Akra: Time To Acknowledge EU’s Real Implementation Problems And Stop Scapegoating
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.
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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.
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.
Companies have been warned if they delay in applying for certification under the new Medical Device and IVD Regulations their products may not be reviewed in time. And the scale of the potential bottleneck is alarming.