CASubmissionFee object

Yes

Application fees (January 2015)
• Class I, IIa, IIb devices (not implantable devices and devices intended for long term use): 20,297 DKK (≈ € 2720)
• Class IIb devices (implantable devices and devices intended for long term use): 25,994 DKK (≈ € 3480)
• Class III devices and active implantable devices: 25,994 DKK (≈ € 3480)
• In vitro diagnostic medical devices (in vitro medical devices intended to come in direct or indirect contact with the human body): 20,297 DKK (≈ € 2720)
• Changes/amendments to authorised clinical investigation plans: 5,036 DKK (≈ € 670)

No waiver possible as the DKMA has no statutory authority to grant exemption from the fee

Applicable fees are published on the website in section
Medicines & medical devices / Medical devices / Clinical investigations / Fees for clinical investigations (en) or in the Ministry of Health and Prevention's Executive Order for fees on medical devices (

No

After receipt of invoice

Yes

Applicable fees are published on the website in section:
Medicines & medical devices / Medical devices / Clinical investigations / Fees for clinical investigations (en)

Yes

Ministry of Health and Prevention's Executive Order for fees on medical devices 2013

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