Fees for Review of Applications under the IVDR

There is a fee for applying for trials of in vitro diagnostic medical devices. The fee is the same for both Article 58 and Article 70 trials.

When submitting applications to MREC, the applicant must complete an invoicing form, which must be sent together with the application. The applicant will then be charged the fee.

For applications submitted in 2023, the fees are as follows:

  • Applications and notifications about clinical trials: DKK 30,174
  • Changes to approved clinical trials: DKK 8,510

Download invoicing forms in English:

Application - Performance study (PDF)

Application - Substantial modifications to authorised performance studies (PDF)




Last updated 01-02-2024

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