Language requirement for information about medical devices
Labelling and instructions for use for medical devices must be in Danish.
Any information, printed and electronic, which is necessary for the safe and correct use according to the purpose of the device (as described by the manufacturer), must be in Danish when the devices is made available to the final user.
This information includes – but is not necessarily limited to – the information contained in the executive orders:
- The Ministry of Health’s executive order no. 1263 of 15 December 2008 on medical devices, section 3(4).
- The Ministry of Interior and Health's executive order no. 1269 of 12 December 2005 on in vitro diagnostic medical devices, section 3(3).
- The Ministry of Health’s executive order no. 1264 of 15 December 2008 on active implantable medical devices, section 3(4).
Requirements for the necessary information are described in:
- Executive order no. 1263, annex 1, section 13.
- Executive order no. 1269, annex 1, part B, section 8.
- Executive order no. 1264, annex 1, sections 13-15.
The language requirement applies to all medical devices comprised by the executive orders - regardless of the user's qualifications or profession.
Exemption from the language requirement
In specific cases, the Danish Medicines Agency may grant exemption from the language requirement and allow the information to be written in another language (typically English). The permission will usually be given for a limited period.
The Danish Medicines Agency may e.g. grant exemption in cases that involve the supply of medical devices for specific hospital departments, clinics or health professionals, and which take account of the users’ qualifications, the device's intended purpose and characteristics and the overall need of treatment. When assessing whether to grant an exemption, the Danish Medicines Agency places emphasis on the professional and linguistic qualifications of the users and their ability to handle the equipment with instructions for use in another language (other than Danish), the characteristics of the device, and if available alternatives are placed on the Danish market.
The Danish Medicines Agency cannot grant exemption from the Danish language requirement for labelling of in vitro diagnostic medical devices intended for self-testing, see section 3(3) of executive order no. 1269 of 12 December 2005 on in vitro diagnostic medical devices.
You can apply for an exemption from the language requirement by sending an application to email@example.com. The application should contain the following information:
- The name of the device and a description of the scope
- The professionals that will handle the device
- The name of the institution(s) or healthcare professionals that will use the device
- Reasons for the application for exemption from the language requirement
- A statement from the institution, clinic, healthcare professional etc. that will use the device about the users' professional and linguistic qualifications and their ability to handle the device with instructions for use in another language (other than Danish)
- A copy of the instructions for use
Software and service manuals
The executive orders do not require that software and service manuals must be provided in Danish. The manufacturer is responsible for defining which information is necessary for the correct and safe use of the device.
Display, buttons and keys
Single words or phrases, such as "Load", "Enter", "Page Down" or the like, are considered to be symbols. Symbols are not required to be translated, but must be explained in the instructions for use.
If the information involves more than two words and provides information/instructions to the user, this must be in Danish, see the above-mentioned exemption.