Orphan Medical Devices Pilot Closes With 13 Positive Status Opinions
October 28, 2026
The European Medicines Agency (EMA) ran an orphan medical devices pilot from 2 August 2024 to 31 March 2026. Under the pilot, Expert Panels gave orphan status advice to manufacturers and notified bodies. All 13 finalised status procedures produced a positive outcome, and the pilot has since become an established service.
The pilot grew out of guidance from the Medical Device Coordination Group (MDCG). In June 2024 the MDCG published guidance 2024-10 on the clinical evaluation of orphan medical devices. Under that guidance, a device is orphan if it is intended for a condition that presents in no more than 12,000 people in the EU per year and at least one of two further conditions holds: alternatives are insufficient, or the device offers an expected clinical benefit over available options.
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