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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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.
BSI would have been disappointed if it had received the comments featured in the first expert panel opinion, but vice-president Gary Slack believes the report provides many insights and opportunities around how this scrutiny process will impact the sector.