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February 5, 2026
Approximately 5 minutes
Language Requirements for Medical Devices in Denmark
Language Requirements for Medical Devices in Denmark
1. General Requirement
Labelling and instructions for use of medical devices must be in Danish when the device is made available to end users or patients in Denmark. All information necessary for safe and proper use, in accordance with the intended purpose, must be provided in Danish, whether in print or electronic form. Source: Danish Medicines Agency Language Requirement Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/
2. Scope
The requirement applies to all medical devices covered by the regulations, regardless of whether intended for professional or lay users. It stems from sections 3(1) and 4(1) of the Danish Executive Order on Medical Devices, with details in Annex I, section 23 of MDR (EU) 2017/745 and Annex I, section 20 of IVDR (EU) 2017/746. Source: Danish Medicines Agency Language Requirement Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/
3. Exemptions
The Danish Medicines Agency may grant time-limited exemptions allowing information in another language (usually English) in specific cases where health concerns support it, per section 3(2) of the Executive Order. Examples include devices for specific hospital departments or healthcare professionals, considering user qualifications, device characteristics, treatment needs, and market alternatives. No exemptions are allowed for in vitro diagnostic devices intended for self-testing or near-patient testing, per section 3(3). Source: Danish Medicines Agency Language Requirement Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/
4. Exemption Application
Applications are submitted by the manufacturer or authorised representative, including device details, justification, user qualifications, plans for Danish labelling, and instructions for use copy. The Agency may request submission from the manufacturer if needed. Source: Danish Medicines Agency Language Requirement Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/
5. Software and Displays
No general requirement to translate software or service manuals to Danish. However, instructions/guidelines for software users must be in Danish if necessary for safe use. Single words/terms on displays (e.g., 'Load', 'Enter') are treated as symbols and need not be translated but must be explained in instructions. Phrases longer than two words serving as instructions must be in Danish. Source: Danish Medicines Agency Language Requirement Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/
6. EU Overview
Member States may set national language requirements under MDR/IVDR. The European Commission provides tables overviewing requirements across EU countries. Source: Danish Medicines Agency Language Requirement Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/
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