EMA establishes regular scientific advice procedure for high-risk devices

Article summary

The European Medicines Agency (EMA) has established a regular procedure for manufacturers of certain high-risk medical devices to request scientific advice on their clinical development strategies. The agency now allows manufacturers of class III devices and class IIb active devices intended to administer or remove medicines to submit requests via a portal for consultation with medical device expert panels. This follows a successful pilot launched in February 2023. EMA has also initiated a separate pilot programme, running until the end of 2025, to support orphan medical devices, with new guidance on clinical evaluation of such devices published by the Medical Devices Coordination Group in June 2024.