IVD Expert Panel: First 15 Reviews Performed With Many Requests For Additional Information
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.
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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.
Despite resistance from the medtech industry, the European Medicines Agency now has a key role in the medical device and IVD expert panels, which have only recently been set up.
IVD manufacturers look set to be granted up to 18 more months to comply with the EU IVD Regulation very soon.