With the introduction of European Regulation 2017/745 and 2017/746, focus on the usability of medical devices and IVD devices has increased due to these newly introduced, specific requirements. Usability can be considered a part of the more general risk assessment of medical devices. A Usability Evaluation is intended to identify and minimise use errors and thereby reduce use-related hazards to an acceptable level. A comprehensive approach to usability assessment involves several crucial phases and follows the reference standards IEC 62366-1 and IEC 62366-2:
- The first phase is the description and analysis of the user interface, which includes the design of the device itself, the instructions for use (IFU), labels, and, if necessary, specific training for users.
- Subsequently, the identification of hazardous situations related to device use is carried out, followed, if necessary, by exploring the interface through Formative Evaluation. The intent of this phase is to identify and resolve usability issues during different stages of device development and ensure that the device has reached an adequate level of quality for the subsequent validation phase.
- The validation phase is called Summative Evaluation, which is particularly critical and often includes a pass/fail usability test with a representative sample of users.
Possible documents that comprise a usability file in compliance with IEC 62366-1 and IEC 62366-2 include: User Interface Specification, Usability Risk Assessment, and in the case of Formative Evaluation, the Formative Plan and Report and the Summative Plan and Report.
Regarding legacy devices, Annex C of IEC 62366-1 presents an alternative process to evaluate the usability of medical devices. Annex C of IEC 62366-1 significantly streamlines the process for evaluating usability, enabling manufacturers to utilise post-market data for unmodified aspects of the design to determine the presence of use errors, use-related hazards, and appropriate mitigation measures without the need for a validation test.
Eurofins Regulatory and Consultancy Services Italy can support manufacturers in planning a usability evaluation, both in terms of documentation and activities to be performed, in accordance with IEC 62366.