News - March 17, 2023

EMA pilots scientific advice for certain high-risk medical devices

The European Medicines Agency (EMA) has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove medicinal product(s)). As of today, manufacturers can submit their letter of interest to be part of the pilot on scientific advice which will be provided by the medical device expert panels.

The expert panels will provide free advice to ten selected applicants on their clinical development strategy and/or proposals for clinical investigation. The pilot will last approximately one year and will help to establish an efficient scientific advice procedure. Scientific advice is a key tool to foster innovation and promotes faster patient access to safer and more effective devices.

The pilot will prioritise 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 for the treatment of a rare condition, known as ‘orphan devices’, and devices for paediatric use;
  • devices addressing medical conditions that are life threatening or cause permanent impairment of a body function and for which current medical alternatives are insufficient or carry significant risks;
  • novel devices with a possible major clinical or health impact.

More information on the process and the selection criteria is available on EMA’s website.

The first five applications will be selected in April. Small and medium-sized enterprises are strongly encouraged to submit their letters of interest.

Once the pilot has been completed, EMA will assess the process and the applicant’s and experts’ experience, and will hold a meeting with stakeholders to discuss potential improvements.

For further information regarding EUCOPE’s work with medical devices or to join our MDR/IVDR Focus Group, please contact Leander Vranken (