EMA establishes regular procedure for scientific advice on certain high-risk medical devices

Manufacturers can request advice on their medical device clinical development programme

EMA, in close collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their intended clinical development strategy and proposals for clinical investigation.

Manufacturers of class III devices and class IIb active devices intended to administer or remove medicines can now submit their request for advice via a portal and consult the medical device expert panels at different stages of the clinical development.

Advice given by the medical device expert panels is a key tool to foster innovation and promote faster patient access to safer and more effective devices.

This regular scientific advice procedure follows a pilot launched in February 2023, which has helped to establish this procedure and gathered positive feedback from manufacturers and panel experts. EMA will publish a report on the pilot in the coming weeks.

There are currently no fees associated with these requests.

More information on the submission process, including step-by-step instructions for applicants and monthly submission deadlines is available on EMA’s website (High-risk medical devices: consultation procedures and advice and Medical Device page) Manufacturers of high-risk medical devices intended for the treatment of a rare condition should apply for advice via the ongoing pilot programme to support orphan medical devices.

EMA provides the secretariat to support the expert panels, based on Regulation (EU) 2022/123