Pilot system for sponsors of clinical investigations of medical devices
Medical Devices, Clinical Investigations Elisabethann Wright Medical Devices, Clinical Investigations Elisabethann Wright

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).

Read More