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Rocky Road So Far For Opinions Published By Device Expert Panels

 
• By Amanda Maxwell

The EU expert panel review is a critical step in the outcome of notified body assessment for certain high-risk devices. But slow progress has been made so far, highlighting many challenges.

Bumpy road (Ramadan farahat/Shutterstock.com)

The first EU expert panel opinion for a medical device was published in June 2021 in rather controversial circumstances. Now eight months later, and despite there being 10 different medical device expert panels across a wide range of medical specialties, just two more opinions have been published in the context of the EU Medical Device Regulation.

None of the three opinions published so far have proved straightforward for the expert panels involved, as the table below summarizing the outcome demonstrates.

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