Medical Devices
Specialist translation of IFUs, operating manuals and regulatory documentation
Medical devices and in vitro diagnostics require precise, consistent and regulatory-aware translation. Instructions for use must communicate safety, performance and correct operation clearly across markets and languages.
Instructions for Use for medical devices
Instructions for Use — often referred to as IFUs, operating manuals or user handbooks — for medical devices and in vitro diagnostics are subject to an extensive network of regulatory requirements. International standards and national laws define not only what information must be communicated, but also how that information must be provided.
In Europe, Regulation (EU) 2017/745 — MDR and Regulation (EU) 2017/746 — IVDR establish the legal framework for medical devices and in vitro diagnostic medical devices. In addition, Commission Implementing Regulation (EU) 2021/2226 sets out when and how electronic Instructions for Use may replace or supplement paper versions.
The recent amendment, Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025, amends Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the Instructions for Use may be provided in electronic form.
Standards such as IEC 62366-1, IEC 60601-1 and ISO 20417 define important structural requirements and integrate documentation into a sound usability-engineering process. Cybersecurity, now a central concern in medical technology, is addressed in IEC 81001-5-1 and reinforced by recent FDA guidance.
Harmonised frameworks from the International Medical Device Regulators Forum (IMDRF) and detailed FDA requirements, although aimed primarily at the United States market, often become de facto best practice worldwide.
Conclusion: drafting and translating Instructions for Use for medical devices and in vitro diagnostics is a demanding task. It requires deep technical expertise and a detailed understanding of the regulatory landscape. Manufacturers must ensure that their instructions comply with each target market’s legal mandates as well as the relevant technical and safety standards. This is essential so that users can operate the product correctly and safely. Cybersecurity measures and the option of electronic Instructions for Use — eIFU — are becoming increasingly important.
What matters in IFU translation
Regulatory precision
Intended purpose, warnings, contraindications, limitations, safety notices and regulatory terminology must be rendered accurately and consistently.
Clear technical structure
The translated IFU must remain logical, readable and usable for the target audience while respecting standards, market expectations and document structure.
Terminological consistency
Units, device names, functions, risks, warnings and safety-related wording must remain consistent across the full documentation set.
