The legal framework for usability is defined on the basis of different legislations (e.g. the MDR ). This sets out certain requirements for efficient usability of medical devices.
The MDR attaches great importance to usability and stipulates in its basic requirements that manufacturers must minimise risks that could arise from inadequate usability. This is to be achieved on the one hand by the ergonomic features of the medical device and the environmental conditions in which it is used. In addition, the technical knowledge, experience and physical requirements of the persons who will later use the medical device should also be taken into account. For example, usability must be adapted accordingly if your product is to be used not only by specialists but also by laypersons. This makes it clear that usability must always be understood in the context of the actual purpose of the product and the people who use it. Good usability can also be ensured, according to the MDR, by accurate technical documentation that includes the results of product verification and validation related to usability. In addition, you should also collect and evaluate user feedback about use problems as part of post-market clinical follow-up and post-market surveillance.
The FDA provides a guidance document entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design”. This “textbook” is not a standard, but it includes some requirements and shows which methods you need to use to analyse risks. It also describes how to conduct and document usability tests. The FDA is guided by IEC 62366 and refers to its regulations.