Fees for clinical investigation of medical devices

Updated 03 February 2023

Fees for the review of applications for authorisation for clinical investigation of medical devices and products without an intended medical purpose in 2023

The fees charged by the Danish Medicines Agency’s review of applications for clinical investigation of medical devices are laid down in the executive order on fees for medical devices and in vitro diagnostic medical devices.

Please be aware that fees are not yet charged for clinical investigations of products without an intended medical purpose. Find more information here.

Application for clinical investigation of Item no. Fee

2023
Class I device (non-implantable device or device not intended for long-term use) 4201 DKK 54,127
Class IIa device (non-implantable device or device not intended for long-term use) 4202 DKK 54,127
Class IIb device (non-implantable device or device not intended for long-term use) 4203 DKK 54,127
Class IIb device (implantable device or device intended for long-term use) 4205 DKK 72,748
Class III device 4206 DKK 72,748
Active implantable device 4207 DKK 72,748
Modification to a clinical investigation of medical devices 4208 DKK 11,978

 

Annual fees for supervision and inspection of clinical investigations in 2023

Annual inspection fee Item no. Fee

2023
All                                                                                                                                                                     4209 DKK 11,962

 

The Danish Medicines Agency charges an annual fee for the supervision and inspection of clinical investigations. All clinical investigations authorised after 1 June 2021 are subject to an annual fee for the Danish Medicines Agency’s task of inspecting clinical investigations.

The annual fee is payable in each calendar year for all ongoing clinical investigations regardless of whether the clinical investigation is selected for inspection. The Danish Medicines Agency invoices the annual fee for clinical investigations at the end of each year.

The annual fee is paid annually from the calendar year in which the authorisation was issued and until the testing has ended at the Danish investigation sites. Pursuant to article 77(3) of regulation 2017/745 on medical devices, the end of a clinical investigation must be notified to the Danish Medicines Agency no later than 15 calendar days after the investigation has ended. An investigation is normally considered to have ended when the last patient has paid the last visit to the site, unless another point in time is set out in the clinical investigation plan.

Payment

All fees must be paid to the Danish Medicines Agency no later than one month after receipt of the invoice.