Download EU MDR Documentation Checklist (PDF)
Translation requirements for medical device compliance
Use this checklist when preparing medical device documentation for EU market access under Regulation (EU) 2017/745. A translation gap in your documentation is a compliance gap in your submission.
Before You Start
EU MDR 2017/745 requires that certain documentation be available in the official language(s) of each member state where your device is made available. This is not optional. A device with English-only documentation does not meet the requirements for placement on the EU market.
This checklist covers the translation-relevant documentation requirements. It does not replace a full regulatory compliance review — but it will ensure your translation scope is complete before you engage a translation partner.
Instructions for Use (IFU)
- IFU content finalised in source language — no pending revisions, no placeholder text, no “refer to website” for required safety information
- Target languages identified for every EU market — each member state where the device will be made available requires documentation in its official language(s)
- IFU includes all MDR-required content — intended purpose, contraindications, warnings, precautions, residual risks, device description, performance characteristics, installation and use instructions, maintenance, disposal
- Symbols and pictograms checked — where symbols are used, they must conform to harmonised standards (EN ISO 15223-1). Any symbol not covered by a harmonised standard requires explanatory text — which must also be translated
- Electronic IFU (eIFU) compliance checked — if providing IFU electronically under Regulation (EU) 207/2012, confirm it meets the conditions, including that paper IFU is available on request
Labelling
- All label text identified for translation — device name, intended purpose, lot/batch number format, UDI carrier, manufacturer details, warnings, storage conditions, sterility status, expiry information
- Label space constraints documented — translated text is often longer than English source. German, French, and Spanish typically require 15-25% more space. Flag space constraints to your translation partner before work begins
- Multilingual label layouts planned — will each market have a single-language label, or will labels carry multiple languages? This affects both translation scope and DTP requirements
- Regulatory symbols confirmed — CE marking, notified body number (where applicable), and MDR-mandated symbols are not translated but must appear correctly on all language versions
EU Declaration of Conformity
- Declaration content finalised — device identification, manufacturer details, notified body information (if applicable), relevant GSPR references, harmonised standards applied, date and signature
- Translation into required languages planned — the declaration must be available in the language(s) required by the member state(s) where the device is placed on the market
- Format allows for multilingual versions — a single multilingual declaration or separate language versions, consistently formatted
Technical Documentation (Annexes II and III)
- Summary of Safety and Clinical Performance (SSCP) language requirements checked — for Class III and implantable devices, the SSCP must be made available to the public. Consider whether translated versions are required for each market
- Clinical evaluation report scope confirmed — while the CER itself may remain in English for notified body review, supporting clinical data referenced in user-facing documentation must be consistent across language versions
- Risk management documentation reviewed — risk-benefit determinations referenced in translated IFU must be consistent with the risk management file
Post-Market Documentation
- Field Safety Corrective Actions (FSCA) language requirements identified — field safety notices must be provided in the language(s) of the affected member states. These are time-critical — establish a rapid translation process now, not during a recall
- Periodic Safety Update Reports (PSUR) language scope confirmed — identify whether competent authorities require translated summaries
- Vigilance reporting language requirements checked — serious incident reports may need to be filed in the language of the member state where the incident occurred
Notified Body Submissions
- Notified body language preferences confirmed — some notified bodies accept documentation in English; others require national language versions. Confirm before submission
- Submission format documented — electronic or paper? If electronic, confirm file format requirements for translated documents
- Supplementary documentation identified — any supporting documents (test reports, clinical data summaries) that may need translation for submission
Quality Management System Documentation
- QMS documentation translation scope defined — identify which QMS documents require translation for audits by notified bodies or competent authorities in specific member states
- Training materials identified — if your device requires user training, training materials must be available in the appropriate language(s)
Translation Planning
- Complete language list confirmed — every EU member state where the device will be made available, plus any EFTA states (Norway, Iceland, Liechtenstein)
- Multi-language member states accounted for — Belgium (French, Dutch, German), Finland (Finnish, Swedish), Ireland (Irish, English), Luxembourg (French, German), Malta (Maltese, English), Cyprus (Greek)
- Glossary of device-specific terminology prepared — intended purpose statements, risk terminology, clinical terms, trade names to retain in English
- Previous translations of related devices provided — earlier IFU versions, predecessor device documentation, related product translations. These build translation memory and ensure terminological consistency
- Regulatory review process defined — who reviews translations for regulatory accuracy? In-market regulatory contacts, your RA team, or the translation provider?
- Timeline built backwards from market access date — source content finalisation, translation, regulatory review, label production, packaging. Each step has dependencies
Gaps We See Repeatedly
These issues appear frequently in medical device translation projects. They are all compliance risks, and they are all avoidable.
IFU updates not propagated. When the source IFU is revised, all translated versions must be updated simultaneously. Partial updates — where some languages reflect the current revision and others do not — create a compliance gap that auditors and market surveillance authorities will find.
Label space not checked before translation. A 12-word English warning becomes 17 words in German. If the label cannot accommodate the translated text, the label design needs changing — not the translation. This is a design constraint that should be flagged at the outset, not discovered at the proofing stage.
eIFU used where paper is required. Not all device classes and use environments qualify for electronic-only IFU under Regulation (EU) 207/2012. Confirm eligibility before eliminating paper documentation.
“Original instructions” language used on documentation. Unlike the old Machinery Directive, EU MDR does not distinguish between “original” and “translated” versions of documentation. All language versions carry equal regulatory weight. Remove any legacy labelling that implies otherwise.
The Single Most Common Delay
It is not the translation. It is waiting for source content to be finalised.
Every week of source content revision after translation has started generates rework across every language. For a device launching in 12 EU markets, one round of source changes creates 12 rounds of translation corrections. The cost multiplies linearly. The timeline extends nonlinearly, because each correction must be reviewed.
Finalise your source documentation before briefing your translation partner. The investment in getting the source right saves multiples in translation rework.
Need Help?
Download more resources: bubblestranslation.com
Questions? info@bubblestranslation.com | 0870 777 7750
Bubbles Translation Services — Specialist medical device translation since 2003
