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EMA: Launch of standard procedure for scientific advice on high-risk medical devices

10 February 2025

EMA: Launch of standard procedure for scientific advice on high-risk medical devices

The European Medicines Agency (EMA), in collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their clinical development strategies and proposals for clinical investigations. Manufacturers of class III devices and class IIb active devices intended to administer or remove medicines can now submit requests for advice through a portal and consult the medical device expert panels at different stages of the development. This advice aims to promote innovation and faster patient access to safer and more effective devices.

This new regular procedure follows a successful pilot program launched in February 2023, which received positive feedback from manufacturers and panel experts. Currently, there are no fees associated with these requests. Additional information on the submission process, including step-by-step instructions and monthly deadlines, is available on the EMA’s website. Manufacturers of high-risk devices for rare conditions are encouraged to apply for advice through the ongoing pilot program for orphan medical devices.

For more information, see here.

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