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February 7, 2026
Approximately 5 minutes
Reviewed by Nate Lam, Founder & Director, ElendiLabs
Notification Requirements for Post-Market Clinical Follow-Up Investigations in Denmark
1. When Notification is Required
Notification to the Danish Medicines Agency is required for post-market clinical follow-up (PMCF) investigations where subjects are submitted to procedures additional to normal use, and these are invasive or burdensome. Notification must occur 30 calendar days before planned commencement. Source: Danish Medicines Agency PMCF Notification Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-of-pmcf-investigation/
2. Responsibility
The sponsor is responsible for sending the notification. Source: Danish Medicines Agency PMCF Notification Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-of-pmcf-investigation/
3. Submission Process
Submit via email to the Danish Medicines Agency. Include:
- Brief description of the investigation.
- Details of additional invasive or burdensome procedures.
- Contact details of sponsor, manufacturer, and Danish investigators.
- Positive opinion from Medical Research Ethics Committees. Source: Danish Medicines Agency PMCF Notification Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-of-pmcf-investigation/
4. Ethics Committee Involvement
The investigation requires a positive opinion from Medical Research Ethics Committees, attached to the notification. Source: Danish Medicines Agency PMCF Notification Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-of-pmcf-investigation/
5. Agency Response
The Agency has 30 calendar days to request more information or inform the sponsor (e.g., of modifications). Source: Danish Medicines Agency PMCF Notification Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-of-pmcf-investigation/
6. Additional Obligations
No authorisation required, but the Agency may modify or terminate under Article 76 MDR. Report serious adverse events with causal link to additional procedures per MDCG 2020-10. General serious incidents reported per safety monitoring rules. Source: Danish Medicines Agency PMCF Notification Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/notification-of-pmcf-investigation/ MDCG 2020-10 Guidance: https://health.ec.europa.eu/system/files/2020-10/md_mdcg_2020_10_1_guidance_safety_reporting_en_0.pdf
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