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February 2, 2026
Approximately 5 minutes
Advertising Rules for Medical Devices in Denmark
1. General Principles
Advertising of medical devices must be adequate and objective, in accordance with the purpose and scope of use of the device, and the information must be verifiable. Non-compliance with these principles implies prohibitions on inadequate or unverifiable information. Source: Danish Medicines Agency Marketing and Advertising Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/marketing-and-advertising/
2. Scope and Application
The rules apply to marketing, sale, distribution, and use of medical devices that comply with the executive order on medical devices. Manufacturers are responsible for device safety, with no prior authority authorization required before marketing. Source: Danish Medicines Agency Marketing and Advertising Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/marketing-and-advertising/
3. Financial Benefits
Businesses offering financial benefits must comply with rules applicable to healthcare professionals and other relevant professionals, as outlined in the executive order on advertising. Source: Danish Medicines Agency Marketing and Advertising Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/marketing-and-advertising/
4. Supervision and Enforcement
The Danish Medicines Agency supervises compliance, receives and investigates serious incidents, and ensures proper handling of safety information. Source: Danish Medicines Agency Marketing and Advertising Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/marketing-and-advertising/
5. Key Legislation
- Executive order on advertising of medical devices no. 715 of 29 June 2022 Source: Danish Medicines Agency Marketing and Advertising Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/marketing-and-advertising/ Full text: https://www.retsinformation.dk/eli/lta/2022/715
6. Additional Guidance
Guidelines on advertising of medical devices provide detailed descriptions of definitions, rules, and prohibitions. Source: Danish Medicines Agency Marketing and Advertising Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/marketing-and-advertising/
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