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EMA – Publication of a Guide to manufacturers on the procedure for requesting advice from expert panels on clinical investigations and / or clinical development strategies for high-risk medical devices

EMA is offering clinical advice to manufacturers of high-risk medical devices through expert panels.

The expert panels advise on intended clinical development strategies and clinical investigation proposals. This is line with the Medical Devices Regulation (Article 61(2) of Regulation (EU) 2017/745).

The advice applies for the following devices: 

  • class III medical devices;
  • class IIb active medical devices intended to administer or remove medicinal products from the body.

Guidance for manufacturers is available below, including step-by-step instructions.

More information on the EMA’s action on Medical devices, on hight risk medical devices and on the expert panels on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (25 mars 2025). EMA – Publication of a Guide to manufacturers on the procedure for requesting advice from expert panels on clinical investigations and / or clinical development strategies for high-risk medical devices. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/13kgn


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