Fees for clinical investigations of medical devices

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 the Interior and Health’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)	19,779 DKK
Class IIb devices (implantable devices and devices intended for long term use)	25,330 DKK
Class III devices and active implantable devices	25,330 DKK
In vitro diagnostic medical devices (in vitro medical devices intended to come in direct or indirect contact with the human body)	19,779 DKK
Changes/amendments to authorised clinical investigation plans	4,907 DKK

Payment

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

Created 16 December 2011, Updated 02 January 2012