European Union Medical Device Registration Fees
EUDAMED government fees for 2026
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EUDAMED
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2026-01-12
Last Updated
European Union (EUDAMED) Fee Overview
The EU has no government registration fees - EUDAMED registration is free. However, Notified Body fees for CE marking range from €4,000 for Class I to €30,000-100,000+ for Class III devices. These are commercial fees, not government charges. Under EU MDR, all manufacturers must register in EUDAMED and appoint an EU Authorized Representative.
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
EUDAMED Registration No government fee | Free | Per registration |
Key Facts About EUDAMED Fees
- 1EUDAMED registration: Free
- 2Notified Body fees: €4,000-€100,000+ (commercial)
- 3EU-AR required for non-EU manufacturers
- 4UDI-DI registration: Free
- 5No annual government renewal fees
Important Notes
- •NO government registration fees
- •EUDAMED registration is FREE
- •Notified Body fees are NOT government fees
- •NB fees vary €4,000-€50,000+ (commercial)
Tips for European Union Registration
- 1EUDAMED fees are free - Notified Body fees vary widely
- 2Get multiple Notified Body quotes
- 3EU-AR costs ~€2,000-€5,000/year (not a government fee)
Frequently Asked Questions
Related Resources
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IndonesiaGovernment fees are subject to change. Last data update: 2026-01-12. Always verify current fees with EUDAMED.