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EU language requirements for product documentation

Which languages must your manuals, labels, warnings and declarations be in? Pick your product type and the countries you sell to, and get the list of languages you need. The table below covers the 27 EU countries, Norway, Iceland, Liechtenstein and Switzerland.

Last reviewed:

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2. Countries you sell to

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Select at least one country to see the languages you need.

Country-by-country table

Languages required for product documentation, by country and product type (10 November 2026)
CountryMachineryMedical devices, lay usersMedical devices, professional usersConsumer productsNotes and sources
AustriaGermanGermanOfficial entry may be outdatedGermanEnglish acceptedGerman English is accepted for professional medical devices. The Commission's table notes that Austria's medical device entry may not be up to date. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
BelgiumDutch, French, GermanFrench, Dutch, Germanone of: French, Dutch, GermanEnglish acceptedDutch, French, German (by language region) Consumer information follows the language region: Dutch in Flanders, French in Wallonia, German in the German-speaking Community, Dutch and French in Brussels. Medical devices for lay users need all three languages. Whether one regional language is enough for machinery is not confirmed: check with FPS Economy. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014); FPS Economy (BE): safety of machines
BulgariaBulgarianBulgarianOfficial entry may be outdatedBulgarianNo English optionBulgarian No English option for professional medical devices. The Commission's table notes that Bulgaria's entry may not be up to date. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
CroatiaCroatianCroatianCroatianEnglish only under conditionsCroatian English for professional medical devices only with the professional user's agreement. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
CyprusGreekCheck with authorityGreekOfficial entry may be outdatedGreekEnglish acceptedGreek Greek. English is accepted for professional medical devices and the declaration of conformity. For machinery, check with the national authority whether English alone is accepted. The Commission's table still cites Cyprus's pre-MDR medical device law. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
CzechiaCzechCzechCzechNo English optionCzechNational rule confirmed Czech even for professional medical device instructions. The medical device declaration of conformity may be in Czech, Slovak or English. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; Czech Trade Inspection Authority: seller information duties
DenmarkDanishDanishDanishEnglish only under conditionsDanish English for professional medical devices only on request. The medical device declaration of conformity may be in English. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
EstoniaEstonianEstonianEstonianEnglish only under conditionsEstonianNational rule confirmed Professionals may accept English, but the Language Act gives them the right to ask for Estonian. Consumers must get Estonian unless they agree otherwise. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; TTJA (EE): consumer protection requirements; Riigi Teataja (EE): Consumer Protection Act (2023 version)
FinlandFinnish, SwedishFinnish, SwedishFinnish, SwedishEnglish only under conditionsFinnish, Swedish Bilingual country: plan for Finnish and Swedish. Information needed for the safe use of a medical device must be in both, even for professional users. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
FranceFrenchFrenchFrenchNo English optionFrenchNational rule confirmed The Loi Toubon makes French mandatory for instructions for use and warranty terms, with fines per offence. Under the Machinery Regulation, machinery instructions may be supplied digitally from 20 January 2027, but a free paper copy must be provided on request. No English option for professional medical devices. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; Lรฉgifrance: Loi nยฐ 94-665 (Loi Toubon); French Ministry of Agriculture: buying safe new machinery (PDF, 2010, Machinery Directive)
GermanyGermanNational rule confirmedGermanGermanEnglish only under conditionsGermanNational rule confirmed Germany has already adopted its national rule under the Machinery Regulation (MaschinenDG ยง2): from 20 January 2027 the instructions, safety information and EU declaration of conformity must be in German, and so must assembly instructions and declarations of incorporation. For medical devices, English is allowed for professional users only in justified cases, and safety information must still be in German or the user's language. Sources: European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; MaschinenDG ยง2 (gesetze-im-internet.de); BAuA: MaschinenDG; ProdSG ยง6 (gesetze-im-internet.de)
GreeceGreekGreekOfficial entry may be outdatedGreekEnglish only under conditionsGreek The medical device rules listed by the Commission still date from before the MDR. English for professional devices only with the competent authority's approval. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
HungaryHungarianHungarianOfficial entry may be outdatedHungarianNo English optionHungarianCheck with authority No English option for professional medical devices. For consumer information, check with the national consumer protection authority, which enforces Hungarian-language rules. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; Hungarian consumer protection authority: press release on Hungarian-language rules for advertising and shop notices (PDF, Jul 2026)
IcelandIcelandicCheck with authorityIcelandicIcelandicEnglish acceptedIcelandicCheck with authority EEA country. Lay instructions for class I and IIa medical devices may also be in English or a Nordic language other than Finnish. For machinery and consumer products, check with the national authority. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025
IrelandEnglishCheck with authorityEnglishEnglishEnglish acceptedEnglish English is sufficient for medical devices; Irish is optional alongside it. For machinery, confirm with the national authority that English alone is enough. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
ItalyItalianItalianOfficial entry may be outdatedItalianNo English optionItalianNational rule confirmed On consumer information, Italian must be at least as visible as any other language. Implant cards need Italian and English. No English option for professional medical devices. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; Normattiva: Codice del consumo (D.Lgs. 206/2005), art. 9
LatviaLatvianLatvianLatvianEnglish only under conditionsLatvianNational rule confirmed The Official Language Law is enforced with administrative fines. Even the medical device declaration of conformity must be in Latvian. English for professional devices only in healthcare facilities that consent. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; Likumi.lv: Official Language Law
LiechtensteinGermanCheck with authorityGermanGermanEnglish only under conditionsGermanCheck with authority EEA country, German-speaking, in a customs union with Switzerland. For machinery and consumer products, check with the national authority. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025
LithuaniaLithuanianLithuanianOfficial entry may be outdatedLithuanianNo English optionLithuanianNational rule confirmed No English option for professional medical devices. Article 17 of the State Language Law requires the names and descriptions of goods to be in Lithuanian. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; e-seimas (LT): Law on the State Language, official translation (Art. 17)
Luxembourgone of: French, Germanone of: French, German, LuxembourgishOfficial entry may be outdatedone of: French, German, LuxembourgishEnglish acceptedone of: French, German, Luxembourgish Under the Machinery Directive, ILNAS accepts instructions in one of Luxembourg's official languages, in practice French or German. Luxembourg's law implementing the Machinery Regulation sets fines but no language rule, so for machinery placed on the market from 20 January 2027, confirm with ILNAS. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014); ILNAS (LU): Machinery Directive factsheet (PDF, 2021)
Maltaone of: Maltese, Englishone of: Maltese, Englishone of: Maltese, EnglishEnglish acceptedone of: English, Maltese Maltese and English are both official: English alone is accepted for medical devices and, in practice, for other products. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
NetherlandsDutchDutchDutchEnglish acceptedDutch Consumers need Dutch. English is widely accepted for professional medical devices and the declaration of conformity. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
NorwayNorwegianNorwegianNorwegianNo English optionNorwegian EEA country. Medical device software interfaces must be in Norwegian too, except standard terms such as On/Off. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
PolandPolishPolishPolishEnglish acceptedPolishNational rule confirmed The Polish Language Act requires Polish for consumer instructions, warnings and warranty terms, and is enforced with fines. It does not cover business-to-business sales. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; Dziennik Ustaw: Act on the Polish language (1999)
PortugalPortuguesePortuguesePortugueseNo English optionPortuguese No English option for professional medical device instructions; the declaration of conformity may be in English. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
RomaniaRomanianRomanianRomanianEnglish only under conditionsRomanian English for professional medical devices needs the competent authority's approval, based on the healthcare professional's written consent. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
SlovakiaSlovakSlovakSlovakEnglish only under conditionsSlovakNational rule confirmed Consumers must get information in Slovak unless they agree to another language they understand. Labels of professional medical devices may be in English, but the instructions for use must be in Slovak; English in professional software interfaces must be explained in the Slovak instructions. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; Slovak Ministry of Economy: Act 108/2024 on consumer protection (EN, PDF)
SloveniaSlovenianSlovenianOfficial entry may be outdatedSlovenianEnglish acceptedSlovenian Slovene, including the medical device declaration of conformity. Instructions for professional-use devices may be in a language the user understands (normally English). The Commission's table notes that Slovenia still applies its pre-MDR Medical Devices Act. Requirements in the Italian and Hungarian bilingual areas are not confirmed. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
SpainSpanishSpanishSpanishNo English optionSpanish + Catalan (Catalonia)National rule confirmed Spanish nationwide. In Catalonia, the Consumer Code gives consumers the right to information in Catalan; the Constitutional Court upheld it with an interpretive reservation, and courts have confirmed fines. No English option for professional medical devices. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; BOE: Real Decreto 1468/1988 (labelling of industrial products); BOE: Constitutional Court ruling on the Catalan Consumer Code (2017)
SwedenSwedishSwedishSwedishNo English optionSwedish Swedish, even for professional medical device instructions. The declaration of conformity may be in English. Sources: Regulation (EU) 2023/1230 on machinery (EUR-Lex); European Commission: language requirements for medical devices (MDR), Rev. 3, Aug 2025; European Commission: national language requirements for toys (overview, 2014)
SwitzerlandGerman, French, ItalianNational rule confirmedGerman, French, ItalianGerman, French, ItalianEnglish only under conditionsGerman, French, Italian (by language region)National rule confirmed Not in the EU or EEA. Instructions must be in the official language of the region where the product is used, but written warnings must be in German, French and Italian, so machinery sold nationwide needs all three. Medical devices for lay users also need all three; fewer languages or English only under strict conditions for professionals. Sources: Fedlex: Product Safety Ordinance (PrSV, SR 930.111); Fedlex: Medical Devices Ordinance (MepV, SR 812.213), Art. 16; Swissmedic: FAQ on medical devices

Legend

National rule confirmed the country has a confirmed national rule for this product type.

General rule based on the official language(s) of the country (the Machinery Directive rule until 19 January 2027) or on the official overviews listed below.

Check with authority we could not confirm the requirement in an official source: check with the national authority before you plan.

Official entry may be outdated the Commission's table marks the country's medical device entry as not recently updated, or the entry still cites pre-MDR national law.

The rules behind the table

EU product rules do not list languages themselves. Most of them require instructions and safety information "in a language which can be easily understood" by users, as determined by the Member State where the product is made available; the medical device rules require an official EU language chosen by that Member State. That is why the answer differs by country.

Machinery Regulation Regulation (EU) 2023/1230

Art. 10(7): instructions and safety information; Art. 11(7): assembly instructions for partly completed machinery; Art. 21(2): EU declaration of conformity translated into the language(s) required by the Member State. Replaces Directive 2006/42/EC. Applies from 20 January 2027. In depth โ†’

Medical Devices Regulation Regulation (EU) 2017/745 (MDR)

Art. 10(11): label and instructions for use in the official Union language(s) determined by the Member State; Art. 19(1): EU declaration of conformity. The IVDR (Regulation (EU) 2017/746, Art. 10(10)) has the same rule for in vitro diagnostics. Applies from 26 May 2021. In depth โ†’

General Product Safety Regulation Regulation (EU) 2023/988 (GPSR)

Art. 9(7): instructions and safety information in a language easily understood by consumers, as determined by the Member State. Applies to consumer products not covered by more specific rules. Applies from 13 December 2024. In depth โ†’

Low voltage, EMC and radio equipment Directives 2014/35/EU, 2014/30/EU, 2014/53/EU

LVD Art. 6(7) and RED Art. 10(8): instructions and safety information; EMC Art. 7(7): instructions and the information required by Art. 18; in a language easily understood by consumers and other end users, as determined by the Member State. Radio equipment applies from 13 June 2016. Applies from 20 April 2016.

Construction Products Regulation Regulation (EU) 2024/3110 (CPR)

Art. 22(6): product information, instructions and safety information; Art. 16(4): declaration of performance and conformity, in the language(s) determined by the Member State. Applies from 8 January 2026.

Personal protective equipment Regulation (EU) 2016/425

Art. 8(7): instructions and information in a language easily understood by consumers and other end users, as determined by the Member State. Applies from 21 April 2018.

Toy safety Directive 2009/48/EC โ†’ Regulation (EU) 2025/2509

Today: Directive 2009/48/EC, Art. 4(7) and Art. 11(3) (warnings). From 1 August 2030 the new Toy Safety Regulation applies: Art. 7(7) and 7(8), and a digital product passport replaces the declaration of conformity. Applies from 1 August 2030.

European Accessibility Act Directive (EU) 2019/882

Art. 7(7): instructions and safety information in a language easily understood by consumers and other end users, as determined by the Member State, for products in scope. Applies from 28 June 2025.

Practical next steps

Start from the countries you already sell to and the ones planned for the next two years, not only the current order. Translate the safety information first: warnings, safe use and maintenance are what authorities check. Keep one approved terminology list per language so that manuals, labels, software and the declaration of conformity say the same thing. Where a country accepts English for professional users, record the decision and the reason in your technical documentation.

Need your documentation in these languages?

Gaetano can look at your manuals and labels and tell you how to plan the translations for your markets, including what can be reused across languages.

Where this information comes from

The table is based on the official text of each EU regulation (EUR-Lex), the European Commission's overview of national language requirements for medical devices (MDR, Rev. 3, August 2025), the Commission's overview of national language requirements for toys under Directive 2009/48/EC (2 October 2014), and the national laws and authority guidance linked in each row. Until 19 January 2027 the Machinery Directive 2006/42/EC applies, which requires instructions in the official language or languages of the country where the machine is used. From 20 January 2027 the Machinery Regulation (EU) 2023/1230 requires a language easily understood by users, as determined by each Member State; where a country has not yet set its own rule, the table shows its official language or languages as the safe choice. Last reviewed: 10 November 2026.

Spotted a change? Tell us and we will update the table.

Reference information, not legal advice. Requirements change: confirm with your notified body or the competent national authority before you release documentation.

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