Expert Panel Review Likely For Just 10% To 20% Of Files Submitted
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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Manufacturers of high-risk class III medical devices and class IIb active medical devices that administer or remove medicinal products from the human body will be able to access expert panel advice prior to applying for CE-marking under a newly-announced European Medicines Agency pilot scheme.
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.
Expert panel review of clinical files for high-risk IVDs are happening for the first time under the new EU IVD Regulation.