# Applying human factors to medical devices

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/eee472c4-62c2-4e40-8b48-751b275f31e4
Type: Guidance
Published: September 18, 2017
Updated: January 15, 2025

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding usability engineering for medical device manufacturers and developers of drug-device combination products. This regulatory framework applies to all device classes and UK-approved bodies, focusing on the design of future products and updates to existing user interfaces. The guidance establishes that usability engineering is an iterative process involving design, testing, and validation stages. Manufacturers are required to integrate this process into their risk management strategies to identify, assess, and mitigate potential hazards to patients and users. A key aspect of the guidance is the focus on the post-market phase, where evidence from clinical practice must be used to inform design improvements. While this document is not an inspection report for a specific company or date, it outlines the mandatory actions for all manufacturers: they must analyze incidents to identify learning opportunities and implement corrective actions that enhance device safety. By prioritizing user-centric design and continuous improvement, the MHRA seeks to minimize the risk of use-related errors and ensure that medical devices remain safe and effective throughout their entire lifecycle.

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## Content

This guidance is primarily aimed at 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. To be read in conjunction with the guidelines on post-market surveillance . It applies to the design of future products and changes in user interfaces of existing products, rather than those already on the 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.

## Attachments

- [Guidance on applying human factors to medical devices](https://assets.publishing.service.gov.uk/media/60521d98d3bf7f0455a6e61d/Human-Factors_Medical-Devices_v2.0.pdf)