt, for example, the questions of the survey that you had sent to your customers in order to collect their feedback.

You may also need to look into how you are collecting this feedback if you were relying on on-site visits. You may want to change and adapt that to the new working environment.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Extra Time to Deal with Specific Extra-EU Situations: Switzerland

[/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 date of application being postponed gives extra time to deal with some specific situations like the European situation. One example is Switzerland. Currently the MDD is fully recognized there. There is an agreement in progress between Europe and Switzerland, and it is considering all the requirements of the MDD, but that is not the case yet for the MDR. So there is also some extra time for both parties to reach an agreement to make sure that it fully includes MDR requirements.

And actually, the Swiss administration confirmed yesterday that they were working on that and that they were still discussing with the EU Commission in order to reach that agreement. But that is not something that has happened yet, so it is not fully certain. This is extra time for you as a manufacturer, specifically a legal manufacturer based in Switzerland, or if you are an authorized representative based in Switzerland, to look for a Plan B in case this mutual recognition agreement is not fully in place by May 2021.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Extra Time to Deal with Specific Extra-EU Situations: Turkey

[/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=””]Similarly, even if it is a different situation, due to the status of Turkey, there is Turkish legislation that is aligned with the MDD with some additional requirements. But again, this is not yet the case for the MDR. And in addition to the MDR being transferred to the Turkish legislation and the European Union, there will soon be a need to have a specific new agreement to deal with MDR CE marked products. That is more time for these two parties to continue working and to reach an agreement by mid-2021. And if that’s not the case, that’s more time for the members of the industry to decide how big Turkey’s market is for you, for example, how you can prevent the adverse consequences of that. This means stockpiling, and making sure that you have products introduced on the Turkish markets before the cut-off 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=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Extra Time to Assess Impact of Changes on International Registrations

[/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=””]More generally speaking, there is also extra time to see the impact of the MDR and anticipate the impact of the MDR on international registrations. This is so you don’t have any adverse consequences for the date of application. As you know, the MDR is going to have some impact on the regulatory labeling, the technical documentation, and administrative documentation, with all of those being used for international registration. So, you may want to see how that is going to impact your registration and how you can combine these changes with upcoming new registrations that you want to make. This is so you do not end up registering your product several times in a couple of months.[/fusion_text][fusion_imageframe image_id=”5968|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”MDR Changes on International Registrations – Regulatory Compliance – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/09/MDR-Changes-on-International-Registrations-Regulatory-Compliance-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Conclusions

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]As a conclusion, the date of application is coming in about 308 days. So, take the time to assess the situation, but also use the time wisely based on what your situation is. Thank You!![/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” box_shadow=”yes” box_shadow_vertical=”5%” box_shadow_horizontal=”5%” box_shadow_blur=”28″ box_shadow_spread=”2″ box_shadow_color=”#f1f6f8″ box_shadow_style=”” padding_top=”” padding_right=”0px” padding_bottom=”” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”#f6f8f8″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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

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[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ 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padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”5873|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Person Responsible for Regulatory Compliance under MDR and IVDR” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/08/Person-Responsible-for-Regulatory-Compliance-under-MDR-and-IVDR.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Guidance on Identifying the Person Responsible for Regulatory Compliance under MDR and IVDR[/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 EU Commission enforced the concept of the person responsible for regulatory compliance (PRRC) in the new guidelines for managing compliance with EU MDR and IVDR. It is imperative that the PRRC role is established and implemented by both the manufacturers and their respective authorized representatives (AR) who are about to place compliant medical devices on the market. The aim of the regulators was to reinforce the professionalism of both manufacturers and authorized representatives while increasing scrutiny and ensuring implementation of vigilance activities.[/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 following is the fourteenth in the series of EU MDR related blogs. To learn more about the EU MDR changes you can view some of the previous posts in the series:

• Medical Device Equivalence vs Demonstration of Equivalence
• Post-market Clinical Follow-up Requirements for EU MDR
• The New European Union MDR: Impact on Technical Files
• Low-risk Device Challenges
• Selecting and Working with your Notified Body
• Medical Devices with Ancillary Medicinal Substances
• Regulatory Challenges Writing EU MDR Compliant Clinical Evaluation Reports (CER)
• International Medical Device Regulators Forum (IMDRF) & Summary of Recent Changes to Clinical Evaluation Guidance
• Remote Medical Audits During COVID-19
• Celegence Webinar: Taking advantage of the EU MDR Delay in Uncertain Times
• Components of an Effective Post-Market Surveillance for Medical Devices
• Medical Device Labeling Changes & Challenges under EU MDR
• EU MDR Risk Management Requirements: From complex regulation to impactful change with the new ISO 14971

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

Article 15 of MDR 2017/745

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Article 15 of MDR 2017/745 states that:

“Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.”

The requisite expertise of the PRRC is also detailed in the regulation and is applicable to manufacturers placing class I devices. However, micro and small enterprises (defined as an organization employing fewer than 50 staff and not exceeding EUR 10 million in annual turnover and/or annual balance sheet total) need not have such a person immediately in their organization, but a PRRC must be available at their disposal.[/fusion_text][fusion_imageframe image_id=”5874|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Article 15 of MDR 2017745 – Person Responsible for Regulatory Compliance PRRC” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/08/Article-15-of-MDR-2017745-Person-Responsible-for-Regulatory-Compliance-PRRC.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Qualifications of the Person Responsible for Regulatory Compliance (PRRC)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

The PRRC is required to have minimum qualifications, that include:

• A diploma, certificate, or other evidence of formal qualification from a university recognized as equivalent by the concerned Member State in law, medicine, pharmacy, engineering, or another relevant scientific discipline, with at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
• Professional experience of at least four years in regulatory affairs or in quality management systems relating to medical devices
• Manufacturers of custom-made devices are to have at least two years of professional experience within a relevant field of manufacturing

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

Roles/Responsibilities of the Person Responsible for Regulatory Compliance (PRRC)

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The PRRC is responsible for ensuring:

• Conformity of the device to the manufacturer’s QMS prior to release
• Technical documentation and EU Declaration of Conformity (DOC) are up to date
• Post-market surveillance obligations follow Article 10(10)
• Reporting obligations referred to in Articles 87 to 91 are fulfilled
• The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation devices

[/fusion_text][fusion_imageframe image_id=”5875|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=”Responsibilities and Roles – Person Responsible for Regulatory Compliance PRRC” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/08/Responsibilities-and-Roles-Person-Responsible-for-Regulatory-Compliance-PRRC.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=””]While the Regulations set out requirements on the qualification of the PRRC, and an overview of their responsibilities, the Medical Device Coordination Group (MDCG) published new guidance documents under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR). These requirements provide additional details that address certain ‘grey zones’ within the regulation, and clarifies the PRRC requirements for manufacturers and AR, notably that:

• Each legal manufacturer must have a PRRC at their disposal, and where organizations have more than one legal manufacturer within the group, each manufacturer must have their own PRRC, the guidance does not clarify if the same PRRC can act for multiple manufactures
• Manufacturers that are not established in the EU must have an AR in a Member State of the EU, who must also have a PRRC. The AR may also subcontract the responsibilities of the PRRC to a third party. One individual cannot be the PRRC for both the manufacturer and the AR, and in the case of a micro or small enterprise, the PRRC of the manufacturer and the PRRC of the AR cannot be from the same external organization
• In terms of location, the PRRC should be in the same place as the manufacturer or AR. Therefore, if a manufacturer is located outside the EU, the PRRC should also be located outside the EU. Manufacturers in the EU should likewise have a PRRC located inside the EU, as the AR will be in the EU, the PRRC will also be located inside the EU
• If the required qualifications of the PRRC were not obtained in the EU, they should be recognized by an EU Member State as equivalent to the EU corresponding qualification
• Professional experience of the PRRC in the regulatory affairs or in quality management systems (QMS) related to the medical device should be related to the EU requirements in the field
• The PRRC appointed should be an employee of the organization
• Micro or small enterprises may subcontract the responsibilities of the PRRC to a third party, provided the PRRC has the relevant qualifications and the manufacturer can demonstrate they are able to fulfil their legal obligations while using a third party who is not within the manufacturers’ organization

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]MDR Provisions to Appoint a PRRC[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]While the MDR allows the appointment of more than one PRRC, it would be ideal to split the responsibilities of the PRRC among different responsible persons in different departments, both within the company, or externally. Each appointed PRRC (including deputies) should have the qualifications as required by the regulation. Additionally, it is important for every PRRC to be registered in the EUDAMED database when it is available. As stated in the regulation, the PRRC will suffer no disadvantage within the manufacturer’s organization in relation to the proper fulfilment of his or her duties, regardless of whether they are employees of the organization.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Conclusions – Identifying the Person Responsible for Regulatory Compliance under MDR and IVDR[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Every stakeholder involved in medical device regulatory compliance is aware that the demands of the new EU MDR are far more complex than the MDD. Although the new requirements under the regulation can be challenging, the adjustments are manageable when tackled systematically. Based on the type and size of your organization, the requirements for a PRRC may vary. The importance of introducing the role of a PRRC by the MDR and IVDR goes beyond the role as that of a safety officer. While the EUMDR mandates to appoint a new figure in the organizational chart of an enterprise, has your organization considered how you will manage the role of the PRRC for regulatory compliance?[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” box_shadow=”yes” box_shadow_vertical=”5%” box_shadow_horizontal=”5%” box_shadow_blur=”28″ box_shadow_spread=”2″ box_shadow_color=”#f1f6f8″ box_shadow_style=”” padding_top=”” padding_right=”0px” padding_bottom=”” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”#f6f8f8″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

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For more information on availing the PRRC services and EU authorized representative services offered by Celegence, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities.

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