Fees

The fees for the Danish Medicines Agency's handling of applications for the authorisation of clinical investigations of medical devices are published in the Ministry of Health and Prevention's Executive Order for fees on medical devices.

The current fees are:

Class I, IIa, IIb devices (not implantable devices and devices intended for long term use)	19,218 DKK
Class IIb devices (implantable devices and devices intended for long term use)	24,611 DKK
Class III devices and active  implantable devices	24,611 DKK
In vitro diagnostic medical devices (in vitro medical devices intended to come in direct or indirect contact with the human body)	19,218 DKK
Changes/amendments to authorised clinical investigation plans	4,767 DKK

Fees for clinical trials should be paid to the Danish Medicines Agency within one month after receipt of the invoice.