Highlights from the second expert panels and notified bodies workshop
EventHumanRare diseases
Date
- Friday, 23 May 2025, All day
Location
- Online
Event summary
The second workshop between expert panels and notified bodies brought together representatives from the European Commission, the Coordination Committee and notified bodies (NBs) to exchange experience and discuss key regulatory processes under the MDR. Discussions focused on the Clinical Evaluation Consultation Procedure (CECP), advice to manufacturers under Article 61(2), and implementation of MDCG 2024-10 guidance on orphan medical devices.
Participants emphasised the value of structured interaction and clear communication in the CECP, highlighting improvements such as more systematic exchanges. The need to update templates and consider a more iterative approach to the procedure was also discussed.
The workshop also addressed advice to manufacturers, noting its role in supporting device development and improving predictability regarding clinical data requirements. Early experience with orphan device guidance highlighted methodological challenges and the importance of a consistent approach across stakeholders.