Innovation To Suffer Under Revised MDR Unless Addressed Now, Suggest MDR Proposal Responses
Damage to SMEs and innovation, overly high notified body costs and concerns over lack of surveillance for critical devices are all topics addressed among responses to the European Commission’s latest MDR proposal.
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The European Commission’s proposal to extend transition timelines for legacy devices in the context of the Medical Device Regulation is already on the move. There are still questions, however, about whether a fast-track adoption is in the best interests of the medtech sector.
All eyes were on the European Commission in January as it edged closer to adopting new legislation that will see the Medical Device Regulation transition deadlines extended.
Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent. It looks like the EU is keeping its foot on the accelerator to adopt its latest proposal despite concerns raised about the text.