Denmark DMA Updates Medical Device Labelling, IFU and Language Requirements

Denmark DMA Updates Medical Device Labelling, Instructions for Use and Language Requirements

Published: 5 May 2026 | Source: Danish Medicines Agency (DMA)

On 5 May 2026, the Danish Medicines Agency (DMA) updated the language requirements for medical device labelling and instructions for use (IFU). Under the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), devices placed on the Danish market must provide Danish-language labelling and IFU. The update clarifies the conditions for electronic instructions for use (eIFU), language exemptions for software and service manuals, the treatment of information displayed on screens and button/key symbols, and the specific process for applying for an exemption from the language requirements. The update directly affects all medical device and IVD manufacturers planning to launch in Denmark or already active on the Danish market, especially companies that need to adjust technical documentation and labelling files.

Source note: This article is based on public information from the Danish Medicines Agency (DMA): https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/. Specific requirements are subject to the latest official publication by the regulator.

Translated Core Content

Labelling and Instructions for Use

Medical device manufacturers must ensure that devices are accompanied by the information required for proper identification and safe use.

Device labelling includes information about the device and the manufacturer and must appear on the device itself and on its packaging. The instructions for use contain more detailed information about the device and its use.

The content requirements for labelling and instructions for use are laid down in the general requirements of Annex I, Section 23 of the MDR and Annex I, Section 20 of the IVDR. Further information is available in the guidance on medical device labelling and instructions for use, which is available in Danish only.

Electronic Instructions for Use

For medical devices covered by the MDR and intended exclusively for professional users, electronic instructions for use (eIFU) may be provided instead of a paper version under the eIFU Regulation. The manufacturer must first carry out a documented risk assessment demonstrating that the safety level provided by electronic instructions is maintained or improved compared with the paper version. The manufacturer must be able to provide a paper version upon request from the user. If it is foreseeable that a device intended exclusively for professional users will also be used by others, a paper version of the instructions for use must be provided.

This rule also applies to medical device accessories, medical devices covered by the transitional provisions of Article 120, and devices listed in Annex XVI that do not have an intended medical purpose.

Danish Language Requirements

When medical devices are made available in Denmark to end users or patients, the labelling and instructions for use must be in Danish. This language requirement is set out in sections 3(1) and 4(1) of the Executive Order on medical devices etc., which is available 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 for professional users or other users.

Software and Service Manuals

The Executive Order on medical devices etc. does not require all software and service manuals to be translated into Danish, but information necessary for the correct and safe use of the device must be in Danish. The manufacturer is responsible for determining which information is necessary for the correct and safe use of the device.

Displays, Buttons and Keys

If the information consists of a single word or term, such as “Load”, “Enter”, “Page Down” or similar, these are regarded as symbols. Symbols do not need to be translated, but they may be explained in the instructions for use.

If the information contains more than two words and provides information or instructions to the user, it must be in Danish.

Exemption from Language Requirements

The Danish Medicines Agency may grant a temporary exemption from the language requirements where this is compatible with public health or patient safety or health interests, see sections 3(2) and 4(2) of the Executive Order on medical devices etc. The Danish Medicines Agency may not grant a language requirement exemption for in vitro diagnostic medical devices for self-testing or near-patient testing, see section 3(3) of the Executive Order.

Manufacturers or their authorised representatives may apply for an exemption from the language requirements. Other parties may apply only if they hold a power of attorney from the manufacturer or authorised representative.

The application must be sent by email and include general information about the device and the extent necessary to permit its temporary sale on the Danish market, including a list of Danish recipients and the quantity for which exemption is sought. The application must also state whether the manufacturer is preparing Danish labelling and instructions for use and whether alternatives to the device are available on the market. In addition, the application must include a statement from a Danish healthcare professional describing the user’s professional and language qualifications and the impact on public health or patient safety or health if the device is unavailable.

When assessing whether to grant an exemption, the Danish Medicines Agency places particular weight on the user’s professional and language qualifications, the intended purpose and characteristics of the device, treatment need, and whether alternatives are already available on the Danish market.

Overview of Language Requirements in Other EU Countries

The MDR and IVDR contain provisions allowing Member States to establish national language requirements for the information supplied with a device. The European Commission has published two tables on its website outlining national rules where Member States have used this option to establish language requirements for manufacturers.

AIMEILI Regulatory Interpretation and Business Impact

The Danish Medicines Agency update is not entirely new legislation, but it is an important compliance signal for Chinese medical device manufacturers planning to enter the Danish market.

Registration Pathway and Product Classification

As an EU Member State, Denmark requires medical devices to be CE marked, and language requirements are a key part of pre-market preparation. Whether a product falls under the MDR or the IVDR, Danish labelling and instructions for use must be provided when the device is placed on the Danish market. This means that Chinese manufacturers must plan Danish versions of labels and IFU when preparing technical documentation, especially for devices that may be used by both professional and lay users. For software products, not all content needs to be translated, but information necessary for correct and safe use must be in Danish. Manufacturers must define this boundary themselves, which increases the complexity of technical file preparation.

Conditions for Electronic Instructions for Use

The permitted conditions for eIFU deserve particular attention. Under the MDR, eIFU is allowed only for devices intended exclusively for professional users and requires a risk assessment demonstrating that safety is not lower than with a paper version. If Chinese manufacturers consider using eIFU to reduce costs, they must complete detailed risk assessment documentation and be able to provide paper copies promptly upon user request. For example, diagnostic equipment used in hospitals may be suitable for eIFU, but if it may be accessed by patients or non-professional users, paper instructions must be supplied. This directly affects IFU delivery strategy and document control processes within the quality management system.

Language Requirements for Displays, Buttons and Keys

The Danish Medicines Agency clarifies that single words or common terms such as “Load” are treated as symbols and do not need to be translated, while information containing more than two words and providing information must be in Danish. Chinese manufacturers should distinguish between symbols and instructional text when designing interfaces. For example, “Select Patient” on a device display should be in Danish, while “OK” may be treated as a symbol. This requires close coordination between hardware and software localisation teams.

Language Exemption Applications

The application process for language requirement exemptions is also important. The Danish Medicines Agency may grant a temporary exemption only where there is an urgent public health or patient safety need, and the exemption does not apply to IVDs for self-testing or near-patient testing. Applications must include a statement from a Danish healthcare professional, user qualifications, information on market alternatives and other evidence. If Chinese manufacturers need an exemption for urgent supply, they must collect the relevant evidence in advance and recognise that any exemption is temporary. The long-term strategy should therefore be to complete Danish documentation proactively rather than rely on exemptions.

Other EU Member States

The overview of language requirements in other EU countries indicates that Member States may establish their own national language rules. When planning EU market access, Chinese companies cannot meet only English requirements; they need to confirm requirements country by country. France, Germany, Italy and other markets have their own language requirements. Manufacturers should establish a multilingual labelling matrix, reserve Member State language versions in the CE technical file, and discuss language compliance plans with notified bodies at an early stage.

Business Impact and Recommended Actions

For Chinese manufacturers that already hold CE certificates but have not yet entered the Danish market, technical files should be reassessed to confirm whether Danish labels and IFU are included. If only English versions exist, translation and localisation should be initiated and relevant quality management system documents updated. For products already on the Danish market, current labels and instructions for use should be checked for compliance, and change control should be initiated where necessary. In summary, the Danish Medicines Agency update reminds manufacturers that EU market access is not limited to CE marking. National language requirements are a practical barrier before launch, and early planning can help avoid launch delays and compliance risks.

FAQ

What is usually the most difficult part of overseas registration for software as a medical device?

The most difficult parts are usually risk classification, software evidence, clinical evaluation, software lifecycle documentation and post-market change management, rather than simply completing the application form.

Can software as a medical device be filed using ordinary software documentation?

Ordinary software documentation should not be applied without a structured assessment. Manufacturers should first confirm whether the product qualifies as software as a medical device, whether it supports decision-making, and whether it affects diagnosis or treatment, and then design the registration dossier accordingly.