IFU translation for medical devices
The EU requires your instructions for use in the official language of every member state you sell in. We translate IFUs that pass notified-body review the first time.
An IFU translation is a regulatory document
An instructions-for-use document is not marketing copy. It is part of your technical documentation under the EU Medical Device Regulation, it is reviewed by notified bodies, and a translation error in a warning, contraindication or dosage step is a nonconformity — or a patient-safety incident.
That is why IFU translation at Link Translation runs through our medical practice group: native-language translators with life-science backgrounds, harmonized terminology (including symbols and safety phrasing your auditors expect), and an independent second review on every file.
What “MDR-ready” means in practice
- Language coverage mapped to your registrations — we help you determine which member-state languages each market requires
- Terminology aligned to harmonized standards — warnings, symbols and device terms translated the way notified bodies expect to read them
- Consistency across the documentation package — IFU, labeling, packaging and interface translated against one term base
- Revision-friendly workflow — translation memory means an updated IFU is quoted on the delta, not the whole document
- Traceability — every target-language file maps segment-by-segment to the source, which simplifies your document control
Beyond the EU
The same practice group handles FDA-market Spanish, Brazilian ANVISA Portuguese, and the language requirements of UK, Swiss, LATAM and APAC registrations — so one supplier covers your global submission calendar.
When machine translation is (and isn’t) acceptable
For IFUs and safety labeling, we translate with humans from the start: the risk profile does not tolerate statistically-plausible guesses. Where MT legitimately saves you money — internal documentation, high-volume support content — we say so in the quote and price it accordingly.
Frequently asked questions
Which languages does the EU MDR require for IFUs?
Each EU member state decides which official language(s) your IFU, labeling and interface must be available in — in practice, selling across the EU means translating into 24+ languages. We help you map exactly which languages your market registrations require.
Can you update an existing IFU translation after a revision?
Yes, and you only pay for what changed. Your previous translations are stored in a translation memory, so a revision that changes 8% of the source text is quoted as an 8% job — with the surrounding text checked for consistency.
Do you translate the labeling and packaging too?
Yes. IFU, labels, packaging, software interface and EUDAMED data fields are handled as one terminology-consistent package, which is how notified bodies expect to see them.
Who translates the medical content?
Native-language linguists from our health-science practice group, with medical or life-science backgrounds, working against harmonized-standard terminology. Every file gets an independent second review.