IMDRF
Introduction

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
accelerate international medical device regulatory harmonization and
convergence.

IMDRF was established in October 2011, when representatives from the
medical device regulatory authorities of Australia, Brazil, Canada, China,
European Union, Japan and the United States, as well as the World Health
Organization (WHO) met in Ottawa to address the establishment and
operation of this new Forum.

IMDRF Management Committee, composed of regulatory officials, provides
guidance on strategies, policies, directions, membership and activities of the
Forum

Current Groups :

1. Working Group

International Medical Device Regulators Forum (IMDRF) working groups may
be established by the Management Committee (MC) to progress
harmonization guidances

2. Management Commiittee

The Management Committee (MC) of the International Medical Device
Regulators Forum (IMDRF) is composed of regulatory officials.

3. GHTF archives:

The International Medical Device Regulators Forum (IMDRF) is continuing the
work of the Global Harmonization Task Force (GHTF).

Current members Group

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• Australia (2022 Chair and Secretariat)
• Brazil
• Canada
• China
• Europe
• Japan
• Russia
• Singapore
• South Korea, and
• The United States of America.

History

GHTF was conceived in 1992 in an effort to achieve greater uniformity
between national medical device regulatory systems.

It was established with two aims in mind: enhancing patient safety and
increasing access to safe, effective and clinically beneficial medical
technologies around the world

The organisation GHTF no longer exists, and has been permanently
replaced by the IMDRF

A partnership between regulatory authorities and regulated industry,
the GHTF was comprised of five Founding Members: European Union,
United States, Canada, Australia and Japan.

The purpose of the GHTF was to encourage convergence in regulatory
practices related to ensuring the safety, effectiveness/performance and
quality of medical devices, promoting technological innovation and
facilitating international trade, and the primary way in which this was
accomplished was via the publication and dissemination of harmonized
guidance documents on basic regulatory practices.

These documents, which were developed by five (5) different GHTF
Study Groups, can be adopted/implemented by member national
regulatory authorities. The relationships between the work of each
Study Group can be represented schematically.

GHTF Study Groups

• Study Group 1 – Premarket Evaluation

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• Study Group 2 – Post-Market Surveillance/Vigilance
• Study Group 3 – Quality Systems
• Study Group 4 – Auditing
• Study Group 5 – Clinical Safety/Performance

Working Groups:

Artificial Intelligence Adverse Event Good Regulatory Review
Medical Devices Terminology Practices

Medical Device Clinical Personalized Medical lDevice Cybersecurity
Evaluation Devices (PMD Guide

Regulated Product
Submission

1. Artificial Intelligence Medical Devices

The Charter of the Artificial Intelligence Medical Devices working group
is to achieve an aligned approach to the management of artificial
intelligence (AI) based-medical devices.

the first project of the working group will cover machine learning-based
medical devices representing AI technology applied to medical devices

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and further standardize terminology for machine learning-based medical
devices among member jurisdictions.

2. Adverse Event Terminology
The purpose of this working group is to:

• improve, harmonize and where necessary expand the terminology and
systems being used to code information relating to medical device
adverse events, and

• establish IMDRF adverse event terminology composed of the following
three parts: terms for medical device malfunction, terms for
patient/user outcome and terms for part/component of medical device.

3. Good Regulatory Review Practices

the charter of the Good Regulator Review Practices (GRRP) working
group is to develop guidance that establishes good regulatory review
practices for regulatory authorities and/or their conformity assessment
bodies.

4. Medical Device Clinical Evaluation

The purpose of the working group is to improve the effectiveness and
efficiency of pre-market review by promoting increased global
harmonization in approach and requirements on leveraging and
evaluating the available clinical evidence, reduce the number of
redundant clinical trials, integrate the principles of post-market clinical
follow up and real world evidence, as applicable, and accelerate the
introduction of new safe and effective medical devices/ technologies to
the patients in variable jurisdictions

5. Medical Device Cybersecurity Guide

As medical devices become more connected, there is the potential to
impact patient safety. This is evident as cybersecurity incidents have
rendered medical devices and hospital networks inoperable, disrupting
the delivery of patient care across healthcare facilities worldwide. The
purpose of this Work Item is to promote a globally harmonized approach
to medical device cybersecurity that at a fundamental level ensures the
safety and performance of medical devices while encouraging

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innovation. The Work Item is thus intended to provide medical device
cybersecurity guidance for stakeholders across the device lifecycle.

6. Personalized Medical Devices (PMD)

The purpose of this Work Item is to develop guidance documents for
providing harmonized recommendations for the regulation of PMDs. The
adoption of consistent and harmonized requirements for PMDs across
various jurisdictions will offer significant benefits to users, patients,
manufacturers, and regulatory authorities.

The document will provide technical guidance on:

• Validation of the specified design envelope that is one of the defining
features of a patient-matched medical device

• Validation of a Medical Device Production System

7. Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
The objective of the Working Group is to review and update Principles
of the in vitro Diagnostic (IVD) Medical Devices Classification document, taking
into account the current level of development and experience in applying the
risk-based approach to the classification of IVD medical devices.

The goal is to promote global harmonization in the premarket review
processes.

8. Regulated Product Submission

The charter of this working group is to build on the common Table of Contents
for medical device regulatory submissions and create a dynamic template that
supports the electronic transmission of regulatory submissions.

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