MHRA Human Factors Guidance for Medical Devices including drug-device combination products

PUBLISHED 20th September 2017

The UK’s Regulatory Agency MHRA has just published its Human Factors and Usability Engineering – Guidance for Medical Devices including Drug-device Combination Products. The guidance states that it is intended for “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.”

The MHRA has worked with a wide range of representatives from academia, notified bodies, trade associations and industry amongst others, including Medical Device Usability. The MHRA makes clear that their guidance is intended to be consistent with current FDA guidance as well as other standards referenced within the document.

The guidance provides background to why this work has been carried out as well as the standards followed and a summary of the usability engineering process. It then goes on to set out the stages of the usability engineering process as well as the importance of usability engineering in the product life cycle, post-market surveillance and continuous improvement.

The MHRA states that the guidance is intended to be advisory, not prescriptive, but the amount of detail included in the document should provide helpful insight into the importance of human factors and usability to anyone developing medical devices including combination products.

It is interesting to draw from the guidance that the MHRA is stressing that human factors and usability should be an integral part of the design and evaluation process of medical devices and should not just be something that is added on at the very end of the process as a “nice to have” exercise.

The MHRA guidance can be found at