Submissions for PECP (Performance Evaluation Consultation Procedure) are accepted since September 3, 2021, by the expert panels in the field of in vitro diagnostic medical devices.
What are the expert panels here for ?
With the new MDR and IVDR, high-risk (class III implantable devices and class IIb actives devices which are intended to administer and/or remove a medicinal product) and IVD medical devices are subject to stricter rules. Thus, expert panels must assess documents of the technical files for these devices and give their views and opinions. These views and opinions are based on documents received from notified bodies and manufacturers, besides their knowledge and experience.
The expert panels can also have an advisory role to actors such as the European Commission or the MDCG. Class C and D IVD devices must as well be tested by an EURL (EU reference laboratory), which has a central role in verifying the safety and performance.
For MDR products, the experts are responsible for reviewing the clinical evaluation assessment reports of notified bodies, the CECP (clinical evaluation consultation procedure).
For IVDR products, they are responsible for reviewing the performance evaluation reports, the PECP (performance evaluation consultation procedure).
What´s possible since September 3, 2021 ?
As announced on the EC website, “The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure“. You can find the list of experts here.
Note that CECP is not needed if there is a renewal of certificate issued under the Regulation, or relevant common specifications available, or a modification of a device already on the market, with certain conditions.
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