Draft
IMDRF/MC/N79 DRAFT: 2023
Guiding Principles to Support
Medical Device Health Equity
AUTHORING GROUP
IMDRF Management Committee
20 June 2023
IMDRF/MC/N79 DRAFT: 2023
Preface
© Copyright 2023 by the International Medical Device Regulators Forum.
This work is copyright. Subject to these Terms and Conditions, you may download,
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“[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
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[adaption/translation].”
All other rights are reserved and you are not allowed to reproduce the whole or any part
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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
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endorsement of any kind by the IMDRF.
Andrzej Rys, IMDRF Chair
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IMDRF/MC/N79 DRAFT: 2023
Contents
1. Background 4
2. Guiding Principles to Support Health Equity 5
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IMDRF/MC/N79 DRAFT: 2023
1. Background
Health equity refers to the absence of unfair and avoidable or remediable differences in
health among population groups. 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 and performance of a medical device. Numerous factors can
contribute to such population differences. Some of the key factors are defined as
follows:
• 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, identities, expressions, and behaviours that a given
society may construct or consider appropriate for the categories of "men" and
"women". It can result in stereotyping and can set expectations about what
people should or can do.
• Gender identity refers to how people may experience gender. This could be
congruent with their birth-assigned sex, or the person may identify with the other
gender ("man/boy" or "woman/girl"), or neither of the genders.
• Race refers to a social construct. It is not grounded in biology but can influence
how people access programs and services. The impacts of racialization and
racism on various race groups (e.g., Black, White, Asian, etc.) should be
measured and assessed along with other identity factors as determinants of
health.
• Ethnicity refers to categorizations of groups of people according to their
cultural expression and identification. Commonalities such as racial, national,
tribal, religious, linguistic, or cultural origin may be used to describe someone's
ethnicity.
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IMDRF/MC/N79 DRAFT: 2023
2. Guiding Principles to
Support Health Equity
Guiding principles have been developed for use by the IMDRF, a voluntary group of
medical device regulators from around the world, to advance health equity discussions
for underrepresented populations in the development 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.
Recognize potential health equity considerations for medical devices: Where
relevant in IMDRF working group discussions, members should broadly consider health
equity, as well as aspects related to its implementation. For example, when drafting
technical documents, where feasible, consider implementing approaches that are
inclusive of population related factors or differences.
Identify any differential impacts of a device on subpopulations: It may be helpful
to identify and take into consideration differential impacts of a device on various
subpopulations, such as sex, gender, age, race, or other characteristics. For example,
where practical, device designs should take into account unique anatomical or
physiological characteristics, or differential rates of use, of people impacted by the
device.
Consider the relevance of disaggregated data: Disaggregated data are broken down
into subcategories or target groups. For some medical devices, in certain scenarios, the
use of quantitative (e.g. sex, gender, race) and/or qualitative disaggregated data 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 different levels of device performance in relation to different
subpopulations.
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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.
