Europe – EC Explains New MDR, IVDR Rules for Designating Expert Device Panels

The European Commission (EC) on Wednesday published an implementing decision on how new medical device expert panels will be designated under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

The panels will provide scientific, technical and clinical assistance to the EC, the Medical Device Coordination Group (MDCG), member states, notified bodies and device manufacturers. In particular, the implementing decision notes that notified bodies are required to carry out consultations of expert panels on clinical evaluations of certain high-risk devices in the context of MDR and on performance evaluations of certain high-risk in vitro diagnostic devices in the context of IVDR.

Panel experts will be objective (EC says they must have no financial or other interests in the device or notified body industries), appointed for three-year terms and paid €450 per each full working day.