/MC/N8
Final Document
IMDRF/MC/N84 FINAL:2024
IMDRF Document
Implementation Report
AUTHORING GROUP
IMDRF Management Committee
30 August 2024
IMDRF/MC/N84 FINAL:2024
Preface
© Copyright 2024 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.
Jeff Shuren, IMDRF Chair
2
IMDRF/MC/N84 FINAL:2024
Contents
1. Introduction 4
2. Report 5
3
IMDRF/MC/N84 FINAL:2024
1. Introduction
The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device
regulators from around the world who have come together to build on the strong foundational work of
the Global Harmonization Task Force on Medical Devices (GHTF) and aims to strategically accelerate
international medical device regulatory convergence.
As indicated in the IMDRF Terms of Reference (ToR), IMDRF activities and initiatives may fall into
several categories, one of which being technical documents created to address technical matters
relating to the regulation of medical devices. The process for developing technical documents is
described in the IMDRF Standard Operating Procedure (SOP) and includes seven stages. The last
stage of development is implementation, which is at the discretion of each regulatory authority
responsible for medical devices in the area. Each regulatory authority may need at least one year to
implement a document after publication in final.
The implementation levels are defined in the IMDRF SOP and repeated below for ease of reference.
Implemented: All relevant elements, concepts and principles of the IMDRF document are
followed.
Partly implemented: The IMDRF document has been implemented in a modified way that a)
does not include all relevant elements, concepts and principles of the IMDRF document or b)
requires application of the document for a smaller range of products than outlined in the IMDRF
document.
Not applicable: The implementation of a specific IMDRF document is not applicable in a
country/region.
Not implemented: The process for the implementation of the IMDRF document has not yet
started or is not completed.
This document provides a report on the status of implementation of all IMDRF technical documents 1 as
self-identified by IMDRF members as of the date of publication. In addition to overseeing IMDRF
documents, the IMDRF Management Committee also oversees documents previously published by the
GHTF. While the implantation status of GHTF documents is not included in this report, these documents
are important foundational tools and continue to be managed by the IMDRF.
1
Documents relevant to the Medical Devices Single Audit Program (MDSAP) are not included in this report.
For information on the MDSAP, please see Medical Device Single Audit Program (MDSAP) | FDA
4
IMDRF/MC/N84 FINAL:2024
2. Report
Implementation Level 2
Working Group Document
Implemented Partly Implemented Not Implemented
Software as a Medical IMDRF/SaMD WG/N10 • Brazil • Australia
Device (SaMD) FINAL:2013 • Canada • S. Korea
• China • UK
Software as a Medical • EU • USA
Device (SaMD): Key • Japan
Definitions • Singapore
• *Argentina
• *Switzerland
IMDRF/SaMD WG/N12 • Brazil • Australia
FINAL:2014 • China • Canada
• EU • Japan
Software as a Medical • Singapore • S. Korea
Device: Possible Framework • *Argentina • UK
for Risk Categorization and • *Switzerland • USA
Corresponding
Considerations
IMDRF/SaMD WG/N23 • Australia • Brazil
FINAL:2015 • China • Canada
• EU • Japan
Software as a Medical • Singapore • S. Korea
Device (SaMD): Application • USA • UK
of Quality Management • *Argentina
System • *Switzerland
2 Note that Official Observers are denoted with an asterisk (*) and “NA” is used to indicate when a specific IMDRF document is not applicable in a
country/region.
5
IMDRF/MC/N84 FINAL:2024
Implementation Level 2
Working Group Document
Implemented Partly Implemented Not Implemented
IMDRF/SaMD • Australia • Canada
WG/N41FINAL:2017 • Brazil • Japan
• China • S. Korea
Software as a Medical • EU • UK
Device (SaMD): Clinical • Singapore
Evaluation • USA
• *Argentina
• *Switzerland
Unique Device IMDRF/UDI WG/N7 • Brazil • Japan • Australia
Identification (UDI) FINAL:2013 • China • S. Korea • Canada
• EU • UK
UDI Guidance: Unique • Singapore
Device Identification (UDI) • USA
of Medical Devices • *Argentina
• *Switzerland
IMDRF/UDI WG/N48 FINAL: • Brazil • Japan • Australia
2019 • China • S. Korea • Canada
• EU • UK
Unique Device Identification • Singapore • *Argentina
System (UDI system) • USA
Application Guide • *Switzerland
Regulated Products IMDRF/RPS WG/N9 • Brazil • Australia • EU
Submission (RPS) FINAL:2019 (Edition 3) • Canada • S. Korea • Japan
• China • USA • UK
Non-In Vitro Diagnostic • Singapore • *Argentina
Device Market Authorization • *Switzerland
Table of Contents (nIVD MA
ToC)
IMDRF/RPS WG/N13 • Brazil • Australia • EU
FINAL:2019 (Edition 3) • Canada • S. Korea • Japan
• China • USA • UK
In Vitro Diagnostic Medical • Singapore • *Argentina
Device Market Authorization • *Switzerland
Table of Contents (IVD MA
ToC)
6
IMDRF/MC/N84 FINAL:2024
Implementation Level 2
Working Group Document
Implemented Partly Implemented Not Implemented
IMDRF/RPS WG/N19 • Brazil • Australia • EU
FINAL:2016 • Singapore • Canada • Japan
• China • *Argentina
Common Data Elements for • S. Korea • *Switzerland
Medical Device Identification • UK
• USA
Standards- Improving the IMDRF/Standards WG/N51 • EU • Australia • UK
Quality of International FINAL:2018 • China • Brazil • *ArgentinaNA
Medical Device Standards • S. Korea • Canada
for Regulatory Use Optimizing Standards for • Singapore • Japan
(Standards) Regulatory Use • USA •
• *Switzerland
Good Regulatory Review IMDRF/GRRP • EU • Australia • Brazil
Practices (GRRP) WG/N40FINAL:2017 • Singapore • China • Canada
• *Switzerland • Japan • *Argentina
Competence, Training, and • S. Korea
Conduct Requirements for • UK
Regulatory Reviewers • USA
IMDRF/GRRP WG/N47 • Brazil • Australia
FINAL:2018 • China • Canada
• EU • UK
Essential Principles of • Japan • USA
Safety and Performance of • S. Korea • *Argentina
Medical Devices and IVD • Singapore
Medical Devices • *Switzerland
IMDRF/GRRP WG/N52: • Brazil • Australia
• China • Canada
Principles of Labelling for • EU • Japan
Medical Devices and IVD • S. Korea • UK
Medical Devices • Singapore • USA
• *Switzerland • *Argentina
7
IMDRF/MC/N84 FINAL:2024
Implementation Level 2
Working Group Document
Implemented Partly Implemented Not Implemented
IMDRF/GRRP WG/N59 • EU • China • Australia
FINAL:2020 • USA • Japan • BrazilNA4
• *Switzerland • S. Korea • CanadaNA
Requirements for • UK • SingaporeNA
Regulatory Authority • *Argentina
Recognition of Conformity
Assessment Bodies
Conducting Medical Device
Regulatory Reviews
IMDRF/GRRP WG/N61 • EU • Australia • BrazilNA
FINAL:2020 • *Switzerland • China • CanadaNA
• Japan • SingaporeNA
Regulatory Authority • S. Korea • *ArgentinaNA
Assessment Method for • UK
Recognition and • USA
Surveillance of Conformity
Assessment Bodies
Conducting Medical Device
Regulatory Reviews
IMDRF/GRRP WG/N63 • EU • Australia • BrazilNA
FINAL:2020 • *Switzerland • China • CanadaNA
• Japan • SingaporeNA
Competence and Training • S. Korea • *ArgentinaNA
Requirements for • UK
Regulatory Authority • USA
Assessors of Conformity
Assessment Bodies
Conducting Medical Device
Regulatory Reviews
IMDRF/GRRP WG/N66 • EU • China • Australia
FINAL:2021 • *Switzerland • Japan • BrazilNA
• S. Korea • CanadaNA
Assessment and Decision • UK • SingaporeNA
Process for the Recognition • USA • *ArgentinaNA
of a Conformity Assessment
Body Conducting Medical
Device Regulatory Reviews
8
IMDRF/MC/N84 FINAL:2024
Implementation Level 2
Working Group Document
Implemented Partly Implemented Not Implemented
IMDRF/GRRP WG/N71 • EU • China • Australia
FINAL:2022 • *Switzerland • S. Korea • BrazilNA
• UK • Canada
Medical Device Regulatory • USA • Japan
Review Report: Guidance • SingaporeNA
Regarding Information to be • *ArgentinaNA
Included
Personalized Medical IMDRF/PMD WG/N49 • Australia • S. Korea
Device (PMD) FINAL:2018 • Brazil • UK
• Canada • USA
Definitions for Personalized • China • *Argentina
Medical Devices • EU
• Japan
• Singapore
• *Switzerland
IMDRF/PMD WG/N58 • Brazil • Australia
FINAL:2020 • EU • Canada
• Japan • China
Personalized Medical • Singapore • S. Korea
Devices - Regulatory • *Switzerland • UK
Pathways • USA
• *Argentina
IMDRF/PMD WG/N74 • Singapore • Australia • UK
FINAL:2022 • Brazil • *ArgentinaNA
• Canada
Personalized Medical • China
Devices Production • EU
Verification Validation • Japan
• S. Korea
• *Switzerland
• USA
9
IMDRF/MC/N84 FINAL:2024
Implementation Level 2
Working Group Document
Implemented Partly Implemented Not Implemented
Adverse Event IMDRF/AE WG/N43 • Australia • Brazil
Terminology (AET) FINAL:2021 (Edition 5) • Canada • China
• EU • Japan
IMDRF terminologies for • S. Korea • *Argentina
categorized Adverse Event • Singapore
Reporting (AER):Terms, • UK
terminology structure and • USA
codes
• *Switzerland
Medical Device Clinical IMDRF MDCE WG/N55 • Australia • Canada • UK
Evaluation (MDCE) FINAL:2019 • Brazil • S. Korea • *Argentina
• China
Clinical Evidence - Key • EU
Definitions and Concepts • Japan
(formerly • Singapore
GHTF/SG5/N1R8:2007) • USA
• *Switzerland
IMDRF MDCE • Australia • Canada • UK
WG/N56FINAL:2019 • Brazil • Japan • *Argentina
• China • S. Korea
Clinical Evaluation (formerly • EU
GHTF/SG5/N2R8:2007) • Singapore
• USA
• *Switzerland
IMDRF MDCE • Australia • Canada • UK
WG/N57FINAL:2019 • Brazil • S. Korea • *Argentina
• China • Singapore
Clinical Investigation • EU
(formerly • Japan
GHTF/SG5/N3:2010) • USA
• *Switzerland
10
IMDRF/MC/N84 FINAL:2024
Implementation Level 2
Working Group Document
Implemented Partly Implemented Not Implemented
IMDRF MDCE • Australia • Canada • Brazil
WG/N65FINAL:2021 • EU • China • UK
• *Switzerland • Japan • *Argentina
Post-Market Clinical Follow- • S. Korea
Up Studies • Singapore
(formerly • USA
GHTF/SG5/N4:2010)
Medical Device IMDRF/CYBER WG/N60 • Australia • China • UK
Cybersecurity (Cyber) FINAL:2020 • Brazil • Japan • *Argentina
• Canada • S. Korea
Principles and Practices for • EU
Medical Device • Singapore
Cybersecurity • USA
• *Switzerland
IMDRF/CYBER WG/N70 • USA • China • Australia
FINAL:2022 • EU • Japan • Brazil
• *Switzerland • Singapore • Canada
Principles and Practices for • S. Korea
the Cybersecurity • UK
of Legacy Medical Devices • *ArgentinaNA
IMDRF/CYBER WG/N73 • Canada • Australia • Brazil
FINAL:2022 • USA • China • S. Korea
• Japan • UK
Principles and Practices for • EU • *ArgentinaNA
Software Bill of Materials • Singapore
for Medical Device • *Switzerland
Cybersecurity
Principles of In Vitro IMDRF/IVD WG/N64 • Brazil • China • Australia
Diagnostic (IVD) Medical FINAL:2021 • Canada • Japan • UK
Devices Classification • EU • Singapore • *ArgentinaNA
(IVD) Principles of In Vitro • S. Korea • USA
Diagnostic (IVD) Medical • *Switzerland
Devices Classification
11
IMDRF/MC/N84 FINAL:2024
Implementation Level 2
Working Group Document
Implemented Partly Implemented Not Implemented
Artificial Intelligence (AI) IMDRF/AIMD WG/N67 • Canada • Japan • Australia
FINAL:2022 • China • Singapore • Brazil
• EU • UKNA
Machine Learning-enabled • S. Korea • *ArgentinaNA
Medical Devices: Key • USA
Terms and Definitions • *Switzerland
12
IMDRF/MC/N84 FINAL:2024
Please visit our website
for more details.
www.imdrf.org
Disclaimer
© Copyright 2024 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.
13
