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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What is the MDCG's recent position paper really trying to say? • Source: Shutterstock

Two leading medtech industry consultants have suggested that a document just published by the Medical Device Coordination Group (MDCG) may implicitly suggest medtech can soon expect the European Commission to publish an implementing act allowing many legacy devices to remain on the market after their certificates have expired under the former directives, or after the Medical Device Regulation deadline of 26 May 2024.

But they expect any leniency to come with be strict conditions

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