Understanding Global Human Factors Compliance for Medical Devices

A key element of any medical device design is how it meets human factors-based standards and requirements. Medical device manufacturers selling their products around the globe are expected to follow one or more of these standards and/or requirements.

In the US, companies have several human factors-based guidance documents to follow. Companies selling to the European Union should follow IEC’s standard on the Application of Usability Engineering to Medical Devices.

China has joined the fold and has published draft guidelines on human factors engineering that is expected to soon be finalized.

Countries outside of the EU like Australia, Canada, and the United Kingdom point to the IEC standard or country-specific versions of the standard.

This article lists key human factors-based guidance documents, standards, guidelines, and/or supporting documents to help medical device manufacturers plan for the human factors elements of their global regulatory compliance.

Much of the region-specific human factors content (e.g., for the US or the EU) has elements common to related documents in other regions.

For example, summative or validation human factors-based testing is expected with regulatory submission documents in the US, EU, UK, and China. The summative testing should be done using a product’s final design and involves a specific number of users of the product in the environment/s and region/s where the product will be used.

Recruiting for summative studies, running them, analyzing the results, etc. can be very time consuming and expensive. Manufacturers should factor this into their medical device development planning, scheduling, and budgeting.

Although there are similarities as noted above, companies planning to sell in multiple regions should keep in mind that specific requirements or expectations will differ from region to region.

For example, China expects to see more user test subjects included in summative testing than are expected in the US or the EU. Also, testing in China will need to be conducted in Chinese with Chinese-speaking test subjects and testers vs. in English in the US.

However, if a product to be sold in the US is expected to be used by a large group of non-English speakers, then plans for testing in multiple languages may need to be part of the summative testing.

Key Guidance Documents and Standards for Human Factors in Medical Device Design

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China

NPMA May 2020 Technical Review Guidelines of Human Factors Design (Draft), Cisema translation

NMPA issued a notice in October 2023 soliciting feedback on its guideline. The feedback will be considered in the eventual final version of the guideline.

European Union

IEC 62366-1:2015+AMD1:2020 CSV | Medical devices - Part 1: Application of usability engineering to medical devices

The link above includes 2020 the revision to the original 2015 version of the standard.

IEC TR 62366-2:2016 | Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

This document is a Technical Report that contains background information and provides guidance that can be helpful with implementing IEC 62366-1.  

ISO 14971:2019 | Medical devices - Application of risk management to medical devices

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. It is specifically referred to in IEC 62366 and can be considered a complementary standard to the 62366 document.

United States

February 2016 FDA Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Medical Devices

December 2022 FDA Draft Guidance for Industry and Food and Drug Administration Staff - Content of Human Factors Information in Medical Device Marketing Submissions

September 2023 US  Guidance for Industry and FDA Staff - Application of Human Factors Engineering Principles for Combination Products: Questions and Answers

United Kingdom

UK MHRA January 2021 Guidance on applying human factors and usability engineering to medical devices including drug-device combination products in Great Britain

Need Support?

If you would like support with navigating global human factors compliance for your medical device, please feel free to reach out to Pure Global for assistance. Also, Pure Global’s online Global Regulatory Intelligence Platform (GRIP) includes an extensive database of clinical trial research. Searching on the term human factors in GRIP returns a large number of records describing medical device human factors research that may provide ideas for human factors testing for your product/s. Pure Global is available to provide online overviews of GRIP, including the use of our Pure Trials database.