First EU Expert Panel Opinion Challenges Notified Body Assessment

 
• By Amanda Maxwell

An EU expert panel has become the first to issue an opinion on clinical evidence, providing an insight into how the scrutiny process works under the new Medical Device Regulation. It wants to see more work done on the Class III implantable product in question.

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Editor's Note: The expert opinion was removed from the European Commission's website after this story was originally published.

The first medical device to be subject to an expert panel opinion under the new EU Medical Device Regulation (MDR) is the Ivory Dentin Graft, a Class III implant intended...

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