The European Medicines Agency (EMA) has launched a new pilot program to support the development and assessment of orphan medical devices in the EU.

The agency has established panels of medical device experts to offer free advice to manufacturers and notified bodies on orphan device status and clinical evaluation.

The expert panels will provide guidance on intended clinical development strategies, proposed clinical investigations, and data required for clinical evaluation during an ongoing conformity assessment.

Manufacturers can consult the expert panels at different stages of the evaluation process. Notified bodies can also request advice at specific points in the assessment of the device.

The program is currently scheduled to run until the end of 2025 as a pilot but EMA is aiming to establish the resource on a long-term basis, it says.

The pilot will prioritise certain types of orphan medical devices, such as devices for treating medical conditions that are life-threatening or can cause permanent impairment of a body function, devices intended for children, and novel devices with potential major clinical benefit.

The orphan device pilot will run in parallel to the scientific advice pilot currently available to manufacturers of devices addressing unmet needs.

The EMA is now accepting letters of interest from manufacturers and notified bodies that would like to be considered for the pilot.

In collaboration with representatives from the European Commission, it is hosting an online event covering the introduction of the new definition and criteria for orphan status for medical devices in the EU.

It will also offer advice on strategies for manufacturers to overcome challenges in generating clinical evidence, particularly considering the limitations in pre-market clinical data.