Author: Suzanne Broussard, PhD | February 25, 2022
The European Union (EU) saw 2021 bring important milestones and changes to the implementation of Medical Device Regulation (MDR) 2017/745. Key highlights included compliance dates, expert opinion panels, newly published guidance and standards.
MDD Grace Period Extension
The original deadline of 26 May 2021 for MDR 2017/745 compliance has come and gone, and many medical device manufacturers with devices granted a CE mark under MDD are taking advantage of the 26 May 2024 grace period to become fully complaint with MDR. As of September 2021, the EU notified bodies had granted only 502 conformity assessment certificates, thus, it is anticipated there will be an extreme bottleneck in 2023 and especially in 2024 due to limited notified body availability as manufacturers scramble to meet the May 2024 deadline.
Ensure successful compliance with MDR requirements by starting early. Many strategic decisions must be made, gaps identified, technical documents updated and brought into compliance, resources and bandwidth identified and deployed. These efforts require a great deal of time, both in work hours and calendar days.
Helpful information on MDR readiness activities can be found here.
First Three Expert Panel Opinions Released
Articles 106 and 48(6) of MDR require the European Commission to create expert panels to support the scientific assessment and provide advice in the field of medical devices.
The first three Expert Panel opinions for MDR were published in 2021.
The first-ever MDR opinion letter was initially published in July 2021 for a dental graft device and spotlighted potential differences that might arise between expert panels and notified bodies. In this case, the expert panel challenged certain aspects of the notified body’s assessment of the manufacturer’s clinical study. The public posting was subsequently taken down at the request of the notified body.
An opinion in the field of circulatory system for the Percutaneous Pulmonary Valve (PPV) and delivery system was published 22 November 2021. The PPV is a self-expanding heart valve designed to replace the native pulmonary heart valve without the need for open-heart surgery.
Many more expert panel opinions are expected in 2022 which manufacturers can leverage for information as they prepare for their devices MDR submissions. Publication of these options provides device manufacturers insights into the thinking behind the evaluation of higher level Class IIb and Class III device in their therapeutic field. While the role of the expert panel is advisory, they were created to play a key role in enforcing the tougher market access rules.
A total of 34 guidance documents were published or updated in 2021, bringing the total of MDCG-endorsed and other guidance documents to 90. Updates ranged from Substantial Modification of Clinical Investigation Under Medical Device Regulation (MDCG 2021-28) to Helsinki Procedure for Borderline and Classification Under MDR & IVDR (Helsinki Procedure).
A full listing of the guidance document can be found here.
Criterion Edge Can Support Your Push to MDR Compliance
Criterion Edge can provide a team of document experts with extensive experience writing technical documents that are MDR compliant. We have written many Clinical Evaluation Reports (CERs) for both small and large medical device manufacturers. We understand how all aspects of the CER align to tell the story of the device, starting with State of the Art and concluding with robust Risk-Benefit analysis and conclusions.
Reach out to Criterion Edge for support getting your technical documents of existing devices ready for MDD to MDR transition or new devices MDR compliant. We have expert medical writers to support your organizations in developing the necessary documents to ensure a smooth transition and meet these fast-moving deadlines. Get a free consultation today.
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