EMA Unveils new Pilot Programme to Support Orphan Medical Devices

European Medicines Agency (EMA) initiated a pilot program for expert panels to assist in the creation and evaluation of rare medical devices in the EU. The pilot program provides free guidance from medical device expert panels to specific manufacturers and notified bodies on orphan device designation and required clinical evaluation data. Although the pilot programme is set to end in 2025, the goal is to create a permanent system for supporting orphan devices.

Orphan devices are medical devices designed for illnesses or conditions that impact a limited number of people annually (less than 12,000 in the EU). Frequently, they are utilized for the treatment or examination of uncommon illnesses or conditions that lack alternative diagnostic or therapeutic choices, thus addressing an unmet medical need.

Manufacturers have the opportunity to seek guidance from expert panels during various phases of their device's clinical strategy development, while notified bodies can ask for advice at certain points during the device's ongoing conformity assessment. In the pilot program, EMA will give priority to specific orphan medical devices, including those for life-threatening conditions, permanent impairment, children, and innovative devices with significant clinical benefits.