Commission Launches Expert Panel Review Of High-Risk IVDs Despite No EURL Appointments Yet
Expert panel review of clinical files for high-risk IVDs are happening for the first time under the new EU IVD Regulation.
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Common specifications, Eudamed arrangements and EU reference laboratories are all topics that should be addressed in EU legislative acts to assist with the implementation of the new medtech regulations.
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.
Work is progressing towards publications of an updated list of standards to support implementation of the EU’s new medtech regulations.