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February 3, 2026
Approximately 5 minutes
Danish Medicines Agency Regulation of Medical Devices
Danish Medicines Agency Regulation of Medical Devices
1. Role of the Danish Medicines Agency
The Danish Medicines Agency regulates medical devices in Denmark in accordance with EU legislation. Most devices require CE marking to confirm safety and performance. For higher-risk classes (IIa, IIb, III), a notified body assesses the manufacturer's documentation. The Agency supervises notified bodies and addresses safety concerns. Source: Danish Medicines Agency Medical Devices Page https://laegemiddelstyrelsen.dk/en/devices/
2. Classification of Medical Devices
Medical devices are divided into risk classes:
- Class I (lowest risk, e.g., walking frames)
- Class IIa
- Class IIb
- Class III (highest risk, e.g., pacemakers, breast implants)
There are over 500,000 different types, including everyday items like glasses and advanced technologies like mobile apps and surgical instruments. Source: Danish Medicines Agency Medical Devices Page https://laegemiddelstyrelsen.dk/en/devices/
3. Key Responsibilities
The Agency:
- Supervises notified bodies issuing CE marks
- Responds to safety issues with specific devices
- Receives incident reports from companies, healthcare professionals, and citizens
- Handles notifications of supply interruptions or discontinuations
- Provides regulatory advice to companies
- Oversees registration and marketing
- Manages clinical investigations and performance studies for IVDs
- Issues Certificates of Free Sale Source: Danish Medicines Agency Medical Devices Page https://laegemiddelstyrelsen.dk/en/devices/
4. Incident Reporting and Vigilance
Manufacturers, distributors, importers, healthcare professionals, and citizens must report malfunctions, failures, or accidents involving medical devices, even if not caused by the device itself. Source: Danish Medicines Agency Medical Devices Page https://laegemiddelstyrelsen.dk/en/devices/
5. Guidance and Resources
The Agency provides information on:
- Supply interruptions
- New technologies
- Device development
- Regulatory advice for companies
- Registration and marketing
- Clinical investigations and IVD performance studies
- Certificates of Free Sale
- Legislation and guidance Source: Danish Medicines Agency Medical Devices Page https://laegemiddelstyrelsen.dk/en/devices/
6. Contact Information
Medical Devices team Telephone: +45 4488 9595 E-mail: Via contact form on the website Fax: +45 4488 9599 Source: Danish Medicines Agency Medical Devices Page https://laegemiddelstyrelsen.dk/en/devices/
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