Specialist service
Medical Device Translation Services
Compliant, accurate translation of IFUs, labelling and technical documentation for MDR, IVDR and global medical device markets.
What Is Medical Device Translation?
Medical device translation covers the technical, regulatory and patient-facing documentation that accompanies a medical device or in-vitro diagnostic (IVD) product into every market where it’s sold — from the Instructions for Use (IFU) a clinician or patient reads before using the device, to the technical file and clinical evaluation report a regulator reviews before granting market access.
Under EU MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746), device labelling and IFUs must be provided in the official language(s) of each member state where the device is marketed — for most lay-user devices, translation is a legal requirement, not an option. Translation errors here carry direct patient safety risk: a mistranslated warning or dosage instruction can lead to device misuse. At TranslationsInLondon, every medical device translation is produced by qualified human linguists with medical device or IVD subject-matter expertise, following an ISO 17100-aligned translation, editing and proofreading (TEP) process. We do not use machine translation for medical device content.
Medical Device Documents We Translate
Document Type
Examples
Instructions for Use & Labelling
Printed and electronic IFUs, device labels, packaging, symbols and warnings
Post-Market Documentation
Post-Market Surveillance (PMS) reports, complaint handling documentation, CAPA records
Technical & Regulatory
Technical files, Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCP)
Software & UI
Software as a Medical Device (SaMD) interface strings, on-screen instructions
Patient & Clinician Materials
Patient information materials, clinician training and reference materials
Our Medical Device Translation Process
- Scoping & Terminology Setup — We review source documents, confirm target languages/markets, and build or apply a device-specific glossary and style guide to ensure consistency across all product variants.
- Translation by Subject-Matter Linguists — Native-speaking translators with medical device or IVD expertise translate the content, never machine translation.
- Independent Editing — A second qualified linguist reviews the translation against the source for accuracy, terminology consistency and register.
- MDR/IVDR Formatting & Symbol Compliance Check — We check that translated labelling, symbols and warnings are consistent with MDR/IVDR requirements and identical in structure across every language version.
- Proofreading & QA — A final quality check confirms formatting, completeness and compliance with any client-specific style requirements.
- Delivery & Certification — Documents are delivered in the required format, with a signed certificate of accuracy where needed for regulatory submission.
Why Device Manufacturers Choose TranslationsInLondon
ISO 17100-aligned process — Every project follows a structured translate–edit–proofread workflow.
Human translation only — No machine translation is used on medical device content; every word is translated and checked by qualified linguists.
MDR/IVDR awareness — We understand the language and formatting obligations of EU MDR and IVDR labelling requirements.
220+ languages — Coverage for simultaneous launches across multiple EU and international markets.
Life sciences specialists — Our linguist network includes translators experienced in pharmacovigilance, clinical trials and regulatory submissions.
ITI Corporate Member — TIL is a Corporate Member of the Institute of Translation and Interpreting.
Confidentiality as standard — NDAs and secure file handling for every medical device engagement.
Frequently Asked Questions
Do you translate IFUs and labelling for MDR/IVDR compliance?
Yes. We translate printed and electronic IFUs, labels, packaging, symbols and warnings, and check that structure and formatting stay consistent across every language version.
Do you handle Software as a Medical Device (SaMD) UI strings?
Yes. We translate on-screen software interface strings and instructions alongside the accompanying technical and regulatory documentation.
Do you use machine translation for medical device documents?
No. All medical device translation at TIL is carried out by qualified human linguists. We do not use machine translation for this type of content.
Can you keep formatting, symbols and warnings identical across all language versions?
Yes. We maintain a device-specific glossary and style guide from the first language version onward, so formatting, symbols and warning conventions stay consistent across every market.
Can you support simultaneous launches across multiple EU markets?
Yes. We regularly manage projects spanning ten or more locales simultaneously, with a single point of contact coordinating terminology and delivery schedules.
What languages do you cover?
We translate to and from 220+ languages. Get in touch with your target markets and we’ll confirm coverage and turnaround.
What's the difference between medical device translation and linguistic validation?
Standard translation is appropriate for most technical and regulatory device documentation (IFUs, technical files, labelling). Linguistic validation is a more rigorous, multi-stage process — including forward translation, reconciliation, back-translation and cognitive debriefing — used where patient-facing content, such as the SSCP’s lay summary or patient information materials, must demonstrate that a lay user genuinely understands it, not just that it reads correctly.
Ready to discuss your medical device translation needs?
Whether you’re preparing a single-market IFU or coordinating a multi-country device launch, our team can scope your translation requirements and provide a clear quote.