Recent guidance from UK medical device market regulators on human factors engineering (HFE) includes some recommendations that differ from HFE requirements established in Europe, suggesting a more standalone British approach to some areas of device development.

The UK Medicines & Healthcare products Regulatory Agency (MHRA) guidance applies to HFE for all medical devices as well as combination drug-device products, and was developed by a task force made up of regulatory, industry and Notified Body members. Furthermore, the guidance targets HFE and usability issues for the design of future devices as well as interface changes to existing devices, but not to devices already CE Marked and commercialized in the UK and Europe.

Beyond current HFE standards?

Below, we list standards utilized by medical device regulators as the basis for their own HFE and usability requirements:

• IEC 62366-1:2015 Medical devices, Part 1: Application of usability engineering to medical devices (recognized by US FDA)
• IEC/TR 62366-2:2016. Medical devices, Part 2: Guidance on the application of usability engineering to medical devices (recognized by European regulators)
• IEC 60601-1-6:2013-10 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (recognized by US FDA)
• IEC 60601-1-6:2010+A1:2015 Medical electrical equipment- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Recognized by European regulators)
• US FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices

Although the MHRA guidance used FDA guidance, IEC 62366 as well as the three European Medical Devices Directives as references, UK regulators appear to be focusing on human factors and usability engineering during device development. This push comes partially in response to the wider use of home-use devices and technologies by patients and lay-caregivers with little to no skills operating complex products.

“A growing number of medical devices are being used for monitoring and treating patients, and errors in use leading to patient harm have been increasingly a cause for concern,” states the MHRA guidance. “Such errors may be due to poor device design, particularly where a complex user interface is involved.”

The guidance cites devices including infusion pumps, ventilators, electronic defibrillators and combination products such as auto-injectors as products for which use-related issues and malfunctions can cause serious harm or death for patients.

Major differences

Key points in the MHRA guidance that differ from US and European regulators’ expectations and recommendations include:

• The MHRA guidance recommends that summative usability tests cover instructions for use validation in terms of content and layout, whereas IEC 62366-1:2015 does not specify such coverage.
• For summative usability testing, which entails validation of a device and its related documentation, MHRA recommends including a minimum of 15 participants per user group, which aligns with FDA recommendations; the IEC 62366-1:2015 standard does not include minimum sample size recommendations.
• MHRA recommends that manufacturers submit a Human Factors Summary Report that is more in line with US FDA Human Factors Engineering and Usability Engineering reports; the IEC 62366-1:2015 standard references a collection of documents under a Usability Engineering File but nothing as substantial as the FDA’s report recommendation.
• The MHRA guidance is focused heavily on post-market surveillance activities as part of an effective HFE strategy. The recommendations in this area include running supplemental usability tests for changes manufacturers implement following adverse events and related post-market issues. These recommendations are consistent with new requirements in the ISO 13485:2016 quality standard covering control of design and development changes.