MDR-compliant IFU translations: five common pitfalls to avoid in 2025

Understanding the critical role of MDR compliance in IFU translations 

The European Medical Device Regulation (MDR) is continuously transforming how medical device manufacturers approach compliance, and one area that often doesn’t get enough attention is the translation of Instructions for Use (IFUs). Accurate, MDR-compliant translations are more than just a regulatory requirement, they are essential for ensuring patient safety, product effectiveness, and seamless market entry. 

In 2025, regulatory bodies are expected to increase scrutiny on post-market monitoring and document traceability. Any lapses in translation quality or compliance could lead to expensive recalls, legal consequences, and damage to your brand reputation. 

To guide you through this complex process, we’ve identified the top five errors to avoid when preparing your IFU translations this year. 

Mistake 1: Relying on non-specialised translators 

When facing tight deadlines or budget constraints, companies might opt for general translators or agencies without expertise in medical terminology. 

This approach often backfires. 

Why it’s problematic: IFU translation demands specialised medical knowledge, familiarity with device-specific jargon and a thorough understanding of MDR regulatory language. Errors in this area can cause compliance failures and misunderstandings that jeopardize patient safety. 

The importance of ISO 13485 certification: Partnering with a translation provider certified to ISO 13485 ensures adherence to internationally recognised quality management standards tailored to medical devices. This includes rigorous controls over external service providers like translators. 

At Novalins, our ISO 13485 certification means every step, from selecting translators to final quality assurance, is meticulously documented and auditable. Clients can trust that their translations meet the same high standards as their own manufacturing processes, minimising risks and ensuring full regulatory alignment. 

Tip: Always work with translators who have proven experience in medical device translation, current knowledge of MDR, and operate within a certified quality system like ISO 13485. 

Mistake 2: Overlooking country-specific linguistic and regulatory nuances 

Some manufacturers focus solely on EU-wide MDR requirements and neglect specific national regulations, local readability expectations, or additional documentation needs. 

Why this matters: Individual countries within the EU, and beyond, may impose their own rules regarding terminology, labeling, or design elements for IFUs and packaging. 

For instance, authorities in Portugal, Sweden, or Serbia may mandate specific terms or formatting. Ignoring these details can delay approvals or lead to non-compliance. 

Tip: Collaborate with local regulatory and linguistic experts who understand MDR and keep up to date with national variations and evolving local regulations. 

Mistake 3: Excluding translations from your Quality Management System (QMS) 

Translations are too often considered an afterthought, managed hastily and outside formal quality workflows. 

Why this is risky: MDR mandates traceability, quality control, and documentation management as integral parts of product lifecycle management. Translation processes must be embedded within your QMS. 

Disconnected workflows risk outdated content, loss of version control, and missed regulatory reviews. 

Tip: Ensure your translation procedures and providers are fully integrated and documented within your QMS. Systematically track version updates, approvals, and language coverage. 

Mistake 4: Ignoring update and change management processes 

IFU translations aren’t static documents, they need to evolve with product updates, safety information, and regulatory changes. 

Why that’s important: Failing to promptly update all language versions following changes to the source IFU may result in distribution of obsolete or incorrect instructions, putting patient safety and compliance at risk. 

Tip: Implement a proactive change management system that triggers translation updates automatically whenever the source IFU is modified, keeping all language versions synchronised. 

Mistake 5: Underestimating readability and user comprehension 

Even technically accurate IFUs can fail if the target audience cannot understand them. 

Why it matters: MDR requires IFUs to be clear, legible, and understandable to intended users, healthcare professionals, caregivers, and sometimes patients themselves. While formal readability testing isn’t mandatory for most devices, it’s considered best practice. 

This is especially crucial for: 

• Devices aimed at lay users or home use 

• Complex or high-risk devices where misunderstanding instructions can affect safety 

In some cases, notified bodies may request evidence that IFUs are understandable, even if formal testing isn’t strictly required. 

Tip: Make sure translations are clear, accessible, and tailored to the reading level of your audience. Good practices include: 

• Using straightforward, simple language 

• Engaging native speakers for review 

• Incorporating visuals to enhance understanding 

• Conducting user feedback sessions where applicable 

This approach enhances patient safety and strengthens your regulatory submissions. 

Bonus advice: harness technology without sacrificing quality 

Tools such as CAT software, translation memories, and AI-assisted solutions can streamline your translation workflows, improve consistency, and lower costs. 

AI translation under MDR: key points 

MDR does not prohibit AI-assisted translations as long as the final IFU is accurate, clear, and fully compliant. 

However, depending solely on AI without thorough validation can be risky: 

Quality varies by language, AI tends to perform well for major languages like French or Spanish but less reliably for complex or less-resourced languages such as Finnish or Hungarian. 

Regardless of method, the manufacturer remains responsible for verifying translation quality and compliance. 

Tip: Conduct pilot tests to find the right balance. 

Novalins offers tailored pilot projects that evaluate AI-assisted translation workflows, helping you: 

• Assess different AI tools’ performance 

• Identify languages suited to AI translation 

• Determine when human-only translations are necessary (especially for complex languages or high-risk products) 

This data-driven approach optimises costs without compromising compliance or safety. 

AI as a quality enhancement tool 

AI can also support quality assurance alongside human translators. At Novalins, AI helps us: 

• Verify the inclusion of all MDR-required elements 

• Automatically compare IFUs against country-specific checklists 

• Highlight potential inconsistencies before human regulatory review 

This hybrid approach combines AI efficiency with human regulatory expertise for maximum reliability. 

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

Beyond translation, Novalins provides a detailed checklist covering: 

• Country-specific labeling requirements 

• Language variants and mandatory terms 

• Formatting and readability criteria 

• Local regulatory preferences 

Contact us to receive this valuable tool. 

MDR compliance audit: a standalone service for peace of mind 

Even if your IFUs are already translated, whether in-house or via another provider, it’s not too late to verify MDR compliance. 

Novalins offers independent MDR compliance audits that: 

• Review existing translations 

• Check alignment with MDR and local requirements 

• Identify gaps or non-compliance 

• Deliver comprehensive reports with practical recommendations 

Ideal for: 

• Companies handling translations internally 

• Manufacturers working with providers unfamiliar with MDR details 

• Teams preparing for audits or regulatory submissions 

You don’t have to translate with us to benefit from our expertise. 

Ensuring MDR-compliant translations in 2025 

As regulatory demands increase in 2025, manufacturers must guarantee that IFU translations are precise, fully compliant, traceable, and user-friendly. 

By steering clear of common pitfalls, leveraging country-specific tools like our MDR checklist, and partnering with ISO 13485-certified experts like Novalins, you protect your business, safeguard patients, and facilitate market access across Europe and beyond. 

If you’re considering AI-assisted translation, remember MDR permits their use, but you remain accountable for accuracy and compliance. Piloting AI projects is the safest way to: 

• Test AI tools’ effectiveness 

• Determine language suitability 

• Choose when to rely on human translation 

Novalins provides customised AI pilot programs and AI-supported quality control to rigorously check IFUs against our MDR compliance checklist. This combined method delivers the speed of technology plus the assurance of expert oversight. 

Interested in auditing your translation process, receiving our checklist, launching an AI pilot, or using our MDR compliance audit? Contact us today. 

We’re committed to helping you translate smarter, safer, and fully MDR-ready.