Overview
The European Medicines Agency (EMA) provides expert advice to support the development and evaluation of orphan medical devices, including guidance on orphan status and clinical requirements.
Key Points
- Applies to all medical device classes
- Open to manufacturers and notified bodies
- No fees currently required
- Non-EU applicants must have an EU authorised representative
Application Process
- Submit Letter of Interest via EMA portal
- Exploratory Meeting with EMA
- Submit Draft Briefing Document
- (Optional) Pre-submission meeting
- Final Submission (procedure starts)
- Expert Questions (if any)
- Discussion & Responses
- Final Advice issued (within ~60 days)
After the Process
- Advice is confidential
- Manufacturers must include it in clinical evaluation reports
- Notified bodies must consider or justify deviations
This process helps ensure safe, effective development of orphan medical devices through expert guidance.
Reference: https://www.ema.europa.eu/en/documents/other/orphan-medical-devices-regular-process-guide-applicants_en.pdf