The webinar will provide a general overview about the Usability Regulatory Landscape, including Risk Management, MDR, IVDR and applicable standards. The Usability Engineering Process as required by IEC 62366 will be described briefly, including the prerequisites required for “grandfather devices”, i.e. for the User Interface of Unknown Provenance (UOUP). A special focus will be on usability evaluation methods. Finally, usability requirements from the legislation and guidelines as well as practical tips will be presented for topics including instructions for use (IFU) and the Summary of Safety and Clinical Performance (SSCP).