EU Compliance Translation: CE Marking, MDR and Machinery Documentation
Products placed on the European market must be accompanied by instructions, safety information and declarations of conformity in the official language or languages of each Member State where they are sold. There is no single European language version. Asiatis translates EU compliance documentation from Singapore into all 24 official EU languages, with in-country linguists and terminology managed across the full document set.
Last updated: 23 August 2026
Which languages does the EU require?
The European Union has 24 official languages, and language obligations are set nationally, not centrally. A regulation adopted in Brussels typically states that information must be supplied in a language determined by the Member State where the product is made available — and each Member State then decides.
Selling one product in five EU countries usually means five complete documentation sets, not one European version.
The table below lists the official language or languages of each EU Member State. It is a planning reference, not a legal determination: the language actually required for a given product depends on the applicable regulation and on that Member State's implementing provisions, which have to be verified per product line.
| Member State | Official language(s) | Notes for documentation planning |
|---|---|---|
| Austria | German | Shares German documentation with Germany |
| Belgium | Dutch, French, German | Three language regions; consumer documentation usually needs Dutch and French |
| Bulgaria | Bulgarian | Cyrillic script — font and DTP implications |
| Croatia | Croatian | Distinct from Serbian and Bosnian; do not substitute |
| Cyprus | Greek, Turkish | Greek in practice for most product documentation |
| Czechia | Czech | Distinct from Slovak; do not substitute |
| Denmark | Danish | Frequently packaged with Swedish and Norwegian |
| Estonia | Estonian | Small linguist pool; plan lead time |
| Finland | Finnish, Swedish | Both official; check requirement per product category |
| France | French | FR-FR, not FR-CA |
| Germany | German | Largest single documentation market; heavy text expansion |
| Greece | Greek | Greek script — font and DTP implications |
| Hungary | Hungarian | Significant text expansion |
| Ireland | Irish, English | English in practice for most documentation |
| Italy | Italian | — |
| Latvia | Latvian | Small linguist pool |
| Lithuania | Lithuanian | Small linguist pool |
| Luxembourg | Luxembourgish, French, German | French and German in practice |
| Malta | Maltese, English | English in practice for most documentation |
| Netherlands | Dutch | NL-NL differs from Belgian Dutch in terminology |
| Poland | Polish | Large market; significant expansion from English |
| Portugal | Portuguese | PT-PT, not PT-BR |
| Romania | Romanian | Largest Central European market after Poland |
| Slovakia | Slovak | Distinct from Czech |
| Slovenia | Slovenian | Small linguist pool |
| Spain | Spanish | ES-ES, not Latin American Spanish |
| Sweden | Swedish | — |
Add Norwegian and Icelandic for EEA coverage, and Swiss German and Swiss French conventions for the Swiss market, which is outside the EU but is normally handled in the same documentation programme.
Some Member States accept English for products intended exclusively for professional users. This is an exception with conditions, not a general rule, and it varies by product regulation and by country. Anything intended for consumers or patients is required in the local language.
Which regulations drive translation obligations?
General Product Safety Regulation — (EU) 2023/988
Applies to consumer products. Manufacturers must supply instructions and safety information in a language that consumers in each Member State where the product is made available can easily understand, where this is necessary for safe use. Digital labels such as QR codes may complement physical labelling — they do not replace it.
Machinery Regulation — (EU) 2023/1230 — applies from 20 January 2027
This is the deadline currently reshaping technical documentation planning, and it matters more than manufacturers assume. Regulation (EU) 2023/1230 replaces Machinery Directive 2006/42/EC in full on 20 January 2027, with no transition period and no option to fall back on the old rules. Machinery placed on the market before that date remains under the Directive; machinery placed on the market on or after it must comply with the Regulation.
Two changes matter directly for translation:
- Every language version now carries the same legal standing. The Directive distinguished “original instructions” from “translations”. The Regulation removes that distinction: instructions for use and safety information simply have to be clear, comprehensible and legible in the language required by the Member State. A manufacturer can no longer point back to the original version to limit liability for a defective translation.
- Digital instructions are permitted, with conditions. Instructions may be supplied digitally, but the format must let the user print, download and save them, they must remain accessible online for the expected lifetime of the product and for at least ten years after it is placed on the market, and any user may request a free paper copy at the time of purchase. For non-professional users, essential safety information must still be provided on paper.
Medical Device Regulation — (EU) 2017/745 — and IVDR (EU) 2017/746
Under Article 10(11) MDR, manufacturers must ensure the device is accompanied by the information in Section 23 of Annex I — labels and instructions for use — in an official Union language or languages determined by the Member State in which the device is made available to the user or patient. Labelling particulars must be indelible, easily legible and clearly comprehensible to the intended user or patient. The Commission maintains a table of national language provisions under the MDR, which is revised as Member States notify changes. Patient- and layperson-facing information must be in the national language.
What we translate
| Document | Typical constraint |
|---|---|
| Instructions for use (IFU) and user manuals | Required in the language of every market; layout rebuilt per language |
| Safety information, warnings and residual-risk notices | Wording cannot be softened or condensed in translation |
| EU Declaration of Conformity and Declaration of Incorporation | Language set by the destination Member State |
| Labelling and packaging | Space-constrained; text expansion is a design problem, not a translation problem |
| Technical files and risk assessments | Terminology must match the harmonised standards cited |
| Datasheets, specifications and installation guides | High repetition; translation memory essential across product ranges |
| Safety data sheets | Format and phrase sets are prescribed |
| Software and HMI strings on machinery | String-length limits; in-context review needed |
Documentation checklist by regulation
Use this to derive the translation scope before requesting a quote. Every line multiplies by the number of target markets.
| Item | GPSR 2023/988 | Machinery 2023/1230 | MDR 2017/745 |
|---|---|---|---|
| Instructions for use | ✔ where needed for safe use | ✔ | ✔ |
| Safety information and warnings | ✔ | ✔ | ✔ |
| Labelling and packaging text | ✔ | ✔ | ✔ |
| EU Declaration of Conformity | — | ✔ | ✔ |
| Declaration of Incorporation | — | ✔ (partly completed machinery) | — |
| Implant card | — | — | ✔ (implantable devices) |
| Summary of Safety and Clinical Performance | — | — | ✔ (implantable and Class III) |
| Technical file / risk assessment | internal | internal, language may be requested by authority | internal, language may be requested by authority |
| Software and interface strings | ✔ where user-facing | ✔ | ✔ |
| Website and support content | commercial | commercial | post-market information regulated |
The internal-only lines still matter: a market surveillance authority or a notified body can request the technical file, and requests do not come with a translation timeline.
Why this goes wrong
Treating translation as the last step. Source documents are finalised, then translated into eight languages, then amended twice. Every source revision multiplies across every language. Freezing the source before translation is the cheapest decision available.
Softening a warning. A mandatory warning that is paraphrased, shortened to fit a layout, or rendered less imperative is a compliance failure, not a stylistic choice.
Assuming English is enough for professional users. It sometimes is, for some products, in some Member States. It is never a default, and the exception has to be verified per country and per regulation.
Layout breaking after translation. English expands substantially into German, Finnish and Polish. A label or an HMI screen designed to fit English exactly will not fit. This has to be anticipated in design, not repaired after delivery.
Terminology drifting across the document set. The manual, the declaration, the labelling and the datasheet must use the same terms in each language. Without a managed termbase, each linguist makes a reasonable but different choice.
Version drift between languages. When a product is updated, some language versions are updated and others are not. Under the Machinery Regulation, where every version carries equal legal standing, an outdated language version is a live liability.
How Asiatis handles EU compliance documentation
In-country European linguists. Every target language is handled by a native linguist based in the target market, not by a bilingual translator based in Asia.
European project management. The Paris office manages the European linguist network, so terminology decisions on German, Finnish or Polish are made in the same time zone as the linguists making them.
Regulated-content specialists. Machinery, medical device and product-safety documentation is assigned to linguists with documented technical qualifications in that field.
Managed terminology across the set. A single termbase per client governs manual, declaration, labelling and software strings in every language.
Translation memory across product ranges. Documentation for a range of related products is heavily repetitive; the memory reduces cost and, more importantly, prevents divergence between models.
Layout rebuilt per language. Multilingual desktop publishing is done in the target layout, with expansion handled by design rather than by cutting content.
Second-linguist revision on every project without exception, on content where an error has safety consequences.
Key facts
- The EU has 24 official languages; language requirements are determined by each Member State, not centrally.
- Regulation (EU) 2023/1230 applies from 20 January 2027 and replaces Machinery Directive 2006/42/EC with no transition period.
- Under the Machinery Regulation, the distinction between "original instructions" and "translations" is removed — every language version carries equal legal standing.
- Digital instructions must remain accessible for the product’s expected lifetime and at least 10 years after it is placed on the market, and a free paper copy must be provided on request at purchase.
- Under MDR Article 10(11), information accompanying a device must be in the official language(s) determined by the Member State where it is made available.
- Selling into five EU markets normally means five complete documentation sets.
See the European languages we translate into, technical translation and the industries we serve. To scope a documentation set, request a quote below.
Frequently asked questions
Do I need to translate my documentation into all 24 EU languages?+
Only into the languages of the Member States where the product is actually placed on the market. A product sold in Germany, France and the Netherlands needs German, French and Dutch, not all 24. The obligation follows market presence, so the language list should be derived from the commercial roll-out plan rather than fixed in advance.
Can I supply documentation in English only for professional users?+
Sometimes, for some product categories, in some Member States — and never as a default. Several countries accept English for devices and machinery intended exclusively for professional users, under conditions that differ by country and by regulation. Anything reaching consumers or patients must be in the national language. Verify per market before deciding.
What changes on 20 January 2027 for machinery documentation?+
Regulation (EU) 2023/1230 replaces the Machinery Directive with no transition period. For documentation, the two material changes are that every language version carries the same legal standing — there is no longer an "original" version to fall back on — and that instructions may be supplied digitally, subject to conditions on printability, availability over the product’s lifetime and free paper copies on request.
Who is responsible if a translated manual is wrong?+
The manufacturer. Under the Machinery Regulation the removal of the original-versus-translation distinction means a defective translation cannot be excused by pointing to a correct source version. This is why translation of regulated documentation is a compliance activity with an audit trail, not a procurement line item.
Does translation memory help with compliance, or only with cost?+
Both, and the compliance benefit is the larger one. A managed memory and termbase keep wording identical across the manual, the declaration, the labelling and every product in a range, in every language. Divergence between language versions is one of the most common findings in documentation audits, and it is a process problem rather than a translator problem.
How far in advance should translation start?+
Start when the source documentation reaches a stable draft, not when it is signed off. Terminology setup, translation, revision and layout for a multi-language documentation set typically take several weeks, and the schedule is driven by the number of languages and the amount of desktop publishing rather than by word count alone.
Can you handle labelling with space constraints?+
Yes. Space-constrained labelling is handled at the design stage by flagging expansion risk per language before layout is finalised, and by working within character limits during translation rather than trimming afterwards. Where a term genuinely cannot be shortened without changing its regulatory meaning, the constraint is escalated rather than resolved silently.
Official sources
- EUR-Lex — Regulation (EU) 2023/1230 (Machinery)
- EUR-Lex — Regulation (EU) 2023/988 (GPSR)
- EUR-Lex — Regulation (EU) 2017/745 (MDR)
- European Commission — national language requirements under the MDR (revised periodically)
Official sources accessed 23 August 2026.
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