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Medtech Experts Voice Mixed Reactions To European Commission's New MDR Proposals

 
• By Amanda Maxwell

Many well respected medtech experts have taken to LinkedIn to voice their opinions on the European Commission’s proposals to address the growing challenges with the implementation of the MDR. A glance at their views shows just how split opinions are.

The balance is good and bad on a white background - Illustration

While a great number have expressed relief that the European Commission is taking official measures to address current challenges around the EU’s Medical Device Regulation deadlines, others consider that the EU situation is so bad it is almost beyond repair.

Changes To The MDR In The Pipeline

The European Commission has announced, following the 9 December EPSCO meeting of EU health ministers, that it is going to present an official proposal in early 2023 aimed at easing pressure on the EU regulatory system so that notified bodies will have more time to complete the huge volume of conformity assessments under the MDR. The measures are intended to also stem the flood of devices that are being removed from the EU market due to notified body bottlenecks and other challenges.

The commission’s intention is to defer the deadlines for the MDR implementation from 26 May 2024 to 26 May 2027 for high risk, class III and IIb devices, and to 26 May 2028 for medium and low-risk devices, classes IIa, and class I needing the involvement of a notified body.

It is also going to present an official proposal which will have the effect of allowing legacy products (those with currently valid conformity assessment certificate under the former Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD)) to remain on the market beyond the current 26 May 2024 hard deadline for the application of the MDR under certain conditions as is laid out in Article 97 of the MDR.

In the meantime, the commission’s implementation body, the Medical Device Coordination Group (MDCG) issued a new EU position paper which will allow for an extension of notified body conformity assessment certificates for legacy devices which are in transition from the former directives for which, despite reasonable efforts undertaken by the manufacturer to obtain certification under the MDR, the relevant conformity assessment procedure involving a notified body has not been concluded in time.

LinkedIn has been awash with commentary and questions as experts attempt to understand how the detail will pan out. Medtech...

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