EU Authorised Representative Cost for Medical Devices
| EU 2017/745 MDR Classification | Annual European Authorized Representative Service | Onetime EUDAMED Setup Fee | Onetime Actor + SRN Activation | Total Fee in EUROS for the 1st year |
|---|---|---|---|---|
| Class I | €900 | €300 | €400 | €1600 |
| Class Is-Im-Ir | €1000 | €300 | €400 | €1700 |
| Class IIa | €1100 | €300 | €400 | €1800 |
| Class IIb | €1200 | €300 | €400 | €1900 |
| Class III | €1300 | €300 | €400 | €2000 |
EU Representative Fee for IVD Devices
| EU 2017/746 IVDR Classification | Annual European Authorized Representative Service | Onetime EUDAMED Setup Fee | Onetime Actor + SRN Activation | Total Fee in EUROS for the 1st year |
|---|---|---|---|---|
| Class A | €900 | €300 | €400 | €1600 |
| Class A (Sterile) | €1000 | €300 | €400 | €1700 |
| Class B | €1100 | €300 | €400 | €1800 |
| Class C | €1200 | €300 | €400 | €1900 |
| Class D | €1300 | €300 | €400 | €2000 |
Important Note
⊗ A signed Declaration of Compliance (DOC) on company letterhead is required, with EMDN / GMDN codes clearly specified.
⊗ EAR annual fees are payable in advance before agreement and mandate drafting begins.
⊗ Annual European Authorised Representative (EAR) fee for each additional device: €100
⊗ Agreement / Mandate modification for any reason: €150
⊗ EUDAMED EAR Information removal fee: €50
⊗ Fee for issuing No Objection Certificate (NOC): €100
⊗ EU Rep Agreement Signing: 4–5 working days
⊗ EUDAMED & EU registration Timeline: 10–16 working days
UDI compliance Service
⊗ UDI Root Entry per Facility / Manufacturer: €500
⊗ UDI Registration: €300 per Registration
Optional Services
⊗ Drafting, Modifying Declaration of Conformity (DOC) for Class I devices: €400
⊗ FSC Application and Processing: €2000
⊗ FSC Legalisation and Notary Attestation: €500
⊗ EU Registration with competent Authority: €600 per device
**Prices effective from 1st January 2026. Page last updated on 1 January 2026.
