Medical Device IFU Translation (UK)
- Richard Hale
- Aug 5
- 4 min read
Translating the Instruction for Use (IFU) for medical devices is not optional… it’s a regulatory necessity. Whether you’re preparing a new UKCA submission, adapting for CE marking, or updating labelling post-market, accurate IFUs in the correct languages are essential for compliance and end-user safety.
At Tongue Tied, with 30+ years in regulated translation and over 2,600 clients served, we combine linguistic precision, regulatory knowledge, and efficient workflows to support medical device manufacturers in the UK and EU.
What Is an IFU and Why It Matters
The IFU (Instruction for Use) is a mandatory document for most medical devices under EU MDR (2017/745) and UK regulations. It provides critical information such as safe usage instructions, manufacturer contacts, warnings, maintenance, disposal, and more, typically enhanced with diagrams or safety symbols.
Under MDR’s Annex I, Section 23.1, the IFU must be legible, in a suitable format, and in language(s) officially required by each member state where the device is sold.
Whether as paper documents or embedded electronic interfaces (eIFUs), both formats need to meet language and clarity requirements for professional and lay users alike.
UK Regulatory Framework & UKCA Relevance
In Great Britain, manufacturers must register devices with the MHRA and choose either UKCA or CE marking, which impacts labelling and IFU language requirements.
From 2021, CE-marked devices remain acceptable in GB until at least 2028 (or 2030 for IVDs), but UKCA is increasingly standard, especially for new device listings under UKCA and UK Responsible Person (UKRP) labelling rules. Manufacturers must also include UKRP details in either the IFU or packaging for UKCA compliance.
Key Challenges in IFU Translation
Translating IFUs involves multiple complexities:
⚙️ Technical & Regulatory Vocabulary
Language must faithfully convey medical safety and performance information and be consistent with ISO symbols and regulatory terminology.
📐 Complex Design & Formatting
IFUs often include tables, icons, multilingual layouts or eIFU UI text, requiring precise formatting to maintain readability and consistency across languages.
🧠 User-Centric Clarity
Text must be intelligible to technicians, clinicians, and lay users alike—MDR demands that language be appropriate to the user's knowledge level.
🔄 Updates & Consistency Across Versions
Version control and consistency across languages is critical, particularly when updates or corrections occur during post-market updates.
Tongue Tied’s UK‑Focused IFU Translation Workflow
Here’s our proven process for UKCA and EU regulatory compliance:
Initial Review & Regulatory Mapping
Identify device class, languages required, target format (IFU vs eIFU), and UKRP labelling requirements under UKCA.
Glossary & Terminology Alignment
Compile sector-specific glossaries referencing ISO-standard safety phrases, MedDRA (where relevant), and existing client terminology lists.
AI‑Augmented Translation Memory (TM)
Reuse approved segments across similar devices or previous versions, saving time and cost.
Specialist Translator Assignment
Linguists with medical device experience and regulatory familiarity handle translations.
Layout, Diagrams & DTP Management
Ensures correct rendering of icons, tables, and multilingual layout templates.
ISO 17100-Certified Editing & QA
Second linguist review to check accuracy, format fidelity, and regulatory phrasing.
Optional UK In-Country Review
UK-based reviewer checks critical fields like UKRP detail, UK-specific phrasing, and compliance with NHS readability norms.
This ensures your IFUs are regulatory-ready, consistently formatted, and safe for end-use.
Why This Matters for Device Manufacturers
✅ Regulatory Compliance and Fast Approvals
Correct language and formatting reduce queries from MHRA or UK approved bodies, especially relevant during UKCA registration.
✅ Clear Safety Communication & User Confidence
Well-translated IFUs improve correct device use across multi-language users, reducing risks and liability.
✅ Efficiency and Cost Savings
Translation memory lets you leverage prior work across revisions, saving up to 70–80% of recurring content costs.
✅ Reduced Review Bottlenecks
Case studies show that accurate multilingual IFUs reduce back-and-forth during conformity assessment and regulatory review.
Mini Case Study: UK Diagnostic Device IFU Bundle
A UK manufacturer needed translations of the IFU and labelling for a Class IIa diagnostic device into French, German, and Spanish, with UKRP inclusion and EU compliance.
We re-used term entries from previous devices via TM, saving 70% on repeat content.
Layout templates maintained symbol integrity and diagram clarity.
Submission to UKCA body passed without translation-related queries.
Experience: More than 3 decades specialising in medical device translations and regulatory documentation.
Expertise: Professional ISO 17100-certified workflows; translators experienced in device design and regulatory requirements.
Authoritativeness: ITI and ATC membership, the translation industry’s trusted bodies.
Trustworthiness: Named project manager, transparency in pricing, and no-charge repeats with TM.
Turnaround & Pricing Overview
Project Type | Estimated Turnaround |
IFU (≤20 pages), one language | 3–4 working days |
IFU (3–5 languages), multilingual bundle | 5–7 working days |
Revisions or TM-assisted updates | 1–2 working days |
Pricing is per word or per project, with TM cost savings automatically applied. Rush options available for urgent regulatory timelines.
FAQs (UK-Centric)
Do I need UKRP details in the IFU under UKCA?Yes—as of current law, UKRP info may appear on the IFU or outer packaging to comply with UKCA labelling rules.
Can I delay IFU translation until after CE approval? No—MDR requires IFUs to be translated into required national languages at submission, not post-certification.
Does GUI text count as IFU if using an eIFU system? Yes—software interfaces may be considered IFUs and must be translated if they contain performance or safety-related text.
Are diagrams translated, or left in English? Our team translates embedded text within diagrams and aligns translations to standard ISO symbols and regulatory phrasing.
Which device types require translated IFUs? Class IIa and above instruments, implantables, and devices intended for lay users often mandate translated IFUs under MDR/IVDR rules.
Speak to Us for Your IFU Translation Needs
If you're launching a medical device under CE or UKCA, updating your labelling, or preparing a multi-language launch, speak to us for a tailored quote and expert support.
📞 +44 1606 352 527
Connect with Richard on LinkedIn for specific UK regulatory translation guidance.
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