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February 7, 2026
Approximately 5 minutes
Application Process for Clinical Investigations of Medical Devices in Denmark
1. Submission Method
Due to delays in EUDAMED functionality, applications for authorisation of clinical investigations must be submitted directly via email to the Danish Medicines Agency and the Medical Research Ethics Committees. Applications may be in Danish or English, but participant information and consent forms must always be in Danish. Large files can be compressed with ZIP or split across multiple emails (maximum 50 MB per email), clearly labelled in the subject line (e.g., 'Mail 1 of 4'). Source: Danish Medicines Agency Application Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/application/
2. Required Documents
Applications must include:
- Completed application form for authorisation of clinical investigation.
- All supporting documents, such as:
- GSPR checklist and list of standards (template available).
- Manufacturer's statement of compliance for investigational devices (template available).
- Participant information and consent forms (in Danish). Source: Danish Medicines Agency Application Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/application/
3. Review Process
The Danish Medicines Agency and Medical Research Ethics Committees conduct a joint review of the application. Source: Danish Medicines Agency Application Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/application/
4. Guidance Documents
Relevant EU/MDCG guidance includes:
- MDCG 2021-6 Rev. 1: Questions & Answers regarding clinical investigation under Regulation (EU) 2017/745.
- MDCG 2020-10: Guidance on safety reporting in clinical investigations (with appendix for summary safety report form).
- MDCG 2024-5: Guidance on the Investigator’s Brochure content.
- MDCG 2024-3: Guidance on content of the Clinical Investigation Plan. These documents are available on the European Commission website. Source: Danish Medicines Agency Application Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/application/ European Commission Guidance: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
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