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February 4, 2026
Approximately 5 minutes
Fees for Clinical Investigations of Medical Devices in Denmark
Fees for Clinical Investigations of Medical Devices in Denmark
1. General Rule
The Danish Medicines Agency does not charge fees for processing applications for authorisation of clinical investigations of medical devices, including substantial modifications and notifications of post-market clinical follow-up (PMCF) investigations. Source: Danish Medicines Agency Fees Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/fees/
2. Scope
This applies to all submissions related to clinical investigations under the MDR and IVDR, including:
- Applications for authorisation.
- Applications for substantial modifications.
- Notifications of PMCF investigations requiring notification. Source: Danish Medicines Agency Fees Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/fees/
3. Related Fees
Fees may apply to other device-related processes, such as conformity assessment or certification by the Agency as a notified body, but not to clinical investigation submissions. Source: Danish Medicines Agency Fees Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/fees/
4. Legislation
The absence of fees for clinical investigations is in line with Danish implementation of EU regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746. Source: Danish Medicines Agency Fees Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/fees/
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