EMA – New pilot programme to support orphan medical devices
EMA has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU). The pilot programme offers 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. While the pilot programme is currently scheduled to run until the end of 2025, the aim is to establish a long-term process for orphan device support.
More information on this news and on the pilot programme the EMA Website.
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vroby (21 octobre 2024). EMA – New pilot programme to support orphan medical devices. ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/12jhc





