Fees for clinical investigations for medical devices

Updated 01 January 2019

The current fees:

Applications for clinical investigations of Item number Fee
Class I devices (non-implantable devices not intended for long-term use) 40122  20.297 kr.
Class IIa devices (non-implantable devices not intended for long-term use) 40123  20.297 kr.
Class IIb devices (non-implantable devices not intended for long-term use) 40124  20.297 kr.
In vitro diagnostic medical devices (in vitro medical devices intended to come in direct or indirect contact with the human body) 40125  20.297 kr.
Class IIb devices (implantable devices and devices intended for long-term use) 40126  25.994 kr.
Class III devices 40127  25.994 kr.
Active implantable devices 40128  25.994 kr.
Amendments to the above (amendments to previously submitted application) 40129  5.036 kr.

 

The fees for the Danish Medicines Agency handling of applications for the authorisation of clinical investigations of medical devices appear from the Ministry of Health's executive order on fees for medical devices (in Danish).

Payment

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

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