[co-author: Julia Fraser]

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on taking human factors into account when designing medical devices and ensuring that they meet the essential safety and performance requirements for devices.

‘Human factors’ refers to how a person uses or interacts with a device taking into account the context and environment in which the device is used, including physical factors such as lighting and temperature, the features of any hardware and software, the training or education of the user, and whether the device is intended for use in a hospital setting or at home. Usability engineering is the application of these factors in the design and safety assessment of devices to ensure that they are easy and safe to use, with the aim of minimising errors in use resulting from the design of the device.

The Guidance is for manufacturers of medical devices and drug-device combination products, as well as notified bodies assessing such products.

The Guidance advises device manufacturers to identify intended users and environmental and operational contexts, assess use- and user-error risks, test usability in appropriate contexts, and to document this process and the test results in a human factor summary report. The Guidance also advises manufacturers to actively and systematically seek feedback from users and incorporate this into continuous product improvement throughout the product lifecycle.

The Guidance refers to the essential requirements under the three existing EU Medical Device Directives (as implemented in the UK by national legislation) and will also be relevant for compliance with the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR), which will apply from May 2020 and May 2022 respectively. It is intended to be consistent with US FDA guidance on human factors related to medical devices.

The full Guidance is available here.