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.

Close-up Of Businessperson Checking Bills With Magnifying Glass

All 15 of the views provided by the IVD expert panel under the IVD Regulation’s Performance Evaluation Consultation Procedures (PECP) by the end of January 2022 were prompted by submissions of just two notified bodies – BSI Netherlands and TÜV-SÜD Product Service.

An expert panel view is provided in the context of the PECP, which is an additional element of conformity assessment...