EU Authorised Representative Cost for Medical Devices
Transparent pricing tailored to your device and regulatory needs.
EU Authorised Representative fees depend on device class, number of devices, Intended use and EMDN. Select your device type below to view indicative pricing. A detailed final quotation will be provided after your online request is submitted
| 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 |
Important Note
⊗ Annual European Authorised Representative (EAR) fee increases by €100 per additional device.
⊗ EAR annual fees are payable in advance before agreement and mandate drafting begins.
⊗ A signed Declaration of Compliance (DOC) on company letterhead is required, with EMDN / GMDN codes clearly specified.
⊗ Agreement / Mandate Modification for any reason an additional service fee of €150 applicable
⊗ EUDAMED Cancellation fee is €150
⊗ EU Rep Agreement signed: 4–5 working days
⊗ EUDAMED & EU registration completed: 10–16 working days
Optional Services
EU Representative Fee for IVD Devices
EU Authorised Representative fees depend on device class, number of devices, Intended use and EMDN. Select your device type below to view indicative pricing. A detailed final quotation will be provided after your online request is submitted
Under MDR/IVDR, the EU Authorised Representative is responsible for holding and maintaining the most up-to-date version of this technical documentation and making it available to competent authorities upon request.
| 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
⊗ Annual European Authorised Representative (EAR) fee increases by €100 per additional device.
⊗ EAR annual fees are payable in advance before agreement and mandate drafting begins.
⊗ A signed Declaration of Compliance (DOC) on company letterhead is required, with EMDN / GMDN codes clearly specified.
⊗ Agreement / Mandate Modification for any reason an additional service fee of €150 applicable
⊗ EUDAMED Cancellation fee is €150
⊗ EU Rep Agreement signed: 4–5 working days
⊗ EUDAMED & EU registration completed: 10–16 working days
Optional Services
**Prices effective from 1st January 2026. Page last updated on 1 January 2026.