On 27 February, the European Medicines Agency (EMA) launched a one-year pilot project to establish an efficient procedure for the provision of scientific advice in the field of medical devices.
Ten applicants selected from among high-risk medical device manufacturers will receive free advice from medical device experts on their clinical development strategy and/or clinical investigation proposals.
All Class III medical devices are covered, alongside Class IIb active devices intended to administer and/or withdraw one or more medicines.
Manufacturers are invited to submit their letter of motivation to be part of the pilot project, especially if they are small and medium-sized enterprises.
The EMA states that the first five applications will be selected in April 2023.
At the end of the one-year pilot project, the process and experiences of stakeholders, experts and manufacturers, will be evaluated and the EMA will seek to identify, together with stakeholders, improvements to the scientific advice procedure.
Link for submission of cover letters: https://aeur.eu/f/5ml (Original version in French by Emilie Vanderhulst)