Guidance

Guidance on applying human factors to medical devices

MHRA has published guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.

Document

Guidance on applying human factors to medical devices

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Details

This guidance is primarily aimed at manufacturers of all device classes and developers of medical devices and drug-device combination products, and notified bodies responsible for assuring the quality of those devices. It applies to the design of future products and changes in user interfaces of existing products, rather than those already approved for the UK and EU market.

The guidance clarifies that usability engineering is an iterative process, involving design, testing and validation of design stages; it also requires attention to the post-market phase, since evidence may come to light while a device is being used in clinical practice that the design requires further improvement.

A usability engineering process can, and should, be applied by device manufacturers in the identification, assessment and mitigation of potential patient and user safety risks; also in the analysis of incidents that have occurred, in order to identify learning and put into place corrective actions to improve device design.

Published 19 September 2017