EU Faces MDR Failure Unless It Adjusts To COVID-19 Crisis And Grows Notified Bodies
Is the current pandemic too big a hurdle for the EU’s medtech regulators and industry alike? What else might hold EU medtech back from the successful implementation of the MDR?
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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?