Medical Devices

Instructions for Use (IFUs), sometimes called operating manuals or handbooks, for medical devices and in vitro diagnostics are tightly controlled by an extensive web of regulations. International standards and national laws dictate both what must be communicated and how that information is delivered, ensuring that patients and users stay safe and the device performs as intended. In Europe, Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) lay down the legal framework. Commission Implementing Regulation (EU) 2021/2226 sets out when and how electronic IFUs may replace or supplement paper versions, and the recent amendment is Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending 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 the document structure and integrate it into a solid usability-engineering process, while cybersecurity, now a central concern, is addressed in IEC 81001-5-1 and reinforced by recent FDA guidance. Harmonized frameworks from the International Medical Device Regulators Forum (IMDRF) and detailed FDA requirements, although aimed at the United States market, often become de facto best practice worldwide. Crafting IFUs is therefore a demanding task that requires deep technical expertise and an intimate grasp of the regulatory landscape; manufacturers must ensure their instructions meet every market’s legal mandates and relevant technical and safety standards so users can operate the product correctly and safely, with cybersecurity measures and the option of electronic IFUs gaining ever greater importance.