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Ten Expert Panel Opinions Published: What Lessons Can Industry Learn?

 
• By Amanda Maxwell

Expert panels pick a minority of high-risk devices whose clinical evaluation they believe needs closer scrutiny, following reports submitted by the notified bodies. With the tenth expert panel opinion out now, what trends are being seen?

Expert Opinion
• Source: Shutterstock

The tenth opinion published by a European Commission expert panel in the context of the Medical Device Regulation (MDR) has highlighted the depth and breadth of these reviews. Once again, the expert panel has recommended additional clinical data and a review of the product’s risks, as with the majority of the devices that have been subject to this additional level of scrutiny.

These opinions have now become a critical part of the safety review of high-risk devices and are prompting deeper analysis...

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• By Natasha Barrow

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• By Amanda Maxwell

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• By Ashley Yeo

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Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

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More from Geography

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• By Natasha Barrow

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• By Elizabeth Orr

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From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 
• By Michael McCaughan

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.