EU Regulatory Translation Requirements (UK Perspective)

Navigating the complex language rules under EU and UK regulations is essential for medical device and pharmaceutical companies. Especially post-Brexit, UK-based businesses must understand not just what must be translated, but when and how—to satisfy both CE / EU MDR/IVDR and MHRA UK requirements.

At Tongue Tied, we bring decades of experience to help you meet these demands with precision, compliance, and regulatory certainty.

📘 Why Translation Compliance Matters in EU Regulation

Under EU MDR (2017/745) and IVDR (2017/746), device manufacturers must provide regulatory documents (labels, IFUs, implant cards, field safety notices, declarations of conformity, and GUI texts) in the official language(s) of each Member State where the product is sold Emergo by UL+8Decomplix+8Win & Winnow - Language services+8Decomplix+5Language Scientific+5mastermindtranslations.co.uk+5. EU guidance makes clear that translation must be in place before market launch or CE marking, not afterwards Win & Winnow - Language services.

As of 17 January 2024, the European Commission published tables showing specific language requirements by Member State, making compliance clearer but still complex to manage translate.one+10Public Health+10mastermindtranslations.co.uk+10.

✅ UK vs EU Language Rules: What Changed After Brexit?

Though UK regulations largely mirror EU MDR and IVDR, key distinctions emerged post-Brexit:

• MHRA and UKRA still enforce language requirements for device documents but no longer adopt EU language lists automatically—manufacturers must follow UK-specific instructions or MHRA guidance Wikipedia+15ICON plc+15Argos Multilingual+15Language Scientific+4Public Health+4Public Health+4.

• The UKCA mark (parallel to CE) is valid until at least 2028–2030, but CE-marked devices are no longer accepted for Great Britain after that without UKCA compliance GOV.UK+1freyrsolutions.com+1.

• UK Responsible Person (UKRP) details must now appear on IFUs or labelling for UKCA compliance—another language element to oversee GOV.UK+1Emergo by UL+1.

🧾 Documents That Require Translation for EU & UK Markets

Under EU MDR/IVDR:

• Label and IFU (Annex I, section 23; Art. 10(11))

• Declaration of Conformity, Implant Card, Field Safety Notices, e.g. FSN (Art. 19, 18, 89 etc.)

• GUI interfaces where safety/performance information is displayed—some Member States require them translated even if EU law doesn't explicitly mandate this Decomplix+3Emergo by UL+3Public Health+3.

Under UK Regulations:

• Same categories apply—but language acceptance may differ by UK-specific policy.

• UKRP contact details must appear on IFU or label under UKCA rules GOV.UK.

• Device must be registered with MHRA and properly labelled per UK compliance.

⚠️ Challenges & Pitfalls in Regulatory Translation

• Manufacturer obligations now extend to providing translated documents before submission—not as a post-market fix Applied Clinical Trials+15translate.one+15freyrsolutions.com+15Public Health+15Win & Winnow - Language services+15Argos Multilingual+15.

• Some countries allow English for professional users only; lay-language versions may still be mandatory depending on jurisdiction mastermindtranslations.co.uk.

• Multiple languages per country (e.g. Belgium uses French, Dutch, German) complicates planning mastermindtranslations.co.uk.

• GUI elements (app text, software prompts) may require translation if they provide safety or usage cues under many national laws Public Health+1mastermindtranslations.co.uk+1.

🛠 Tongue Tied’s Process for Meeting EU & UK Translation Needs

1.  Mapping Regulatory Scope

   
   

    Identify which documents require translation per MDR/IVDR and UK regulations; build language sets per country using the EU commission’s guidelines freyrsolutions.com+6Emergo by UL+6mastermindtranslations.co.uk+6.

2.  Terminology & Glossary Setup

   
   

    Align messages using EU/MDR-approved phrases, client glossaries, or UK-specific terms including UKRP inclusion.

3.  Translation Memory (TM) Use

   
   

    Reuse validated phrases across documents and languages—helps with consistency, cost-efficiency, and faster turnaround.

4.  Specialist Translator Assignment

   
   

    Native linguists with experience in regulatory translation, medical devices, pharmaceutical or clinical documentation.

5.  ISO-Certified Editing & QA

   
   

    All translations are quality-checked under ISO 17100 standards and implemented in secure platforms.

6.  Optional UK In‑Country Review

   
   

    For MHRA compliance, we offer review by UK-based compliance linguists to ensure UKCA and UK-specific phrasing is correct.

7.  Submission-Ready Delivery

   
   

    Provide files suitable for eCTD, CTIS, or dossier bundling in EU or UK formats.

🎯 Why You Need an EU–UK-Savvy Translator

• Avoid EU/MHRA submission delays due to improper language choice.

• Keep aligned terminology across documentation sets.

• Tailor GUI translations to differ by national regulation if needed.

• Handle multiple languages and glossary maintenance for recurring updates.

Case Study

A UK medical device sponsor needed IFU, PIL, protocol, and SSCP translated into six languages for UE submission and separate UKCA upload. We cross-referenced EU tables and MHRA guidance, used TM to reuse terms across docs, and delivered all translations within 6 days. Client was approved without translation-related queries.

🏅 Experience, Expertise, Authority & Trust

• Experience: 30+ years in regulated translation for devices and pharma.

• Expertise: Translators with domain knowledge in CTR, MDR, clinical protocols.

• Authority: ISO 17100 certified, members of ITI and ATC; GDPR/ISO 27001-compliant workflows.

• Trust: Dedicated project management, sector confidentiality, and validation-ready deliverables.

📅 Turnaround & Pricing

Project	Turnaround	TM Cost Saving
SmPC or IFU into one language	3–5 working days	Up to 60%
Full EU dossier (multi-doc, 3–5 languages)	5–8 working days	High
Protocol translation under CTR	4–6 working days	Medium

Fixed quotes available per word or project. Rush options can be arranged if needed for submission deadlines.

❓ FAQs (EU–UK Focus)

Do I need separate translations for UK and EU markets? Yes—if there are differences in templates, language variants, or wording (e.g. UKCA vs CE). Use UK in-country review to ensure applicability.

Is English acceptable for professional-use devices? Some Member States accept English for healthcare professionals; patient-facing content generally must match national languages (£only as permitted) Emergo by UL+1GOV.UK+1Wikipedia+1Win & Winnow - Language services+1omcmedical.com.

Are GUI translations mandatory? Not universally—but if safety or usage instructions appear in the GUI, many countries require translation for compliance under MDR/Annex I §23 or national law mastermindtranslations.co.uk.

How frequently must translations be updated? If safety warnings or design details change, translation updates are required immediately. Version control and TM help manage incremental changes.

Can machine translation help with regulatory documents? Only in early drafting phases. Final translations for submission must be human-reviewed, structured, and meet regulatory phrasing standards.

Let’s Help You Navigate EU & UK Translation Rules

If you’re planning a CE-marked launch, preparing clinical trial submissions, or updating device documentation for the EU or UK, reach out for expert translation services that align with both EU MDR and MHRA requirements.

📧 sales@ttmltd.com 📞 +44 1606 352 527 Connect with Richard on LinkedIn for tailored UK/EU regulatory translation advice.