Third workshop between notified bodies and expert panels

• Date:
  Thursday, 04 December 2025 , 17:30 - 18:30 Amsterdam time (CET)
• Location:
  Online

Event summary

The third workshop between expert panels and notified bodies brought together representatives from the European Commission, the Coordination Committee and notified bodies (NBs) to continue the exchange of experience on the clinical evaluation consultation procedure (CECP) under the MDR. The session built on previous discussions, with a focus on communication, transparency and further refinement of the procedure.

From the expert panels' perspective, key scientific and regulatory considerations were outlined, including the distinction between clinical data interpretation, performance evaluation and benefit–risk assessment. Challenges related to the availability and quality of clinical evidence were also highlighted, in particular in relation to long-term data and the use of appropriate endpoints.

NBs shared practical perspectives on the implementation of the CECP, noting areas where further clarification and alignment could be beneficial. The discussion reflected a common interest in supporting consistent and scientifically robust assessments, with continued dialogue and targeted exchanges identified as potentially valuable going forward.

Documents

Draft agenda – Workshop between notified bodies and expert panels

Draft

Highlights from the third expert panels and notified bodies workshop

Registration

Registration is closed.