2025-10-31

How to Ensure Compliant MDR/IVDR Medical Translations: 5 Best Practices

Your guide to achieving accuracy, efficiency, and full regulatory alignment in medical translations under MDR and IVDR.

How to Ensure Compliant MDR/IVDR Medical Translations: 5 Best Practices
Your guide to achieving accuracy, efficiency, and full regulatory alignment in medical translations under MDR and IVDR.
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Why Should Medical Device Manufacturers Care About Translation Best Practices?

With new legislative and regulatory expectations around MDR/IVDR (Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation) intensifying toward 2026, translation has become more than a linguistic task, it’s a core compliance, risk, and quality lever for manufacturers.
 
As the regulatory landscape grows increasingly complex, companies must ensure that every translated document, whether a label, IFU (Instructions for Use), or technical file, meets strict linguistic, cultural, and legal standards. Failing to do so can result in costly delays, compliance breaches, or even product recalls, making translation management an essential component of any MDR/IVDR readiness strategy.
 

In this article, you will learn:

  • The translation risks under MDR/IVDR and what’s changing
  • Five essential best practices for compliant and efficient medical translations
  • How to future-proof your translation workflow with technology, structure, and governance

Context: Why Translation Matters under MDR/IVDR and What’s Ahead

Changes to EU regulations mean that medical device and IVD manufacturers face new, more stringent translation and documentation requirements.
 
Under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), manufacturers must provide device-related documents (e.g. IFUs, labels, technical documentation) in the official languages of each EU Member State where the device is marketed.
 
These translation requirements are non-negotiable: missing or incorrect translations may trigger delays in conformity assessments, regulatory rejections, usability, or safety risks. Crucially, as the MDR/IVDR regime evolves, translation workflows must be robust, auditable, and adaptive.
 
With that in mind, below are the five best practices you should apply, or revisit.

1. Build and Govern Multilingual Terminology & Style Assets

Why it Matters:

Inconsistent terminology or style across documents (IFUs, DoCs, labels) introduces confusion. Regulators and notified bodies may flag misalignment.

What to Do:

  • Establish a centralized, curated glossary and term base covering key regulatory and clinical terms.
  • Harmonize with international regulatory vocabularies such as MedDRA, EDQM Standard Terms, or EUDAMED nomenclatures.
  • Use style guides that enforce consistency (capitalization, unit notation, formatting).
  • Ensure all translators and reviewers access and update the same assets.
A well-governed terminology system cuts down rework, speeds review, and enhances auditability.

2. Leverage Technology: TMS, MT + Post-Editing, Automation

Why it Matters:

Translation volume under MDR/IVDR is huge. Content can include labels, IFUs, technical files, software strings, labeling changes, post-market reports, and it will continue evolving. Manual-only approaches won’t scale.

What to Adopt:

  • Translation Management System (TMS) to orchestrate workflows, version control, approvals, and integration with source authoring systems (CMS/PLM/ALM).
  • Machine Translation (MT) + Post-Editing (MTPE): Applying MT for volume and translate faster, while ensuring expert post-editing for regulatory fidelity.
  • Workflow automation (e.g., content pre-processing, checklist gating, review handoffs).
  • Structured content and modular translation - break content into reusable chunks or XML/DITA modules for future re-use.
  • Automated QA checks (terminology, consistency, numeric checks).

This combination of human and machine ensures speed, traceability, and compliance readiness.

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Trusted by healthcare, pharma, biotech, and clinical research teams for regulatory-compliant translation and content services.

3. Define a Clear Multi-step Review & In-Country Validation Workflow

Why it Matters:

Translations must be accurate, culturally correct, and compatible with national regulatory expectations. Skipping proper review or relying solely on local affiliates can lead to delays or inconsistencies.

Here's A Recommended Review Flow:

  1. Translation
  2. Linguistic quality review (LQR)
  3. In-country/regional regulatory review
  4. Final QA check (formatting, numeric checks)

For high-risk devices, consider adding a clinical subject-matter expert or native-speaking regulatory reviewer.

Use review constraints (track changes, commenting tools, side-by-side display) and enforce feedback loops with the glossary and term base to capture new translation insights.
 
An alternate approach is to embed validation steps within your translation provider's workflow, rather than depending on fragmented in-country reviews, to streamline consistency. The goal: a defensible translation trail ready for audits or notified body review.

4. Plan for Change: Governance, Versioning & Ongoing Compliance

Why it Matters:

Translation for MDR/IVDR isn’t a one-and-done exercise. As devices evolve, labeling is updated, standards shift, and regulatory guidance is revised, your translation program must remain nimble.

What to Implement:

  • Version control and change tracking: tie translations back to source versioning, change logs, and justification.
  • Governance committee or review board to vet major term changes, translation rules, and updates.
  • Structured content architecture (XML, DITA, component reuse) to reduce translation burden for updates.
  • Periodic audits and quality metrics (KPIs) to monitor error rates, review turnaround and translation consistency.
  • Roadmap for emerging trends: translation implications of software/AI-as-medical-device, evolving MDCG guidance, interoperability with EUDAMED, device software localization.
  • Invest in continuous training of translators and reviewers to keep them aligned with new regulatory updates.

By embedding these governance layers, you ensure translation integrity and responsiveness over the device lifecycle.

5. Partner With A Specialist MDR/IVDR Translation Provider

Why it Matters:

By relying on a general translation agency, or non-specialist partners, you may be opening the door to errors in regulatory nuance, medical terminology, risk language, or regional conventions.

What to Look for in a Translation Provider:

  • Certifications & standards — e.g. ISO 17100 (translation), ISO 9001, ISO 13485 (quality systems for medical devices).
  • Domain expertise in medical devices, IVD, regulatory documents, quality systems.
  • Knowledge of MDR/IVDR and MDCG guidance (or willingness to stay updated).
  • Strong QA and review workflows including clinical or in-country regulatory review.

By working with a specialist, like Acolad, you safeguard your compliance risk and free internal teams to focus on device design and regulatory strategy.

“Partnering with a specialist MDR/IVDR translation provider can be crucial to ensure that translations are not only linguistically accurate but also fully aligned with compliance frameworks, clinical precision, and audit expectations. Translation in regulated life sciences is not just about words - it’s about traceability, version control, and reducing ambiguity in risk statements. Our experience helps clients pass audits, reduce time to market, and avoid costly non-conformities.”

Updated Headshot 2025


Joseph Tringale
Senior Director - Global Medical Device Strategy and Development, Acolad

What to Watch in 2026 & Beyond

As the regulatory landscape continues to evolve, several key developments are expected to shape MDR and IVDR translation strategies in the coming years. Here’s what manufacturers and localization teams should keep an eye on:
 
  • Final maturation of MDCG guidance, especially on software, AI, EUDAMED, and harmonized interpretation of language rules.
  • Full rollout of EUDAMED and its device-level data alignment (labels, registration, language records).
  • Increased scrutiny on software-as-a-medical-device (SaMD) localization - UI strings, alerts, clinical logic must be localized correctly.
  • Greater importance on readability, human factors, and usability linguistics in patient-facing materials under MDR/IVDR.
  • Interplay with AI regulation (e.g. AI Act) for devices embedding machine learning or decision logic, your translation workflows must keep pace with algorithm updates.

Be sure to revisit your translation strategy periodically, especially when regulatory or software changes occur.

Success Story: Medical Device Translation Centralization with Acolad

 
Acolad's specialized life sciences teams helped a global Fortune 50 client centralize its translation strategy by unifying more than 100 translation suppliers into a coherent network, unifying linguistic assets (TM, glossaries), and integrating with the client’s procurement and SAP systems.

In another example, with HealthiVibe, Acolad built a process that reduced quality assurance overhead and sped up life sciences regulatory translation across 50 languages.

These successes illustrate how technology, governance, and domain know-how combine to meet the stringent demands of regulated industries.
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Are Your Translation Workflows Ready for the MDR/IVDR Challenge?

Speak to our regulatory translation experts today.

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