Fees paid for clinical investigations of medical devices

Updated 01 January 2026

Fee rates for the assessment of applications for authorisation of clinical investigation of medical devices and products without an intended medical purpose in 2026

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

2026
Class I devices (non-implantable device or device not intended for long-term use) 4201 DKK 48,835
Class IIa devices (non-implantable device or device not intended for long-term use) 4202 DKK 48,835
Class IIb devices (non-implantable device or device not intended for long-term use) 4203 DKK 48,835
Class IIb devices (implantable device or device intended for long-term use) 4205 DKK 62,947
Class III devices 4206 DKK 62,947
Active implantable devices 4207 DKK 62,947
Modification of clinical investigations of medical devices 4208 DKK 10,364

 

Application related to clinical investigation of medical devices without a medical purpose Item no. Fee

2026
Class I devices (non-implantable device or device not intended for long-term use) 4210 DKK 59,135
Class IIa devices (non-implantable device or device not intended for long-term use) 4211 DKK 59,135
Class IIb devices (non-implantable device or device not intended for long-term use) 4212 DKK 59,135
Class IIb devices (implantable device or device intended for long-term use) 4213 DKK 79,479
Class III devices 4214 DKK 79,479
Active implantable devices 4215 DKK 79,479
Modification of clinical investigations of medical devices 4216 DKK 13,086

 

Annual fees for supervision and inspection of clinical investigations in 2026

Annual fee for inspection Item no. Fee

2026
All                                                                                                                                                                     4209 DKK 13,069

 

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.