Pilot system for sponsors of clinical investigations of medical devices

Sponsors of clinical investigations in the EU have been invited to apply to participate in a pilot scheme introducing a coordinated assessment of clinical investigations and performance studies as provided in Articles 78 of the Medical device Regulation and Article 74 of the in vitro diagnostic medical devices Regulation (https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en).

The pilot will permit sponsors to submit a single application for a coordinated assessment. It is hoped that the pilot will lead to the establishment of a harmonised, predictable process across EU Member States, reducing administrative burden for sponsors and ensuring transparency and consistency in the coordinated assessment.

Application is limited to medical devices falling within defined classes. These are; for medical devices investigational devices in class III, invasive investigational devices in class IIa, and invasive investigational devices in class IIb, for IVDs where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies, or performance studies involving companion diagnostics. Applications for participation in the pilot scheme should be submitted before 30th June 2025.