Language requirement for information about medical devices
Danish language requirements for information on medical devices
The labelling and instructions for use of medical devices must be in Danish.
All information, whether in print or electronic form, necessary to ensure the safe and proper use of the device pursuant to its intended purpose (as described by the manufacturer) must be in Danish when the device is made available to end users or patients in Denmark.
The Danish language requirement appears from:
Section 3(2) and section 4(2) of the Danish Ministry of Health’s executive order on medical devices and in vitro diagnostic medical devices.
The required information is described in:
Annex I, section 23 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
Annex I, section 20 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices
The language requirement applies to all medical devices comprised by the regulations and the executive order – regardless of the user’s professional training.
Exemption from the language requirement
The Danish Medicines Agency may, by way of exception and in specific cases, grant an exemption from the language requirement and allow the information to be in another language (usually English). If so, the exemption will usually be time-limited.
For example, the Danish Medicines Agency may grant an exemption in the case of devices supplied to specific hospital departments, clinics or healthcare professionals and where, for example, the qualifications of the users, the purpose and characteristics of the device and treatment needs are taken into account. In its assessment of whether to grant an exemption, the Danish Medicines Agency will in particular look at the users’ professional qualifications and language skills for handling the device by means of instructions for use in another language (than Danish), the characteristics of the device and whether there are any marketed alternatives available on the Danish market.
The Danish Medicines Agency cannot grant an exemption from the requirement for the labelling and instructions for use to be in Danish for in vitro diagnostic medical devices intended for self-testing or near-patient testing, cf. section 4(3) of Danish executive order no 714 of 24 May 2022 on medical devices and in vitro diagnostic medical devices.
You can apply for an exemption from the language requirement by submitting an application. The application should include the following information:
- Name of device, unique device identifier and a description of the device’s scope of application.
- The risk class of the device
- The professional group that will be handling the device
- The name of the institution(s) or healthcare professionals that will be using the device
- The rationale for applying for an exemption from the language requirement
- A statement from the institution, clinic, healthcare professional or the like that will be using the device on the users’ professional qualifications and language skills for handling the device by means of instructions for use in another language (than Danish)
- Information on whether the manufacturer is preparing Danish labelling and instructions for use together with a timeline for this
- Information on whether the manufacturer will make available a Danish translation of the labelling and instructions for use on its website until the time the device is likely to be supplied with Danish labelling and instructions for use
- A copy of the instructions for use
Software and service manuals
There are no general requirements in the executive order for software and service manuals to be translated to Danish. The instructions for use/guidelines intended for the software user must be in Danish. It is the responsibility of the manufacturer to define which information is necessary for the proper and safe use of the device.
Display, buttons and keys
If the information concerns single words or terms like "Load", "Enter", "Page Down" or the like, these are considered to be symbols. Symbols are not be translated, but must be explained in the instructions for use.
If the information includes more than two words and serves as information/instructions for the user, it must be in Danish, see also the above regarding exemption.