Key takeaways
- EU MDR Article 10(11) requires the label and instructions for use in the official Union language or languages determined by each Member State where the device is made available.
- The MDR also sets language rules for implant cards, the EU declaration of conformity and field safety notices, not only for labels and IFUs.
- Annex I, Section 23.1(a) of the MDR requires instructions for use to be written in terms readily understood by the intended user, so a literal translation is not enough.
- Electronic instructions for use are allowed only for certain professional-use devices under Implementing Regulation (EU) 2021/2226, with paper copies supplied within 7 calendar days on request.
- In Great Britain, the Medical Devices Regulations 2002 require label information and instructions for use in English.
This guide is for regulatory affairs, labelling and quality teams at medical device manufacturers, authorised representatives and importers placing products on the EU market. It explains what the EU Medical Device Regulation says about language, which documents it covers and how to plan translation so that it does not delay market access.
It also covers the related rules for in vitro diagnostic devices, electronic instructions for use, and the position in Great Britain and Northern Ireland, where different legislation applies.
What does Article 10(11) of the EU MDR require?
Article 10(11) of the EU Medical Device Regulation (MDR), Regulation (EU) 2017/745, requires manufacturers to supply the information listed in Annex I, Section 23 in the official Union language or languages chosen by each Member State where the device reaches the user or patient. The Regulation sets the principle, and each Member State decides which of its official languages apply.
"Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient." (Regulation (EU) 2017/745, Article 10(11))
Section 23 of Annex I covers the label, meaning the information printed on the device or its packaging, and the instructions for use (IFU), the document that tells the user how to use the device safely. The same paragraph of Article 10 adds that label particulars must be "indelible, easily legible and clearly comprehensible to the intended user or patient".
Annex I, Section 23.1(a) sets a usability standard on top of the language rule: instructions for use "shall be written in terms readily understood by the intended user". A translation that is accurate word for word but unclear to a home user or a theatre nurse does not meet that standard.
Which medical device documents must be translated under the MDR?
The EU MDR sets language rules for several documents beyond the label and IFU. The table summarises the main provisions in Regulation (EU) 2017/745.
| Document | MDR provision | Language rule |
|---|---|---|
| Label and instructions for use | Article 10(11) and Annex I, Section 23 | Official Union language(s) determined by each Member State where the device is made available |
| Implant card and information for patients with an implanted device | Article 18(1) | Language(s) determined by the Member State concerned, written so that a lay person readily understands it |
| EU declaration of conformity | Article 19(1) | Translated into the official Union language(s) required by the Member State(s) where the device is made available |
| Field safety notice | Article 89(8) | Official Union language(s) determined by the Member State where the corrective action is taken |
| Documents requested by a competent authority | Article 10(14) | An official Union language determined by the Member State concerned |
| Summary of safety and clinical performance (implantable and class III devices) | Article 32(1) | Written so that it is clear to the intended user and, if relevant, to the patient |
Annex II of the MDR also asks for the technical documentation to contain the labels and the instructions for use "in the languages accepted in the Member States where the device is envisaged to be sold". Your notified body will therefore see your translated labelling, not only the English master.
Do all EU countries require their own language?
Each EU Member State sets its own language requirements for device labelling under the MDR, so there is no single EU-wide list. Because each country decides, the requirement can differ from one market to the next, and national rules may treat professional-use and lay-use devices differently.
Because national rules differ and can change, check the current requirement with the competent authority of each target country before you finalise artwork. Record the decision for each market in your labelling file, so that the language matrix can be shown to a notified body or authority if asked.
Devices for lay users deserve extra care. A product sold to patients at home will almost always need the national language, and its wording must work for people with no medical training. Professional devices may, in some countries, have more flexibility, but the "readily understood by the intended user" test in Annex I still applies.
Can instructions for use be supplied electronically?
Electronic instructions for use, often called e-IFU, are allowed only for specific devices under Commission Implementing Regulation (EU) 2021/2226. Article 3 limits them to implantable and active implantable devices, fixed installed devices, and devices with a built-in system that displays the instructions, and only where the devices are intended exclusively for professional users.
An e-IFU does not remove the translation obligation. The Implementing Regulation requires the instructions to be on the manufacturer's website "in an official language of the Union determined by the Member State in which the device is made available to the user or patient". Manufacturers must also supply paper instructions at no extra cost, at the latest within 7 calendar days of a user's request.
How do the IVDR language rules compare?
The In Vitro Diagnostic Medical Devices Regulation (IVDR), Regulation (EU) 2017/746, mirrors the MDR in Article 10(10), referring to the information in Section 20 of its Annex I. It adds a specific sentence for tests used outside the laboratory.
Under the IVDR, information supplied with devices for self-testing (used by lay people) or near-patient testing (used by health professionals outside a laboratory) "shall be easily understandable and provided in the official Union language(s) determined by the Member State". For home test kits, translators must make the result interpretation steps unmistakable, because a misread result can lead to a wrong health decision.
What applies in Great Britain and Northern Ireland?
In Great Britain, regulation 9 of the Medical Devices Regulations 2002 treats the labelling requirements as met only if the information is in English, "whether or not it is also in another language and whether or not the device is for professional use". The instructions for use must also be in English.
The MHRA's guidance on regulating medical devices in the UK states that CE-marked devices will be accepted on the Great Britain market until, at the latest, 30 June 2030. It also states that devices placed on the Northern Ireland market "must meet EU labelling requirements". A single pack sold in the UK and Ireland therefore has to satisfy both sets of rules.
How to plan MDR labelling translation: step by step
- Build a language matrix. List every target country, the languages each requires, and whether the device is for professional or lay use.
- Freeze the English source. Translate only approved text. Late source changes multiply across every language.
- Create a terminology list. Fix the translation of device names, components, warnings and symbols' explanatory text before translation starts.
- Translate with medical device specialists. Use translators who know the clinical context and the conventions of IFUs in their language.
- Review independently. A second linguist checks accuracy, completeness and consistency with the terminology list.
- Check the artwork. Proofread the typeset labels and IFUs, because text expansion, hyphenation and font problems appear only after layout.
- Keep records. Store translations, reviews and approvals with the technical documentation for your notified body.
Common mistakes with MDR translation
- Translating only the IFU. Implant cards, declarations of conformity and field safety notices have their own language rules.
- Assuming English is enough for professional devices. Check the national rule in writing for each country instead of relying on what a distributor or competitor does.
- Forgetting text on screens. Software menus, alarms and on-device messages are part of the information supplied with many devices.
- Leaving field safety notices until a recall. Prepare templates and approved terminology in advance, because notices must reach users "without delay".
- Using raw machine translation. Our guide to machine translation in healthcare explains why unchecked output is unsuitable for safety-critical text.
For a wider view of medical device, medicines and clinical translation, see our medical and pharmaceutical translation guide. If your product is a medicine rather than a device, the rules for patient information leaflet translation apply instead. Our article on why medical translation needs subject-matter experts explains what to look for in a translator.
How TranslationWorks can help with MDR translation
TranslationWorks is a UK-based translation agency that translates medical device labels, instructions for use, implant cards and safety notices through native-speaking professional linguists in more than 150 languages. Our medical and pharmaceutical translation team works remotely with manufacturers and regulatory consultants, using human translation with independent review.
TranslationWorks holds ISO 17100, ISO 9001 and ISO 27001 registration and Cyber Essentials certification, which matters when you share unreleased product documentation. We have served more than 300 companies. Send us your source files and your list of target countries, and we will reply with a free quote for your device translation within 24 hours.
