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February 6, 2026
Approximately 5 minutes
Clinical Investigations of Medical Devices in Denmark
Clinical Investigations of Medical Devices in Denmark
1. Overview and Requirements
Clinical investigations of medical devices must be notified to the Danish Medicines Agency before initiation in Denmark. Sponsors (or their legal representatives) are responsible for submission. Investigations require approval from a research ethics committee, except for certain post-market studies. Source: Danish Medicines Agency Clinical Investigations Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/
2. Types of Investigations
- Pre-market clinical investigations (PMCI) for non-CE marked or off-purpose devices.
- Post-market clinical follow-up (PMCF) for CE-marked devices.
- Performance studies for in vitro diagnostic devices (IVDs) under IVDR. Source: Danish Medicines Agency Clinical Investigations Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/
3. Notification and Application
Applications are submitted via the electronic system at kliniskeforsog.dk. Required documents include protocol, investigator's brochure, patient information, and ethics application. The Agency aims to process within 10 days for complete applications; incomplete ones trigger a 30-day clock-stop for supplements. Source: Danish Medicines Agency Clinical Investigations Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/
4. Ethics Committee Approval
All clinical investigations require research ethics committee approval, coordinated through the national system. PMCF investigations not posing additional invasive procedures may be exempt if justified. Source: Danish Medicines Agency Clinical Investigations Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/
5. Substantial Modifications
Modifications significantly affecting safety, health, or rights require Agency approval before implementation. Notification via the electronic system; processing within 38 days maximum. Source: Danish Medicines Agency Clinical Investigations Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/
6. Fees and Legislation
No fees for notification or modifications. Governed by MDR (EU) 2017/745 Articles 62-82, IVDR Articles 58-78, and Danish executive orders. Source: Danish Medicines Agency Clinical Investigations Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/
7. Guidance and Contact
Detailed guidance available on application requirements, EUDAMED delays (using national systems until functional), and combined trials. Contact the Agency for questions. Source: Danish Medicines Agency Clinical Investigations Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/
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