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EMA is initiating a new pilot programme for the expert panels to support manufacturers manufacturing and notified bodies certifying orphan medical devices with the challenges linked to generating clinical evidence for these devices in the premarket phase (see Medical devices).
The expert panels can offer advice on the orphan device’s status, the intended clinical development strategies, proposed clinical investigations, or on the data required for the clinical evaluation during an ongoing conformity assessment. This programme is being launched as a pilot to help implement the processes outlined in the MDCG 2024-10 document on clinical evaluation of orphan medical devices.
Starting from 2 August 2024, EMA will begin accepting letters of interest from manufacturers and notified bodies that would like to be considered for this pilot. Therefore, 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 that will cover the following topics: