Fees for applications for clinical investigations of medical devices

Applications for investigations of medical devices are subject to a fee. The fee is the same for article 62, 74 and 82 investigations and is changed annually.

Fee applicable in 2022:

  • Applications and notifications of clinical investigations: DKK 18,275
  • Amendments to authorised clinical investigations: DKK 4,561

When submitting applications to the MREC, the applicant must complete a billing form and submit it with the application. The fee will hereafter be charged to the applicant.

Download billing forms:

Applications and/or notifications of clinical investigations (PDF)

Amendments to authorised clinical investigations (PDF)