Module 18 - Drug Device Combinations and Other Technologies

07/12/2023

What are the current Human Factors and Usability Engineering regulations?

Medical Devices: Application of Usability Engineering to Medical Devices v2.0.

MHRA HFE Guidance

2021

FDA Guidance: Content of Human Factors Information in Medical Device Marketing Submissions. NMPA Draft Guidance: The application of human factors and usability engineering to medical devices.

FDA – Marketing Submissions

2022

NMPA –HFE Guidance

2023

? (Watch this space!)

2024

?

FDA – Generic Devices As seen, there are always new requirements and regulations to meet that require manufacturers to provide evidence of use safety and effectiveness. This is unlikely to change in the future. 2018

ISO 11607 1:2019

2019

EU MDR 2017/745/EC

2020

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

21

China – the latest Human Factors needs NMPA Human Factors requirements:  Involves class II and class III medical devices only.  Requires human factors studies in China with Chinese populations.  Requires a minimum of 15 participants per user group in a Summative Human Factors study, but very strongly recommends 20 participants per user group.  For legacy/mature devices and systems, a comparative human factors evaluation is recommended.

 The guidance details high-risk medical devices (generally class III devices)

 It is still a draft but is in a second round of feedback.

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

22

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