Medical device labeling translation
Labels and packaging are the most space-constrained regulatory text you own. We translate them to fit — linguistically, physically and per market requirements.
The smallest documents carry the biggest scrutiny
A device label may hold thirty words. Every one of them is regulated. Under the EU MDR, labeling and packaging text must be provided in the official language of each member state where the device is made available — and it must remain accurate, legible and consistent with the IFU your notified body already reviewed. A storage temperature rendered wrong, a sterile-barrier warning that drifted from the IFU wording, an intended-purpose statement that no longer matches the technical file: on a label, there is no surrounding context to soften an error.
Labeling is also where translation meets physics. German and French text typically runs 20-30% longer than English. A label designed around English copy can simply not have room for a compliant translation — a problem you want discovered at the translation stage, not on the packaging line.
What we translate
- Device labels — primary and secondary packaging, in every required market language
- Packaging text and inserts — including multi-language layouts covering several markets on one carton
- Symbols and accompanying text — harmonized device symbols used correctly per market, with translated captions only where required
- UDI data and EUDAMED fields — kept consistent with the printed label
- Patient-facing card and implant documentation — plain language, per MDR requirements
Every item is translated against the same term base as your IFU, so the documentation package reads as one set. That consistency is not cosmetic: notified bodies compare label, packaging and IFU side by side, and mismatched warnings are a finding.
Space-constrained translation is a specialty
Translating a label is a different craft from translating a manual. There is no room for a translator’s natural instinct to explain. Our medical linguists translate to the character count where one exists, use market-standard abbreviated forms where regulators accept them, and flag every case where a compliant translation cannot physically fit — with options, not just a problem. Our desktop publishing team then returns print-ready artwork with the translated text placed, sized and checked against the original layout.
As with all our medical work, translation is done by native-language specialists with life-science backgrounds and independently reviewed by a second specialist. Machine translation is not used on labeling: a statistically plausible guess on a thirty-word label is a recall risk, not a saving.
Multi-market labeling without drift
Since 2005, Link Translation has handled labeling programs across 30+ languages with a 500+ translator network. Translation memory keeps every approved label string reusable, so a new product variant or a revised warning is quoted on what changed — and the approved wording from the last audit stays exactly as approved. Fixed quote, with deadline, within 24 hours.
Frequently asked questions
Do labels really need translation if we use symbols?
Harmonized symbols reduce the text burden but rarely eliminate it. Warnings, storage conditions, intended-purpose statements and market-specific mandatory text still need translating into the official language(s) of each member state where the device is sold. We help you map what each label variant actually requires.
How do you handle text that will not fit on the label?
Translated text often runs 20-30% longer than English. Our translators work to the physical space available, flag where a compliant translation cannot fit, and our desktop publishing team delivers print-ready artwork — so the fit problem surfaces before printing, not after.
Can you translate labeling and IFU as one package?
Yes, and you should. Labels, packaging, IFU and interface text are translated against a single term base, so the warning on the box matches the warning in the booklet word for word. Inconsistency between label and IFU is a classic notified-body finding.
What about UDI and EUDAMED data fields?
UDI — the unique device identifier that traces each device — comes with data fields registered in EUDAMED, some of which need language versions. We translate those fields consistently with your labeling, which matters once EUDAMED becomes fully mandatory in May 2026.