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.
A review of expert panel opinions related to high-risk medical devices shows no challenges yet by notified bodies to their findings.
There had been handful of warning signals against well-known notified bodies designated against the MDR. Why were they there and why have they just been removed?