Final Document
IMDRF/MC/N79FINAL: 2024
Guiding Principles to Support
Medical Device Health Equity
AUTHORING GROUP
IMDRF Management Committee
6 February 2024
IMDRF/MC/N79FINAL: 2024
Preface
© Copyright 2024 by the International Medical Device Regulators Forum.
This work is copyright. Subject to these Terms and Conditions, you may download,
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include the following acknowledgement (delete inapplicable):
“[Translated or adapted] from [insert name of publication], [year of publication],
International Medical Device Regulators Forum, used with the permission of the
International Medical Device Regulators Forum. The International Medical Device
Regulators Forum is not responsible for the content or accuracy of this
[adaption/translation].”
All other rights are reserved and you are not allowed to reproduce the whole or any part
of this work in any way (electronic or otherwise) without first being given specific written
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rights are to be sent to the IMDRF Secretariat.
Incorporation of this document, in part or in whole, into another document, or its
translation into languages other than English, does not convey or represent an
endorsement of any kind by the IMDRF.
Jeffrey Shuren, IMDRF Chair
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IMDRF/MC/N79FINAL: 2024
Contents
1. Background 4
2. Guiding Principles to Support Health Equity 5
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IMDRF/MC/N79FINAL: 2024
1. Background
Health equity is the absence of unfair and avoidable or remediable differences in health
among population groups, including the absence of unfair systems and policies that
cause health inequalities, allowing everyone to attain their full potential for health and
well-being. Evidence demonstrates that biological, economic and social differences
among diverse groups of people can contribute to differences in health outcomes. The
consideration of these differences as part of International Medical Device Regulators
Forum (IMDRF) working group discussions could help to promote health equity.
In some circumstances, regulators may consider population differences when
assessing the safety, effectiveness and performance of a medical device. Numerous
factors can contribute to such population differences. Some of the key factors are
defined as follows:
• Age: refers to the amount of time during which a person has lived. Different age
groups experience health differently.
• Sex refers to a person's biological and physiological characteristics. A person's
sex is most often designated by a medical assessment at birth.
• Gender refers to roles, expressions, and behaviours that a society constructs
and uses to categorize individuals, for example as "men" and "women". Gender
identity refers to how people experience their gender and biological sex and it
may or may not be congruent with their birth-assigned sex.
• Ethnicity refers to the categorization of groups of people according to their
cultural expression and identification. It is related to socio-demographic
characteristics, including language, religion, geographic origin, nationality,
cultural traditions, ancestry and migration history, among others.
• Race refers to the social construct used to categorize people based on
perceived differences in physical appearance. There is no scientifically-
supported biological basis behind this construct.
• Socio-economic status refers to an individual’s experience of social and
financial factors such as income, education, housing, and community.
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IMDRF/MC/N79FINAL: 2024
2. Guiding Principles to
Support Health Equity
Guiding principles have been developed for use by the IMDRF to advance health equity
discussions for underrepresented populations in the development, evaluation and
regulation of medical devices. This document is intended to assist IMDRF working
groups in considering health equity principles, where relevant, in the development of
IMDRF technical documents. These principles should be considered throughout the
total product lifecycle. Each working group will determine how best to use this document
in their discussions and deliverables.
Recognize and address potential health equity considerations for medical
devices: Where relevant in IMDRF working group discussions, members should
broadly consider implementing aspects that support health equity. For example, when
drafting technical documents and, where feasible, considering approaches that are
inclusive of subgroup related factors or differences.
Consider the relevance of disaggregated data: Disaggregated data are broken down
into subcategories. Looking at data within and across specific categories (e.g. age, sex,
gender, ethnicity, race, socioeconomic status) can allow for a better understanding of
medical device safety and performance in the different populations expected to use the
device. For example, the use of disaggregated data could detect inequitable levels of
device use or performance in relation to different subgroups. This principle hinges on
data collection processes that lead to sufficient information across different categories
to enable meaningful analysis and assessment between populations, both for pre-
market and post-market data collection.
Identify any differential impacts of a device on subgroups: It may be helpful to
identify and take into consideration differential impacts of a device on various
subgroups, such as age, sex, gender, ethnicity, race, socio-economic status, or other
characteristics. For example, where practical, device designs should consider sex- and
gender-related factors, unique anatomical or physiological characteristics, or differential
rates of access to or use among people impacted by the device. Differential impacts
can be assessed with data from clinical trials and from post-market surveillance.
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Disclaimer
© Copyright 2023 by the International Medical Device Regulators Forum.
This work is copyright. Subject to these Terms and Conditions, you may download,
display, print, translate, modify and reproduce the whole or part of this work for your
own personal use, for research, for educational purposes or, if you are part of an
organisation, for internal use within your organisation, but only if you or your
organisation do not use the reproduction for any commercial purpose and retain all
disclaimer notices as part of that reproduction. If you use any part of this work, you must
include the following acknowledgement (delete inapplicable):
“[Translated or adapted] from [insert name of publication], [year of publication],
International Medical Device Regulators Forum, used with the permission of the
International Medical Device Regulators Forum. The International Medical Device
Regulators Forum is not responsible for the content or accuracy of this
[adaption/translation].”
All other rights are reserved, and you are not allowed to reproduce the whole or any
part of this work in any way (electronic or otherwise) without first being given specific
written permission from IMDRF to do so. Requests and inquiries concerning
reproduction and rights are to be sent to the IMDRF Secretariat.
Incorporation of this document, in part or in whole, into another document, or its
translation into languages other than English, does not convey or represent an
endorsement of any kind by the IMDRF.
