Module 14 2022

24/03/2022

What are the current Human Factors and Usability Engineering regulations?

Globally, there should be a pattern of use of the Human Factors and Usability standards as follows:

 For meeting the Essential Requirements of the European Medical Device Regulation (2020) use IEC 62366-1 and IEC 62366-2.  In addition, if the UK is a target market, use the MHRA Human Factors and Usability Engineering standard.  For the US domestic market, where an FDA review is required, use one of the FDA Guidances for Human Factors and Usability Engineering as relevant to the type of device under evaluation.  Many countries such as China, Japan, South Korea, India Australia, South Africa and Saudi Arabia recognise IEC 62366-1, but in some cases, IEC 62366 (2007) is the harmonised Usability Engineering standard. They are quite different in their process!

The Organisation for Professionals in Regulatory Affairs

Human Factors and usability testing during development

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What are the current Human Factors and Usability Engineering regulations?

The European Medical Device Regulation (2017/45/EC) Compliance to the Performance Requirements stated in Annex I are the basis for CE Marking a medical device if this is the regulatory route chosen. The ones related to human factors and usability are specific and are:

Not limited to, but include Sections - 1, 3(b), 3(c), 4(c), 5(a), 5(b), 8, 10.2, 11.1, 11.2, 14.2(a), 14.4, 14.6, 14.7, 18.4, 22.1 & 22.2. The terms ergonomics, usability, safe use or human factors are frequently stated in the new MDR!

The Organisation for Professionals in Regulatory Affairs

Human Factors and usability testing during development

14

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