Fees for clinical investigations of medical devices
Fees for clinical investigations
The Danish Medicines Agency charges fees to cover the costs associated with performing tasks related to clinical investigations, in accordance with the Danish Executive Order on Fees for Medical Devices, etc., and the Danish Executive Order amending the Executive Order on Fees for Medical Devices, etc.
The fee rates in the Executive Orders are adjusted once a year on 1 January by the rate for the general price and wage index set by the Ministry of Finance. The actual rates stated on the invoice/the Danish Medicines Agency’s website may therefore differ from the fee rates in the Executive Orders. The fee rates stated on the invoice/the Danish Medicines Agency’s website will be the correct ones.
Application fee
The Danish Medicines Agency charges an application fee for applications for authorisation to conduct a clinical investigation and for applications for authorisation of a substantial modification to an investigation.
|
Application for authorisation of a clinical investigation of medical devices and application for authorisation of a modification to a clinical investigation of medical devices for the period 2025-2027 |
Item no. |
Fee |
|
Class I devices (non-implantable devices or devices not intended for long-term use) |
4201 |
DKK 46,835 |
|
Class IIa devices (non-implantable devices or devices not intended for long-term use) |
4202 |
DKK 46,835 |
|
Class IIb devices (non-implantable devices or devices not intended for long-term use) |
4203 |
DKK 46,835 |
|
Class IIb devices (implantable devices or devices intended for long-term use) |
4205 |
DKK 62,947 |
|
Class III devices |
4206 |
DKK 62,947 |
|
Active implantable devices |
4207 |
DKK 62,947 |
|
Modification (amendment) of a clinical investigation of medical devices |
4208 |
DKK 10,364 |
|
Application concerning clinical investigation of products without an intended medical purpose |
Item no. |
Fee |
|
Class I devices (non-implantable devices or devices not intended for long-term use) |
4210 |
DKK 59,135 |
|
Class IIa devices (non-implantable devices or devices not intended for long-term use) |
4211 |
DKK 59,135 |
|
Class IIb devices (non-implantable devices or devices not intended for long-term use) |
4212 |
DKK 59,135 |
|
Class IIb devices (implantable devices or devices intended for long-term use) |
4213 |
DKK 79,479 |
|
Class III devices |
4214 |
DKK 79,479 |
|
Active implantable devices |
4215 |
DKK 79,479 |
|
Modification (amendment) of a clinical investigation of medical devices |
4216 |
DKK 13,086 |
Annual fee
The Danish Medicines Agency charges an annual fee for the supervision and inspection of clinical investigations. The annual fee is charged for all ongoing investigations authorised after 1 January 2021, until the investigation has ended at the Danish investigation sites.
Pursuant to Article 77(3) of Regulation (EU) 2017/745 on medical devices (MDR), the end of an investigation must be notified to the Danish Medicines Agency within 15 calendar days. An investigation is normally considered to have ended in Denmark when the last patient in Denmark has had their last visit/last data collection time point, unless another time point is defined in the clinical investigation plan.
- For investigations authorised before 1 January 2026, the annual fee is charged in December. These investigations are charged an annual fee per calendar year, with the current year counted as a full year, regardless of whether the investigation only runs for a few weeks or months of the year.
- For investigations authorised after 1 January 2026, the annual fee is charged in July for investigations authorised during the first six months of the year, and in December for investigations authorised during the last six months of the year. These investigations are charged an annual fee that covers the period from the date on which authorisation was granted and for 12 months thereafter.
If the investigation has not ended by the same date in the following year, a new year is considered to have begun, and a new annual fee will be charged.
|
Annual fee for supervision and inspection |
Item no. |
Fee |
|
All |
4209 |
DKK 13,069 |
Payment
Fees must be paid to the Danish Medicines Agency no later than one month after receipt of the invoice. Questions regarding fees for clinical investigations should be sent to this email address.