Instructions for use (IFU)
Description
The IFU is more than just a guide; it is a critical compliance document regulated by bodies such as the FDA and EMA under frameworks like the MDR and IVDR. Every medical device manufacturer has an obligation to create an accurate and effective IFU that ensures the device is used exactly as intended. If documentation is unclear or inaccurate, it risks patient safety and exposes manufacturers to significant legal liability for harm or damage.
Creating an IFU that is easy to search, understand and apply is of utmost importance. However, maintaining this accuracy across multiple product variants, languages and formats (print, web, mobile) is a major challenge. Traditional word-processing tools often lead to document version control errors and duplicated effort. This is why leading manufacturers are shifting to structured content. Structured content allows teams to build documentation using small, reusable components rather than static files. With a structured content authoring tool, authors, editors and Subject-matter experts (SMEs) can create a safety warning or operating instruction once and reuse it across every relevant IFU. If a change is required, updating the source content automatically propagates the correction to all instances – ensuring that storage information, handling instructions or installation steps remain accurate and consistent everywhere they appear.
Example use cases
- Safety: Provide clear, validated instructions to prevent misuse and ensure effective treatment.
- Submission: Generate compliant IFUs for submission to notified bodies as part of the technical file.
- eIFU: Publish digital instructions for use (eIFU) directly from a single source of truth to portals.
- Alignment: Ensure that warnings in the IFU match product labeling and packaging exactly.
- Translation: Streamline translation by only sending new or changed text components for localization.
Key benefits
RWS perspective
RWS helps life sciences organizations transform their IFU management through Tridion Docs, our intelligent Component Content Management System (CCMS). By moving away from document-based workflows to a structured, component-based approach, manufacturers can ensure that every instruction, warning and specification is traceable, compliant and up to date.
Our solution combines human expertise in regulatory writing and localization with intelligent technology that enforces content governance. Whether you are managing complex product variations or transitioning to electronic instructions for use (eIFU), RWS provides the rigorous version control and single-source publishing needed to meet global regulatory standards with confidence.