EMA launches scientific consultancy pilot project for some high-risk medical devices

The expert panels will provide free advice to ten shortlisted candidates on their clinical development strategy and/or their clinical investigation proposals. The pilot project will last approximately one year and will help establish an efficient scientific advice procedure. Scientific advice is a fundamental tool for promoting innovation and facilitating faster access for patients to safer and more effective devices.

27 FEB – EMA has launched a pilot project to provide scientific advice on the envisaged clinical development strategy and clinical investigation proposals for some high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or or remove medicines). Starting today, manufacturers can submit their letter of interest to participate in the pilot project on the scientific advice that will be provided by the medical device expert panels.

The expert panels will provide free advice to ten shortlisted candidates on their clinical development strategy and/or their clinical investigation proposals. The pilot project will last approximately one year and will help establish an efficient scientific advice procedure. Scientific advice is a fundamental tool for promoting innovation and facilitating faster access for patients to safer and more effective devices.

The pilot project will prioritize certain types of medical devices:
– devices that benefit a small group of patients in the treatment or diagnosis of a disease or condition, such as devices intended to treat a rare condition, known as “orphan devices”, and devices for pediatric use;

– devices that treat medical conditions that are life-threatening or cause permanent impairment of a bodily function and for which current medical alternatives are insufficient or pose significant risks;
– new devices with a possible major clinical or health impact.

The first five applications will be selected in April. Small and medium-sized businesses are strongly encouraged to submit their letters of interest. Once the pilot project is complete, EMA will evaluate the process and experience of applicants and experts and organize a meeting with stakeholders to discuss potential improvements.

Learn about medical device expert panels and scientific advice
The Medical Device Expert Groups provide opinions and views on the clinical evaluation carried out by Notified Bodies in the context of the certification of certain high-risk medical devices and in vitro diagnostic medical devices.

EMA took over the coordination of the expert groups on medical devices on 1 March 2022, as part of the extension of its mandate on crisis preparedness and management of medicines and medical devices under Regulation (EU) 2022 /123.

February 27, 2023
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