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To foster innovation and accessibility to safer and effective devices that address patients’ needs, on 2 August 2024, the EMA launched a pilot program offering free advice from the medical device expert panels to selected manufacturers and notified bodies on the orphan device status and the data needed for their clinical evaluation.
Orphan devices are medical devices which are intended to be used for diseases or conditions affecting only a small number of individuals each year (not more than 12,000 individuals in the EU per year) and are often used to treat or diagnose rare diseases or conditions for which no or insufficient alternative diagnostic or therapeutic options exist, thereby fulfilling an unmet medical need.
Through this program, manufacturers can consult the expert panels at different stages of the development of the clinical strategy for their device, while notified bodies can request advice at specific moments of the ongoing conformity assessment of the device. As part of the pilot program, EMA will prioritize certain types of orphan medical devices, such as devices for treating a medical condition that is life-threatening or that could cause permanent impairment of a body function, devices intended for children, and novel devices with potential major clinical benefit.
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