A diagnostic result is only as useful as the instructions that get the user to it. In vitro diagnostic devices place particular pressure on short labels, sample steps and the explanation of limits.
In brief
- Article 10(10) of Regulation (EU) 2017/746 requires the information in Annex I, Section 20 in the official Union language or languages determined by the Member State where the device is made available.
- The EU declaration of conformity must be translated into the language or languages required by the destination Member State.
- Self-tests need wording a non-specialist can follow; laboratory devices need specialized technical revision.
The IVDR language rule
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has applied since 26 May 2022, subject to transitional arrangements for certain devices.
Article 10(10) requires the manufacturer to provide the information specified in Annex I, Section 20, in the official Union language or languages determined by the Member State where the device is made available to the user or patient. This includes labels and instructions for use, with the information appropriate to the device and intended user.
Article 17(1) requires the EU declaration of conformity to be translated into the official Union language or languages required by the destination Member State. For self-testing and near-patient testing, the information must be easy to understand: the person reading it may not be a laboratory specialist. National choices differ, so an EU-wide English file is a useful master, not an automatic substitute for target-market versions.
Translate the sequence, not isolated strings
Think of a home test: collect the sample, add it to a cassette, wait a precise interval, then interpret a control and test line. The order and timing matter.
“Invalid,” “negative” and “inconclusive” are not marketing variants; they are distinct results.
Labels, quick-start cards, IFU diagrams, screen prompts and support pages must use the same terms and units. A design change to one step should trigger a check of every linked language asset.
Professional laboratory devices present a different reader profile. Performance characteristics, specimen types, storage conditions and interpretation limits require specialized technical revision. The translation brief must say who uses the device and in which workflow.
What to send before translation begins
- Approved device scope: intended purpose, users, specimen and test method.
- Complete content set: label, IFU, packaging, software text, declaration and performance material.
- Critical values: units, time windows, temperatures and result criteria with a single approved source.
- Market map: destination states and the languages they require.
- Review plan: linguistic, scientific and layout checks, plus version sign-off.
The regulatory team owns the intended purpose and evidence. The language team preserves their meaning for the professionals and patients who rely on the result.
Related reading: our medical devices language services and Medical devices under the MDR: translating information people rely on. The European Commission’s medical devices regulation pages ↗ gather its guidance documents on the MDR and IVDR.
Primary legal text: Regulation (EU) 2017/746 ↗ (Articles 10(10) and 17; Annex I, Section 20). Further reading: European Commission: Medical devices – new regulations ↗. This article explains selected language provisions and does not replace a product-specific regulatory assessment.