News Category: Regulatory news
The EMA is initiating a new pilot programme for the expert panels to support manufacturers manufacturing and notified bodies certifying orphan medical devices. The panel is being set up to address the challenges linked to generating clinical evidence for these devices in the premarket phase.
The EMA, in collaboration with representatives from the European Commission, the Medical Device Coordination Group (MDCG) and the expert panels, is planning a joint information session.
The session will address some of the key topics in relation to orphan medical devices, provide an overview of the pilot programme. There will also be an interactive Q&A session.
Date and time
Monday 23 September 13:00 – 15:00 GMT
Who should attend?
Organisations that manufacture and notified bodies that certify orphan medical devices
Further information
For more information and to register, visit the EMA event page.