MDCG Throws Ball Back Firmly In Manufacturers' Court As Pressure Grows For MDR Solutions
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.
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Neither manufacturers nor notified bodies are to blame for delays in implementing the EU Regulations on medical devices and in vitro diagnostics. It is down to bad project management; there are ways forward through dialogue and compromise, but time is tight, Bassil Akra tells Medtech Insight.
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.
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.