EMA launches procedure for manufacturers working with high-risk medical devices
The European Medicines Agency's new standard procedure allows manufacturers to request advice from medical device expert panels
The medical device expert panels are intended to foster innovation and provide faster patient access to devices. Image credit: ©PeakPoints/peopleimages.com – stock.adobe.com
The European Medicines Agency (EMA) has created 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. The announcement comes after the agency launched a pilot in February 2023, which has allowed them to establish this procedure and gather feedback from manufacturers and panel experts. The EMA created the new procedure in close collaboration with the European Commission.1
Now, manufacturers of class III devices and class IIb active devices designed to administer or remove medicines can submit their request for advice through a portal, as well as consult the medical device expert panels at different stages of clinical development. Currently, no fees are associated with these requests.
According to the European Commission, Class IIb devices are intended for long-term use, such as catheters, long-term corrective contact lenses and stents; class III devices are intended "to control, diagnose, monitor or correct" pathologies related to the heart, central circulatory system or central nervous system.2
The medical device expert panels will be an essential tool to foster innovation and provide faster patient access to safer and more effective devices. In the next few weeks, the EMA plan to publish a report of the pilot procedure and findings from the last 2 years.
Information on the submission process can be found on the EMA’s website.
Reference:
EMA establishes regular procedure for scientific advice on certain high-risk medical devices. European Medicines Agency. Published February 10, 2025. Accessed February 10, 2025. https://www.ema.europa.eu/en/news/ema-establishes-regular-procedure-scientific-advice-certain-high-risk-medical-devices
MDCG 2021-24 Guidance on classification of medical devices. Medical Device Coordination Group (MDCG). Updated October 2021. Accessed February 10, 2025. https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf
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