EMA launches early scientific advice program for high-risk medical devices

The European Medicines Agency (EMA) and the European Commission have developed a standard procedure for certain high-risk medical device manufacturers to ask for scientific advice from a panel of experts regarding their clinical development strategies and clinical investigations, based on requirements under the Medical Device Regulation (MDR).

On 10 February, EMA said manufacturers of certain high-risk medical devices can now submit requests for advice from expert panels. The agency said that no fees are currently associated with the scientific advice requests.

The procedure was developed based on a pilot program that EMA launched in February 2023. After receiving positive feedback from manufacturers and panel experts, the agency decided it was time to implement the full program. Results from the pilot program will be published in the coming weeks, EMA said.

“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,” said EMA. “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.”

Manufacturers’ questions can only pertain to the product's clinical aspects, and questions regarding its clinical investigation may only be for investigations that have not yet started. Orphan device manufacturers are asked to seek advice from the orphan medical device pilot program instead.

“The medical device expert panels provide opinions and views on the clinical assessment conducted by notified bodies in the context of the certification of certain high-risk medical devices and in vitro medical device diagnostics,” said EMA.

EMA also provided a table with instructions for the procedure, which begins with the manufacturer submitting a letter of interest using the agency's ServiceNow platform. Eventually, the agency said it would upload the expert panel feedback using ServiceNow and email the manufacturers directly.

While EMA will not publicly publish the advice, it said it will publish aggregated information based on the expert panels' advice annually and may also present such information at meetings with stakeholders hosted by the agency.

EMA announcement

EMA launches early scientific advice program for high-risk medical devices

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