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 that will advise on the best possible way to design and conduct clinical investigations and address questions concerning clinical development strategies to support the certification of the devices. This will help manufacturers have timely access to early consistent advice through a single EU regulatory pathway on the clinical development of their products, thus enhancing the predictability on clinical evidence generation and ultimately facilitating healthcare professionals and patients access to innovative, safe and effective devices without unnecessary delays.
This interim report provides an overview of the applications received during the pilot until the end of December 2024. A final report on the pilot will be published once all pilot procedures are finalised.
Based on the successful outcome of the pilot, the advice to manufacturers was fully implemented as of February 2025. Improvements to the procedure were made considering the feedback received from both experts and manufacturers during the pilot.
More information on the scientific advice for high-risk medical devices on the EMA Website.
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vroby (16 mai 2025). 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. ELSIBI. Consulté le 12 janvier 2026 à l’adresse https://doi.org/10.58079/13xyc





