EU Representative Fee (Medical Devices)
EU Representative fee depends on device class, number of devices, GMDN Code, etc. Please select your chosen device type and risk class from the options provided below. Please keep in mind that the fees shown are just meant as a basic guide. Following receipt of your proposal request, we will provide you with a comprehensive and detailed offer.
| SL. No. | ACTIVITY | FEE | EACH ADDITIONAL DEVICE |
| 1 | Annual EU Representative Service | € 850 | € 50 |
| 2 | EUDAMED or EU Registration | € 550 | € 250 |
| TOTAL | £ 1400 | – | |
| 3 | Review and Correction of DOC including GMDN Code | € 300 | € 300 |
| 4 | Application and Processing Fee for FSC | € 2200 | – |
| 5 | Legalization and Notary Attestation | £ 650 | – |
⇒ The Payment in Advance.
⇒ Customer must provide signed DOC in company letterhead.
⇒ The EMDN / GMDN Code must be clearly mentioned in the DOC.
⇒ EU Rep Agreement Signing in 4-5 working days and EUDAMED / EU Registration timeline is 10-16 working days.
| SL. No. | ACTIVITY | FEE | EACH ADDITIONAL DEVICE |
| 1 | Annual EU Representative Service | € 950 | € 50 |
| 2 | EUDAMED or EU Registration | € 550 | € 250 |
| TOTAL | £ 1500 | – | |
| 3 | Review and Correction of DOC including GMDN Code | € 300 | € 300 |
| 4 | Application and Processing Fee for FSC | € 2400 | – |
| 5 | Legalization and Notary Attestation | £ 650 | – |
⇒ The Payment in Advance.
⇒ Customer must provide signed DOC in company letterhead.
⇒ The EMDN / GMDN Code must be clearly mentioned in the DOC.
⇒ EU Rep Agreement Signing in 4-5 working days and EUDAMED / EU Registration timeline is 10-16 working days.
| SL. No. | ACTIVITY | FEE | EACH ADDITIONAL DEVICE |
| 1 | Annual EU Representative Service | € 1150 | € 50 |
| 2 | EUDAMED or EU Registration | € 550 | € 250 |
| TOTAL | £ 1700 | – | |
| 3 | Review and Correction of DOC including GMDN Code | € 300 | € 300 |
| 4 | Application and Processing Fee for FSC | € 2600 | – |
| 5 | Legalization and Notary Attestation | £ 650 | – |
⇒ The Payment in Advance.
⇒ Customer must provide signed DOC in company letterhead.
⇒ The EMDN / GMDN Code must be clearly mentioned in the DOC.
⇒ EU Rep Agreement Signing in 4-5 working days and EUDAMED / EU Registration timeline is 10-16 working days.
| SL. No. | ACTIVITY | FEE | EACH ADDITIONAL DEVICE |
| 1 | Annual EU Representative Service | € 1350 | € 50 |
| 2 | EUDAMED or EU Registration | € 550 | € 250 |
| TOTAL | £ 1900 | – | |
| 3 | Review and Correction of DOC including GMDN Code | € 300 | € 500 |
| 4 | Application and Processing Fee for FSC | € 2800 | – |
| 5 | Legalization and Notary Attestation | £ 650 | – |
⇒ The Payment in Advance.
⇒ Customer must provide signed DOC in company letterhead.
⇒ The EMDN / GMDN Code must be clearly mentioned in the DOC.
⇒ EU Rep Agreement Signing in 4-5 working days and EUDAMED / EU Registration timeline is 10-16 working days.
EU Representative Fee (In-Virto Diagnostic Devices)
In-Vitro diagnostic device manufacturer must meticulously plan and prepare the technical documentation as per EU IVDR 2017/746 with all necessary contents as per Annex II and Annex III. As you know the EU Representative has the responsibility to maintain the latest version of the technical documentation for the disposal of competent authorities if requested. Prior to act as EU Representative for your company, it’s most important to know the quality of Declaration of Conformity for each device and GMDN code covered in the scope.
| SL. No. | ACTIVITY | FEE | EACH ADDITIONAL DEVICE |
| 1 | Annual EU Representative Service | € 850 | € 50 |
| 2 | EUDAMED or EU Registration | € 550 | € 250 |
| TOTAL | £ 1400 | – | |
| 3 | Review and Correction of DOC including GMDN Code | € 300 | € 300 |
| 4 | Application and Processing Fee for FSC | € 2200 | – |
| 5 | Legalization and Notary Attestation | £ 650 | – |
⇒ The Payment in Advance.
⇒ Customer must provide signed DOC in company letterhead.
⇒ The EMDN / GMDN Code must be clearly mentioned in the DOC.
⇒ EU Rep Agreement Signing in 4-5 working days and EUDAMED / EU Registration timeline is 10-16 working days.
| SL. No. | ACTIVITY | FEE | EACH ADDITIONAL DEVICE |
| 1 | Annual EU Representative Service | € 950 | € 50 |
| 2 | EUDAMED or EU Registration | € 550 | € 250 |
| TOTAL | £ 1500 | – | |
| 3 | Review and Correction of DOC including GMDN Code | € 300 | € 300 |
| 4 | Application and Processing Fee for FSC | € 2200 | – |
| 5 | Legalization and Notary Attestation | £ 650 | – |
⇒ The Payment in Advance.
⇒ Customer must provide signed DOC in company letterhead.
⇒ The EMDN / GMDN Code must be clearly mentioned in the DOC.
⇒ EU Rep Agreement Signing in 4-5 working days and EUDAMED / EU Registration timeline is 10-16 working days.
| SL. No. | ACTIVITY | FEE | EACH ADDITIONAL DEVICE |
| 1 | Annual EU Representative Service | € 1150 | € 50 |
| 2 | EUDAMED or EU Registration | € 550 | € 250 |
| TOTAL | £ 1700 | – | |
| 3 | Review and Correction of DOC including GMDN Code | € 300 | € 300 |
| 4 | Application and Processing Fee for FSC | € 2400 | – |
| 5 | Legalization and Notary Attestation | £ 650 | – |
⇒ The Payment in Advance.
⇒ Customer must provide signed DOC in company letterhead.
⇒ The EMDN / GMDN Code must be clearly mentioned in the DOC.
⇒ EU Rep Agreement Signing in 4-5 working days and EUDAMED / EU Registration timeline is 10-16 working days.
| SL. No. | ACTIVITY | FEE | EACH ADDITIONAL DEVICE |
| 1 | Annual EU Representative Service | € 1350 | € 50 |
| 2 | EUDAMED or EU Registration | € 550 | € 250 |
| TOTAL | £ 1900 | – | |
| 3 | Review and Correction of DOC including GMDN Code | € 300 | € 300 |
| 4 | Application and Processing Fee for FSC | € 2200 | – |
| 5 | Legalization and Notary Attestation | £ 650 | – |
⇒ The Payment in Advance.
⇒ Customer must provide signed DOC in company letterhead.
⇒ The EMDN / GMDN Code must be clearly mentioned in the DOC.
⇒ EU Rep Agreement Signing in 4-5 working days and EUDAMED / EU Registration timeline is 10-16 working days.