EU Authorised Representative Cost for Medical Devices
EU Authorised Representative Cost depends on medical device class, number of devices, GMDN Code, etc. Please select your chosen device class below and contact us.
| EU 2017/745 MDR Classification | Annual EU Authorised Representative Service cost | Onetime EUDAMED Setup cost (Optional) | Onetime Member State CAs administrative cost | 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 | €1250 | €300 | €400 | €1950 |
| Class III | €1500 | €300 | €400 | €2200 |
EU Authorised Representative Cost for IVD,s
| EU 2017/746 IVDR Classification | Annual EU Authorised Representative Service | Onetime EUDAMED Setup cost (Optional) | Onetime Member State CAs administrative Fee | 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 | €1250 | €300 | €400 | €1950 |
| Class D | €1500 | €300 | €400 | €2200 |
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 EU Authorised Representative cost 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
⊗ Custom made device: Base fee plus €200 yearly
⊗ EU Rep Agreement Signing: 4–5 working days
⊗ EUDAMED & EU registration Timeline: 10–16 working days
Optional Services
**Prices effective from 1st January 2026. Page last updated on 1 January 2026.
