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 is wavering as pressure builds for it to allow initial audits to be performed virtually under the Medical Device Regulation.
With growing urgency for the IVD industry to start compliance with the IVD Regulation, NSF’s Robyn Meurant explains the importance of getting clinical evidence right first time
There is no choice: manufacturers must start EU MDR compliance now, however incomplete implementation is. And some MDR clauses apply to all products as of May 2021, regardless of the grace period.