Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation, MDR) Article 106 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (In Vitro Diagnostic Medical Devices Regulation, IVDR) Article 48 provide the legal basis for the establishment of the Expert Panels on medical devices and for in vitro diagnostics, respectively. The MDR has been applicable since 26 May 2021 and the IVDR has been applicable since 26 May 2022.
According to Article 61(2) of the MDR, the Expert Panels can provide advice to manufacturers on their clinical development strategy and/or proposals for clinical investigation, for certain high-risk medical devices.
Regulation (EU) 2022/123 on a reinforced role for the EMA (“the Agency”) in crisis preparedness and management for medicinal products and medical devices has given the Agency the responsibility to provide the Secretariat for the Expert Panels, which was handed over from the European Commission’s Joint Research Centre to the Agency on 1 March 2022…
