First EU Expert Panel Opinion Challenges Notified Body Assessment
An EU expert panel has become the first to issue an opinion on clinical evidence, providing an insight into how the scrutiny process works under the new Medical Device Regulation. It wants to see more work done on the Class III implantable product in question.
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The very first expert panel opinion under the Medical Device Regulation was published this summer, but quickly withdrawn. Now, a new opinion, falling under the IVD Regulation, has been made public.
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.
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.