In the last years both, Notified Bodies and FDA increasingly paid attention to the usability of medical devices. Thus, it is not surprising that MDR/IVDR explicitely contains usability as well. Furthermore, Annex I has been renamed into "General safety and performance requirements" underlining the importance of usabillty again. With the introduction of MEDDEV 2.7/1 rev. 4 as well as MDR usability becomes more and more important for the clinical evaluation as well.

EN 62366 defines the application of usability for medical devices. Its first part describes the process while the second part explains it in further detail. FDA underlines the human factor in this context. Correspondigly FDA named its respective guidance "Applying Human Factors and Usability Engineering to Medical Devices" (2016).

Within the usability analysis first the main functions and the safety-related functions need to be identified. Thus, usability relies on the risk analysis. Then, the implementation of these critical functions will be verified and validated.