Another German Notified Body Designation Brings EU MDR Total To 13
Germany now accounts for well over half the notified bodies designated under the EU’s Medical Device Regulation. Is there is time for other countries to catch up before the MDR’s extended deadline is reached?
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Despite industry’s urgent need to have their products assessed by notified bodies under the MDR, appointments are coming through slowly.
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The European Commission has finally published detailed guidance on the EU IVDR’s classification rules. The IVDR’s completely new classification regime means guidance is urgently needed.