The EMA is inviting manufacturers of high-risk medical devices and notified bodies to apply for its pilot program to support orphan medical devices. The program provides free advice on a possible orphan device status and on the clinical evaluation of orphan medical devices.
The goal of this initiative is to ease the transition under the new MDR (EU) 2017/745 rules and concretely bring new orphan medical devices onto the EU market, while preserving market access for legacy devices. The program is envisioned to run until late 2025 and is designed to establish a long-term process for requesting support from expert panels. Devices for treating medical conditions that are life-threatening or cause permanent impairment, devices intended for children, and novel devices promising a potentially major clinical benefit will be prioritized. Applications may be submitted via a dedicated portal link and by providing a letter of interest for the pilot phase.
Relevant Dates:
Full information can be found here
