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Expert Panel Review Likely For Just 10% To 20% Of Files Submitted

 
• By Amanda Maxwell

Expert panel review of clinical files for high-risk devices is happening for the first time under the new EU medtech regulations. The process has begun but expert panel opinions may be rarer than many had originally expected.

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The European Commission only expects 10-20% of files sent by notified bodies for expert panel review will actually need an expert panel opinion.

The expert panels, just recently set up, have only received two files so far in the context of the Medical Device Regulation, Paul Piscoi, policy officer in the commission medical devices unit, told the EU MDR Exchange

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