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February 9, 2026
Approximately 5 minutes
Notified Bodies for Medical Devices: Role and Oversight in Denmark
Notified Bodies for Medical Devices: Role and Oversight in Denmark
1. Role of Notified Bodies
Notified bodies are independent organisations designated by national authorities to assess manufacturers' technical documentation and verify compliance with statutory requirements before certification. They are required for conformity assessment of higher-risk medical devices (above Class I or Class A for IVDs, except certain cases like sterile or measuring function devices). Upon successful assessment, the notified body issues a certificate enabling CE marking. Manufacturers remain fully responsible for compliance and certificate maintenance. Source: Danish Medicines Agency Notified Bodies Page https://laegemiddelstyrelsen.dk/en/devices/notified-bodies/
2. Danish Medicines Agency as Competent Authority
The Danish Ministry of Health has appointed the Danish Medicines Agency as the supervisory authority for notified bodies in medical devices and in vitro diagnostic medical devices. The Agency handles professional assessments for designation, grants or withdraws designations for Danish companies, and ensures ongoing compliance. Source: Danish Medicines Agency Notified Bodies Page https://laegemiddelstyrelsen.dk/en/devices/notified-bodies/
3. Designation Process
Companies seeking designation as a notified body in Denmark submit an application to the Danish Medicines Agency, specifying activities and device types, with documentation proving compliance with MDR/IVDR Chapter IV and Annex VII. Applications in English are recommended. The process includes pre-audit review, on-site audit, corrective action plan, and final designation, taking 15-24 months. No fees apply. Source: Danish Medicines Agency Notified Bodies Page https://laegemiddelstyrelsen.dk/en/devices/notified-bodies/
4. Supervision and Re-assessment
The Agency supervises through annual on-site inspections and participation in EU working groups. Notified bodies must report changes affecting compliance within 15 days. Re-assessment occurs every five years with a joint EU team. Source: Danish Medicines Agency Notified Bodies Page https://laegemiddelstyrelsen.dk/en/devices/notified-bodies/
5. Current Status and Manufacturer Guidance
Currently, no notified bodies are designated in Denmark under MDR or IVDR. Manufacturers must select a notified body from another EU country via the NANDO database. Source: Danish Medicines Agency Notified Bodies Page https://laegemiddelstyrelsen.dk/en/devices/notified-bodies/ NANDO Database: https://ec.europa.eu/growth/tools-databases/nando/index.cfm
6. Additional Resources
For general information on notified bodies: European Commission page https://ec.europa.eu/health/md_topics-interest/notified_bodies_en Source: Danish Medicines Agency Notified Bodies Page https://laegemiddelstyrelsen.dk/en/devices/notified-bodies/
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