MHRA Unveils Guidance on Applying Human Factors in Device Design

The UK’s Medicines and Healthcare products Regulatory Agency published new guidance on human factors and usability engineering for medical device manufacturers — pulling back the curtain on the UK’s regulatory structure, and showing how various usability engineering strategies stack up against each other.

The document also delves into the stages of a usability engineering process, post-market surveillance, and various concerns during the medical device lifecycle.

Aimed at manufacturers of all device classes and drug-device combination products, as well as notified bodies responsible for assuring the quality of those devices, the guidance focuses on ways human factors can be applied so products are optimized for the intended users.

MHRA said those involved in procurement and risk management of activities involving medical devices, as well as physicians and other stakeholders may also find the guidance relevant to their roles.