Highlights from the first Expert Panels and Notified Bodies workshop
Event
Human
Rare diseases
Date
- Monday, 22 April 2024, All day
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
On 22 April 2024, EMA organised a workshop to present and discuss to Notified Bodies (NBs) the current activities being developed by the Expert Panels.
The secretariat presented an overview of the consultation procedures - Clinical Evaluation Consultation Procedure (CECP) and Performance Evaluation Consultation Procedure (PECP) - focusing on their applicability to high-risk medical devices and in vitro diagnostic devices and the need for better forecasting of submissions. The ongoing process of advice to medical device manufacturers was also discussed.
An update to the CECP publication process was presented, as well as the future role of Expert Panels in orphan medical device development and assessment.
Participants emphasized the need for continued collaboration and regular exchanges between the Expert Panels and NBs to ensure the success of the activities.