MDR-ready IFU translations: 5 mistakes to avoid in 2025 

The high stakes of MDR compliance for IFU translations 

As the European Medical Device Regulation (MDR) continues to reshape the landscape for medical device manufacturers, one crucial element is sometimes underestimated: the translation of Instructions for Use (IFUs). High-quality, MDR-compliant IFU translations are not just a regulatory formality, they directly impact patient safety, product success, and market access. 

In 2025, regulators will likely intensify their focus on post-market surveillance and document traceability, leaving no room for error. Failing to meet MDR translation standards can lead to costly product recalls, legal penalties, and reputational damage. 

To help you navigate this critical area, we’ve compiled the top five mistakes to avoid when preparing your IFU translations in 2025. 

Mistake 1: assuming that generalist translators are sufficient 

When companies are under pressure to meet deadlines or control budgets, they may be tempted to use generalist translators or agencies without medical specialisation. 

This is a costly shortcut. 

Why it’s a mistake: IFU translations require in-depth medical expertise, familiarity with device-specific terminology (Certified medical translator), and a clear understanding of MDR’s regulatory language. Mistakes can have serious consequences, from compliance failures to user misunderstandings that could endanger patient safety. 

Why ISO 13485 matters: Choosing a translation partner certified under ISO 13485 gives you an additional layer of security. ISO 13485 is the internationally recognised quality management standard for medical devices, including the processes of external partners like translation providers. 

At Novalins, our ISO 13485 certification guarantees that our translation workflows, from translator selection to quality control, are fully documented, traceable, and systematically audited. For our clients, this means translations are managed with the same rigor as your own medical device processes, reducing risks and ensuring regulatory alignment. 

Tip: Always select translators with proven medical device experience, up-to-date MDR knowledge, and a certified quality framework like ISO 13485 to guarantee quality and compliance at every step. 

Mistake 2: neglecting local linguistic and regulatory requirements 

Many manufacturers focus on meeting EU MDR requirements and overlook country-specific rules, readability expectations, or additional documentation demands. 

Why it’s a mistake: Each country within the EU, and even outside, may have specific national regulations, labeling requirements, or linguistic preferences that go beyond MDR’s general provisions. 

For example, in Portugal, Sweden, or Serbia, the local authorities may require specific terminology or design elements on packaging and IFUs. Ignoring these nuances can delay approvals or result in non-compliant documentation. 

Tip: Work with local regulatory experts and linguists who not only understand MDR but are also fully aware of national variations and stay up to date with evolving local requirements. At our company, we collaborate not only with native translators but also with in-country experts, a combination you can request as a specific requirement from your language service provider. 

Mistake 3: failing to integrate translation processes into your QMS 

Too often, translations are treated as an afterthought, ordered last-minute and handled outside of formal quality processes. 

Why it’s a mistake: Under MDR, traceability, quality management, and documentation control are not optional. Translations must be part of your end-to-end product lifecycle management and integrated into your Quality Management System (QMS). 

A disjointed process increases the risk of using outdated versions, losing control of translation updates, or missing key regulatory checkpoints. 

Tip: Make sure your translation providers and workflows are fully documented within your QMS. Track version control, approvals, and language coverage systematically.  

Mistake 4: overlooking updates and change management 

IFU translations are not static. They must evolve alongside product modifications, safety updates, and regulatory changes. 

Why it’s a mistake: If you update your source IFU but fail to trigger timely translations in all languages, you risk distributing outdated or incorrect instructions. This can compromise patient safety and lead to regulatory action. 

Tip: Set up a proactive change management process that automatically flags translation updates whenever the source content is modified. Keep multilingual versions aligned at all times. You can also request that your language service provider use your existing translation memories and assign the same translators for updates, ensuring consistency and alignment across all revisions. 

Mistake 5: underestimating readability and patient comprehension 

Even when the content is technically correct, it can fail if it’s not easily understood by the intended user. 

Why it’s a mistake: The MDR explicitly requires that IFUs are clear, legible, and understandable by the intended audience, which may include healthcare professionals, caregivers, and, in some cases, laypersons. However, formal readability or comprehension testing is not mandatory under MDR for most medical devices. 

• Use simple, straightforward language 

• Involve native-speaking reviewers 

• Consider visual aids to improve understanding 

• Optionally conduct user feedback sessions for layperson devices 

This not only improves user safety but also strengthens your regulatory file. 

Bonus tip: leverage technology without losing quality 

Translation technologies like CAT tools, translation memories, and AI-assisted solutions can help streamline processes, improve consistency, and reduce costs. 

AI translation and MDR: what you need to know 

AI translation is not prohibited under MDR. In fact, MDR does not restrict the use of specific translation methods, as long as the final IFU is clear, accurate, and fully compliant. 

However, relying on AI translations without careful validation can be risky: 

• AI translation quality varies significantly by language. For example, machine translation often performs well for major languages like Spanish or French but may produce unreliable results for complex languages such as Finnish, Hungarian, or those with fewer linguistic resources. 

• Clients are responsible for verifying the quality and MDR compliance of the final IFU, regardless of the translation method used. 

Tip: run a pilot test to find the right balance 

At Novalins, we help clients test AI-assisted translation workflows through customised pilot projects. This allows you to: 

• Assess the performance of different AI tools 

• Identify which languages are suited for AI translation 

• Decide when to use AI and when to prioritise human-only translations (especially for complex languages or high-risk products) 

This flexible, data-driven approach helps you optimise costs without compromising compliance or safety. 

AI as a quality support tool 

AI can also be used to enhance quality control, even when human translators are involved. At Novalins, we use AI as an additional quality layer to: 

• Check that all MDR-required elements are present 

• Automatically compare IFUs against our country-specific MDR checklist 

• Flag potential discrepancies before human regulatory experts review them 

This dual approach ensures that AI provides valuable support while final responsibility always remains with our MDR compliance specialists. It’s a smart way to combine efficiency, regulatory precision, and human expertise. 

Novalins’ country-specific checklist: a practical MDR compliance tool 

At Novalins, we go beyond translation. We’ve developed a country-specific MDR checklist that covers all the critical elements we verify to ensure each IFU meets local regulatory and linguistic requirements. 

This checklist includes: 

• Specific labeling obligations per country 

• Language variants and mandatory terminologies 

• Formatting and readability guidelines 

• Local authority preferences and nuances 

If you would like to receive our checklist, contact us directly and we will be happy to share this valuable tool with you. 

MDR compliance check: a standalone service for your peace of mind 

Even if your IFUs have already been translated, whether internally or by another provider, it’s not too late to ensure MDR compliance. 

Novalins offers MDR compliance checks as a separate service. 

We can: 

• Review existing translations 

• Verify alignment with MDR and country-specific requirements 

• Flag missing or non-compliant elements 

• Provide a full compliance report with actionable recommendations 

This service is particularly useful for: 

• Companies who translate in-house 

• Manufacturers who work with vendors unfamiliar with MDR nuances 

• Teams preparing for audits or regulatory submissions 

You don’t need to translate with us to benefit from our regulatory expertise. We’re here to help you secure your multilingual IFUs, whatever your process. 

Getting MDR-ready translations right in 2025 

As regulatory expectations tighten in 2025, medical device manufacturers must ensure their IFU translations are not only accurate but fully compliant, traceable, and patient-friendly. 

By avoiding these five common mistakes, using country-specific tools like our MDR checklist, and partnering with ISO 13485-certified specialists like Novalins, you can protect your business, safeguard patients, and ensure smooth market access across the EU and beyond. 

If you are exploring AI-assisted translations, remember that MDR allows their use, but the responsibility for accuracy and compliance remains with you. Running a pilot project is the safest way to: 

• Test which AI tools perform best 

• Assess which languages are suitable for AI 

• Decide when to prioritise human translations 

At Novalins, we offer tailored AI translation pilots and AI-supported quality control processes that systematically check IFUs against our country-specific MDR compliance checklist. This combined approach gives you the speed of technology, backed by the safety and precision of our regulatory experts. 

If you’d like to audit your current translation process, request our country-specific checklist, explore an AI pilot, or benefit from our MDR compliance check service, even if you don’t translate with us, get in touch with us today. 

We’re here to help you translate smarter, safer, and fully MDR-ready.