New Voices Clamor For Urgent MDR Action To Avoid Major Clinical Crisis
Industry and notified bodies have long warned of the hurdles to implementation of the Medical Device Regulation. Now competent authorities and medical and research societies are adding to the pressure for the EU to find solutions fast.
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EU manufacturers who delay applying to notified bodies for conformity assessment of their medtech products well in advance are being held accountable for implementation problems with the EU Medical Device Regulation.
The IVD expert panel has reviewed the performance of the 16th IVD that it has been asked to assess. The outcome is generally favorable – but with some reservations, including its use in the EU.
New designations of notified bodies under the Medical Device Regulation continue to trickle through slowly. The latest brings the EU’s total to 33, still way short of the previous 80 or so under the Medical Devices Directive.