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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
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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.
Ethics of clinical trials of medical devices 17
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].
Another random document with
no related content on Scribd:
handsome as my great-grandmother’s; dark eyes, long sallow cheeks,
compressed, thin lips, two or three black ringlets on a high forehead, a cap
that Mrs. Grier might wear,—altogether an appearance of fallen fortunes,
worn-out health, and excessive but guarded irritability. To me there was
nothing of that engaging, captivating manner which I had been taught to
expect by many even of her enemies; she seemed to me to be alive only to
literary quarrels and jealousies; the muscles of her face as she spoke, or as
my father spoke to her, quickly and too easily expressed hatred and anger
whenever any not of her own party were mentioned.”
A frontispiece to the 1802 edition of Arnaud Berquin’s (1749–1791)
works represents his bust being garlanded and crowned, and his “L’Ami des
Enfans” being regarded by a group of admirers, both young and old. But
though this very volume was received with honours by the French
Academy, and though by it Berquin claims his right to immortality, French
children of the present refrain from reading him as systematically as we
refrain from reading “Sandford and Merton,” which, as it happens, Berquin
translated into French. There are popular editions of “L’Ami des Enfans,”
but children do not relish the tameness of such moral literature. The editor
detailed to write Berquin’s short life, which was spent in the study of letters,
and in following up one “Ami” by another, sacrifices incident and fact for
encomium. It is easy to claim for Berquin modesty and goodness during his
residence in his native town near Bordeaux and after his arrival in Paris
during 1772; it is interesting to know that he was encouraged to use his
talents by the praise of his friends, but far more valuable would it have been
to tell just in what manner he reached that ethical state which overflowed in
his “L’Ami des Enfans,” published during the years 1782 and 1783. The full
purport of the volume is summed up exuberantly in the following
paragraph:
“Quelle aimable simplicité! quel naturel! quel sentiment naïf respirent
dans cette ingénieuse production! Au lieu de ces fictions extravagantes, et
de ce merveilleux bizarre dans lesquels on a si longtemps égaré
l’imagination des enfans, Berquin ne leur présente que des aventures dont
ils peuvent être témoins chaque jour dans leur famille.”
The tales and playlets written by Berquin are almost immoral in their
morality. It is a question whether the interest of children will become
absorbed by the constant iteration of virtue; whether goodness is best
developed through the exploitation of deceit, of lying, of disobedience, and
of wilful perverseness. To be kind means to be rewarded, to be bad is
synonymous with punishment. Berquin and his followers might have drawn
up a moral code book in pocket form, so stereotyped was their habit of
exacting an eye for an eye and a tooth for a tooth. What are the punishments
of vanity, what the outcome of playing when the afternoon task is to watch
the sheep? The pictures made to illustrate the stories depict boys and girls
kneeling in supplication, while the grown persons almost invariably stand in
disdainful attitude. The children who would be their own masters and go
out in a boat, despite parental warning, are upset: there is the algebraic
formula. “Plainness the Dress of Use” is probably a worthy subject for a
tale, and “A Good Heart Compensates for Many Indiscretions” a pathetic
title for a play. But young people as a general rule are not maudlin in their
feelings; even granting that there are some given that way, they should not
be encouraged in holding a flabby standard of human, as well as of divine,
justice. “L’Ami des Enfans” is filled with such sentimental mawkishness.
II. The Edgeworths; Thomas Day; Mrs. Barbauld;

and Dr. Aikin.
At the early age of twenty-three, Richard Lovell Edgeworth (1744–1817)
decided to educate his son, Richard, according to the principles set down by
Rousseau. He thrust the little fellow back into a state of nature by taking his
shoes and stockings off and by cutting the arms from all his jackets. But, try
as he did in every way to make a living Émile out of young Richard, the
father found that the theories did not work. When he took the luckless boy
to Paris and called upon Rousseau, there ensued an examination of results,
and the sum-total was pronounced a failure. Hon. Emily Lawless writes in
some glee:
“It is impossible to read without a smile of the eminently unphilosophic
wrath expressed by the sage, because each time that a handsome horse or
vehicle passed them on their walk, his temporary charge—a child of seven
—invariably cried out, ‘That’s an English horse!’ ... a view which he
solemnly pronounced to be due to a sadly early ‘propensity to party
prejudice’!...”
Edgeworth lost entire faith in the practical application of the Rousseau
scheme in after years; but the lasting effect it seems to have produced upon
the unfortunate victim was to place him in the ranks of mediocrity, for he
was hardly ever spoken of thereafter by his family; and in order to remove
himself from further disturbance, as soon as he reached years of discretion,
he hastened to place miles between himself and the scenes of his youth;
Richard came to America.
Edgeworth’s love affairs—for four times he was married—are involved,
and do not concern us, save as they effect Thomas Day. But, personally, he
enters our plan as influencing his daughter, Maria Edgeworth (1767–1849),
with whom he wrote “Practical Education.” There are some men—and
Edgeworth was bordering on the type—who assume an almost dreadful
position in a household; who torture the mind of boy or girl by prying, and
by wishing to emphasise hidden meaning in everything; who make children
fear to ask questions lest a lecture, dry and unoriginal, be the penalty. Such
men have a way of fixing youth with intense, severe gaze—of smiling with
a fiendish self-complacency over their own superiority—of raising their
eyebrows and reprimanding should the child be watching the flight of a
sparrow instead of being ever alert for an unexpected question or bit of
information which a grown person might put to him on earth. Such men are
the kind who make presents of Cobbet’s “Advice to Young Men,” and who
write mistaken sentiments of nobility on the fly-leaf of Samuel Smiles’s
“Self-Help.”
Edgeworth’s redeeming trait was his earnest desire to bring the best
within reach of his children, and he considered his severity the proper kind
of guidance for them. Whatever sin of commission is to be laid to his
charge, it is nevertheless true that it was not so great as to destroy the love
Maria had for him. The literary critic has to reckon with the total amount of
effect his teaching, his personal views had upon the writings of his
daughter. That he did influence her is certain, and nowhere more thoroughly
shown than in her work for children. In theory this work traces its origin to
Rousseau, while in its modelling it bears a close relationship to Madame de
Genlis and to Berquin.
Banish dolls is the cry in “Practical Education,” and if you have toys in
the nursery at all, let them be of a useful character—not mechanical
novelties, but cubes, cylinders, and the like. Place before children only
those pictures which deal with familiar objects, and see to it that the pose of
every figure, where there are figures, is natural; a boy once went with Sir
Joshua Reynolds through an art gallery, and invariably he turned with
displeasure away from any form represented in a constrained attitude. This
is the general tone of the Edgeworths as teachers.
The set notions that fill the pages of “Practical Education” often border
on the verge of bathos. They leave no room for the exercise of spontaneous
inclination; by their limitations, they recognise no great amount of common
sense in others. They create in one a desire at times to laugh, and again a
desire to shake the authors who were in the frame of mind to hold such
views. There are certain instincts which are active by reason of their own
natures,—and one is the love of parent for offspring. We even accredit the
wild animal with this quality. When the Edgeworths declare that “My dear,
have you nothing to do?” should be spoken in sorrow, rather than in anger,
the advice irritates; it is platitudinous; it must have irritated many naturally
good mothers, even in those days when such a tone in writers was more the
rule than the exception.
On the subject of books Miss Edgeworth and her father become more
interesting, though none the less startling in their suggestions. One of
Maria’s early tasks in 1782 had been to translate “Adèle et Théodore”; to
her this book was worthy of every consideration. In the choice of reading
for young folks, the two do not reach very much beyond their own
contemporaries: Mrs. Barbauld’s “Lessons,” the Aikin’s “Evenings at
Home,” Berquin’s “L’Ami des Enfans,” Day’s “Sandford and Merton” were
recommended. And in addition there were mentioned Madame de Silleri’s
stories, known as the “Theatre of Education,” Madame de la Fite’s “Tales”
and “Conversations,” and Mrs. Smith’s “Rural Walks.” Despite the fact that
fairy tales are at this period frowned upon as useless frivolities, “Robinson
Crusoe,” “Gulliver’s Travels,” “The Three Russian Sailors,” and the
“Arabian Nights’ Entertainment” are suggested because of the interest and
profit to be had in voyages and travels of all kinds. Fancy was thus held at a
discount.
Two books of nature are mentioned, and curiously one is emphasised as
of special value for children provided it is beforehand judiciously cut or
blotted out here and there. The Edgeworths obtained this idea from an over-
careful mother who was in the habit of acting as censor and editor of all
juvenile books that found their way into her house. In Russia, the
authorities take an ink pad and stamp out the condemned passages of any
book officially examined. In the same summary manner, English parents
were advised to treat their children’s stories. The Edgeworths went even
further, suggesting that, besides striking out separate words with a pen, it
would be well to cut the undesirable paragraphs from the page, provided by
so doing the sense of the text on the reverse side was not materially
interfered with. To mark the best thoughts for young readers was also
strongly recommended.
The authors are never wanting in advice. If children are good, what need
is there to introduce them to evil in their stories? Evil is here meant in its
mildest sense. They should be kept from all contagion. But bad boys and
girls should be told to read, in “The Children’s Friend,” tales like “The
Little Gamblers” and “Honesty is the Best Policy,” which will teach them,
by examples of wickedness, to correct their ways. Such strange
classification suggests that literature was to be used as a species of moral
reformatory. Two significant facts are to be noted in this chapter on books:
there is an attempt to grade the literature by some age standard, bringing to
light a gap between four and seven years which may be offset by a similar
gap to-day; so, too, does there seem to have been, then as now, a great lack
of history and biography.
The idea upon which the “Parent’s Assistant” was founded began to
shape itself in Miss Edgeworth’s mind early in life. Left alone for a short
period with her younger brothers and sisters, she manufactured tales for
their edification, many of which, in after years, she utilised. In 1796 she
gathered together and published some of her best stories, among them “The
Purple Jar” and “Lazy Laurence.” “Simple Susan” would probably not be
so widely emphasised were it not for the fact that Sir Walter Scott recorded
“that when the boy brings back the lamb to the little girl, there is nothing
for it but to put down the book and cry.”
Miss Edgeworth and her father had much preferred that the book be
called “The Parent’s Friend,” for lodged in the former’s memory were
disagreeable thoughts of an old-time arithmetic which had plagued her early
years, and was named “The Tutor’s Assistant.”
The theatricals performed in the Edgeworth household afforded much
pleasure. It is very likely that the custom was gleaned from Madame de
Genlis. Plays were written for every festive season. The publication of the
“Parent’s Assistant” suggested the acting of some of the playlets contained
in the book. There seem to have been two theatres, one fitted up just over
Richard Lovell’s study, and another temporary stage erected in the dining-
room. Here, one evening, was enacted the exemplary dialogue of “Old
Poz,” where a poor man is suspected, by a Justice, of stealing what a
magpie has in reality secreted. Lucy, the good little daughter, clears the
innocent fellow, upon whom her father sits in very stern, very unreasonable,
and most unnatural judgment. Irritable to a degree, the Justice, who is
positive about everything, shuts up any one who gainsays a word contrary
to his obstinacy, but “Oh, darling,” he remarks to his daughter, after her
excellent deed, “you shall contradict me as often as you please.” This
method is neither more nor less than poisonous; it is polluted with a certain
license which no good action ever sanctions. There is small doubt that
children see the absurdity of it, for it cheapens right-doing in their eyes.
The compensating balance of good and bad is exercised to a monotonous
degree in Miss Edgeworth’s tales. There are the meek, innocent girl, and the
proud, overbearing girl in “The Bracelet”; the heedless, extravagant boy,
and the thoughtful, thrifty boy in “Waste Not, Want Not.” Disaster follows
disaster; reward courts reward. Not content with using these extremes of
human nature in one story, Miss Edgeworth rings the changes, slightly
altered in form, in others of her tales.
“The Purple Jar” in substance is the same as “Waste Not, Want Not”; the
moral applications are identical. One has but to glance through the pages of
the latter story to note its didactic pattern. Yet Miss Edgeworth possessed
her literary excellencies in human characterisation, in that power of
narrative which gained effect, not through ornamentation, but through deep
knowledge of the real qualities of common existence. The dominant fault is
that she allowed her ultimate object to become crystallised into an
overshadowing bulwark, a danger which always besets the “moral” writer,
and produces the ethical teacher in a most obtruding form. When Miss
Edgeworth’s little girl sprains her ankle and her father picks her up, she
consciously covers her leg with her gown. Fate seems never to have worked
so swiftly, so determinedly, as in those tales where thoughtless boys on their
walks had the consequences of their bad acts visited upon them during the
homeward journey. The hungry, the lame, the halt, the blind turn
unexpected corners, either to wince beneath the jeers of one type of mortal
child, or to smile thanks to the other kind for a gentle word or a much-
needed penny.
No one can wholly condemn the tale, typified by Miss Edgeworth’s
“Parent’s Assistant.” Childhood is painted in quaint, old-fashioned colours,
even though the staid little heroes and heroines have no interests. They take
information into their minds as they would take physic into their bodies.
They are all normal types, subjected to abnormal and unnaturally successive
temptations, and given very exacting consciences. A writer in Blackwood’s
becomes indignant over such literary treatment:
“They [the girls] have good reason to expect from these pictures of life,
that if they are very good and very pious, and very busy in doing grown-up
work, when they reach the mature age of sixteen or so, some young
gentleman, who has been in love with them all along, will declare himself at
the very nick of time; and they may then look to find themselves, all the
struggles of life over, reposing a weary head on his stalwart shoulder....
Mothers, never in great favour with novelists, are sinking deeper and deeper
in their black books,—there is a positive jealousy of their influence; while
the father in the religious tale, as opposed to the moral and sentimental, is
commonly either a scamp or nowhere. The heroine has, so to say, to do her
work single-handed.”
What is true of these young people is therefore likewise true of their
grown-up associates. They have definite personalities, and they are either
monstrosities of excellence or demons of vice and temper. But here also a
careful distinction was preserved. Mr. Lucas says in his “Old-Fashioned
Tales”:
“The parents who can do no wrong are very numerous; but they are, it
should be pointed out, usually the parents of the central child. There are
very often parents and relations of other and subsidiary children whose
undesirable habits are exceedingly valuable by way of contrast.”
Despite the fact that there is so much to condemn in this genre of writing,
Miss Edgeworth was endowed with that sober sense and inexhaustible
power of invention claimed for her by critics of the period. Her care for
detail, her exhibition of small actions that mark the manners of all people in
different walks of life, were distinguishing features of her skill.
With her father Miss Edgeworth laboured on other things besides the
“Practical Education”; while the two were preparing the essay on “Irish
Bulls,” published in 1802, she plainly states that the first design was due to
him, and that in her own share she was sedulously following the ideas
suggested by him. Throughout her autobiographical data she offers us many
glimpses of that family unity which existed—whether from voluntary desire
or because of the domineering grip of Edgeworth, is not stated. She was
continuously solicitous for his welfare, not through any forced sense of
duty, but because of her desire to give pleasure in small ways; she found it
agreeable to sit of an evening doing needle work, while Edgeworth “read
out” Pope’s Homer. In the course of such hours she first became acquainted
with Scott’s “Lady of the Lake” and “Waverley.”
The friendship between Miss Edgeworth and Scott was deep and cordial;
one was not without abiding influence on the other. She describes with
graphic pen the first sound of his voice at Abbotsford; and the biographer
has no more agreeable material to work upon than her fortnight spent as a
guest of the novelist, and his return visit to Edgeworthtown in 1825.
For a man whose avowed detestation of women was well known to every
one, Thomas Day (1748–1789) succeeded in leading a life of romantic
variety. Yet he was not a person of strong passion; in fact, was more
inclined to brooding melancholy. His intimacy with the Edgeworth family
began when he met Richard Lovell at Oxford; and it was when he saw the
training of Émile applied to his friend’s son that his mind was seized with
the idea of carrying out a similar scheme himself. He held a great contempt
for dress; and his numerous vagaries regarding the conduct and duties of a
wife were so pronounced that it is most likely they came between himself
and Maria Edgeworth, with whom it is thought there was some romantic
understanding.
Unlike Edgeworth, Day had no child to experiment upon. So he set about
“breeding up” two girls, away from conflicting influences, and according to
nature. One was obtained from an orphan asylum, and was known as
Sabrina Sidney; the other, called Lucretia, was taken from a Foundling
Hospital. In order to give a moral tone to the situation, these girls were
bound out to Edgeworth, who was a married man. Not many knew that Day
had hastened with both of the damsels to Avignon. Here he began to
educate them with the intention of training one for his future wife.
Events did not progress smoothly, however; the girls quarrelled as saints
would have quarrelled under the circumstances, and they occupied their
time by falling out of boats and having smallpox. What their schooling
consisted of may be imagined from the fragment of a letter written by
Sabrina to Mr. Edgeworth:
“I hope I shall have more sense against I come to England—I know how
to make a circle and an equilateral triangle—I know the cause of day and
night, winter and summer.”
At the advanced age of twenty-two—even younger than Edgeworth when
he first became imbued with the Rousseau doctrines—Day returned to
Lichfield—the home of Johnson and of Dr. Charles Darwin—bringing with
him his charges: Lucretia, who was hopelessly dull, and Sabrina, who
proved the favourite and was by far the more attractive of the two, with her
fetching auburn ringlets, her long amorous eyelashes, and her very
melodious voice. The young ladies had failed to become thoroughly steeled
against the slings and arrows of outrageous fortune. In most respects they
persisted in remaining like the average woman with sensibility. When hot
sealing-wax was dropped upon the shapely arm of Sabrina, to harden her
against the fear of pain, she refused to behave heroically; when a pistol was
fired at her petticoats—a volley of lead for all she knew—her screams and
frantic jumps indicated that her nerves were not impervious to the
unexpected.
Day did not fail to show his disgust and disappointment. While Sabrina
was at boarding-school, he hastened to forget all about her, and fell in love
with Honora Sneyd, whose fame chiefly rests upon the fact that she was
once courted by Major André. To make the situation more awkward,
Edgeworth, despite his married state, likewise possessed strong affection
for the same lady. She refused Day, and what followed contains the zest of a
wicked little comedy. He fell ill, and had to be bled; then he summoned up
sufficient strength to escape to France with Edgeworth, who felt it best to
remove himself from temptation. It was during this trip that he visited
Rousseau with poor little Richard. But before crossing the Channel, Day
had succeeded in transferring his affections to Honora’s sister, Elizabeth.
“Go,” she said to him in substance, “try to assume some of the graces
that you sorely lack. Learn to dress stylishly, and be taught the proper curl
for a wig. Train yourself into a fashionable-looking husband, and come
back to me.”
Thus commanded, Day spent many weary hours wielding the foil, and
being carried through the intricacies of the dance. And those legs of his—
how he put them into exercise, hoping against hope to straighten them ere
he returned to England!
But there was evidently no improvement in the end, for when the lady
saw him, she unhesitatingly refused him. It is sufficient to say that, in time,
Edgeworth married both sisters, Death regarding kindly his love of novelty.
With affections thus left high and dry, Day turned once more to Sabrina.
He had long ago discarded Lucretia, who apprenticed herself to a milliner,
and later became the wife of an honest draper. But Sabrina was fair to look
upon and Day saw no reason why she should not satisfy his ideas of
wifehood, provided she would dress according to his tastes. We applaud the
shake of those auburn ringlets as she refused his wishes, and thus escaped
matrimony with him.[32] There was another lady upon whom this honour
was to descend.
When Miss Milnes, of Wakefield, was approached by Day, she was
informed of all his requirements, and was deceived as to none of his
vagaries. It must have been somewhat of a surprise to him when she
accepted him, outlandish attire and all; and it is a pleasant disappointment
to know that the marriage was a happy one, despite the fact that Mrs. Day
insisted upon holding opinions of her own.
Day was most content when he was theorising; at the same time, it must
not be lost sight of that he had timely interests. His feelings were strongly
aroused against the state of negro slavery in America, and he was earnest in
his advocacy of parliamentary reform. His great fault was that he was
always carried to extremes whenever good motives prompted him. His
earnest concern for the poor, during 1781, was accompanied by stern
denials of pleasures for himself,—well-nigh of the necessities of life.
Day realised the failures of his theories as applied to grown people; had
he not done so, we most likely would not have had “Sandford and Merton.”
His attention was soon attracted to the infant mind as an unworked field; the
Edgeworths were meeting success with their children’s books; he would
attempt the same thing, and so, during 1783, 1787, and 1789, the three
successive volumes of his famous story appeared—an elongated “Waste
Not, Want Not.”
Day had heretofore suggested a certain effeminate bearing in his
character; he recognised it, and was now suddenly beset with a consuming
desire to supplant this manner by an overtowering manliness, by the
exercise of firmness and strength. But the new policy was to prove his
undoing. On the afternoon of September 28, 1789, he went to ride on an
unbroken horse, believing to curb him by the discipline of command rather
than of the stock. The animal took fright and threw him; he received
injuries from which he almost immediately died. On the evidence of Miss
Seward, it is recorded that Mrs. Day thereafter “lay in bed, into the curtains
of which no light was admitted, ... and only rose to stray alone through her
garden when night gave her sorrows congenial gloom.”
The estimate of such a work as “Sandford and Merton” cannot be based
upon modern standards; all of the factors characteristic of the didactic
writers for children, such as persistent questioning, the encyclopædic grown
person in the shape of Mr. Barlow, and the monotonous interchange of
narrative and dialogue, are employed as vehicles for knowledge. The book
is unique, inasmuch as it sought to supply a variety of stories suitable in
style and content for the beginner.
“The only method I could invent,” writes Day, “was to select such
passages of different books as were most adapted to their experience and
understanding. The least exceptionable that I could find for this purpose
were Plutarch’s Lives, and Zenophon’s History of the Institution of Cyrus,
in English translations; with some part of Robinson Crusoe, and a few
passages in the first volume of Mr. Brook’s Fool of Quality.”
In those days, if authors are to be believed, birds were in the habit of
alighting on the hands of good children; they are more timid now, though
children are not less good. The poor boy was made to feel how kind the
good rich boy was to him throughout his shocking adversity; we are more
considerate to-day. And so, Tommy Merton and Harry Sandford, products
of a stilted age, are clad in uniforms similar to those worn by Miss
Edgeworth’s children. They are endowed with no exceptional qualities, with
no defined will power; they stand in a long row of similarly subjected
slaves of theory.
Miss Agnes Repplier calls this story one of her early moral pitfalls. She
read it at a period when information was being forced down her, and
“which,” so she writes, “I received as responsively as does a Strassburg
goose its daily share of provender.”
Among the writers of this period, none are more important than Anna
Letitia Aikin Barbauld (1743–1825). Her position is a unique one, for,
being acquainted with all of her literary contemporaries and subject to their
influence, she stands in a transition stage. Through her mental
independence, she succeeded partially in breaking from the introspective
method of motive-hunting, and foreshadowed the possibilities of Mrs.
Hemans, the Brontés, and Mrs. Browning. She was reared in an atmosphere
of intellectuality by her father, John Aikin, a professor and a man of
advanced opinions regarding female instruction, two points which argued
for her less conventional mind and for her less stilted manner.
When she married Rochemont Barbauld, who had been a student under
her father, and who was a non-conformist, she was well versed in Greek and
Latin, and in every way was equipped to do literary work. She was more or
less influenced by her husband’s religious independence; he changed his
congregation from English Presbyterianism to Unitarianism, and it is not
surprising to find the English public looking somewhat askance at Mrs.
Barbauld’s fitness to write for children. Madame de Genlis was in like
fashion criticised for the religious views she held, and we shall find Miss
More subject to the same scrutiny. The Aikins were the first to introduce the
material lines in children’s literature, “but the more anxiously religious
mothers felt a certain distrust of the absence of direct lessons in Christian
doctrines; and Mrs. Trimmer was incited to begin a course of writing for
young people that might give the one thing in which, with all their far
superior brilliancy, the Aikins were felt to be deficient.”
We are not concerned with all of Mrs. Barbauld’s work; she used to write
poetry, some of it in repartee vein which struck the acute fancy of Charles
Lamb; her essays were of an exceptional order, in a few instances expressed
in imitation of Johnson; he himself had to acknowledge that of all who tried
to ape him, she was most successful. Her educational opinions, sent from
time to time in letters to Mrs. Montague, marked her ability as a teacher;
but the method that she believed in was well nigh Socratic and ofttimes
wearisome in its persistency; history and geography were given to infant
minds in the form of lectures. Around 1802 William Godwin, of whom we
shall have something to say later in his connection with the Lambs, wrote:
“I think Mrs. Barbauld’s little books admirably adapted, upon the whole,
to the capacity and amusement of young children.... As far as Mrs.
Barbauld’s books are concerned, I have no difficulty. But here my judgment
and the ruling passion of my contemporaries divide. They aim at cultivating
one faculty; I should aim at cultivating another.... Without imagination,
there can be no genuine ardour in any pursuit or for any acquisition, and
without imagination there can be no genuine morality, in profound feeling
of other men’s sorrow, no ardent and persevering anxiety for their interests.
This is the faculty which makes the man, and not the miserable minuteness
of detail about which the present age is so uneasy.”
Childless herself, Charles Aikin was adopted by Mrs. Barbauld, the little
Charles of “Early Lessons for Children,” composed especially for him. The
latter work was followed by “Hymns in Prose for Children,” consisting of
translations from all tongues, put into simple language, and not into verse,
for fear they might fail to reach the comprehension otherwise. These hymns
are probably most representative of Mrs. Barbauld’s individual writings, for
the work by which she is best known, the “Evenings at Home,” was written
in collaboration with her brother, Dr. Aikin.
In the “Evenings” a new tone is detected; despite a stilted style, the two
authors aroused an interest in external objects, and, by their descriptions
and suggestions, attempted to infuse meaning into the world surrounding
the child. This small departure from the sectarian tendency prevailing in so
much of the literature of that period, imperceptible though it may be, was
due to a shifting of attitude toward women which was taking place in
England. Mrs. Barbauld might be considered a “bold” example of feminine
intellect reaching out for a larger sphere. We read that Fox was surprised
that a woman could exhibit such clearness and consistency of viewpoint as
were to be discovered in such of her essays as “Monastic Institutions”; and
there were others who wondered at the alertness and interest she manifested
in all matters pertaining to public affairs. Her force of intellect pleased
some, her manner others. Scott confessed that her public reading of poetry
inspired him to court the muse; Wordsworth unfolded so far as to envy the
beauty of her stanzas on “Life,” which toward the end contain these
attractive, hopeful, and faith-abiding lines:
“Life! we’ve been long together,
Through pleasant and through cloudy weather;
’Tis hard to part when friends are dear;
Perhaps ’twill cost a sigh, a tear;
Then steal away, give little warning,
Choose thine own time;
Say not good-night, but in some brighter clime,
Bid me good-morning.”
Mrs. Barbauld was one of a group of women writers, seeking through the
force of their opinions to destroy the conventional barriers which kept the
exercise of feminine minds within prescribed bounds. Harriet Martineau has
outlined the tyrannical limitations which beset a young girl of the early
nineteenth century; decorum stood for mental annihilation. When genteel
persons came to call at the home of Jane Austen, the latter, out of regard for
family feeling, and for fear of being thought forward and unmaidenly, was
constrained to cover her manuscript with a muslin scarf.
Mrs. Barbauld did not make any revolutionary declaration, nor attempt
any public defiance of custom; however, she did, by her reaching toward
the manifest facts of life, secularise our concern for the common things
about us. She encouraged, through her plea for the freedom of thought, the
movement which resulted in the emancipation of her sex, and which found
vent, on the one hand, in Mary Wollstonecraft’s[33] “The Right of Woman”
(1792) and, on the other, with more determined force, in John Stuart Mill’s
“On the Subjection of Women” (1869). As this freedom became more and
more assured, there underwent a change in the educational attitude; a girl’s
mind had something more to work on than the motto of a sampler; her
occupations became somewhat altered. And the women writers began to
emphasise, in their stories for children, the individual inclinations of hero
and heroine.
Wherever Charles Lamb discourses upon books, he assumes the critical
attitude that deals with literature as a living force, as something built for
human appeal. He met Mrs. Barbauld and Mrs. Trimmer on several
occasions, and we can imagine the delight he took in shocking their ladylike
senses by his witty and sudden remarks. At one period some dispute and ill-
feeling existed between himself and Mrs. Barbauld, due to a false report
that she had lampooned his drama, “John Woodvil.”
Elia was not the sort of literary devotee to sanction anemic literature for
children; his plea was for the vitalising of the nursery book. On October 23,
1802, he wrote to Coleridge:
“Mrs. Barbauld’s stuff has banished all the old classics, ... and the
shopman at Newbery’s hardly deign’d to reach them off an exploded corner
of a shelf, when Mary ask’d for them. Mrs. B’s and Mrs. Trimmer’s
nonsense lay in piles about. Knowledge insignificant and vapid as Mrs. B’s
books convey, it seems, must come to a child in the shape of knowledge,
and his empty noddle must be turned with conceit of his own powers, when
he has learnt that a horse is an animal, and Billy is better than a horse, and
such like; instead of that beautiful interest in wild tales which made the
child a man while all the time he suspected himself to be no bigger than a
child.”
He saw the penalty that lay in cramming the child with natural history
instead of furnishing him with some creative appeal. We can forgive Elia all
his pranks when he thus pleads the genial claim of imagination; if, in a
witty vein, he called Mrs. Barbauld and Mrs. Inchbald the “bald” old
women, we must understand that Lamb had his petulant hours, and that
children’s literature of the day was sufficient to increase them!
The purport of “Evenings at Home” is instruction. Within the compass of
a few pages, objects crowd one upon the other as thick and as fast as virtues
do in Miss Edgeworth. Such keenness and alertness in observing common
things, as are cultivated in “Eyes and No Eyes,” stagger the intellect. It is
well to teach your young companions to feel the hidden possibilities of
nature and to cultivate within them a careful observation; but there is a
vacation time for the mind, and the world, though it may be a school-room,
is also a very healthy place to play in. Mr. Andrews, the immaculate
teacher, is represented by the artist, in my copy of the book, as seated in a
chair, with a compass in one hand resting upon a book, while behind him
stretches the outline of a map; the two boys stand in front of him like
prisoners before the bar. Here then is a new algebraic formula in the
literature for the young.
Mrs. Barbauld thus represents a transition stage in juvenile writing;
education and narrative walk side by side. She made it possible, in the
future, for Peter Parley and for Rollo to thrive. Thomas Day foreshadowed
the method of retelling incidents from the classics and from standard history
and travel,—a form which is practised to a great extent by our present
writers, who thread diverse materials on a slender wire of subsidiary story,
and who, like Butterworth and Knox, invent untiring families of travellers
who go to foreign parts, who see things, and then who talk out loud about
them.
But before this secularisation gained marked hold, a new tributary is to
be noted, which flowed into the moral stream,—a tributary which afforded
the moral impulse a definite field to work in, which centred its purpose
upon a distinct class. For heretofore the writers of juvenile literature had
aimed for a general appeal. The struggle was now to be between the
Sunday-school and the text-book.
III. The Sunday-school; Raikes; Hannah More;
Mrs. Trimmer.
If the Sunday-school movement had not assumed some proportions about
this time, it would have been necessary to create a practical outlet for the
moral energy which dominated the authors of whom we have been writing.
Had Robert Raikes not conceived his plan when he did, the ethical impulse
would have run riot in a much wilder fashion, and would have done no
good at all. For, whatever may be said against the old-time Sunday-school
in a critical vein, one cannot ignore that its establishment brought
immediate benefit. As it was, the new institution furnished the objective
point for which the didactic school was blindly groping, and developed the
idea of personal service. The social ideal was beginning to germinate.
Robert Raikes (1735 or 6–1811) was by profession a printer. He was of
benevolent disposition and met with much to arouse his sympathy for the
lower classes, whom he found indifferent to religion and hopelessly
uncouth in their daily living. With the religious revival which swept through
England around 1770, caused by the preaching of George Whitefield,
Raikes began his work in earnest, first among the city prisons, where he
was brought in contact with surprising conditions which had long lain in
obscurity because of a wide-spread public indifference.
His observation thus trained to follow along this particular social line, he
soon became attracted toward the children apprenticed to a certain pin
factory. He saw that the discipline of work, however exacting, however it
denied them the care and attention due to all young persons, was the only
restrictive guidance they had. When Sunday came, they ran wild, relieved
of duty, and not imbued with any idea of personal control. Their elders were
living immoral lives; they had no opportunity or incentive to improve; and
their natural inclination was to follow animal impulse and blind desire. To
such a religious man as Raikes, the mandate, “Suffer little children to come
unto me,” was most naturally suggested by such circumstances. Some
means of occupying these children on the Sabbath day must be devised.
So it was that on January 26, 1781, the first Sunday-school was opened.
Raikes poured his whole energy into organization, and, through the medium
of his own paper, the Gloucester Journal, spread broadcast his written
suggestions about the work to be done, and his descriptions of the particular
localities which most needed attention. He was in a position to gain
publicity, and his own personal earnestness counted for a great deal.
Already we have noted his relationship to Newbery, whose literary
connections probably afforded Raikes some assistance.
The movement had been of five years’ growth, when, in 1786, Raikes
was summoned before King George III. Their Majesties, both the King and
Queen, were interested by what they had heard, and wished to know
something more. The Queen was being almost daily enthused through the
intensity of Mrs. Trimmer’s pleadings. This good lady, already known for
her children’s books, had put into operation a Sunday-school of her own at
Brentwood, and it was to this that the King had paid a memorable visit,
leaving behind him a reputation for “kind and condescending behaviour,”
which won the hearts of all the children. In this way was the official
sanction placed upon Christianity as a practical force; there was even every
prospect of starting a Sunday-school at Windsor. “A general joy reigns
among the conductors,” cried the enthusiastic Mrs. Trimmer, when she
realised what interest was being shown in every quarter.
The programme framed for Raikes’s little protégés was indeed
sufficiently full to keep them from the highways. He writes:
“The children were to come after ten in the morning, and stay till twelve;
they were then to go home and return at one; and after reading a lesson,
they were to be conducted to Church. After Church, they were to be
employed in repeating the catechism till after five, and then dismissed, with
an injunction to go home without making a noise.”
Lamb and Leigh Hunt, when together at Christ Hospital, were regarded
as veritable monks in their knowledge of the Bible; but these little waifs
were slaves of a rigorous order; there was nothing voluntary in their desire
for spiritual light. The time was to arrive when more sunshine was to be
mixed with the teaching, but in the beginning it was necessary for Raikes to
keep the Sabbath forcibly observed rather than to devise a less exacting
routine. He went about, untiring in his efforts; he plead personally with
parents, besides hoping that, through the moral instruction being given to
their children, they might be made to see the outlet for their own salvation.
Years after, testimony was obtained from the survivors of Raikes’s
discipline. One William Brick had been a scholar of his, and the memory of
those days was vivid—perhaps a little too much so, but none the less
picturesque:
“I can remember Mr. Raikes well enough,” he said. “I remember his
caning me. I don’t suppose I minded it much. He used to cane boys on the
back of a chair. Some terrible bad chaps went to school when I first went....
I know the parents of one or two of them used to walk them to school with
14-lb. weights tied to their legs, to keep them from running away.... When a
boy was very bad, he would take him out of the school, and march him
home and get his parents to ‘wallop’ him. He’d stop and see it done, and
then bring the young urchin back, rubbing his eyes and other places....
Every one in the city loved and feared him.”
Such a scene is not prepossessing; nor does moral suasion appear to have
been as efficacious as the rod. Besides which, Raikes had a way of looking
at a trembling victim through his reading-glass, and exclaiming in
thunderous voice: “Ah, I can see you did not say your prayers this
morning.” An old man of eighty spoke of this circumstance with deep
feeling; and, in awe-stricken tones, he ended by saying: “The boys believed
he could see through stone walls with that glass; and it magnified his eye, so
that they were sometimes frightened, and told wonderful stories about what
Mr. Raikes could do with his wonderful glass.”
The immediate influence this movement had upon children’s books was
to create a demand for tracts. Later on, after Thomas Carlyle, in 1839, had
plead the cause of London public libraries, it suggested a special class of
library as a part of the Sunday-school machinery. A general call was raised
for juvenile books of a strictly religious nature, with an appeal intended for
a poorer class of readers. Miss Hannah More represents the chief exponent
of this grade of writing. “All service ranks alike with God,” says Browning.
But these ladies, who were untiring in their devotion to the cause, who
were, in their parochial character, forerunners of the social worker of to-
day, each was known through her special interest. We speak of Miss
Catherine Sinclair, author of “Holiday House,” as the first to introduce
benches in the parks of Edinburgh, as the originator of drinking-fountains,
as the founder of cooking-depots; of Priscilla Wakefield as the originator of
savings-banks for the poor; of Miss More as the author of tracts; and of
Mrs. Elizabeth Oakes Smith, one of the forgotten New-England writers, as
the first to draw attention to the condition of the newsboys. Mrs. Trimmer,
therefore, is justly connected with the history of the development of
Sunday-schools.
In a tabular indication of the trend of juvenile literature, Sarah Kirby
Trimmer (1741–1810) may be said to have been a disciple of Madame de
Genlis and of Mrs. Barbauld, quite as much as a follower of Rousseau and
of Raikes; she inherited from her father an overweening religious
inclination, and several glimpses of her in the society of the day reveal how
deeply seated her serious nature was. In London she talked with Dr.
Johnson, Mr. Gainsborough, and Mr. Hogarth, and, through recognised
powers of reading aloud, she charmed many of her friends. But it was a
hopeless situation to cope with in a young girl, when, a dispute having
arisen between Sir Joshua Reynolds and one of his friends, Sarah, being
called upon to settle the point—a doubtful passage in “Paradise Lost”—
drew the volume from the pocket of her skirt! At twenty-one she was
married, destined to be the mother of six sons and six daughters, and no
sooner was the first child born than she directed all of her attention, as
Madame de Genlis did, to the subject of education.
Wearisome it is to come in contact with a person of one idea. Mrs.
Trimmer naïvely confesses in her journal that she must have worn out the
patience of many a visitor with her views upon education. As the years
advanced, her opinions became more narrowed and more sectarian.
Mrs. Trimmer exhibited piety which was of the emotional, almost of the
hysterical kind, yet sincere in its whole-souled acceptance of Bible truths.
She questioned nothing; she believed with a simple faith that lacked
proportion. One has to view her entirely from the standpoint of this single
interest which had her under complete control. In her “Guardian of
Education” she dwelt much upon the dangerous matter contained in
children’s books; in her “New Plan of Education” she condemned any
attempt to extend the scope of education for the poor. Her chief motive in
both cases was to keep away from faith any cause of its possible undoing.
The earnestness put into her charity work, her untiring devotion to the
Sunday-school, a certain gentle charm of conversation won for Mrs.
Trimmer wide-spread attention. Her life was guided by the belief in a divine
mission; her days were well ordered, from the hours before breakfast, which
she reserved for the learning of poetry, to the evenings, when she would
give herself up to meditation and prayer. In fact, during twenty-five years,
she kept a diary, penned in secret moments of retreat, a curious display of
over-welling feeling—pietistical neurasthenia. These pages are hardly to be
considered interpretative—they are outpourings, giving one an awful sense
of unworthiness, if life consists simply in submitting to biblical strictures
and in uttering biblical paraphrases.
But Mrs. Trimmer was withal an active little woman, whose three hours,
spent every Sunday over her journal, represented meditation only: in her
practise of Christianity she was zealous; and her pen was employed in
preparing the kind of food to foster a proper feeling among children and
cottagers and servants. In this latter respect there was a change indeed from
Miss Edgeworth, who considered the advisability of separating young
people entirely from any possible contact with servants.
Among her children and her grandchildren, Mrs. Trimmer exerted
profound influence; the Sabbath day was observed with great strictness;
toys set aside while Stackhouse’s “Commentary on the Bible”[34] was
brought forth to look at; stories were told, and the progress of Bible heroes
traced upon maps of the Holy Land. The spirit of rest and peace followed
Mrs. Trimmer, who was averse to reading books of controversy. We are
given a picture of her in her venerable old age, walking with her grandson
among the plants and flowers, while she explained, with a certain lyric
simplicity, the truths, as she saw them with her meek spirit, underlying the
growth of the grass; and described the flight of a sparrow which escaped not
the notice of God. There was thus unfolded to this little boy the holiness of
all things in nature, permeated with a divine grace; he was made to consider
the lilies of the field, and not a bush but might become to him a burning
flame, not a stone but might be rent asunder by the resurrection of a dried-
up seed.
Mrs. Trimmer’s “Easy Lessons for Children,” her “Easy Introduction to
the Knowledge of Nature,” her “Sacred History for Young Persons,” and
her works explaining the catechism, were among the rare books available
for the purposes of Raikes’s followers. They were easily understood; they
explained satisfactorily for children, according to grown-up standards,
certain religious teachings. In the Catholic church to-day, Mother Loyola is
said to possess that same ability to unfold the meaning of the most difficult
doctrine so that Catholic children can understand. Priests turn to her books
rather than trust to their own interpretations. The general interest aroused
for the poor, for the lower classes, appealed to Mrs. Trimmer; she became
wholly absorbed; she wrote “The Servant’s Friend” and edited a “Family
Magazine,” intended for their special instruction and amusement. Adopting
Madame de Genlis’s idea of using prints as a factor in nursery education,

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Medical Device Regulations: A

Complete Guide Aakash Deep

For Information on all Academic Press publications

Publisher: Mara Conner

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

2.3.7 Subject privacy and confidentiality of data

2.3.8 Document and data control

2.3.9 Investigational device accountability

2.3.10 Accounting for subjects

2.4 ISO 14155:2011

2.5 International Council on Harmonization of Good Clinical Practice

2.6 International Council on Harmonization of Good Clinical Practice