European Commission Proposal To Extend MDR Deadlines As Far As 2027 and 2028
The Commission will present a mixture of likely elements of a legislative proposal for a targeted amendment of the MDR and IVDR for consideration at the 9 December EPSCO Health Council meeting.
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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?