Danish language requirements and requirements for labelling and instructions for use
Labelling and instructions for use
The manufacturer of a medical device must ensure that the device is accompanied by the information necessary for the device to be identified and used safely and correctly.
Device labelling consists, among other things, of information about the device and the manufacturer, and must appear on the device itself and its packaging. The instructions for use contain more detailed information about the device and its use.
Content requirements for labelling and instructions for use are set out in the general requirements in Annex I, Section 23 of the Medical Device Regulation (MDR) and Annex I, Section 20 of the In Vitro Diagnostic Medical Devices Regulation (IVDR). More information is available in the guidance on labelling and instructions for use for medical devices (in danish only).
Electronic instructions for use
Medical devices covered by the MDR and intended exclusively for professional use by professional users, it is permitted, under the Regulation on electronic instructions for use of medical devices, to supply the device with electronic instructions for use (eIFU) instead of a paper-based version. The manufacturer must first carry out a documented risk assessment demonstrating that the level of safety provided by instructions for use in electronic form is maintained or improved in comparison with instructions for use in paper form. The manufacturer must be able to make a paper-based version available if requested by the user. If it can be foreseen that devices intended to be used by professional users will also be used by other persons, a paper-based version of the instructions for use must be supplied.
The rules also apply to accessories for medical devices, medical devices covered by the transitional provisions in Article 120, and devices without an intended medical purpose listed in Annex XVI.
Danish language requirements
Labelling and instructions for use
Labelling and instructions for use of medical devices must be in Danish when the device is made available to the final user or patient in Denmark. The Danish language requirement is laid down in section 3(1) and section 4(1) of the Executive Order on medical devices, etc (in danish only). The language requirement applies to all medical devices covered by the MDR, the IVDR and the Executive Order, regardless of whether the device is intended to be used by professional users or by other persons.
Software and service manuals
The Executive Order on medical devices, etc. does not impose a general requirement for all software and service manuals to be translated into Danish, but the information necessary for the device to be identified and used safely and correctly must be in Danish. It is the manufacturer's responsibility to define which information is necessary for the correct and safe use of the device.
Displays, buttons and keys
If the information consists of single words or terms such as "Load", "Enter", "Page Down" or similar, these are regarded as symbols. Symbols do not have to be translated but may be explained in the instructions for use.
If the information comprises more than two words and provides information or instructions to the user, it must be in Danish.
Exemption from the language requirement
The Danish Medicines Agency may grant a temporary exemption from the language requirement where this is in the interest of public health or patient safety or health; see section 3(2) and section 4(2) of the Executive Order on medical devices, etc. The Danish Medicines Agency cannot grant an exemption from the language requirement for in vitro diagnostic medical devices intended for self-testing or near-patient testing; see section 3(3) of the Executive Order on medical devices, etc.
The manufacturer or its authorised representative may apply for an exemption from the language requirement. Other parties may apply only if they hold a power of attorney from the manufacturer or the authorised representative.
The application must be sent by e-mail and must contain general information about the device and the extent to which there is a need for it to be temporarily permitted on the Danish market, including a list of Danish recipients and the number of units for which an exemption is sought. The application must also state whether the manufacturer is in the process of preparing Danish labelling and instructions for use, and whether alternatives to the device are available on the market. In addition, the application must contain a statement from a Danish healthcare professional setting out the users' professional and linguistic qualifications, as well as the consequences for public health or for patient safety or health if the device is not available.
When assessing whether an exemption may be granted, the Danish Medicines Agency places particular emphasis on the users' professional and linguistic qualifications, the device's intended purpose and characteristics, treatment needs, and whether marketed alternatives are available on the Danish market.
Overview of language requirements in other EU countries
MDR and the IVDR contain provisions allowing Member States to lay down language requirements at national level for manufacturers in respect of the information accompanying the device. On its website, the European Commission has published two tables providing an overview of national provisions where Member States have made use of the option to lay down language requirements for manufacturers.