Download EU MDR Translation Requirements: A Compliance Guide (PDF)
What medical device manufacturers need to know about multilingual documentation
Regulation (EU) 2017/745 — the EU Medical Device Regulation — has been fully applicable since 26 May 2021. It replaced the Medical Devices Directive 93/42/EEC and brought significantly more demanding requirements for documentation, clinical evidence, post-market surveillance, and — critically for this guide — language.
The language requirements in EU MDR are not new in principle. The requirement to provide documentation in the official language(s) of the member state where a device is made available existed under the Directive. But the Regulation expands the scope of documentation that falls under this requirement, raises the bar for quality, and increases the consequences of non-compliance.
This guide sets out the translation requirements under EU MDR, explains where they apply, and provides practical guidance for medical device manufacturers planning their multilingual documentation strategy.
It is written for regulatory affairs managers, quality managers, product safety specialists, and documentation teams responsible for getting medical device documentation right.
Who This Applies To
This guide is relevant if your organisation:
- Manufactures medical devices placed on the EU market
- Exports medical devices from the UK to EU member states
- Provides accessories or components for medical devices sold in the EU
- Manages technical documentation or labelling for medical device product lines
- Holds or is applying for CE marking under EU MDR
If any of those apply, the translation requirements outlined here are part of your compliance obligations.
The Language Requirement
What the Regulation says
Article 10(11) of EU MDR states that manufacturers must ensure the device is accompanied by information as set out in Annex I, Section 23, in an official Union language(s) determined by the member state in which the device is made available to the user or patient.
This is not a recommendation. It is a legal requirement for market access.
What this means in practice
If you sell a Class IIa medical device in Germany, France, Italy, Spain, the Netherlands, and Poland, the documentation specified in Section 23 of Annex I must be available in German, French, Italian, Spanish, Dutch, and Polish respectively.
The manufacturer is responsible for ensuring the accuracy and completeness of all language versions. There is no hierarchy between language versions — the German translation is not subordinate to the English original. It must stand on its own as accurate, complete documentation.
The 24 official EU languages
The EU has 24 official languages. Not every device is sold in every member state, so not every manufacturer needs all 24. But for manufacturers with broad EU market coverage, the language requirement is substantial:
Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish.
Some member states have multiple official languages. Belgium requires French, Dutch, and potentially German. Finland requires Finnish and Swedish. Luxembourg may require French and German. Ireland requires English and Irish.
What Must Be Translated
Instructions for Use (IFU)
The IFU is the primary document affected by the language requirement. Under Annex I, Section 23.1, the IFU must include:
- The device’s intended purpose
- Identification of the manufacturer (name, address, contact)
- Performance characteristics relevant to the user
- Contraindications, warnings, and precautions
- Residual risks and any undesirable side effects
- Installation and use instructions
- Maintenance and calibration information
- Information on reprocessing (if applicable)
- Information enabling verification of correct installation
- Disposal information
- Information for professional users on hazards and precautions
All of this content must be available in the required language(s). Partial translation — translating the safety warnings but leaving the maintenance section in English — does not satisfy the requirement.
Labelling
Article 10(10) and Annex I, Section 23.2 set out labelling requirements. Label content includes:
- Device name and intended purpose
- Manufacturer identification
- Lot or batch number
- UDI carrier
- Warnings and precautions
- Storage and handling conditions
- Sterility status (where applicable)
- Expiry date (where applicable)
Label text must be in the required language(s). For multilingual labels, space constraints become a significant practical consideration — particularly since translated text is typically longer than English source.
EU Declaration of Conformity
The EU Declaration of Conformity must be available in the language(s) required by the member state(s) where the device is placed on the market. Under EU MDR, the content of the declaration includes:
- Device identification (name, product code, model)
- Manufacturer details
- Statement that the declaration is issued under the sole responsibility of the manufacturer
- Reference to the relevant General Safety and Performance Requirements (GSPRs)
- Reference to harmonised standards or common specifications applied
- Notified body identification and certificate reference (where applicable)
- Date and authorised signatory
Summary of Safety and Clinical Performance (SSCP)
For Class III devices and implantable devices, manufacturers must draw up a Summary of Safety and Clinical Performance (SSCP). This summary must be made available to the public through EUDAMED.
While the SSCP’s language requirements are linked to EUDAMED availability, manufacturers should consider whether translated versions in the languages of their key markets are prudent — particularly for devices where patients or healthcare professionals may access the summary.
Post-Market Documentation
Field Safety Corrective Actions (FSCA)
When a Field Safety Corrective Action is required, the associated Field Safety Notice must be provided in the language(s) of the affected member states. This is time-critical — FSCA notices often need to be issued within days.
Manufacturers should have a rapid translation process established in advance, not scramble to find a translation provider during a recall. The languages needed for an FSCA may not be predictable — it depends on which markets are affected.
Vigilance Reporting
Serious incident reports filed under the vigilance system may need to be submitted in the language required by the competent authority of the member state where the incident occurred.
Periodic Safety Update Reports (PSUR)
For Class IIa, Class IIb, and Class III devices, periodic safety update reports must be prepared. The language requirements for PSURs depend on competent authority expectations, which may vary by member state.
What Does Not Need Translating (But Might Benefit From It)
Technical Documentation (Annexes II and III)
The technical documentation compiled under Annexes II and III — including the clinical evaluation report, risk management file, design and manufacturing information, and verification/validation data — does not carry the same automatic language requirement as the IFU and labelling.
However:
- Notified body requirements vary. Some notified bodies accept technical documentation in English. Others require documentation in their national language, or at least key sections of it. Confirm requirements before submission.
- Competent authority access. Competent authorities may request access to technical documentation during market surveillance. If documentation is only available in English and the authority requests it in the national language, the manufacturer must provide it.
The practical advice: confirm notified body language preferences early. Budget for potential translation of key technical documentation sections, even if it is not a blanket requirement.
Clinical Investigation Documentation
If conducting clinical investigations in EU member states, informed consent documents, patient information sheets, and ethics committee submissions must typically be in the local language. This is mandated by the clinical investigation chapter of the Regulation and by national requirements.
Practical Considerations
Text Expansion
Translated medical device documentation is typically longer than the English source. This has practical implications:
| Language | Typical Expansion |
|---|---|
| German | 15-25% longer |
| French | 15-20% longer |
| Finnish | 20-30% longer |
| Spanish | 15-20% longer |
| Italian | 10-15% longer |
| Dutch | 10-15% longer |
| Polish | 10-20% longer |
For labelling, this expansion must be accommodated in the label design. For IFUs, it affects page count and print cost. Plan for expansion from the outset — retrofitting longer translated text into a fixed English layout creates formatting compromises.
Terminology Management
Medical device documentation uses defined regulatory terms — terms that appear in the Regulation itself and in harmonised standards. These terms have established translations in each EU language.
Maintaining a terminology database across all language versions ensures:
- Consistent use of regulatory terms
- Consistent product-specific terminology
- Alignment between IFU, labelling, and declaration of conformity
- Efficiency on subsequent translations (translation memory leverage)
Timing
Translation is a downstream activity — it cannot start until source content is finalised. But it sits on the critical path to market access.
A realistic timeline for a medical device IFU into 8 EU languages:
| Activity | Duration |
|---|---|
| Source IFU finalisation | Variable |
| Translation briefing and setup | 3-5 days |
| Translation | 10-15 days |
| Review and editing | 5-8 days |
| DTP and formatting | 3-5 days |
| Client review | 5-10 days |
| Corrections and final approval | 3-5 days |
| Total from final source | ~6-8 weeks |
This assumes the source content is genuinely final. Every revision after translation starts generates rework across all languages.
Electronic IFU (eIFU)
Regulation (EU) 207/2012 permits electronic-only IFU for certain device categories, subject to conditions. If providing eIFU:
- The manufacturer must provide paper IFU on request, free of charge
- Safety information for consumer devices must be provided on paper regardless
- The eIFU must be accessible at the point of use
- All language versions must be available electronically
eIFU does not change the language requirement — it changes the delivery mechanism.
Updates and Revisions
When the source IFU is revised, all translated versions must be updated to match. Under EU MDR, the obligation is to ensure all language versions are accurate and complete at all times. An outdated translated IFU is a non-compliant IFU.
Building translation memory from the outset means that updates are faster and cheaper — only changed content needs translating, while unchanged content is confirmed automatically.
Common Compliance Gaps
Based on our experience translating medical device documentation, these are the gaps we see most frequently:
Incomplete language coverage. The device is sold in 12 EU markets but documentation exists in only 8 languages. Four markets are technically non-compliant.
Label text overflow. The English label fits. The German translation doesn’t. The label design needs revising — not the translation.
IFU updates not propagated. The English IFU was updated six months ago. Three of eight translated versions still reflect the previous revision.
No rapid translation process for FSCA. A field safety corrective action requires notice in 6 languages within days. Without an established translation relationship, this becomes a scramble that delays a time-critical safety communication.
Terminology inconsistency between documents. The IFU uses one German term for “intended purpose,” the labelling uses another, and the declaration of conformity uses a third. All are technically correct, but the inconsistency suggests a lack of control.
Planning Your Approach
Step 1: Map your language requirements
List every EU member state where your device is currently placed on the market or will be within the next 12 months. For each, identify the official language(s) required.
Step 2: Audit existing translations
For devices already on the market, verify that all translated documentation is current, complete, and consistent with the latest source version.
Step 3: Establish terminology
Create or update a multilingual terminology database for your device portfolio. Include regulatory terms, product-specific terms, and terms that should not be translated.
Step 4: Build translation memory
Provide your translation partner with all existing approved translations. This builds the translation memory that reduces cost and ensures consistency on future projects.
Step 5: Plan for updates
Establish a process for triggering translation updates when source documentation is revised. This should be automatic, not ad hoc.
Step 6: Prepare for FSCA
Agree a rapid-response translation process with your translation partner before you need it. Identify likely language requirements, agree turnaround expectations, and establish a communication protocol.
About Bubbles Translation Services
We have translated medical device documentation for over 20 years. Our translators are native speakers with domain expertise in medical devices, diagnostics, and life sciences. We understand EU MDR documentation requirements and work with manufacturers to ensure their multilingual documentation meets compliance obligations.
Get in touch:
bubblestranslation.com
info@bubblestranslation.com
0870 777 7750
Guide prepared: 2026
Bubbles Translation Services
This guide is provided for general information. For specific regulatory compliance questions, consult the official Regulation text and appropriate legal or regulatory advice.
