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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Global Medtech Guidance Tracker: June 2022
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. More than 40 documents have been posted on the tracker since its last update.
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.
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.