Fees for performance studies of in vitro diagnostic medical devices

Application fees for the authorisation for performance studies of in vitro diagnostic medical devices in 2024

The fees for the Danish Medicines Agency’s review of applications for the authorisation of a performance study of in vitro diagnostic medical devices are laid down in the executive order on fees for medical devices etc.

Annual fees for supervision and inspection of performance studies in 2024

Note: A phase-in period will apply from 2022-2024, cf. the executive order on fees for medical devices etc. The fees will be price and wage adjusted in the coming year.

The Danish Medicines Agency charges an annual fee for the supervision and inspection of performance studies. All authorised performance studies are subject to an annual fee for the Danish Medicines Agency’s task of inspecting performance studies.

The annual fee is payable in each calendar year for all ongoing performance studies regardless of whether the performance study is selected for inspection. The Danish Medicines Agency invoices the annual fee 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 performance study has ended at the Danish investigation sites. Pursuant to article 73(3) of regulation 2017/746 on in vitro diagnostic medical devices (IVDR), the end of a performance study must be notified to the Danish Medicines Agency no later than 15 calendar days after the study has ended. A performance study 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 performance study plan.

Payment

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