Scope EU medical-device language work by country, intended user and document type: labels, IFUs, declarations, technical documentation and revision control.
View references (3) ↓- Language is set per member state
- Define the document scope before counting languages
- When the language set gets fixed decides how hard the rest will be
- Revisions are the real test
Language is set per member state
For information accompanying a device, MDR Article 10(11) and IVDR Article 10(10) refer to official Union languages determined by the relevant Member State. The required set depends on the market, document and intended user, including professional-use provisions where applicable.
Use the Commission’s country tables as a starting point, then verify the current national position. Notified-body documentation languages and customer-facing labels or IFUs are separate questions; not every device requires a notified-body assessment.
Define the document scope before counting languages
Record the requirement and approval owner for each category. Technical-documentation language is not automatically the same as the IFU language set.
| Document | What to verify |
|---|---|
| Labels and IFU | Member State provisions, intended user and applicable exceptions. |
| Declaration of conformity | Languages required where the device is made available. |
| Technical documentation | Authority or assessment-route requirements and, where applicable, languages accepted by the notified body. |
| GUI and revision notices | Applicable national rules and consistency with the controlled document set. |
When the language set gets fixed decides how hard the rest will be
Teams frequently finalise the English source, then discover the required language count late and compress translation into the last weeks before launch. That is where quality and consistency problems concentrate — not because the translators are weak, but because the same terminology question is being decided independently, in a dozen languages, at the same time.
So if you want to know whether a manufacturer has its language work under control, you learn more from when the market list was fixed than from a translation sample. The later that list lands, the more every downstream revision costs — and those costs rarely appear in the translation budget.
Revisions are the real test
Devices change, and labelling changes with them. The common failure is not a mistranslation — it is updating some language versions and not others, leaving markets holding different revisions of the same document with no one able to say what differs.
Version-control gaps can emerge at initial review or later revisions; check them throughout the document lifecycle. The test of whether a language asset is genuinely maintainable is simple: when one source passage changes, can you say which languages and which paragraphs it affects? If not, every revision is being done from scratch.
| Ask | If you can answer it | If you cannot |
|---|---|---|
| When one source passage changes, which languages does it affect? | The change is scoped, and only the affected versions are reopened. | Every revision is being done from scratch. |
| Which paragraphs in those languages does it affect? | Reviewers check a delta instead of re-reading a document. | Some language versions get updated and others do not. |
| Which revision is each market currently holding? | You can state, per market, what is in force. | Markets hold different revisions of the same document and no one can say what differs. |
The common failure here is not a mistranslation. Under MDR 2017/745 and IVDR 2017/746 the language set is fixed per member state, so the later that market list lands, the more every downstream revision costs — and those costs rarely appear in the translation budget. Confirm the current requirement per market with your notified body.
Questions
How many languages will we actually need?
Does the technical file need translating too?
Can you handle all required languages?
Sources
- Regulation (EU) 2017/745 — Medical Device RegulationArticles 10(11), 19(1), 52(12) and Annex I section 23 address different documentation and language questions; use the current consolidated text linked by EUR-Lex.
- Regulation (EU) 2017/746 — In Vitro Diagnostic Medical DevicesArticle 10(10) addresses information accompanying the device. Check the current consolidated text and national requirements.
- European Commission — language requirements for device manufacturersCountry tables are a starting point; check the table revision, document category, intended user and national provisions.