Which languages are required to place medical devices on the market in the European Union?

If you are wondering which languages are required for your company to place medical devices on the market in the European Union, the answer depends on the countries where you plan to sell them, the type of information involved and the intended end user of the medical device.

It is also important to know that there are exemptions. Some countries accept English for certain documents or medical devices intended for healthcare professionals.

Software interfaces require particular attention because the MDR does not contain a specific article addressing their language requirements, and some countries do not require them to be translated.

Therefore, to define the scope of translation, you need to identify the requirements that apply in each target market. The European Commission’s MDR and IVDR language requirements tables provide an overview of the differences between countries, documents and user types, including specific information on user interfaces. They are not entirely up to date, but they provide a good starting point.

Do you need to translate into all official EU languages?

The EU has 24 official languages: Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish. This list describes the EU’s language regime, but does not in itself establish which translations are mandatory for your devices.

As we will see in the next section, the scope depends on where you market them. For this reason, budgeting for ‘all official EU languages’ without first reviewing the documentation can lead to unnecessary costs.

How can you determine which languages your medical device documentation needs to be translated into?

Article 10(11) of Regulation (EU) 2017/745 on medical devices, known as the MDR, stipulates that labelling and instructions for use, as defined in Section 23 of Annex I, must be provided in the official EU languages determined by the Member State in which the device is made available to the user or patient.

The starting point is therefore to identify markets where you plan to sell your devices. Next, you need to check the requirements in each country for labelling, instructions for use and any other applicable information. It is also important to distinguish between medical devices intended for healthcare professionals and those intended for patients or people without healthcare training (referred to as lay persons in the MDR).

For in vitrodiagnostic devices, refer specifically to the corresponding IVDR table. While the approach is similar, it is advisable to check each regulatory framework separately. The European Commission’s language requirements tables serve as a useful reference tool. However, bear in mind that the applicable legislation takes precedence over any other reference source, including MDCG guidance.

The following table sets out the languages into which you will need to translate labelling and instructions for use, regardless of the risk class of your medical devices:

Source: European Commission, language requirements for manufacturers under the MDR, revision 3 (August 2025), cross-checked against the national legislation in force as of October 2026. The Commission’s table does not contain up-to-date information for Austria, Bulgaria, Hungary, Italy or Lithuania, and the Danish order it cites has been superseded. Iceland, Liechtenstein and Norway apply the MDR as members of the European Economic Area (EEA), whereas Turkey has its own national regulation aligned with the MDR. Indicative summary: check the national legislation currently in force, the type of user and the specific document.

Which documents need to be translated?

Start by identifying the information supplied with the device and the information intended for users, whether healthcare professionals or lay persons. Then review the documents intended for competent authorities or notified bodies. Separating these two groups will help you define a more precise scope.

The main content to review includes:

The MDR establishes distinct requirements for these documents. There is no general obligation to translate the full technical documentation into all the languages of the countries where the device will be placed on the market. Before commissioning any translations, it is worth confirming which documents need to be translated.

For the summary of safety and clinical performance, MDCG 2019-9 guidance recommends translating it into the languages accepted in the Member States where the device is sold, with a separate document for each language.

The notified body validates only one language version. If that version is not in English, the guidance states that the manufacturer should provide an English translation within 90 days. The remaining translations are not reviewed by the notified body, so their accuracy depends on the manufacturer's quality management system.

For the implant card, MDCG 2019-8 guidance recommends using symbols to avoid the need for national language versions, although the product type field must be provided in the language of each country.

When preparing the translation of the instructions for use (IFU), it is advisable to also provide any related labels, illustrations and on-screen text, where applicable. This makes it easier to maintain consistent terminology for components, warnings and user actions.

Examples of cases where translation into the national language is not required

Some countries accept alternatives for certain documents or devices intended for professional use. These options must be checked against the specific conditions that apply. The fact that a hospital routinely operates in English is not, by itself, sufficient grounds for omitting a translation.

The following examples, taken from the European Commission’s table of language requirements for manufacturers under the MDR, revision 3, August 2025, illustrate why each combination of country, document and intended recipient needs to be assessed individually:

• Netherlands: the MDR table distinguishes between information intended for lay persons, which must be in Dutch, and information intended for professional users, which may be provided in Dutch or English.
• Malta: the table lists Maltese and/or English for labelling and instructions for use.
• Germany: there are specific conditions under which certain information intended exclusively for healthcare professionals may be provided in English or another language they understand.

In Germany, Article 8 of the national medical devices legislation requires these cases to be justified. In addition, safety information must also be available in German or in the user’s language. The same article allows the EU declaration of conformity to be drawn up in German or English, demonstrating that language requirements may differ from one document to another.

Before applying an exemption, document the applicable legal basis and the conditions your device meets. Do not apply a language exemption to other documents, users or markets without checking that it is also valid in those cases.

Translation of medical software interfaces (SaMD): a separate check

Interfaces warrant a separate review, both in software as a medical device (SaMD) and in software that operates as an accessory to medical equipment. This is because translation can be costly and the regulations provide little guidance on whether these interfaces need to be translated.

In the ‘Graphic User Interface (GUI)’ section of the page Overview of language requirements for manufacturers of medical devices, the European Commission clarifies that the MDR and IVDR do not contain a specific article dedicated to language requirements for user interfaces.

The same page explains that some countries have national legislation and rules governing these interfaces, with the relevant requirements listed in the last column of the tables available for both the MDR and the IVDR. Therefore, translating the instructions for use does not automatically ensure compliance with the interface language requirements.

In the ‘Example of a GUI’ section of the page, the Commission provides the example of a ‘Save’ button, but the explanation is ambiguous: it states that information about this function is already available in the language of the country where the device is used, without specifying where this information is provided or which element is deemed not to require translation.

However, it seems reasonable to interpret this as a reference to information already contained in the instructions for use, particularly as the guidance then suggests using an icon whose function is described in those instructions. That example must be assessed in context and does not provide general authorisation to keep the entire interface in English.

There is no consistent approach among national authorities either. In Hungary, the competent authority accepts an English-language interface only if the Hungarian manual explains it in detail with screenshots, and considers it likely that a complex or text-heavy interface will require a Hungarian version.

In Estonia, the authority does not require the entire interface to be translated into Estonian if the instructions for use provide the necessary information, for example through images.

Romania accepts English-language interfaces on devices intended for healthcare professionals only with the user’s written consent, while Slovenia allows software interfaces to be provided in Slovenian or English.

In Poland, devices intended for lay users must have an interface in Polish or use harmonised symbols.

Also bear in mind that, according to MDCG 2018-5 guidance, changing the language of a medical software interface requires a new UDI-DI. That is why it is advisable to decide which languages the interface will include before assigning identifiers, and to plan each new language version as a change to the device.

Conclusion

To answer the question of which languages are required to place medical devices on the market in Europe, you need to consider three factors: where you intend to sell your devices, who will use them and what information you need to provide. Taking these factors together helps you determine which translations are needed and whether any applicable exemptions exist.

At AbroadLink, our life sciences translation services can help you prepare the language versions of your documentation and software. With a clear list of markets, documents and language versions, you can plan the work and maintain translation consistency during device updates.