Medical Device Translation: Labels and IFUs

What gets translated

A device ships with more text than most people realise: the label on the device and its packaging, instructions for use (IFU), the patient information leaflet or implant card, software screens and alarms, service manuals for technicians, and, in clinical investigations, informed-consent forms and patient diaries. Each audience reads differently. A surgeon reads the IFU once and needs it unambiguous; a patient reads the leaflet at home and needs it plain. The translation follows the register of the original for each.

United States: English first

For the US market the rule is simple and strict: required labelling is in English. A manufacturer may add Spanish or other languages, which many do for home-use devices, but the moment one statement appears in a foreign language, every required statement has to appear in that language too. A bilingual label with a translated brand claim and an English-only warning breaks the rule. When we translate labelling for the US, we check the English master for every required element and translate all of them.

European Union: the country decides the language

Under the MDR, each member state sets which of its official languages must be used for information supplied with a device. Belgium can require three; Ireland accepts English. The practical consequence is a language matrix per product per market, and one master text that every language version is translated from, so a change in the English IFU flows into every version at the next revision. Symbols from ISO 15223-1 reduce how much text needs translating, but their meaning must be explained in the IFU, which then needs translating itself.

How we keep versions consistent

• A term list built from your existing approved translations, so a component has one name in every document.
• Warnings and contraindications translated without softening: "must not" stays "must not".
• Units, tolerances and model numbers carried over exactly.
• A change list when you update the master, so only the changed text is retranslated and paid for.

What to send with the order

The approved English master in an editable format (Word, InDesign export or XML), not a PDF of the printed leaflet; any translations already approved for earlier versions, so the new text matches them; the list of target markets, so we know which languages and spelling conventions apply (Brazilian or European Portuguese, Canadian or European French); and the symbol glossary used on the label. If the device has a display, send a list of the on-screen terms so the IFU refers to them exactly as the device shows them. A short note on who reads each document, clinician or patient, settles the register before translation starts rather than at review.