Explainer
What Language Must a Manual Be In?
The Short Answer
The Member State Decides
Across the EU product regulations read for this article, the pattern is the same. The instructions and safety information must be in a language users can easily understand, and which language that is gets determined by the Member State where the product is made available. No regulation read here lists the languages for each country. The manufacturer has to find the national rule for every market.
Machinery recital 39 gives the reason: the instructions should be easily understandable and available in a language users can easily understand. This article is an explainer, not legal advice. Read the text of the regulation that covers your product and confirm each country's rule with your conformity advisers.
The Wording
Four Regulations, One Pattern
- Machinery: Regulation (EU) 2023/1230
- Instructions for use, safety information, and the Annex III information must be in “a language which can be easily understood by users, as determined by the Member State concerned” (Article 10(7)). Importers must ensure the Article 10(7) instructions accompany the product (Article 13), and distributors must verify the language as determined by the Member State where it is made available (Article 15).
- Medical devices: Regulation (EU) 2017/745
- The information in Section 23 of Annex I must accompany the device “in an official Union language(s) determined by the Member State in which the device is made available to the user or patient” (Article 10(11)).
- Consumer products: Regulation (EU) 2023/988
- Clear instructions and safety information in “a language which can be easily understood by consumers, as determined by the Member State in which the product is made available on the market” (Article 9(7), with the importer duty in Article 11). Online offers carry the same rule for warnings and safety information (Article 19(d)).
- Construction products: Regulation (EU) 2024/3110
- Instructions for use and safety information in a language determined by the Member State, or, if the Member State has not determined one, “a language which can be easily understood by users” (Article 22(6)). This is the one rule read here that writes the fallback into the text.
The medical device text says "language(s)" because a Member State can require more than one for a market. For the digital side of the same regulations, see EU rules on digital manuals compared.
Machinery
More Than the Manual
The machinery regulation applies from 20 January 2027; our guide to Article 10(7) and digital instructions covers the dates and the delivery conditions. On language, the duty reaches well past the instruction booklet.
- Warnings and information on the machine
- Annex III section 1.7.1 prefers readily understandable symbols or pictograms, and says any written or verbal information and warnings must be in a language easily understood by users, as determined by the Member State concerned.
- Assembly instructions for partly completed machinery
- Article 11(7) requires a language easily understood by the person who incorporates the machinery, as determined by the Member State concerned. The same article lets that person ask for paper, free of charge, within one month.
- Contact details
- The manufacturer's contact details must be in a language easily understood by users and market surveillance authorities (Article 10(6)).
- The EU declaration of conformity
- It must be translated into the language or languages required by the Member State in which the machinery is placed on the market, made available, or put into service.
- Documents for an authority
- On a reasoned request from a national authority, the manufacturer provides the documentation in a language that authority can easily understand (Article 10(10)).
One exception is written into Annex III section 1.7.4. Maintenance instructions intended for specialized personnel mandated by the manufacturer or its authorized representative may be supplied in only one official language of the Union that those personnel understand. It is narrow: it covers maintenance instructions for mandated specialists, not the operator's instructions.
The regulation's text does not set up a single "original" instruction set that every other language merely follows. The duty attaches to the instructions the user actually receives, so each language you ship has to meet the content and clarity rules on its own, including the Annex III contents.
Devices and Authorities
Beyond the User's Copy
The MDR applies the same idea across the device lifecycle. Documentation requested by a competent authority goes in an official Union language determined by the Member State concerned (Article 10(14)). Notified body certificates are in a language determined by the Member State where the body is established, or another official Union language the body accepts (Article 56(1)). A field safety notice is edited in the official Union language or languages determined by the Member State where the corrective action is taken (Article 89). The EU declaration of conformity is translated into the languages the Member States where the device is made available require.
So the language list is a lifecycle matter. A device that ships with the right instructions can still need a notice in a language it never shipped in. For the medical device instruction rules in a wider frame, see eIFU.
In Practice
A Workable Process
- List every Member State where the product will be made available. The language duty follows the market, not the factory or the manufacturer's head office.
- For each, find the national rule or authority guidance on which language or languages are accepted. The EU text delegates the choice; it does not give a list.
- Record the result per market in the technical documentation, with the date checked and who checked it, so a later audit can see the basis for each language shipped.
- Tie every translated set to the source revision it came from and to the product model, so a correction in one language can be traced to the others.
- Plan for the other documents in the chain: the declaration of conformity, contact details, on-product warnings, and any notice you may have to issue after sale.
The source text matters because every language starts from it. Short, consistent sentences and controlled terms make each language set easier to check against the others; see writing to STE and the ASD-STE100 standard. Content kept in a single source lets one correction reach every language set.
FAQ
Questions We Hear
Does the EU publish a list of required languages per country?
Not in the regulations read for this article. They say the language is whatever the Member State concerned determines, so the answer sits in each country's own rules or authority guidance. Check each market you sell into, and keep a record of what you found.
Is English enough for the EU?
Only if the Member State concerned accepts a language that users there easily understand and its rules allow it, and that is a national decision. The EU text does not name English or any other language. Do not assume one language covers the Union.
Can I use pictograms instead of translating?
Symbols help, and the machinery rule prefers readily understandable symbols or pictograms for on-product warnings (Annex III section 1.7.1). They do not replace the duty for written and verbal information, which must still be in the required language.
Do these rules apply if my company is outside the EU?
They apply to products placed or made available on the EU market, and the obligations fall on the manufacturer, importer, and distributor in turn. The machinery regulation, for example, applies to products placed on the EU market including from outside the Union. Read the text of the regulation that covers your product.
Does the language rule change when instructions are digital?
The machinery text puts the same language requirement on digital instructions as on paper, because Article 10(7) applies to the instructions however they are supplied. See our guide to the digital conditions for the rest of that article. Other regulations should be read the same way for their own text.
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