Rocky Road So Far For Opinions Published By Device Expert Panels
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.
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Just two notified bodies have submitted files to the European Commission’s expert panel for review of the manufacturer performance evaluation report to date. And the feedback is mixed.
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.
IVD manufacturers look set to be granted up to 18 more months to comply with the EU IVD Regulation very soon.