EMA Launches Pilot Program for Orphan Medical Devices in EU

The European Medicines Agency (EMA) has launched a pilot program aimed at supporting manufacturers of high-risk medical devices and notified bodies in the context of orphan medical devices. The program offers free advice on obtaining orphan device status and advice on the clinical evaluation of these devices. This initiative is designed to facilitate the introduction of new orphan medical devices to the EU market and to assist legacy devices in complying with the Medical Device Regulation (EU) 2017/745 (MDR). The pilot will operate until the end of 2025, depending on the availability of resources. Applications submitted in October 2024 will be evaluated in November 2024, and four applications will be chosen for the initial phase.

What does the EMA pilot program for orphan medical devices do?

Manufacturers selected for the program will receive expert panel advice on the potential orphan status of a device and on clinical development strategies or clinical investigation proposals. Notified bodies, in collaboration with manufacturers, will receive advice on orphan device status or on clinical evaluation data requirements during conformity assessments.

The advice may cover various aspects, including orphan device status, clinical evaluation data sets, justification for limited clinical data, clinical uncertainty, and post-market clinical follow-up activities. Priority will be given to devices for life-threatening conditions or those causing permanent impairment, devices intended for children, and novel devices with significant clinical benefits. Applications can be submitted through a dedicated portal, and applicants should detail the specific issues related to orphan device status and/or clinical data needed for pre-market evaluation, as well as post-market follow-up activities.

Guidance on determining orphan status and clinical evaluation for orphan devices has been published by the Medical Devices Coordination Group (MDCG) in June 2024, providing benchmarks for manufacturers and notified bodies.

You can read the full document here.

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