EU Medical Device Regulation and IVDR requirements for translated technical files, IFU instructions, and Declaration of Conformity. Language requirements for EU27.
- Language is set per member state
- When the language set gets fixed decides how hard the rest will be
- Revisions are the real test
Language is set per member state
Under MDR 2017/745 and IVDR 2017/746, instructions for use and labelling must be provided in the language or languages accepted by each member state where the device is placed on the market — and each member state determines that for its own territory.
The practical consequence is that there is no single "EU version". Your language set is defined by your target markets, and it grows as those markets do. Confirm the current requirement per market with your notified body.
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.
None of this shows during the first certification. It surfaces on the second or third revision. 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.