EMA Expert Panel Advice Pilot Ends With a Streamlined 60-Day Procedure
October 28, 2026
The EMA expert panel advice pilot for high-risk medical devices closed in February 2026, with advice given on 27 applications. The European Medicines Agency’s final report on the pilot shows the process getting faster as experience grew, and it confirms that a more streamlined 60-day procedure was implemented for manufacturers.
The pilot started in February 2023 to put Article 61(2) of the Medical Device Regulation into practice. That article lets manufacturers of all class III devices, and of class IIb active devices intended to administer and/or remove medicinal product(s), consult an expert panel before clinical evaluation or investigation. The aim is to review the intended clinical development strategy and the proposals for clinical investigation. EMA has provided the secretariat for the expert panels since 1 March 2022, when the work passed over from the European Commission’s Joint Research Centre.
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