Resources - Orphan Devices

What Resources Exist to Better Understand Orphan Devices?

• Guidance (MDCG 2024-10): Provides advice for manufacturers and notified bodies on orphan devices
• EMA Orphan Medical Device Pilot Program: Offers free advice from expert panels to manufacturers and notified bodies 
• EMA Information Session: Sept. 23, 2024, online meeting on the pilot for expert panels' advice for orphan medical devices (recording, Q&A)
• DeCODe: Develop Child and Orphan Device Evaluation support
• EU Orphan Devices: Understanding the Regulatory Pathway and Clinical Evidence Requirements, Jan. 21, 2025, (Webinar Slides)
• Orphan and Paediatric Medical Devices in Europe: Recommendations to Support Their Availability for On-Label and Off-Label Clinical Indications, Expert Review of Medical Devices, September 2024
• Orphan Medical Devices and Pediatric Cardiology: What Interventionists in Europe Need to Know, and What Needs to be Done, Pediatric Cardiology, October 2022