Fees paid for clinical investigations of medical devices
Fee rates for the assessment of applications for authorisation of clinical investigation of medical devices and products without an intended medical purpose in 2025
The fee rates charged by the Danish Medicines Agency for its assessment of applications for authorisation of clinical investigations of medical devices are established in the Danish Executive Order on Fees for Medical Devices, etc. and in the amended Danish Executive Order on Fees for Medical Devices, etc.
| Application related to clinical investigation of medical devices and to change of clinical investigation of medical devices for the period 2025-2027 | Item no. | Fee
2025 |
|---|---|---|
| Class I devices (non-implantable device or device not intended for long-term use) | 4201 | DKK 46,097 |
| Class IIa devices (non-implantable device or device not intended for long-term use) | 4202 | DKK 46,097 |
| Class IIb devices (non-implantable device or device not intended for long-term use) | 4203 | DKK 46,097 |
| Class IIb devices (implantable device or device intended for long-term use) | 4205 | DKK 61,956 |
| Class III devices | 4206 | DKK 61,956 |
| Active implantable devices | 4207 | DKK 61,956 |
| Modification of clinical investigations of medical devices | 4208 | DKK 10,201 |
| Application related to clinical investigation of medical devices without a medical purpose | Item no. | Fee
2025 |
|---|---|---|
| Class I devices (non-implantable device or device not intended for long-term use) | 4210 | DKK 58,204 |
| Class IIa devices (non-implantable device or device not intended for long-term use) | 4211 | DKK 58,204 |
| Class IIb devices (non-implantable device or device not intended for long-term use) | 4212 | DKK 58,204 |
| Class IIb devices (implantable device or device intended for long-term use) | 4213 | DKK 78,227 |
| Class III devices | 4214 | DKK 78,227 |
| Active implantable devices | 4215 | DKK 78,227 |
| Modification of clinical investigations of medical devices | 4216 | DKK 12,880 |
Annual fees for supervision and inspection of clinical investigations in 2024
| Annual fee for inspection | Item no. | Fee
2025 |
|---|---|---|
| All | 4209 | DKK 12,880 |
The Danish Medicines Agency charges an annual fee for supervision and control of clinical investigation. Any clinical investigation authorised after 1 June 2021 is subject to an annual fee for the inspection services undertaken by the Danish Medicines Agency.
The annual fee is charged every calendar year for all ongoing clinical investigations. The fee is payable regardless of whether the clinical investigation is selected for inspection. The annual fee for clinical investigation is charged at the close of the year.
The annual fee is payable from the calendar year in which the authorisation is granted and until the end of an investigation at Danish investigation sites. Pursuant to article 77(3) of Regulation 2017/745 on Medical Devices (the MDR), the Danish Medicines Agency must be notified within 15 days of the end of the clinical investigation. A clinical investigation is normally considered to have ended when the last patient has paid the last visit, unless another point in time is established in the clinical investigation plan.
Payment
Fees must be paid to the Danish Medicines Agency no later than one month after receipt of the invoice.