Medical Device News (UK)

Guidance on applying human factors to medical devices

Today (12th February 2021) the MHRA have released the latest update to their document ‘Guidance on applying human factors to medical devices, version 2.0, January 2021.’

This very useful and important document outlines the importance of applying human factors and usability engineering into medical devices, so they are designed and optimised to minimise patient and user safety risks.

The original guidance published on 19 September 2017 and this latest update reflects mainly the changes to the regulation of medical devices in the UK as a result of the end of the transition period with the EU. The guidance should now be considered as being specific to medical devices placed on the market in Great Britain (England, Wales, Scotland).

This guidance is intended for manufacturers of all device classes and developers of medical devices and drug-device combination products, and UK Approved Bodies responsible for assuring the quality of those devices. The document starts with an introduction and provides context and then explains why human factors matter for patient safety.

The document also provides very useful information about the applicable regulatory framework, standards and then a very helpful summary of the usability engineering process. Dialogue is provided to support the reader through the various process stages and then flows into the post-market obligations, product lifecycle and continuous improvement.

Overall, a very useful and informative document: