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Medical Device Regulations
Medical Device Regulations
A Complete Guide
AAKASH DEEP
Department of Pharmaceutical Sciences, Chaudhary Bansi Lal
University, Bhiwani, Haryana, India
Academic Press is an imprint of Elsevier
125 London Wall, London EC2Y 5AS, United Kingdom
525 B Street, Suite 1650, San Diego, CA 92101, United States
50 Hampshire Street, 5th Floor, Cambridge, MA 02139, United States
The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, United Kingdom
Copyright © 2022 Elsevier Inc. All rights reserved.
No part of this publication may be reproduced or transmitted in any form or by any means,
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can be found at our website: www.elsevier.com/permissions.
This book and the individual contributions contained in it are protected under copyright by the
Publisher (other than as may be noted herein).
Notices
Knowledge and best practice in this field are constantly changing. As new research and
experience broaden our understanding, changes in research methods, professional practices, or
medical treatment may become necessary.
Practitioners and researchers must always rely on their own experience and knowledge in
evaluating and using any information, methods, compounds, or experiments described herein. In
using such information or methods they should be mindful of their own safety and the safety of
others, including parties for whom they have a professional responsibility.
To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors,
assume any liability for any injury and/or damage to persons or property as a matter of products
liability, negligence or otherwise, or from any use or operation of any methods, products,
instructions, or ideas contained in the material herein.
British Library Cataloguing-in-Publication Data
A catalogue record for this book is available from the British Library
Library of Congress Cataloging-in-Publication Data
A catalog record for this book is available from the Library of Congress
ISBN: 978-0-323-91126-9
For Information on all Academic Press publications

visit our website at https://www.elsevier.com/books-and-journals
Publisher: Mara Conner

Acquisitions Editor: Carrie Bolger
Editorial Project Manager: Rafael G. Trombaco
Production Project Manager: Sojan P. Pazhayattil
Cover Designer: Christian J. Bilbow
Typeset by MPS Limited, Chennai, India
Contents
Preface xiii
1. Introduction to medical devices 1

1.1 Introduction 1
1.2 Classifications of medical devices on the basis of risk 1
1.2.1 Medical device safety and performance 1
1.3 The basic design and manufacturing principles listed in this section apply to
IVD and medical devices 2
1.3.1 Common principles 2
1.3.2 Clinical investigation 3
1.3.3 Physicochemical and biological properties 3
1.4 History of medical device regulations globally 3
1.5 Product life cycle of medical device 5
1.6 The five stages of the medicinal product life cycle 5
1.6.1 Investigation 5
1.6.2 Design 5
1.6.3 Validation 6
1.6.4 Launch 6
1.6.5 Postmarket review 6
1.7 International Medical Device Regulators Forum 7
1.8 IMDRF Management Committee 7
1.8.1 Purpose of IMDRF 7
1.8.2 Organizational convergence IMDRF 7
1.9 Global Harmonization Task Force (GHTF) 8
1.9.1 Safety management 8
1.10 Summary Technical Documentation 8
1.11 Global medical device nomenclature 10
1.12 Conclusion 10
References 10
2. Ethics of clinical trials of medical devices 13

2.1 Introduction 13
2.1.1 Clinical investigation of medical devices 13
2.2 Clinical investigational plan for medical devices 13
2.3 Clinical investigation conduct 13
2.3.1 General 13
2.3.2 Investigation site initiation 14
v
vi Contents
2.3.3 Investigation site monitoring 14

2.3.4 Adverse events and device deficiencies 14
2.3.5 Clinical investigation documents and documentation 14
2.3.6 Additional members of the investigation site team 14
2.3.7 Subject privacy and confidentiality of data 14
2.3.8 Document and data control 15
2.3.9 Investigational device accountability 15
2.3.10 Accounting for subjects 15
2.3.11 Auditing 15
2.4 ISO 14155:2011 15
2.5 International Council on Harmonization of Good Clinical Practice 16
2.6 International Council on Harmonization of Good Clinical Practice principles 16
2.7 ISO 13485:2016: quality management system of medical devices requirements
for regulatory purposes 17
2.8 General requirements of quality management system 18
2.9 ISO 14971:2019 medical device risk management applications 18
2.10 Risk management application throughout the lifecycle of the device 19
2.10.1 Planning 19
2.10.2 Documentation 19
2.10.3 Risk analysis/evaluation 19
2.10.4 Risk control 20
2.10.5 Production and postproduction information 20
2.10.6 Risk management process 20
2.11 Conclusion 21
References 21
3. Regulations for medical devices in the United States 23

3.1 Introduction 23
3.2 US Food & Drug Administration 23
3.3 Classification of medical devices (I, II, and III) 23
3.3.1 Class I devices 23
3.3.2 Class II devices 24
3.3.3 Class III devices 24
3.4 Regulatory approval process for medical device 24
3.5 Premarket notification 510 (k)—21 CFR Part 807 E 25
3.6 Premarket approval 25
3.7 Approval process of medical devices in the USA: it follows some steps 27
3.8 Investigational device exemption 28
3.9 Quality system requirements 21 CFR part 820 28
3.10 Labeling requirements 21 CFR Part 801 29
3.11 Postmarketing surveillance of medical device 30
Contents vii
3.12 Unique device identification of medical device 30

3.13 Conclusion 31
References 31
4. Regulations of medical devices in Europe 33

4.1 Introduction 33
4.2 Classification of medical devices 33
4.3 Medical devices’ laws in Europe 34
4.4 The new approach for regulating products—key features 35
4.5 Regulatory approval process of medical device 35
4.6 Notified bodies in Europe 37
4.7 CE Marking in Europe for medical devices 37
4.8 Procedure 37
4.9 Documents required for medical device marketing approval 37
4.10 Labeling requirements 38
4.11 Medical device labeling: EU Regulation MDR 2017/745 38
4.12 Product labeling and QMS—EU MDR 38
4.13 Conclusion 39
References 39
5. Regulations of medical devices in ASEAN countries 41

5.1 Introduction 41
5.2 Members of the Association of Southeast Asian Nations 41
5.3 ASEAN Common Submission Dossier Template 42
5.4 Product registration on the basis of CSDT ASEAN 42
5.5 General criteria to register a medical device 42
5.6 ASEAN CSDT format 43
5.6.1 Summary 43
5.6.2 Elements of the common submission dossier template 43
5.7 Registration process in ASEAN countries 44
5.7.1 Thailand 44
5.7.2 Singapore 45
5.7.3 Malaysia 45
5.7.4 Indonesia 47
5.7.5 Vietnam 48
5.7.6 Brunei Darussalam 49
5.7.7 Laos 50
5.7.8 Cambodia 50
5.7.9 Myanmar 51
5.7.10 Philippines 53
5.8 Conclusion 53
References 54
viii Contents
6. Regulations of medical devices in Japan and China 57

6.1 Introduction on medical device in Japan 57
6.2 Regulatory authorities 57
6.2.1 Japan’s agency for pharmaceutical products and medical devices 57
6.2.2 Japan’s Ministry of Health, Labor, and Welfare 58
6.3 Medical device classification 58
6.4 Regulatory approval process in Japan 58
6.4.1 Marketing authorizing holder in Japan 58
6.4.2 Review procedure 59
6.4.3 Approval process: process flowchart showing the approval process 59
6.5 Introduction to medical device in China 62
6.6 Regulatory authorities 62
6.7 Classification 62
6.8 Registration procedure 63
6.10 Challenges 64
6.11 Conclusion 64
References 65
7. Regulations of medical devices in Canada 67

7.1 Introduction 67
7.2 Definition of medical device 67
7.3 Action plan for medical devices from the Canadian Health Ministry 67
7.5 Medical device premarket requirements in Canada 69
7.6 Canadian Medical Devices Conformity Assessment System 69
7.7 Application form for registration of medical device 69
7.8 Registration requirements 74
7.9 Note 74
7.10 Registration procedure 75
7.11 Medical Device License 76
7.12 Labeling requirements of medical device in Canada (Section 21) 77
7.13 Timeframe: the approval process varies by device class 78
7.14 Special requirements 79
7.15 Local fees 79
7.16 License validity 79
7.17 License transfer 79
7.18 Authorized representative/license holder 79
7.19 Conclusion 79
References 80
Contents ix
8. Regulations for medical devices in India 83

8.1 Introduction 83
8.2 Classification of medical device in India 84
8.3 Proposed classification system for medical devices 84
8.4 Regulations in India 85
8.5 Market of medical devices 85
8.6 Central Drugs Standard Control Organization (CDSCO) 85
8.7 Medical device definition as per CDSCO 86
8.8 Medical device registration process 87
8.9 The documents needed for registration 87
8.10 Approval process of medical device in India 88
8.11 Manufacture of medical devices for sale or for distribution 88
8.11.1 Class A and B 88
8.11.2 Class C and D 89
8.12 Import of medical devices 90
8.13 Inspection of foreign manufacturing facilities 90
8.14 A proposal to regulate medical devices in India 90
8.15 New proposed regulations for clinical trials 92
8.16 Reporting of medical devices in India 93
8.17 Labeling of medical devices 94
8.18 Recall of medical devices 94
8.19 Conclusion 94
References 95
9. Regulations of medical devices in Australia 97

9.1 Introduction 97
9.2 An overview of Australia’s medical devices regulatory authority 97
9.3 Definition of medical device as per TGA 97
9.4 Classification of medical device 98
9.5 Lifecycle approach to regulation 98
9.6 Postmarketing regulations 99
9.7 Medical device registration in Australia 99
9.8 Medical device regulatory system in Australia 100
9.9 Essential principle of medical devices in Australia 100
9.10 Declaration of Conformity 101
9.11 Overview of medical device regulations in Australia 101
9.12 Regulatory framework of medical device in Australia 101
9.13 Conformity assessment and ARTG inclusion 103
9.14 Templates Declaration of Conformity (medical devices) 103
9.15 Medical device inclusion process 106
9.16 Postmarket surveillance 107
x Contents
9.17 Fees of medical devices in Australia 107

9.18 Conclusion 111
References 112
10. Regulations of medical devices in Gulf Cooperation Council countries 113

10.1 Introduction: Gulf Cooperation Council countries 113
10.2 Saudi Arabia 113
10.3 Saudi Food and Drug Authority 114
10.4 Medical device definition as per SFDA 115
10.5 Classification of medical devices in Saudi Arabia 115
10.6 Medical device regulations in Saudi Arabia 116
10.7 Required documents 116
10.8 Medical device technical documentation 117
10.9 Essential principles of medical devices 119
10.10 Supplying medical devices to the KSA market 119
10.11 Registration and listing requirements 120
10.12 Medical devices marketing authorization 121
10.13 The approval process for medical devices in Saudi Arabia 122
10.14 Timeframe 123
10.16 Local fees 123
10.20 Labeling requirements of medical devices 124
10.21 Postmarketing surveillance of medical device 124
10.22 Kuwait 124
10.24 Documents required for registration 126
10.25 Registration and regulations of medical devices in Kuwait 126
10.26 Timeframe 127
10.28 Local fees 127
10.32 Bahrain 128
10.34 Authorized representative registration 128
10.35 Registration of medical devices 129
10.36 Validity 130
Contents xi
10.37 Renewal 130

10.38 Qatar 130
10.40 Additional information 130
10.41 Oman 131
10.43 Documents required for registration of medical device 131
10.44 Medical device regulations in Oman 133
10.45 Time period 133
10.47 Authorized representative 133
10.48 United Arab Emirates 133
10.50 Medical device registration and regulation procedure in UAE 135
10.51 Documents required for the registration: two registrations required 135
10.52 Registration process flowchart 137
10.53 Timeframe 138
10.55 Authorized representative 138
10.56 Conclusion 138
References 138
11. Regulations of medical devices in Sri Lanka 141

11.1 Introduction 141
11.2 Scope and responsibilities of the NMRA for the approval of medical devices 141
11.3 Medical device definition as per NMRA 142
11.4 Medical Device Evaluation Committee 142
11.5 Medical device classification system 142
11.6 Registration process of medical device 142
11.6.1 MAH or applicant responsibilities 143
11.6.2 Sample license request 143
11.6.3 Application submission 143
11.6.4 Multiple applications 147
11.6.5 File submission procedure 148
11.6.6 Special needs 148
11.6.7 Technical documents 149
11.6.8 Evaluation processing 149
11.6.9 Extension of the validity period of registration certificate and license 150
11.6.10 Application for import license 150
11.7 Conclusion 151
References 151
xii Contents
12. Regulations of medical devices in Russia 153

12.1 Introduction 153
12.2 Medical device definition 154
12.4 Documents required 155
12.5 Russia medical device registration requirements 156
12.7 Documents required for foreign manufacturer 157
12.8 Approval of medical devices in Russia 158
12.9 Regulations of medical devices in Russia 159
12.10 Renewal of certain national standards related to medical devices in Russia 161
12.11 State registration of medical devices 161
12.12 Conclusion 162
References 162
Index 165
Preface
The idea of writing this book was conceived when my own students found great diffi-
culty in getting the recent literature regarding the Regulation of Medical Devices.
A major aim of this book was to provide recent literature regarding the current
Regulation of Medical Devices. The current book is a compilation of a brief review
of various regulatory bodies of major developed and developing countries around the
world and the Registration Procedure of Medical Device of such Pharmaceutical
Regulatory Organizations in delivery of safe and effective healthcare products.
I thank the worthy Vice Chancellor of Chaudhary Bansi Lal University, Bhiwani,
Prof. Raj Kumar Mittal, for his constant motivation and support. I thank Dr. Jitender
Kumar Bhardwaj, Registrar, Chaudhary Bansi Lal University, Bhiwani, for the moti-
vation and guidance.
It is my proud privilege to express my sincere gratitude to Prof. Narasimhan B.,
Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, for
his constant unceasing encouragement to combine my mental images with emotion of
desire to accelerate their realization.
I gratefully acknowledge my Chairman Prof. Nitin Bansal, Department of
Pharmaceutcial Sciences, Chaudhary Bansi Lal University, Bhiwani, Dr. Prabodh
Chander Sharma, Delhi Pharmaceutical Sciences and Research University, New
Delhi, and Prof. D.N. Mishra for their blessings.
I feel to thank to my parents, Sh. Raj Karan and Smt. Kamla Devi and my better
half Priyanka, sisters Sharda, Sangeeta, and Meenakshi, and my kids Hargun and Seerat
who have helped me in bringing out this book.
I humbly and generously call upon all my colleagues to give due considerations to
this piece of art. Thanks are also due to my energetic and dynamic publisher Elsevier
Publishing Company to bring out this book well in time.
Dr. Aakash Deep
xiii
CHAPTER 1
Introduction to medical devices
1.1 Introduction
The term “medical device” includes everything from highly complex computerized
medical equipment to simple wooden tongue inhibitors. Unlike drugs, the fundamental
way of working the medical device on the physical body is not metabolic, immunologi-
cal, or medicinal.
“Medical device” means any device, implant, reagent, or titrator in the laboratory,
any program, tool, or any other similar or related material intended by the manufac-
turer for use alone or together with humans with one or more of the targets set for
• diagnosis, control, prevention, treatment, or relief from disease;
• diagnosis, monitoring, treatment, relief, or compensation for injury;
• investigate, replace, modify, or support anatomy;
• physiological process;
• support or preserve life;
• design control;
• disinfection of medical devices; and
• providing medical information through a laboratory examination of the physical
body samples that do not accomplish the intended primary action on or on the
physical body by medicinal, immunological, or metabolic means, but can be
accompanied in its function by these means [1].
1.2 Classifications of medical devices on the basis of risk

The International Medical Device Regulators Forum (IMDRF) classifies medical devices
based on risk to assess the level of premarket regulatory control that is necessary for using
medical devices, with the goal of ensuring that these controls are appropriate for each
class to protect the health and safety of patients, users, and other people. As shown in
Fig. 1.1, the outcome of the system is to group IVDs (in vitro diagnostic device) into
one of four risk classes (A D) [2].
1.2.1 Medical device safety and performance

A medical device and IVD manufacturer should design and manufacture a product
that is both safe and effective throughout its life cycle. This document outlines the
Medical Device Regulations r 2022 Elsevier Inc.

DOI: https://doi.org/10.1016/B978-0-323-91126-9.00001-8 All rights reserved. 1
2 Medical Device Regulations
Figure 1.1 Classification of IVD medical devices.
basic design and manufacturing standards, referred to as the “Essential Principles of

Safety and Performance,” that must be met to achieve this result [3].
1.3 The basic design and manufacturing principles listed in this

section apply to IVD and medical devices
1.3.1 Common principles
IVD and medical devices should meet the manufacturer's [4,5] performance expecta-
tions, and they should be designed and manufactured in such a way that they are
suitable for their intended use under the conditions of intended use. They should be
safe and operate as intended and present acceptable risks compared to the benefits for
the patient, and they must not harm the clinical condition or patient safety, or the
safety and health of users, or others, if any.
To ensure the quality, safety, and continuous performance of the medical device
and IVD, manufacturers should develop, implement, document, and maintain a risk
management system. Risk management should be viewed as an ongoing iterative pro-
cess that requires regular periodic updates throughout the life of the medical device
and IVD. To implement risk management, manufacturers must:
• make a risk management plan for each IVD and document it;
• provide safety information (precautions/warnings/contra-indications) and appropri-
ate training to users; and
• ascertain the known and expected risks associated with and medical device.
Introduction to medical devices 3
1.3.2 Clinical investigation

A clinical evaluation may be required in some cases, depending on jurisdictional
requirements. A clinical evaluation should evaluate clinical data to determine if the
medical device and IVD have a favorable benefit risk determination in the form of
one or more of the following:
• clinical research reports (for clinical performance appraisal reports);
• publications/scientific journals published; and
• clinical experience.
Clinical research should be carried out in accordance with the ethical principles
outlined in the Declaration of Helsinki. These principles protect human rights, secu-
rity, and welfare, and they are the most important considerations in science and soci-
ety, and they will prevail. At every stage of clinical investigation, these principles must
be understood, observed, and applied. In addition, some countries may have specific
regulatory requirements for prestudy protocol review, informed consent, and the use
of excess IVD samples [6].
1.3.3 Physicochemical and biological properties

With regard to the chemical, physical and biological properties of a medical device
and an IVD, special attention should be given to the following [7]:
• The choice of materials used, especially with regard to:
• biocompatibility,
• toxicity, and
• flammability;
• The effect of operations on the properties of materials;
• Where possible, previously validated biophysical or modeling research results;
• The mechanical properties of the materials used, which, when applicable, reflect issues
like strength, ductility, break strength, wear resistance, and fatigue resistance; and
• Surface properties.
1.4 History of medical device regulations globally

1. Janet E. Trunzo, Senior Advisor to the President and Senior Executive Vice
President, Technology and Regulatory Affairs, for the Advanced Medical
Technology Association (AdvaMed) who leads a team of regulatory experts, pre-
sented a summary of efforts to harmonize regulatory approaches for medical
devices. The coordination decision came from various stakeholders, including
governments, industry, and therefore the public. Coordination provides a consis-
tent application of organizational principles and approaches and improves the
effectiveness and efficiency of the organizational system. There is a discount on

repeated organizational activities, saving time and cost. New products and tech-
nologies come to market in a cumulative and improved way, and the process is
more transparent [8].
2. Many regulatory programs use international standards and guidelines as a basis for
their national technical regulations. Trunzo noted that a large number of Food and
Drug Administration (FDA) staff participated in various regulatory standards com-
mittees. It is also important that regulatory systems seek the views of stakeholders
as part of the coordination process.
3. Global Harmonization Task Force (GHTF) was a voluntary group created in 1992
as a link to regulators and therefore to an organized industry. The founding mem-
bers were the United States, the European Union, Canada, Australia, and Japan.
There were links with other organizations around the world, including the Asian
Coordination Working Group; the GHTF had a Memorandum of Understanding
(MOUs) with ISO and, accordingly, with the Independent Ethics Committee,
working directly with the World Health Organization, and thus with the Pan
American Health Organization. GHTF has been permanently replaced by
International Medical Device Regulators Forum (IMDRF) in 2011 [9].
4. The objectives of the Global Forum to Promote Growth were to promote the conver-
gence of global regulatory practices and the commercialization of technology innovation
and international trade through coordinated regulatory processes. The working group
was also designed to act as a forum for the exchange of information (GHTF did not
evaluate the effectiveness of regulatory systems around the world) [10].
5. GHTF Structure: The GHTF Forum was chaired by a panel of 4 regulatory and 4
industry representatives from each of the three geographic regions: North America,
Europe, and Asia Pacific (total of 24 members). The direction of the committee
changed every 3 years. In addition to the committee, which guided the work and
defined the organization's strategic plan, there were five study groups and
unplanned working groups, as need dictated.
6. The premarket research group (Study Group 1) produced a number of papers that
helped to shape the concept of a harmonized regulatory model. Study Group 2,
which focused on postmarketing issues, was charged with developing procedures
to monitor and report negative events. Quality systems, the primary objective of
Study Group 3, benefit from the International Standard ISO 13485 Quality
Management Systems.
7. The main theme of the activity is the principles of classification; in particular,
the creation of standard vocabulary. Other core topics include technical
requirements, the shape and content of sales applications, evaluation and review
practices, postmarketing activities, quality management system, and business
function requirements [11].
1.5 Product life cycle of medical device

The Medical Product Life Cycle is associated with regulatory processes for industry
leaders in the United States, the European Union, and other countries that mimic
their policies. However, the relationship between the Legislative Council and regula-
tion is not always clear to many. Managing products throughout their lifecycle is
essential for end users, and thus for the companies that produce and market them.
Understanding the inseparable link between regulation and markets and therefore
the medical device industry is essential for the assembly of safe and effective devices,
sustainable clinical improvements for the industry, and thus for long-term medical
ethics dating back to “do not hurt” [12].
1.6 The five stages of the medicinal product life cycle

Medical devices are most commonly used to diagnose or treat patients, but some are
also frequently used to educate people about their health. Regardless of their intended
use, these devices would go through the same five steps: research, production, testing,
launch, and postmarket assessment.
1.6.1 Investigation
The concept may be an idea for a new or improved system based on the use of an
existing device. In any case, thorough research is essential to ensure a viable definition.
Many products will not progress beyond this stage because their developers have not
thoroughly researched their idea. They can, ideally, respond to the following
questions:
• Who is the target audience for this product?
• What are the threats associated with mechanical and manufacturing processed?
• Is the concept unique in relation to all or any other devices designed to perform a
similar function?
• It is best to discuss a concept with an experienced engineer who has previously
worked on similar medical devices. To help answer those questions, they will con-
duct a critical assessment of a commodity.
1.6.2 Design
The machine has been developed, reviewed, updated, and redesigned using agile
product engineering. Computer models and prototypes are used to test the design and
assess its marketability. Here are some tools to help you think positively:
• 3D printing: 3D printing made rapid prototypes available to the general public by
allowing manufacturers to create models quicker and gain a better understanding
of them. This gives the designer a rough idea that he or she can use to develop the
product.
• Powder Layer Mergers—a high-density laser that fuses powdered metal materials
into 3D models and shapes. Powder bed combinations enable designers to build
stronger designs, making them a common option for medical device prototypes.
• Computer numerical control (CNC) machining: this approach is particularly useful
when working with raw materials to create a design. Since the machine controls
manufacturing equipment and 3D printers, a complex, detailed design, and high-
quality prototypes are produced.
1.6.3 Validation
The FDA has developed guidelines for certain medical devices. The controls and para-
meters varied by device type, with devices being classified on a scale of one to three in
terms of their function, invasiveness, and risk level. When it comes to checking the
result and ensuring a positive outcome, the device's class will decide what controls
are required. Clinical trials should be performed and submitted at this stage, if they are
needed, so that the maker can request premarket approval.
1.6.4 Launch
• The content creator will begin promoting and selling its goods after obtaining pre-
sale approval from the FDA, if necessary.
• Premarket approval may be a an FDA message to content creators indicating that it
is secure for the general public.
• If the device requires such approval, it will not be possible to start marketing or
selling before receiving it. On the positive side, only about 5% of all medical
devices require this strict and costly process. This is great news for many young
creators, who may not have the $94 million needed to provide the general public
with a tool that requires premarket approval.
• To ensure that the materials comply with legislation and that the marketing strate-
gies are acceptable, marketing must work closely with a legal team. Marketing
messages and methods must be carefully planned through this matter and are likely
to be better managed by companies with specific medical device expertise.
1.6.5 Postmarket review

The project does not stop until the device is released to the public. After the product
is released, the creator must monitor for harmful effects, complete necessary checks,
report adverse events, and likely complete recalls and device removals. Postmarket
monitoring is an important aspect of this, as developers must keep track of the effects
of their goods and keep meticulous records of them. It is also important to keep track
of medical history and keep track of patient registries. This stage may also include
launching the device in secondary markets [13].
1.7 International Medical Device Regulators Forum

The International Medical Device Regulators Forum (IMDRF) was designed in
February 2011 as a forum to discuss future directions for coordinating the regulation
of medical devices. It is a voluntary group of medical device organizers from all over
the world who have been able to build on the strong foundational work of the Global
Medical Devices Coordination Group (GHTF) and accelerate the fulfillment of aims
to the international device coordination and convergence of physicians [14].
1.8 IMDRF Management Committee

The IMDRF Management Committee, made up of regulators, advises on forum strat-
egies, procedures, directives, membership, and events. The management committee
also manages working groups that draw on the expertise of numerous stakeholder
groups, including industry, academia, health practitioners, and customers and business
groups. The current members are [7]:
• Brazil
• Canada
• Australia
• Singapore
• South Korea
• United States
• China
• Europe
• Japan
• Russia.
1.8.1 Purpose of IMDRF

The mission of the IMDRF is to strategically accelerate the regulatory convergence of
international medical devices to commercialize an effective and efficient medical
device regulatory model that responds to new challenges in this sector while protect-
ing public health and maximizing security.
1.8.2 Organizational convergence IMDRF

Organizational convergence (hereinafter referred to as “convergence”) is a voluntary
mechanism in which regulatory criteria and approaches in countries and regions
become more similar or harmonized over time as a result of the adoption of
comparable technical documents, norms, and scientific principles. Coordination and

similar organizational practices and procedures are encouraged. The process of conver-
gence is a critical form of organizational cooperation that permits additional and
improved types of cooperation and synergy between regulatory authorities [15].
1.9 Global Harmonization Task Force (GHTF)

1. Global Harmonization Task Force was established to coordinate (GHTF) in 1993 by
governments and industry representatives from Australia, Canada, Japan, and the
European Union, and the United States. GHTF aimed to promote the convergence of
standards and regulatory practices associated with the safety, performance, and quality of
medical devices. The Global Technical Forum also promoted technological innovation
and facilitated international trade. The main way to achieve its goals were to publish
and publish harmonized guidance documents for core organizational practices.
2. Medical devices are subject to inadequate national policies and legislation in the major-
ity of developing countries. WHO cooperation with the World Health Forum can
facilitate developing countries (importers and industrialists) access to [16]:
• information on the major medical device regulatory frameworks;
• approvals for medical equipment and reviews of health technology from highly
regulated markets;
• adoption of a single nomenclature for medical devices;
• innovative technology advances; and
• postmarket monitoring and vigilance networks.
1.9.1 Safety management

The safety and performance of medical devices depend on two main critical elements
(premarket and postmarketing surveillance). Premarket (group 1) review contributes to
product control, and postmarketing surveillance (group 2) ensures that medical devices in
use continue to be safe and effective. There is an important third element, which is the
representation of the product to the user [17]. All three elements are depicted in Fig. 1.2.
1.10 Summary Technical Documentation

1. The Summary Technical Documentation (STED) has been developed to encourage
further standardization of regulatory cards for medical devices in all markets [18,19].
2. STED is recognized by American, European, Canadian, Australian, and Japanese
regulators, as well as in other markets.
3. The IMDRF has planned STED format updates, but so far there is little in the
scope for determination.
Figure 1.2 Elements of safety management.
4. Manufacturers of all categories of IVD must demonstrate compliance of IVD with

the basic principles of safety and performance of medical devices 5 by preparing
and storing technical documents explaining how to develop the medical device,
design and manufacture each IVD with descriptions and explanations necessary to
understand the manufacturer's decision regarding this compliance. These technical
documents have been revised to reflect the current state of the IVD via the manu-
facturer's regular Quality Management System application.
5. For conformity assessment purposes, the manufacturer collects STED from existing
technical documents to supply approved representative (AR)/conformity assess-
ment body (CAB) proving that the relevant IVD conforms to basic principles.
STED reflects the condition of the IVD at a specific point in time (e.g., at the
time of premarket rendering or when ordering AR for postmarketing purposes)
and is ready to respond to regulatory requirements.
6. Before and after market use, however, the conditions for use of STED are differ-
ent. When STED is sent to the AR/CAB, it must be written in a language
acceptable to the examination authority. The depth and detail of knowledge found
in STED is mainly based on classification topic of IVD.
7. Send feedback.
8. History.
9. Saved.
10. Community.
1.11 Global medical device nomenclature

1. GHTF (now IMDRF) proposes Global Medical Device Nomenclature (GMDN)
for unique device identifier (UDI) [20].
2. Ethics Committee (EC) proposes GMDN for the EUDAMED (market surveillance
database).
3. EUCOMED supports the utilization of GMDN in meeting the needs of European
manufacturers.
4. EC has translated the GMDN into 20 languages.
5. WHO and Medecins Sans Frontieres (MSF) use GMDN in guidance for develop-
ing countries Collaboration Agreement with International Health Terminology
Standards Development Organisation (IHTSDO) (Snomed CT).
6. US FDA is using GMDN within the first national implementation of UDI.
1.12 Conclusion
The present study provides desirable information of medical devices for medical pur-
poses and provides all information regarding their use, marketed surveillance, and all
safety protocols to reduce risks that arouse during their use and information on the
main regulatory systems for medical devices. Medical devices are regulated by various
regulatory authorities who are recruited by management committees to smoothly run
the devices and reduce all risks.
References
[1] WHO, Medical Device Regulations. Global Overview and Guiding Principles [Internet]. [cited April
29, 2020]. https://www.who.int/medical_devices/publications/en/MD_Regulations.pdf, 2020.
[2] Principles of In Vitro Diagnostic (IVD) Medical Devices Classification. Available From: https://www.imdrf.
org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-wng64.pdf. 2021, 2021 (cited 08-08-22).
[3] EMERGO, India: Draft Essential Principles for Medical Device Safety and Performance Out for
Comment. [cited April 29, 2020]. https://www.emergobyul.com/blog/2017/07/india-draft-essen-
tial-principles-medical-device-safety-and-performance-out-comment, 2020.
[4] RAPS, IMDRF Guidance Addresses Essential Principles for Medical Devices, IVDs. [cited 29 April
2020]. https://www.raps.org/news-and-articles/news-articles/2018/1/imdrf-guidance addresses-
essential-principles-for, 2020.
[5] Government of India, Essential Principles for Safety and Performance of Medical Device Guideline.
[cited February 2, 2021]. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-docu-
ments/medical-device/Essentialprinciples.pdf, 2021.
[6] S.S. Altayyar, The essential principles of safety and effectiveness for medical devices and the role of
standards, Med. Devices Evid. Res. 13 (2020) 49 55.
[7] IMDRF, Essential Principles of Safety and Performance of Medical Devices and IVD Medical
Devices. [cited April 30, 2020]. http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-
181031-grrp-essential-principles-n47.pdf, 2020.
[8] Advanced Medical Technolgy Association, Jant E. Tronzo. Senior Advisor to the President and
Senior Executive Vice President, Technology & Regulatory Affairs. [cited 17 February 2021].
https://www.advamed.org/about/leadership/janet-trunzo, 2021.
[9] IMDRF, About IMDRF. [cited 30 April 2020]. http://www.imdrf.org/about/about.asp, 2020.

[10] Lexology, A Brief Overview of Regulatory Framework for Medical Devices in India. [cited 30 April
2020]. https://www.lexology.com/library/detail.aspx?g 5 e39ba922-f7c6-4568-a7e0-9b753769ada6, 2020.
[11] T. Wizemann, The Global Framework for Regulation of Medical Devices. [cited April 30, 2020].
https://www.ncbi.nlm.nih.gov/books/NBK209785/, 2020.
[12] B. Fiedler, Y. David, Reframing product life cycle for medical devices, in: Managing Medical
Devices Within a Regulatory Framework, 2017, pp. 3 16. [cited 30 April 2020]. https://www.
sciencedirect.com/science/article/pii/B9780128041796000010.
[13] S. Daugherty, Understanding the Medical Device Product Life Cycle. [cited April 30, 2020].
https://www.pacific-research.com/understanding-the-medical-device-product-life-cycle-prl/, 2020.
[14] International Medical Device Regulators Forum, [cited April 30, 2020]. http://www.imdrf.org/, 2020.
[15] MassMEDIC, International Medical Devices Regulators Forum (IMDRF). [cited April 30, 2020].
https://www.massmedic.com/wp-content/uploads/2014/12/IMDRF-Presentation-Dec2014.pdf, 2020.
[16] WHO, Global Harmonization Task Force (GHTF). [cited April 30, 2020]. https://www.who.int/
medical_devices/collaborations/force/en/, 2020.
[17] S. Ramakrishna, L. Tian, C. Wang, S. Liao, W. Teo, Global harmonization of medical devices,
Med. Devices (2015) 207 213.
[18] EMERGO, What Is the STED Format for Medical Device Technical Documentation? [cited April
30, 2020]. https://www.emergobyul.com/blog/2016/10/what-sted-format-medical-device-techni-
cal-documentation, 2020.
[19] IMDRF, Summary Technical Documentation (STED) for Demonstrating Conformity to the
Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices. [cited April
30, 2020]. http://www.imdrf.org/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n063-2011-sum-
mary-technical-documentation-ivd-safety-conformity-110317.pdf, 2020.
[20] WHO, Global Medical Device Nomenclature (GMDN). [cited April 30, 2020]. https://www.who.
int/medical_devices/global_forum/Workshop_10_GMDN.pdf, 2020.
CHAPTER 2
Ethics of clinical trials of medical devices
2.1 Introduction
2.1.1 Clinical investigation of medical devices
The regulations for conducting medical device (MD) clinical trials worldwide have varied
widely [1]. Consequently, complications arise when a trial is conducted in one country
having protocols to be followed which is different from the clinical trial protocols defined
in another country where the device is to be used so that the use of a tool to plug the
gaps in GCP, which is possible in one country, might not be allowed in the stricter
country [2]. Besides, data produced under one set of rules could also be considered ques-
tionable given different requirements in different countries. Reciprocal acceptance of
Good Clinical Practices (GCPs) would facilitate multinational studies and promote the
utilization of clinical data to support regulatory submissions in multiple countries [3].
2.2 Clinical investigational plan for medical devices

1. General: All parties involved in conducting clinical research must be eligible
through education, training, or experience to perform their tasks, and this must
be documented correctly;
2. Risk assessment;
3. The rationale for planning clinical research;
4. Clinical Research Plan (PIC);
5. IB Investigator Booklet;
6. Case Reporting Forms;
7. Monitoring scheme;
8. Search site choice;
9. Agreement (agreements);
10. Signatures to be appended; and
11. Data Monitoring Committee [4].
2.3 Clinical investigation conduct

2.3.1 General
The clinical investigation must follow the protocol laid out in the CIP. The clinical
investigation will not begin until the Ethics Committee (EC) and, if necessary, the
Medical Device Regulations r 2022 Elsevier Inc.

DOI: https://doi.org/10.1016/B978-0-323-91126-9.00006-7 All rights reserved. 13
appropriate regulatory authority of the countries where the clinical investigation is tak-
ing place has given their written approval/positive opinion [5].
2.3.2 Investigation site initiation

The establishment of a trial site ensures that all necessary trial authorizations and docu-
ments are in place and that the protocol and trial procedures are discussed and agreed
with the principal investigator and the principal investigator's trial personnel in compli-
ance with the protocols, standard operating procedures (SOPs), GCP, and relevant
regulatory requirements.
2.3.3 Investigation site monitoring

Monitoring is an important part of a clinical trial's quality management procedures and
is used to ensure the study's enduring quality. Once it's decided which SOP to adhere
to, it will be followed with all the clinical trials funded or cosponsored by one or
more of the partner organizations. From time to time, trials sponsored by organizations
other than the partner organizations may be tracked in accordance with the SOP.
2.3.4 Adverse events and device deficiencies

Any unfavorable medical case, accidental disease or injury, or unfavorable clinical signs,
such as an abnormal laboratory finding, in subjects, consumers, or other stakeholders,
whether or not connected to the device under investigation, may come under trial in
the form of a clinical investigation.
2.3.5 Clinical investigation documents and documentation

All relevant forms and records must be amended, if need, and updated in a manner
appropriate to GCP, with a statement explaining the change, if any. It is important to
keep track of the subjects who have decided to participate in the clinical trial. The EC
must approve any significant changes to the investigation plan.
2.3.6 Additional members of the investigation site team

Apart from the Principal Investigator who conducts clinical investigation-related pro-
cedures and/or makes essential clinical investigation-related and medical care decisions,
individual members of the investigation site team at an investigation site are appointed
to work under the supervision of the Principal Investigator.
2.3.7 Subject privacy and confidentiality of data

The Institutional Review Board (IRBs) must decide if sufficient care is taken to pro-
tect the confidentiality of data collected.
Ethics of clinical trials of medical devices 15
2.3.8 Document and data control

All related documents of external origin, such as national standards or client contracts
and drawings, must be tracked and regulated. The team must maintain record control
procedures, control notices, and other temporary data sources, such as hand-written
information, with a data archival system for backing up your machine.
2.3.9 Investigational device accountability

Device accountability logs of all unopened study devices must be recorded upon
receipt (keep shipping logs), disposition (per subject usage, including the amount used,
amount remaining, etc.), transfer (if applicable), and return to the site must be
maintained.
2.3.10 Accounting for subjects

The costs incurred during the study from the moment a patient takes part in a clinical
trial of a device to its winding up will be accounted for. Despite CROs handling the
analysis, it needs someone with expertise in the accounting system to carry out the
costing of the study. Contingencies, like the death of a patient during the study, must
be accounted for as costs by the accounting model.
2.3.11 Auditing
Usually done only once or twice during the duration of a clinical trial, auditing covers
a wide range of topics. The auditors analyze a selection of data from a cross-section of
research sites. They also look over regulatory documents, including the research proto-
col, IRB correspondence and approvals, informed consent documentation, and inves-
tigator biographies.
2.4 ISO 14155:2011

The data integrity requirement is ensured using international standards such as ISO
14155:2011
1. ISO 14155:2011 examines GCP for planning, conducting, recording, and report-
ing human-managed clinical research for regulatory purposes to assess the safety or
performance of MDs.
2. The principles outlined in ISO 14155:2011 refer to all or any other clinical
research and will be applied to the greatest extent possible, taking into account the
scope of clinical research and, therefore, national regulatory requirements.
3. ISO 14155:2011 specifies the general criteria for protecting the rights of human
subjects, and their safety and well-being, ensuring, clinical scientific research is con-
ducted with the greatest attention to national and international concerns and,
therefore, ensuring the integrity of the findings and determining sponsor obliga-
tions. The sponsors, scholars, Ethics Board, regulatory bodies, and other agencies
interested in determining MD enforcement are aided by the Principal Investigator.
4. ISO 14155:2011 has been technically revised and replaced by ISO 14155:2020,
which made some changes, such as inclusion of clinical quality management, guidance
for EC, guidance on clinical investigation audits, and risk-based monitoring [6,7].
2.5 International Council on Harmonization of Good Clinical Practice

1. The International Council on Harmonization (ICH) technical criteria for the classifica-
tion of pharmaceutical products for humans are ideal for planning, conducting, per-
forming, tracking, auditing, documenting, reviewing, and publishing clinical trials while
ensuring that recorded data and findings are correct and credible, as well as ensuring the
privileges, fairness, and confidentiality of the trial's human subjects.
2. Ethical and scientific quality criteria are concerned with the design, conduct, moni-
toring, and recording of human subjects' participation in trials to protect the rights,
safety and well-being of those who are the subject on whom the devices are being
tested. It also ensures the data from clinical trials accurate [8].
3. GCP can be a global standard for the scientific and ethical quality of designing,
implementing, recording, and tracking trials involving people's participation.
4. Compliance with this standard guarantees the public the protection of the rights, safety,
and well-being of persons who submit to investigations having to do with device test-
ing, in accordance with the principles ensuing from the Declaration of Helsinki (DoH)
that laid down the policy assuring data from clinical trials are credible [9].
5. The ICH GCP Directive aims to provide a common standard for the EU and
Japan, thus facilitating the mutual acceptance of clinical data by regulatory authori-
ties in these jurisdictions.
6. The regulation was developed with consideration for the good clinical practices
used by the European Union, Japan, and the United States, as well as Australia,
Canada, the Nordic nations, and the World Health Organization (WHO).
7. When producing clinical trial data for transmission to regulatory authorities, the advice
given here is mandatorily followed. Other clinical research that could have an effect on
human safety and well-being will benefit from the precepts outlined in this guide [10].
2.6 International Council on Harmonization of Good Clinical Practice

principles
1. Clinical trials must be conducted in accordance with the ethical principles of the
Declaration of Helsinki, which comply with GCPs and, accordingly, with appli-
cable regulatory requirements.
2. Before attempting a clinical trial of a medical device, the expected benefits for
and costs to the society should be compared to the expected benefits for and costs
to the organization and individual. The trial must be attempted and continued as
long as the expected benefits outweigh the risks.
3. The rights, safety, and well-being of those who agree to medical device being tested
on them, i.e., who are being studied, are the ones who deserve critical concern, and
their interests will take precedence over the interests of science and society.
4. The clinical and nonclinical details on the study product must be sufficient to support
the clinical trial that is being proposed. New methodologies will enhance the conduct
of quality clinical trials, as well as trial reliability and efficacy. GCP training is important.
5. Clinical trials must be scientifically sound and informative enough to be outlined
in a protocol.
6. The attempt must be carried out in accordance with a procedure that has received
IRB/Independent Ethics Committee/affirmative opinion approval.
7. A professional doctor or professional dentist, where appropriate, may provide
medical assistance and make medical decisions on behalf of the subjects.
8. Each person involved in the implementation of an attempt must be qualified with the
education, training, and knowledge necessary to perform their respective assignment(s).
9. The approval given freely by each subject must be obtained before their partici-
pating in the clinical trial.
10. All clinical trial information must be recorded, managed, and stored in a format
that allows for accurate reporting, interpretation, and verification. This principle
applies to all registrations referred to in this guide or part thereof, regardless of the
type of broker used.
11. The confidentiality of records that describe subjects should be protected, thus
adhering to the principles of data confidentiality and non-compromised data as
required by relevant regulatory precepts.
12. Good manufacturing practices (GMPs) must be followed when manufacturing,
processing, and storing the products under investigation. It must be used in accor-
dance with the protocol that has been approved.
13. Systems must be introduced with protocols to ensure that each part of the exami-
nation is completed to the highest possible standard [11 14].
2.7 ISO 13485:2016: quality management system of medical devices

requirements for regulatory purposes
At its meeting in London, United Kingdom, in October 2019, the International
Organization for Standardization Technical Committee 210 (ISO/TC 210) reaffirmed
ISO 13485, which will remain unchanged for the next five years.
1. ISO 13485:2016 spells out the requirements for a high performance quality man-
agement system (QMS) a company must use to demonstrate its ability to provide
MDs and related services that are always compliant with applicable regulatory
requirements and customer requirements. These organizations are often involved
in one or more stages of the MD lifecycle, such as design, creation, manufacturing,
storage, delivery, installation, or maintenance, as well as method and development
and related activities (such as technical support). Suppliers outside the parties that
provide products, including QMS services, to these organizations may also use ISO
13485:2016.
2. Unless otherwise noted, ISO 13485:2016 applies to all organizations, regardless of
size or form. As criteria for MDs are recognized, the needs for conformance to reg-
ulations will also extend to the organization's related services.
3. Operations that are mandated by ISO 13485:2016 but are not conducted by the
organization are the responsibility of the organization and are accounted for in the
QMS by inspection, maintenance, and control of operations.
4. If relevant regulatory regulations allow for design and development controls to be
waived, alternative methods that must be considered in a quality control frame-
work may be provided by these regulatory criteria. It is the duty of the company
to ensure that any exclusion from design and development checks is reflected in
declarations of adherence to ISO 13485:2016 [13,14].
2.8 General requirements of quality management system

1. In compliance with the requirements of this International Standard and relevant
regulatory requirements, the company must record and maintain a high-QMS.
2. Any specifications, processes, operations, or arrangements that will be registered
under the precepts of the International Standard or the relevant regulatory require-
ments must be developed, implemented, and maintained by the organization.
3. The organization must document the roles that the organization plays in accor-
dance with established regulatory requirements.
Note: The manufacturer, authorized agent, importer, or distributors are examples
of the organization's functionaries [15].
2.9 ISO 14971:2019 medical device risk management applications

The ISO 14971 is examined in order to identify regulatory requirements during
design, preclinical validation, and clinical validation for devices that include wearable
sensors as critical components of clinical trials [16,17].
1. This document outlines the terminology, principles, and processes for managing
MD risk, including programs, such as MDs and laboratory diagnostic devices. The
purpose of the method described in this document is to assist MD manufacturers in
discovering risks associated with the MD, assessing and managing associated risks,
controlling these risks, and monitoring the effectiveness of controls.
2. The specifications of this document extend to all or part of the MD's lifecycle.
3. In certain jurisdictions, the procedure outlined in this document may be extended to items
that are not inherently MDs, and it may be used by other actors in the MD lifecycle [16,17].
2.10 Risk management application throughout the lifecycle of the device

To meet regulatory and consumer requirements, the risk management system must function
properly. However, as devices become more advanced and regulators' demands become
more stringent, it will be a daunting challenge to comply with regulatory requirements. Any
good risk management system (RMS) should back up the PI’s team's risk management
efforts by putting in place an end-to-end process, all the way through the product lifecycle.
2.10.1 Planning
An effort to incorporate an efficient risk management framework is to define the scope
of risk management activities and integrate these into your QMS processes. This needs
identification of governance and oversight responsibilities and roles, setting up risk
acceptance requirements, conceptualizing a framework for collecting and reviewing
production and postproduction data, and more, based on your preferences.
2.10.2 Documentation
This needs familiarity with a wide range of reporting formats and methods that show
the ability to monitor all risks. When it's a question of supporting product documenta-
tion activities, the need to understand how each feature fits into the overall risk man-
agement process becomes primordial for spotting possible deficiencies or opportunities
for change.
2.10.3 Risk analysis/evaluation

This needs expertise in the knowledge of and experience in the various stages of risk
analysis and evaluation, particularly in terms of facilitating a clear understanding of the
intended use and users, as well as a thorough understanding of the security features.
To recognize possible risks and to make the risk assessment and evaluation process
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1. Introduction to medical devices 1

2. Ethics of clinical trials of medical devices 13

2.3.3 Investigation site monitoring 14

3. Regulations for medical devices in the United States 23

3.12 Unique device identification of medical device 30

4. Regulations of medical devices in Europe 33

5. Regulations of medical devices in ASEAN countries 41

6. Regulations of medical devices in Japan and China 57

7. Regulations of medical devices in Canada 67

8. Regulations for medical devices in India 83

9. Regulations of medical devices in Australia 97

9.17 Fees of medical devices in Australia 107

10. Regulations of medical devices in Gulf Cooperation Council countries 113

10.37 Renewal 130

11. Regulations of medical devices in Sri Lanka 141

12. Regulations of medical devices in Russia 153

Dr. Aakash Deep

Introduction to medical devices

1.2 Classifications of medical devices on the basis of risk

1.2.1 Medical device safety and performance

Medical Device Regulations r 2022 Elsevier Inc.

Figure 1.1 Classification of IVD medical devices.

basic design and manufacturing standards, referred to as the “Essential Principles of

1.3 The basic design and manufacturing principles listed in this

1.3.2 Clinical investigation

1.3.3 Physicochemical and biological properties

1.4 History of medical device regulations globally

effectiveness and efficiency of the organizational system. There is a discount on

1.5 Product life cycle of medical device

1.6 The five stages of the medicinal product life cycle

1.6.5 Postmarket review

1.7 International Medical Device Regulators Forum

1.8 IMDRF Management Committee

1.8.1 Purpose of IMDRF

1.8.2 Organizational convergence IMDRF

comparable technical documents, norms, and scientific principles. Coordination and

1.9 Global Harmonization Task Force (GHTF)

1.9.1 Safety management

1.10 Summary Technical Documentation

Figure 1.2 Elements of safety management.

4. Manufacturers of all categories of IVD must demonstrate compliance of IVD with

1.11 Global medical device nomenclature

[9] IMDRF, About IMDRF. [cited 30 April 2020]. http://www.imdrf.org/about/about.asp, 2020.

Ethics of clinical trials of medical devices

2.2 Clinical investigational plan for medical devices

2.3 Clinical investigation conduct

Medical Device Regulations r 2022 Elsevier Inc.

2.3.2 Investigation site initiation

2.3.3 Investigation site monitoring

2.3.4 Adverse events and device deficiencies

2.3.5 Clinical investigation documents and documentation

2.3.6 Additional members of the investigation site team