EU MDR Guidances: Can Stakeholders Be Punished For Not Applying Them?
Over 70 guidance documents have been drafted to support MDR implementation. But there is confusion over whether guidance is legally binding, especially where it applies to notified bodies.
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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?