Reading Between The Lines: Is There A Positive Message Hidden In MDCG’s Blame Document?
The hope is now that a new EU document will be issued to address head on the scale of bottlenecks at notified bodies and of products needing to be removed from the market.
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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.
With a sense of desperation building among stakeholders over the challenges in ensuring all products are compliant with the Medical Device Regulation in time, high-level solutions are being considered. But a further MDR delay is not an option.
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.