The FDA sets clear requirements for human factors engineering (HFE) and usability engineering of medical devices. This article provides a comprehensive overview of the FDA’s usability requirements and shows you how to successfully implement them in your product development.
DetailsEU Regulation 2017/745 (MDR) establishes the general requirements for instructions for use (IFU). Whether they can also be provided in electronic form (eIFU) is regulated by Implementing Regulation (EU) 2021/2226. It was revised by Implementing Regulation (EU) 2025/1234. A consolidated version is also available now. We have summarized the requirements for electronic instructions for use for you.
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