Medical device translation
Your entire device documentation package — IFU, labeling, clinical files, QMS records — translated by medical specialists into every language your registrations require.
Translation is part of your regulatory file
For a medical device, translation is not a marketing task. The EU Medical Device Regulation (MDR) requires your instructions for use and labeling in the official language of every member state where you sell. Notified bodies — the auditors that certify your device for the EU market — review translated documents with the same scrutiny as the originals. A mistranslated warning or contraindication is a nonconformity, and in the worst case a patient-safety incident.
The pressure is increasing. From May 26, 2026, EUDAMED — the EU central medical device database — is fully mandatory, and device records must link to documentation that meets the MDR language requirements. Manufacturers selling across the EU can need 15 to 20 language versions per device family. That volume cannot be compressed into the weeks before a deadline.
One package, one terminology
Notified bodies expect your documentation to read as one consistent set. We translate it that way:
- Instructions for use (IFUs) — the core regulatory document, in every required market language
- Labels, packaging and UDI data — including symbols and space-constrained text
- Clinical evaluation reports and clinical data — for technical file review
- SSCP and patient-facing materials — plain language where the regulation demands it
- QMS documents — SOPs and work instructions for multi-market audits
- Software interfaces and EUDAMED data fields
Everything runs against one client-specific term base, so a device component or clinical term is never translated two different ways across the file. Terminology drift between documents is one of the most common triggers for notified-body findings — and one of the easiest to prevent.
Why specialist humans, not just fluent ones
A bilingual generalist can produce a translation that reads well and is clinically wrong. Medical device content demands translators who understand device classification, clinical terminology and the phrasing regulators expect. Link Translation runs medical work through a dedicated health-science practice group: native-language linguists with medical or life-science backgrounds, working in their specialty. Every file then gets an independent second review by another specialist — a separate set of qualified eyes before anything reaches your technical file.
Machine translation produces output that looks polished, which is exactly the danger: the errors hide in dosage steps, contraindications and procedural sequences. Machines help us with consistency and cost — translation memory means a revised IFU is quoted on what changed, not the whole document. Humans translate and sign off on everything safety-critical.
How a project runs
You send the documentation; we return a fixed quote within 24 hours. Terminology is aligned before translation starts. A medical specialist translates, a second specialist reviews independently, and QA checks numbers, units, symbols and references before delivery. Since 2005 we have built a network of 500+ specialist translators covering 30+ languages, so a full EU language portfolio runs in parallel instead of one market at a time.
Frequently asked questions
Which documents does the EU require in local languages?
Under the EU MDR, the instructions for use, labeling and packaging text must be available in the official language(s) of each member state where the device is sold. For Class III and implantable devices, the Summary of Safety and Clinical Performance must also be publicly available in all EU official languages. We help you map the exact scope for your registrations.
What changes with EUDAMED in May 2026?
EUDAMED — the EU central database on medical devices — becomes fully mandatory on May 26, 2026. Device records must link to compliant documentation, including IFUs that meet the MDR language requirements. An English-only IFU does not satisfy that, regardless of device class.
Can you keep terminology consistent across our whole portfolio?
Yes. We build a controlled term base per client and store every approved translation in a translation memory. The same clinical term is rendered the same way across IFUs, labels, software and clinical files — which is exactly what notified-body reviewers check for.
Do you use machine translation on medical content?
Not on safety-critical content. IFUs, labeling and clinical documentation are translated by human specialists from the start, with an independent second review. Where MT genuinely fits — internal documents, high-volume support content — we say so in the quote.