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