Module 14: Design Development and Certification of Medical Devices

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 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.

❑ For China, use the NMPA Guidance even if it is still draft!

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development