Module 18 2021

09/02/2021

What are the current Human Factors and Usability Engineering regulations?

Medical Devices: Application of Usability Engineering to Medical Devices.

2015

IEC 62366-1

FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices FDA Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. MHRA Guidance: Human Factors and Usability Engineering – Guidance for Medical Devices including Drug-device Combination Products. FDA Guidance: Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-device Combination Product submitted in an ANDA . Packaging for terminally sterilised medical devices – Part 1: Requirements for

FDA – Medical Devices

2016

FDA – Combination Devices

2017

MHRA HFE Guidance

2017

FDA – Generic Devices

2018

ISO 11607- 1:2019

2019

materials, sterile barrier systems and packaging systems. European Medical Device Regulation, 2017/745/EC.

EU MDR 2017/745/EC

2021

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

11

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 (2021) 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 Drug device combination products (2016) as directed by the FDA .  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

Assessing Usability and Performance during development

12

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