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 strategy. The Agency just announced the project on 10 February 2025, two years after a successful pilot which helped to establish this procedure.
EMA advice for class III and specific class IIb medical devices
Manufacturers of class III and specific class IIb devices can now seek guidance through a portal at various stages of the clinical development. In particular, 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
The advice is free of charge, and details on the submission process are available on EMA’s website. Manufacturers can also consult “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”, available in our library of documents.
A separate pilot program for high-risk medical devices exists for orphan medical devices.
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