Medical device translation that passes MDR & IVDR scrutiny
Medical device translation that clears MDR and IVDR review
Medical device translation here covers IFU translation in print and as eIFU, device labels and packaging artwork, technical files, SSCPs and EUDAMED registration data. Every file runs through an ISO 17100 process with an obligatory revision by a second qualified translator, and a qualified linguist signs off at every stage.
Labels, packaging and IFUs must carry the official Union languages of each member state where the device is sold. MDR Article 10(11) and IVDR Article 10(10) set the rule, and the same EU MDR translation requirements and IVDR translation requirements apply to every class of device, including low-risk Class I. EUDAMED's first four modules became mandatory on 28 May 2026, and registration data and SSCP summaries carry language obligations of their own. eIFU hosting follows Implementing Regulation 2021/2226: required languages are published, updates are communicated, and paper copies stay available on request.
The documents that travel with a device
IFU translation covers the print IFU and the eIFU, plus every document that travels with the device:
- Device label and packaging artwork, EU Declaration of Conformity, technical file, SSCP, CER and PER, PSUR, FSN and FSCA, implant card, QMS documentation.
- Clinical investigation documents: protocol, informed consent form, investigator brochure, case report forms.
- UDI and EUDAMED registration data with GS1 codes on label and packaging.
- Tender responses for HSE, NHS and EU procurement must match the CE scope of the product.
Where device translation goes wrong
Three problems repeat: terminology drift, layout limits and deadline pressure. Claims must not exceed the intended purpose of the device (MDR Article 7). Fixed label space leaves no room for text expansion, and German text runs about 30 per cent longer than English. UDI and QR codes must survive re-artworking, and printers reject PDF-only translations. MDR devices face transition deadlines of 31 December 2027 or 2028; IVDs face deadlines of 2027, 2028 or 2029. Submissions bunch at these cliffs, and translation sits on the critical path. ISO 13485:2016 requires documented supplier control and records that withstand notified body audit.
How we work: certified process, insider fluency
Every translation runs through an ISO 17100 process with obligatory revision by a second qualified translator. Every project also runs 6-eyes at minimum: in-house preparation, translation or post-editing, then in-house proofreading, and revision is a further pass.
ISO 9001, ISO 17100 and ISO 18587 certified since 2021.
A second qualified translator with subject competence revises every translation. IFU and label translators bring RA reading to the work.
Device names, intended purpose, contraindications and GSPR phrasing are checked against source. ISO 15223-1 symbols, EMDN terms and a per-client glossary keep everything consistent.
eIFU translation covers web HTML and version-sync across languages, per Regulation 2021/2226.
Multilingual DTP runs in the original InDesign and Illustrator files. Layout QA is expansion-aware, with print-ready return. UDI and QR codes are verified to survive re-artworking.
Safety-critical text is translated by qualified linguists. Where the client directs it, governed post-editing with defined light and full specifications applies. Human review stays on warnings and contraindications.
Why buyers choose a Dublin-based team
We work the MDR and IVDR routes with the HPRA, the Irish regulator. Coverage is EU and UK. Dual-market buyers get the UK route: MHRA, UKCA and CE, and a UK responsible person. We know EUDAMED modules, UDI and GS1 labelling formats, and eIFU publishing mechanics. We pair mid-market responsiveness with an MDR and IVDR niche. Confidential handling starts at intake: NDAs, DPAs, EU data residency and access controls.
Process and timeline
We scope the language matrix per target market up front.
- Scope and language matrix per target market.
- Terminology alignment from client glossary, MDCG and EMDN terms.
- Translation with obligatory revision.
- DTP and expansion-aware layout QA.
- Delivery with versioned records for your audit file.
The timeline is anchored to your transition or submission date.
Frequently asked questions
Can you meet our notified body or transition deadline?
Yes, we work backwards from your submission date. An early-warning calendar tracks the 31 December 2027, 2028 and 2029 MDR and IVDR cliffs. An urgent lane and a dedicated project manager keep the critical path moving.
How do you keep terminology consistent across 24 languages and every document?
A per-client glossary in the TMS holds device names, intended purpose and contraindications. MDCG and EMDN terms are reused, translation memory compounds, and every file passes 6-eyes review at minimum. Label, IFU and technical file stay in step, per MDR Article 7.
Will the translation pass notified body review?
Every translation carries an obligatory revision under ISO 17100, and terminology is checked against source. Records are documented and versioned to meet ISO 13485 supplier expectations. Acceptance itself is the notified body's assessment, which we do not claim to control. We give the notified body nothing to find in the translation.
Can you handle our InDesign label artwork and UDI barcodes?
DTP runs in the original InDesign and Illustrator files. Layout QA is expansion-aware, so German text fits the fixed label space. UDI and QR codes are verified to survive re-artworking. Output is print-ready for your artwork supplier.
How do you protect confidential clinical and technical documents?
NDAs and DPAs are signed at intake. EU data residency, access controls and GDPR-compliant handling protect patient data and trade secrets.
Do you use machine translation?
Safety-critical text is translated by qualified linguists. Where the client directs it, governed post-editing with defined light and full specifications applies. Human review stays on warnings and contraindications.
Talk to us about your device launch calendar
A Dublin-based team that speaks MDR, IVDR, UDI and EUDAMED. Tell us your target markets and your transition or submission date, and we will scope the language matrix and confirm capacity for your calendar.