Medical-device translation under EU rules

The MDR and IVDR language provisions

MDR Regulation (EU) 2017/745, Article 10(11), requires the Annex I, section 23 information accompanying a device in the official Union language or languages determined by the Member State where it is made available. This covers information on labels and instructions for use (IFU). Label particulars must be indelible, legible and clearly comprehensible. Source: EUR-Lex, MDR Article 10(11). Checked 31 October 2026.

For in vitro diagnostic devices, the equivalent provision is IVDR Regulation (EU) 2017/746, Article 10(10), referring to Annex I, section 20. Its Article 10(11) concerns non-conformity and corrective action, not the language rule. Information for self-testing or near-patient testing must also be easily understandable and in the language or languages determined by the Member State. Source: EUR-Lex, IVDR Article 10. Checked 31 October 2026.

These provisions do not establish one English-language package for the whole EU. A language matrix should connect each destination country to the relevant device and document. The regulatory owner should approve that matrix before translation starts, distinguishing the legal requirement from a distributor’s commercial preference. Where an exception is proposed, its legal basis needs to be recorded for the actual product and user group.

National language tables and their limits

The European Commission publishes MDR and IVDR language tables that list, by Member State, the languages accepted for labels and IFU, often separately for lay and professional users. They are a practical starting point for a language matrix. Legislation prevails over the tables, and some entries note that current national information is unavailable. Source: European Commission language tables. Checked 31 October 2026.

National law can add conditions, such as the languages required for particular user groups or for registration documents. Where a table entry is uncertain or silent, the manufacturer should obtain confirmation from the national competent authority for the specific device and route. A table entry is a planning input, not a legal opinion on a particular product.

A safe procurement brief records each required language as a planned deliverable and leaves any proposed exclusion with the manufacturer’s regulatory function. It should not ask a translator to decide whether a device falls within an exemption. If clarification changes the required package, the language matrix, artwork inventory and purchase scope should be updated together before release.

Create a document and market matrix

The matrix should identify document type, product family, source revision, intended user, destination and approved language. It also needs an owner for regulatory decisions and an owner for terminology. The medical translation page describes Babylon Translations’ verified medical specialism; this article explains procurement considerations rather than promising acceptance of every listed document type.

Each deliverable should be linked to the approved source. A label, folded leaflet and online instructions can share warnings while using different layouts and revision identifiers. Treating them as unrelated files makes it easier for one version to retain obsolete wording. Shared source identifiers and a release record allow the team to see which language assets depend on a changed instruction.

The brief should also distinguish supplied translation from adaptation of the underlying regulatory content. A translation query can identify an unclear statement or conflict, but a linguist should not silently change a medical claim. The manufacturer’s authorised owner needs to approve any source correction and decide which other documents require the same change.

UDI text needs a controlled boundary

The MDR and IVDR contain UDI provisions, including labelling requirements in their respective Annex VI frameworks. Translation planning should distinguish surrounding explanatory wording from the identifier itself. UDI data must not be treated as ordinary prose for free rewriting. Sources: EUR-Lex, MDR and IVDR Annex VI. Checked 31 October 2026.

In practical file preparation, identifiers, catalogue references, software tokens and barcode content should be marked for controlled handling. A label can contain both translatable text and immutable data in the same small area. The file owner should explain which parts belong to each category; visual similarity alone is not a reliable guide for the language team.

Verification should compare the delivered text with the approved source and inspect the final artwork separately. That check should include line breaks, units, omitted characters and placement beside the intended field. A correct translation in a spreadsheet can still be placed beside the wrong symbol during artwork production, so linguistic approval and artwork approval need named owners.

PSUR summaries and public summaries are different

MDR Article 86 requires periodic safety update reports (PSURs) for class IIa, IIb and III devices. Article 32 concerns the summary of safety and clinical performance (SSCP) for implantable and class III devices, excluding custom-made and investigational devices. A PSUR is not the same document as an SSCP. Source: EUR-Lex, MDR Articles 32 and 86. Checked 31 October 2026.

IVDR Article 81 addresses PSURs for class C and D devices. Its Article 29 addresses a summary of safety and performance (SSP) for class C and D devices other than performance-study devices. The SSP terminology should be retained for IVD material, rather than automatically substituting MDR’s SSCP label. Source: EUR-Lex, IVDR Articles 29 and 81. Checked 31 October 2026.

MDCG 2019-9 Revision 1 recommends SSCP translation into languages accepted in the Member States where sale is envisaged and addresses the patient section’s languages. This is guidance, not a separate directly binding language provision. It should not be used to assert that every PSUR summary follows the IFU language rule. Source: European Commission, MDCG 2019-9 Rev.1. Checked 31 October 2026.

A request for a ‘PSUR summary’ therefore needs clarification: the exact sections, intended recipient and purpose should be specified. The language provider can quote the defined text, while the regulatory owner determines whether it meets the submission or communication requirement. A public-facing summary may also need a different register from a technical report even when the underlying evidence is shared.

ISO 13485 supports quality-system evaluation

ISO 13485:2016 describes quality management systems for medical devices and regulatory purposes. It is relevant when assessing a supplier’s controlled processes, but certification does not itself approve a device or establish that a translation meets every market requirement. Source: ISO catalogue. Checked 31 October 2026. Babylon Translations’ verified scope includes translation for life sciences and medical devices; the quality overview presents the agency’s standards.

A buyer should ask how document versions, instructions, terminology decisions and feedback will be handled for the proposed job. ISO 17100 addresses translation-service processes, including second-person revision; the ISO 17100 guide explains that distinction. Neither standard removes the manufacturer’s need to approve the source and final market package.

Build terminology around concepts and use

Device terminology should connect the approved source concept to its equivalent in each target language, definition and product context. Similar-looking components may have different functions, while one component can have several informal names across engineering and marketing files. A controlled glossary should identify the preferred term and any prohibited alternative, supported by a diagram or usage example where needed.

Warnings, operating modes, measurements and user actions need particular attention. Consistency means preserving distinctions, not forcing every source synonym into the same target word. A terminology query should include the sentence, device context and proposed interpretation so that the manufacturer’s expert can make a recorded decision. Approved decisions should then reach every affected document and language batch.

The final handoff should identify approved language files, unresolved source issues and the version used for checking. The translation preparation guide explains reference packages and review ownership. Technical documentation, artwork and public summaries should retain distinct approvals even when one project manager coordinates the translation order.