Download EU Language Requirements by Regulation (PDF)
How to Use This Guide
Every EU regulation that applies to your product has language requirements buried in it. Miss one, and your documentation fails compliance. Miss several, and your product doesn’t reach the market.
This guide pulls those requirements into a single reference. Regulation by regulation, it sets out which documents need translating, into which languages, and where to find the official guidance.
Keep it bookmarked. Refer to it when planning a new market entry, preparing for an audit, or scoping a translation project.
Important: This guide reflects requirements as of early 2026. Regulations are updated periodically — always verify against the latest official texts for specific compliance decisions.
When Language Requirements Apply
The general principle is straightforward: end users and authorities must be able to read safety-critical and compliance documentation in their own language.
EU language requirements apply whenever a regulation mandates that certain documentation must be available in the official language(s) of the member state where the product is placed on the market or put into service.
In practice, this means:
- Instructions for Use — Almost always required in the local language
- Labels and packaging — Usually required in the local language
- Declarations of Conformity — Required in the language of the member state where the product is placed on the market
- Technical files — Requirements vary; often accepted in English by notified bodies, but national authorities may request local language versions
The EU has 24 official languages. If you sell across the entire EU, your documentation may need to be available in all 24.
CE Marking / EU Machinery Regulation
Current: Directive 2006/42/EC (until 19 January 2027)
Documents requiring translation:
| Document | Language Requirement |
|---|---|
| Instructions (user manual) | Official language(s) of the member state where the machinery is placed on the market |
| Original instructions | Must be provided in at least one official EU language; marked “Original instructions” |
| Translation of original instructions | Must be marked “Translation of the original instructions” and accompanied by a copy of the original |
| EC Declaration of Conformity | Must accompany the instructions; translated into the same language(s) |
Key points:
– The manufacturer decides which language version is the “original”
– Translations must be clearly identified as translations
– Instructions must accompany the machinery (paper or, under the new regulation, digital)
New: Regulation (EU) 2023/1230 (from 20 January 2027)
What changes:
| Change | Detail |
|---|---|
| Digital instructions | Instructions for use may be provided in digital format (with paper available on request at no extra cost) |
| Declaration format | EU Declaration of Conformity replaces EC Declaration |
| Risk assessment | Updated essential health and safety requirements |
| High-risk categories | New Annex I categories requiring third-party conformity assessment |
Language requirements remain fundamentally the same: instructions and declarations must be in the official language(s) of the member state where the product is placed on the market.
No transition period. The new regulation applies from 20 January 2027 without a grace period from the current Directive.
Official guidance:
– Regulation (EU) 2023/1230 — Official Journal of the European Union
– European Commission Machinery page — ec.europa.eu/growth/sectors/mechanical-engineering/machinery_en
EU Medical Device Regulation (EU MDR)
Regulation (EU) 2017/745
Documents requiring translation:
| Document | Language Requirement |
|---|---|
| Instructions for Use (IFU) | Official language(s) of the member state where the device is made available to the user or patient |
| Label | Official language(s) of the member state where the device is made available |
| Implant card | Official language(s) determined by the member state |
| Summary of Safety and Clinical Performance (SSCP) | Required in the languages accepted by the member states where the device is marketed |
| EU Declaration of Conformity | Must be translated into the official language(s) required by the member state(s) |
Key points:
– For EU-wide distribution, IFUs may need to be available in up to 24 languages
– Member states can determine which languages they accept
– Some member states accept English for professional-use devices; others do not — verify per market
– Labels must include the UDI carrier and comply with space constraints while meeting language requirements
– Electronic IFUs (eIFUs) are permitted for certain device classes under specific conditions
Additional requirements for clinical investigation documentation:
– Informed consent forms must be in the language of the clinical investigation site
– Clinical investigation applications must meet national language requirements
Official guidance:
– Regulation (EU) 2017/745 — Official Journal of the European Union
– MDCG guidance documents — ec.europa.eu/health/md_sector/new_regulations
– Eudamed database — ec.europa.eu/tools/eudamed
EU In Vitro Diagnostic Regulation (EU IVDR)
Regulation (EU) 2017/746
Documents requiring translation:
| Document | Language Requirement |
|---|---|
| Instructions for Use (IFU) | Official language(s) of the member state where the device is made available |
| Label | Official language(s) of the member state where the device is made available |
| EU Declaration of Conformity | Official language(s) required by the member state(s) |
| Summary of Safety and Performance (SSP) | Languages accepted by the member states where the device is marketed |
Key points:
– Language requirements mirror EU MDR in structure
– IVDs sold to professional users may have different language acceptance in some member states
– Self-testing IVDs intended for lay users typically require local language in all markets
– IVDR transition timelines differ from MDR — verify current status for your device class
Official guidance:
– Regulation (EU) 2017/746 — Official Journal of the European Union
– MDCG guidance documents applicable to IVDR
REACH Regulation
Regulation (EC) 1907/2006
Documents requiring translation:
| Document | Language Requirement |
|---|---|
| Safety Data Sheet (SDS) | Official language(s) of the member state(s) where the substance or mixture is placed on the market |
| Extended SDS (with exposure scenarios) | Same as SDS |
| Labels (CLP) | Official language(s) of the member state(s) where the product is placed on the market |
Key points:
– SDS must follow the 16-section format prescribed by Annex II of REACH (as amended by Regulation (EU) 2020/878)
– Language requirements are absolute — no exceptions for professional-only products
– SDS must be dated and include version numbering
– Suppliers must provide the SDS in the language of the member state free of charge
– Updates must be provided to all recipients within the previous 12 months
Official guidance:
– REACH Regulation (EC) 1907/2006
– ECHA Guidance on the compilation of Safety Data Sheets — echa.europa.eu
– Regulation (EU) 2020/878 amending Annex II (SDS format)
CLP Regulation
Regulation (EC) 1272/2008 (Classification, Labelling and Packaging)
Documents requiring translation:
| Document | Language Requirement |
|---|---|
| Product label | Official language(s) of the member state(s) where the substance or mixture is placed on the market |
| Hazard statements (H-statements) | Standardised translations exist — must use the official translation for each language |
| Precautionary statements (P-statements) | Standardised translations exist — must use the official translation for each language |
| Supplemental hazard information (EUH-statements) | Standardised translations — must use official versions |
Key points:
– CLP labels must include the product identifier, hazard pictograms, signal word, hazard statements, precautionary statements, supplier identification, and nominal quantity
– Hazard and precautionary statement translations are standardised in Annex III and Annex IV — you must use the official translated versions, not your own translations
– Labels must be legible, indelible, and in the official language(s) of the member state
– Multi-language labels are permitted provided all required languages are included
– Fold-out labels or tie-on tags may be used where the packaging is too small
Official guidance:
– CLP Regulation (EC) 1272/2008
– ECHA guidance on labelling and packaging — echa.europa.eu
– Annex III (Hazard statements) and Annex IV (Precautionary statements) for standardised translations
Other Relevant Regulations
Low Voltage Directive (2014/35/EU)
- Instructions and safety information must be in a language easily understood by end users, as determined by the member state
- EU Declaration of Conformity must be translated into the required language(s)
Radio Equipment Directive (2014/53/EU)
- Instructions and safety information in the language determined by the member state
- Applies to electronic products with radio functionality (wireless, Bluetooth, Wi-Fi)
Electromagnetic Compatibility Directive (2014/30/EU)
- Instructions for installation, use, and maintenance in the language(s) determined by the member state
- EU Declaration of Conformity must be translated
Personal Protective Equipment Regulation (EU) 2016/425
- Instructions and information must be in the official language(s) of the member state
- Particularly strict language requirements due to safety implications
Construction Products Regulation (EU) 305/2011
- Declaration of Performance must be provided in the language(s) required by the member state
- Instructions and safety information accompanying the product must be in the local language
- Currently under review — a revised regulation is expected
Toy Safety Directive (2009/48/EC)
- Warnings and safety information must be in the official language(s) of the member state
- Particularly relevant for packaging and instructions
Pressure Equipment Directive (2014/68/EU)
- Operating instructions must be in the official language(s) of the member state
- Safety-critical documentation with strict language requirements
Quick Reference Table
| Regulation | Key Documents | Languages Required | Notes |
|---|---|---|---|
| Machinery Regulation (2023/1230) | Instructions, Declaration of Conformity | Official language(s) of market member state | New regulation from Jan 2027; digital instructions now permitted |
| EU MDR (2017/745) | IFU, Labels, SSCP, Declaration | Official language(s) of market member state | Up to 24 languages for EU-wide distribution |
| EU IVDR (2017/746) | IFU, Labels, SSP, Declaration | Official language(s) of market member state | Mirrors MDR requirements |
| REACH (1907/2006) | Safety Data Sheets | Official language(s) of market member state | 16-section format mandatory |
| CLP (1272/2008) | Labels, H/P statements | Official language(s) of market member state | Must use standardised translations |
| Low Voltage (2014/35/EU) | Instructions, Declaration | Language determined by member state | End-user accessibility focus |
| RED (2014/53/EU) | Instructions, Declaration | Language determined by member state | Wireless/radio products |
| EMC (2014/30/EU) | Instructions, Declaration | Language(s) determined by member state | Electronic products |
| PPE (2016/425) | Instructions, Declaration | Official language(s) of member state | Safety-critical |
| CPR (305/2011) | Declaration of Performance | Language(s) required by member state | Under review |
| Toy Safety (2009/48/EC) | Warnings, Instructions | Official language(s) of member state | Consumer safety focus |
| PED (2014/68/EU) | Operating instructions | Official language(s) of member state | Safety-critical |
The 24 EU Official Languages
For reference, the 24 official languages of the European Union:
| Language | Member State(s) |
|---|---|
| Bulgarian | Bulgaria |
| Croatian | Croatia |
| Czech | Czech Republic |
| Danish | Denmark |
| Dutch | Netherlands, Belgium |
| English | Ireland (and historically UK) |
| Estonian | Estonia |
| Finnish | Finland |
| French | France, Belgium, Luxembourg |
| German | Germany, Austria, Belgium, Luxembourg |
| Greek | Greece, Cyprus |
| Hungarian | Hungary |
| Irish | Ireland |
| Italian | Italy |
| Latvian | Latvia |
| Lithuanian | Lithuania |
| Maltese | Malta |
| Polish | Poland |
| Portuguese | Portugal |
| Romanian | Romania |
| Slovak | Slovakia |
| Slovenian | Slovenia |
| Spanish | Spain |
| Swedish | Sweden, Finland |
Note: Some member states accept English for professional-use products even where it is not an official national language. Always verify the specific requirements for your product category and target market.
Sources & Further Reading
- EUR-Lex — Official EU legislation database: eur-lex.europa.eu
- ECHA — European Chemicals Agency guidance: echa.europa.eu
- European Commission — Internal Market — ec.europa.eu/growth
- MDCG Guidance Documents — Medical Device Coordination Group guidance
- Blue Guide 2022 — Guide to the implementation of EU product rules (comprehensive reference for CE marking directives and regulations)
Need Help Planning Your Language Requirements?
Knowing what needs translating is the first step. Getting it done accurately, on time, and in every required language is the harder part.
We’ve been translating regulatory and technical documentation for European markets since 2003 — from CE technical files and Safety Data Sheets to EU MDR submissions across all 24 official languages. If you’re scoping a translation project, planning a new market entry, or preparing for the 2027 Machinery Regulation, we can help you work out what’s needed and deliver it.
Bubbles Translation Services
bubblestranslation.com
info@bubblestranslation.com
0870 777 7750
Reference guide prepared: 2026
Bubbles Translation Services
This guide is provided for general reference. For specific regulatory compliance decisions, always consult the official regulation texts and seek appropriate professional advice.
