EMA – Publication of the Interim report on the experience with the pilot from February 2023 to December 2024 on the Pilot on advice from expert panels to manufacturers of high-risk medical devices

A pilot on advice to manufacturers on their clinical development strategy and/or proposals for clinical investigation for certain high-risk medical devices, as provided for in Article 61(2)1 of the Medical Devices Regulation, was launched by the European Medicines Agency (EMA) in February 2023 and is currently concluding. The advice is provided by Expert Panels. This is the first time in the European Union (EU) that manufacturers have access via a dedicated regulatory procedure to experts th...