Fees for performance studies of in vitro diagnostic medical devices

Fees for performance studies

The Danish Medicines Agency charges fees to cover the costs associated with performing tasks relating to performance studies, pursuant to the Executive Order on Fees for Medical Devices, etc. 

The fee rates in the executive order are adjusted once a year on 1 January by the rate for the general price and wage index set by the Danish 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 order. 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 performance study and for applications for authorisation of a substantial modification of a study.

Annual fee

The Danish Medicines Agency charges an annual fee for the supervision and inspection of performance studies. The annual fee is charged for all ongoing studies authorised after 1 January 2021, until the study has ended at the Danish investigation sites.

Pursuant to Article 73(3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the end of a study must be notified to the Danish Medicines Agency within 15 calendar days. A study 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 performance study plan.

•     For studies authorised before 1 January 2026, the annual fee is charged in December. These studies are charged an annual fee per calendar year, with the current year counted as a full year, regardless of whether the study only runs for a few weeks or months of the year.

•     For studies authorised after 1 January 2026, the annual fee is charged in July for studies authorised during the first six months of the year and in December for studies authorised during the last six months of the year. These studies are charged an annual fee that covers the period from the date on which authorisation was granted and for 12 months thereafter. If the study 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.

Payment

Fees must be paid to the Danish Medicines Agency no later than one month after receipt of the invoice. Questions regarding fees for performance studies should be sent to this email address.