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
- Plan the language set before the content
- Keep the set aligned across revisions
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.
Plan the language set before the content
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.
Deciding the market list early lets terminology be established once and applied across all targets in parallel, rather than each language re-deciding the same questions under time pressure.
Keep the set aligned across revisions
Devices change, and labelling changes with them. The common failure is updating some language versions and not others, leaving markets holding different revisions of the same document.
A maintained termbase and translation memory make revision propagation tractable — the changed portion is identified and updated across the set rather than each version being handled independently.