Under the EU Medical Device Regulation, the Instructions for Use (IFU) are no longer just supporting documentation—they are a core part of the safety information provided with the product.
For Regulatory Affairs, Quality and Marketing teams, this represents a shift in mindset. A translation error in a warning, contraindication or instruction isn’t just a linguistic issue—it can lead to a documented non-conformity, with potential implications for product assessment, user experience and patient safety.
Successfully passing a Notified Body review requires clear evidence of control, traceability and consistency. Below are the key areas to focus on to ensure your multilingual documentation stands up to scrutiny under the MDR 2017/745 and aligns with best practices such as ISO 17100.
The hidden cost of a non-compliant IFU
Time-to-market remains one of the biggest pressures for manufacturers. Any issue raised during the review of technical documentation can delay certification, product updates or market expansion.
IFUs are particularly sensitive because they bridge the gap between product design and real-world use whether by healthcare professionals, patients or caregivers. If instructions are unclear or inconsistent, the risk of misuse increases.
Common issues identified during audits and reviews:
- Terminology inconsistencies: using different terms for the same warning, contraindication or feature
- Misalignment with the SSCP: discrepancies between the IFU and the Summary of Safety and Clinical Performance, especially for implantable and Class III products
- Poor localisation: literal translations that don’t reflect standard medical language or user expectations in the target market
- Disconnect from risk management: safety information that doesn’t align with the product’s risk analysis
What ISO 17100 brings to the table
The MDR does not require translations to be carried out under ISO 17100. However, the standard provides a strong framework for demonstrating that the translation process is controlled, documented and handled by qualified professionals.
In practice, ISO 17100 helps show that IFU translation is not treated as an ad hoc task, but as a structured and verifiable process within the manufacturer’s quality system.
A compliant workflow typically includes:
- translation by a linguist with both language expertise and technical knowledge
- independent revision by a second qualified reviewer
- clear documentation of roles, versions and deliverables
- final quality checks for completeness, formatting and consistency
During an MDR audit, it’s not enough to say the text is correct you need to show that your process is designed to minimise risk and ensure consistency across languages.
Terminology consistency and documentation traceability
Traceability is a core expectation under the MDR. Manufacturers must be able to demonstrate that the information supplied with the product is consistent with the technical documentation, clinical evaluation, risk management and, where applicable, the SSCP.
A specialised language provider should be able to supply clear evidence, such as:
- version history
- identification of translator and reviewer
- validated glossaries
- translation memories for each product or product family
- records of changes between versions
- QA checklists covering both language and format
Translation memories and glossaries don’t just improve efficiency—they help ensure that critical warnings, instructions and safety related terms remain consistent across all languages and future updates.
The challenge of multilingual layout (DTP)
One of the most common risk points comes at the final stage: layout and formatting.
When translations are imported into design tools such as InDesign or Illustrator, new errors can be introduced—even if the translation itself is accurate.
Typical multilingual DTP issues include:
- truncated safety warnings
- missing or misplaced mandatory symbols
- errors in technical tables
- loss of visual hierarchy between warnings, precautions and instructions
- layout issues caused by text expansion in certain languages
Symbols used in IFUs must also remain compliant with standards such as ISO 15223-1.
For this reason, a final post-layout review is essential before printing, publishing or distribution. This step ensures the document is accurate, readable and visually consistent in its final form.
Language requirements across EU Member States
Article 10(11) of the MDR 2017/745 requires manufacturers to provide product information in the language(s) specified by each Member State where the product is marketed.
This means language management cannot be improvised. Each country may have specific requirements for IFUs, labelling and accompanying documentation.
Managing multiple languages is not just an operational challenge—it is a regulatory responsibility. An error in any localised version can have the same impact as an error in the source text if it affects safety, intended use or user understanding.
A structured, traceable process allows manufacturers to manage this complexity without compromising on content quality or compliance.
MDR audit checklist: are you ready?
Before submitting your documentation to a Notified Body, consider the following:
- Can you demonstrate who translated, reviewed and approved each version?
- Do your linguists have proven experience in MedTech?
- Is there a validated glossary covering safety, clinical performance and intended use?
- Is the IFU fully aligned with the technical documentation, risk management and, where applicable, the SSCP?
- Has a final post-layout review been carried out?
- Is the translation process documented and aligned with ISO 17100 principles?
- Have you verified language requirements for each target market?
Final thought: translation as part of risk control
Ensuring your IFU passes an MDR audit means treating translation with the same level of rigour as any other critical part of your technical documentation.
Poorly controlled translation of instructions, warnings or contraindications can lead to audit findings, delays, corrective actions and ultimately, increased risk for the end user.
At Lexic, we help manufacturers turn multilingual complexity into a controlled, traceable process aligned with MDR expectations.
Because in MedTech, a well-translated IFU doesn’t just support approval—it protects users, patients and your product.
