A clinician needs to understand how a device works. A patient may need to understand what was implanted. The same technical vocabulary must serve different readers without changing the facts.
In brief
- Under Article 10(11) of Regulation (EU) 2017/745, the information in Annex I, Section 23 must be provided in the official Union language or languages determined by the Member State where the device is made available.
- The EU declaration of conformity and, for certain implantable devices, patient information and the implant card raise separate language questions.
- Approved terminology and in-context review keep the label, IFU, software and patient information consistent.
The MDR asks for more than a translated leaflet
Regulation (EU) 2017/745 has applied since 26 May 2021. Under Article 10(11), manufacturers ensure that a device is accompanied by the information in Annex I, Section 23, in the official Union language or languages determined by the Member State where the device is made available to the user or patient. The label, instructions for use, warnings, intended purpose and performance limits form a connected information set.
Article 19(1) separately requires the EU declaration of conformity to be translated into the official Union language or languages required by the destination Member State. For certain implantable devices, Article 18 requires information for patients and an implant card; its patient information must be understandable and may need a different register from the professional IFU.
The European Commission publishes an overview of national language requirements, but the destination market and device pathway still need to be confirmed for each launch. Its medical devices regulation pages ↗ also gather the Commission’s implementation guidance.
Why terminology control matters clinically
Consider a reusable instrument with a sterilization cycle, a contraindication and a patient-facing explanation. “Clean,” “disinfect” and “sterilize” are not interchangeable instructions. A single incorrect number or qualifier in a warning can change handling.
Approved terminology should link the label, IFU, training material, software screen and any patient information. Technical review by people familiar with the device then checks whether the translated action is executable in the actual workflow.
The source set should include images, tables, symbols, units and all cross-references. Short labels are often the hardest to translate because the available space is limited while the meaning cannot be compressed casually.
A release checklist for language teams
- Map markets and readers. Record required languages and whether content is for clinicians, patients or service technicians.
- Establish one source of truth. Use the approved intended purpose, risk information and validated IFU revision.
- Translate in context. Review callouts, figures, controls, warnings and decimal conventions in the final layout.
- Separate approvals. Linguistic revision, clinical/technical sign-off and regulatory approval answer different questions.
- Maintain traceability. Link each language file to the device version and its EU declaration.
Translation supports a compliant information package; it does not replace the manufacturer’s risk management, clinical evaluation or regulatory decisions.
Related reading: our medical devices language services and IVD instructions across borders: the language of a reliable test.
Primary legal text: Regulation (EU) 2017/745 ↗ (Articles 10(11), 18 and 19; Annex I, Section 23). Further reading: European Commission: Medical devices – new regulations ↗. This article explains selected language provisions and does not replace a product-specific regulatory assessment.