Interim report on the experience with the pilot from February 2023 to December 2024
The advice is provided by Expert Panels. This is the first time in the European Union (EU) that
manufacturers have access via a dedicated regulatory procedure to experts that will advise on the best
possible way to design and conduct clinical investigations and address questions concerning clinical
development strategies to support the certification of the devices. This will help manufacturers have
timely access to early consistent advice through a single EU regulatory pathway on the clinical
development of their products, thus enhancing the predictability on clinical evidence generation and
ultimately facilitating healthcare professionals and patients access to innovative, safe and effective
devices without unnecessary delays.
This interim report provides an overview of the applications received during the pilot until the end of
December 2024. A final report on the pilot will be published once all pilot procedures are finalised.
Based on the successful outcome of the pilot, the advice to manufacturers was fully implemented as of
February 2025. Improvements to the procedure were made considering the feedback received from
both experts and manufacturers during the pilot.