Becker / Menzel / Rupprath | CE-marking for medical devices (E-Book, PDF) | E-Book | sack.de
E-Book

E-Book, Englisch, 341 Seiten

Becker / Menzel / Rupprath CE-marking for medical devices (E-Book, PDF)


a guide throgh the maze of requirements in europe

E-Book, Englisch, 341 Seiten

ISBN: 978-3-8249-1897-3
Verlag: TÜV Media
Format: PDF
 Kopierschutz: Kein

Medical devices are widely used – from prevention and diagnostics to treatment and rehabilitation. They are indispensable for the health sector, and do represent an important economic factor. Efficacy and safety of a product is of key importance for patients and users. CE-marking has to be affixed on all medical devices in Europe and is the visible feature of conformity of the medical device with essential legal requirements. CE-marking therefore is one of the most important objectives for manufacturers that want to distribute medical devices in Europe. The authors are working in the medical devices industry for many years. With their expertise they provide a competent but also practice-oriented overview of the European and national requirements for medical devices. This book is meant to be a workbook including exercises to deepen the knowledge on the CE-marking process for medical devices.
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Autoren/Hrsg.

Becker, Myriam
Menzel, Stefan
Rupprath, Carsten
Scholtz, Sibylle

Fachgebiete

Weitere Infos & Material

1;Titel
;1
1.1;Impressum
;3
1.2;Editors and Authors;4
1.3;Note from the authors
;8
2;Table of Contents
;10
3;Chapter 0: Introduction;12
4;Chapter 1: Medical Devices Jurisdiction and European Directives
;18
4.1;1.1 Learning Objective ;18
4.2;1.2 Historical Background;18
4.3;1.3 Authorities, Institutions and other Relevant Players
;23
4.3.1;1.3.1 Learning Objective;23
4.3.2;1.3.2 The European Commission, Parliament & Council
;23
4.3.3;1.3.3 National Legal Institutions and Authorities;23
4.3.4;1.3.4 Notified Bodies
;24
4.3.5;1.3.5 Standardization Organizations
;25
4.3.6;1.3.6 Importers and Distributors
;25
4.3.7;1.3.7 User of Medical Devices
;26
4.3.8;1.3.8 The Manufacturer
;26
4.3.9;1.3.9 The European Representative
;27
4.4;1.4 Summary
;28
4.5;1.5 Test Your Knowledge
;29
4.6;1.6 References
;30
5;Chapter 2: Conformity Assessment
;32
5.1;2.1 Learning Objective
;32
5.2;2.2 Conformity Assessment – an Overview ;32
5.3;2.3 Conformity Assessment – Essential Requirements ;36
5.4;2.4 Establishing a Technical Documentation
;37
5.5;2.5 Summary
;41
5.6;2.6 Test Your Knowledge
;41
5.7;2.7 References
;42
6;Chapter 3: Product Classification and Rules of Classification
;44
6.1;3.1 Learning Objective
;44
6.2;3.2 Introduction
;44
6.3;3.3 Medical Device – Definition
;44
6.4;3.4 Risk Classes
;45
6.5;3.5 Summary
;51
6.6;3.6 Test Your Knowledge
;52
6.7;3.7 References
;53
7;Chapter 4: The Process of CE-Marking
;54
7.1;4.1 Learning Objective
;54
7.2;4.2 Introduction
;54
7.3;4.3 Medical Device – Definition
;55
7.4;4.4 Significance of CE-marking of a Medical Device
;56
7.5;4.5 Standardization of the CE-marking ;57
7.6;4.6 Regulatory Registration Pathways & Registration Strategies Depending on Product Categories/Classes
;58
7.7;4.7 Establishing a Regulatory Plan
;62
7.8;4.8 Who is Responsible if a CE-mark is Wrongly Affixed? Who Monitors that Claims are Met?
;64
7.9;4.9 Additional Marks
;65
7.10;4.10 Summary
;65
7.11;4.11 Test Your Knowledge
;66
7.12;4.12 References
;67
8;Chapter 5: Borderline Products
;68
8.1;5.1 Learning Objective
;68
8.2;5.2 Introduction
;68
8.3;5.3 Short Overview of the Underlying Regulations Regarding the Differentiation of Medical Devices and Medicinal Products
;70
8.4;5.4 Medical Devices that Incorporate a Substance as an Integral Part
;73
8.5;5.5 Medical Devices Incorporating Material of Animal Origin, Human Blood, Human Plasma or Human Tissue
;83
8.6;5.6 Summary
;84
8.7;5.7 Helpful Documents
;85
8.8;5.8 Test Your Knowledge
;86
8.9;5.9 References
;86
9;Chapter 6: Software as Medical Device
;88
9.1;6.1 Learning Objective
;88
9.2;6.2 Introduction
;88
9.3;6.3 Classification
;89
9.4;6.4 Requirements to
the QM System of the Manufacturer for Software;91
9.5;6.5 Conformity Assessment
;91
9.6;6.6 Summary
;95
9.7;6.7 Test Your Knowledge
;95
9.8;6.8 References
;96
10;Chapter 7: Essential Requirements
;98
10.1;7.1 Learning Objective
;98
10.2;7.2 Introduction
;98
10.3;7.3 Structure of Essential Requirements
;99
10.4;7.4 Harmonized Standards
;100
10.5;7.5 Presumption of Conformity
;101
10.6;7.6 Obligation of Documentation
;101
10.7;7.7 EU Declaration of Conformity
;101
10.8;7.8 Further Examples
;103
10.9;7.9 Summary
;103
10.10;7.10 Test Your Knowledge
;104
10.11;7.11 References
;105
11;Chapter 8: Technical Documentation
;106
11.1;8.1 Learning Objective
;106
11.2;8.2 Introduction
;106
11.3;8.3 Structure of a Technical Documentation
;106
11.4;8.4 Benefit of the Technical Documentation
;107
11.5;8.5 Technical Documentation and Classification of Medical Devices
;108
11.6;8.6 Technical Documentation File
;109
11.7;8.7 Summary
;126
11.8;8.8 Test Your Knowledge
;126
11.9;8.9 References
;127
12;Chapter 9: Norms and Standards
;128
12.1;9.1 Learning Objective
;128
12.2;9.2 Introduction
;128
12.3;9.3 European Norms
;129
12.4;9.4 International Standards
;131
12.5;9.5 Application of Standards – Assessment of Conformity of Medical Devices
;132
12.6;9.6 Revision of Harmonized Standards
;133
12.7;9.7 Summary
;133
12.8;9.8 Test Your Knowledge
;134
12.9;9.9 References
;134
13;Chapter 10: Regulatory Intelligence
;136
13.1;10.1 Learning Objective
;136
13.2;10.2 Introduction
;136
13.3;10.3 How to Keep up with Worldwide Regulatory Changes?
;136
13.4;10.4 Summary
;138
13.5;10.5 Test Your Knowledge
;139
13.6;10.6 References
;139
14;Chapter 11: Criteria for the Selection of a Notified Body (NB)
;140
14.1;11.1 Learning Objective
;140
14.2;11.2 Introduction
;140
14.3;11.3 Definition of a NB
;140
14.4;11.4 Accreditation and Experience of a Notified Body
;142
14.5;11.5 NB: Size and Staffing
;143
14.6;11.6 Summary of the Selection Criteria of a Notified Body
;144
14.7;11.7 Exchanging a Notified Body
;147
14.8;11.8 Summary
;148
14.9;11.9 Test Your Knowledge
;149
14.10;11.10 References
;149
15;Chapter 12: Usability
;152
15.1;12.1 Learning Objective
;152
15.2;12.2 Introduction
;152
15.3;12.3 Application of the Relevant Standard for Medical Devices: IEC 62366-1
;152
15.4;12.4 Conformity with IEC 62366
;154
15.5;12.5 DIN EN ISO 9241
;157
15.6;12.6 Glossary
;158
15.7;12.7 Summary
;159
15.8;12.8 Test Your Knowledge
;159
15.9;12.9 References
;160
16;Chapter 13: Quality Management
;162
16.1;13.1 Learning Objective
;162
16.2;13.2 Introduction
;162
16.3;13.3 EN ISO 13485 – The Basis of the QMS of Medical Devices
;162
16.3.1;13.3.1 Structure of EN ISO 13485
;164
16.3.2;13.3.2 Prerequisites for Getting Accredited According to EN ISO 13485
;165
16.3.3;13.3.3
Documentation Requirements;166
16.3.4;13.3.4
Retention Period;167
16.3.5;13.3.5
Proving the Effectiveness of a QMS;168
16.3.6;13.3.6
Internal Communication and Management Review;169
16.3.7;13.3.7
Resource Management;170
16.3.8;13.3.8
Product Realization;171
16.3.9;13.3.9
Production and Service Provision;173
16.3.10;13.3.10
Measurement, Analysis and Improvement;175
16.3.11;13.3.11
Analysis of Data and Improvement;177
16.4;13.4
Change Control;178
16.5;13.5
Design Control;180
16.6;13.6
Summary;181
16.7;13.7
Test Your Knowledge;181
16.8;13.8
References;183
17;Chapter 14: Clinical Assessment of Medical Devices, "Literature Route"
;186
17.1;14.1
Learning Objective;186
17.2;14.2
Introduction;186
17.3;14.3
Significance of the Clinical Assessment of Medical Devices;186
17.4;14.4
Conducting the Clinical Assessment of Medical Devices;187
17.5;14.5
Recommendation for Conducting a Clinical Assessment;188
17.6;14.6
Detailed Information on the Literature Route;188
17.7;14.7
Criteria for Assessing Equivalence/Comparability of Medical Devices;190
17.8;14.8
Presentation of the Results;191
17.9;14.9
Initiation of a Clinical Investigation;192
17.10;14.10
Regulatory Requirements;193
17.11;14.11
Summary;194
17.12;14.12
Test Your Knowledge;195
17.13;14.13
References;195
18;Chapter 15: Risk Management for Medical Devices according to ISO 14971;198
18.1;15.1 Learning Objective
;198
18.2;15.2
Introduction;198
18.3;15.3
Risk Management and Medical Devices;198
18.4;15.4
Summary;204
18.5;15.5
Test Your Knowledge;204
18.6;15.6
References;204
19;Chapter 16: Regulatory Risk Management;206
19.1;16.1
Learning Objective;206
19.2;16.2
Introduction;206
19.3;16.3 "Cooperation & Communication" – Which Partner to Address?
;206
19.3.1;16.3.1
Notified Body;206
19.3.2;16.3.2
Cross-functional Cooperation at the Manufacturer;207
19.3.3;16.3.3
Distributors;208
19.4;16.4 Summary;208
19.5;16.5
Test Your Knowledge;210
19.6;16.6
References;210
20;Chapter 17: Interactions with other Departments – Inside or outside the
Company;212
20.1;17.1
Learning Objective;212
20.2;17.2
Introduction;212
20.3;17.3
Role of Regulatory Affairs;212
20.4;17.4
Definition of the Scope of RA Activities;213
20.5;17.5
Summary;217
20.6;17.6
Test Your Knowledge;218
20.7;17.7
References;218
21;Chapter 18: Selected National Peculiarities – Notification Obligation for
Medical Devices that are Placed on the Market;220
21.1;18.1
Learning Objective;220
21.2;18.2
Introduction;220
21.3;18.3
Which Countries are Affected;221
21.3.1;18.3.1
EU Countries;221
21.3.2;18.3.2
Italy;221
21.3.3;18.3.3
Ireland;221
21.3.4;18.3.4
Belgium;222
21.3.5;18.3.5
France;222
21.3.6;18.3.6
Germany/Austria;222
21.3.7;18.3.7
Portugal;224
21.4;18.4
Summary;224
21.5;18.5
Test Your Knowledge;224
21.6;18.6
References;225
22;Chapter 19: Promotion of medical devices;226
22.1;19.1
Learning Objective;226
22.2;19.2
Introduction;226
22.3;19.3
National Regulations;226
22.3.1;19.3.1 Italy
;226
22.3.2;19.3.2 Spain
;226
22.3.3;19.3.3 France
;227
22.3.4;19.3.4 Germany
;227
22.3.5;19.3.5 Austria
;228
22.3.6;19.3.6 Switzerland
;228
22.3.7;19.3.7 Belgium
;229
22.3.8;19.3.8 Other EU Countries
;229
22.4;19.4 Promotion for Medical Devices without a CE-mark
;229
22.5;19.5 Summary
;229
22.6;19.6 Test Your Knowledge
;230
22.7;19.7 References
;230
23;Chapter 20: Market Surveillance and Reporting Obligations
;232
23.1;20.1 Learning Objectives
;232
23.2;20.2
Basics and Definitions in the European Environment Surveillance;232
23.3;20.3 Example for the Implementation into National Law: The German Medical Device
Vigilance System;237
23.3.1;20.3.1
Tasks of the Authority;237
23.3.2;20.3.2
Reporting Obligation;240
23.3.3;20.3.3
Notification Deadline;242
23.3.4;20.3.4
Notification Procedure;243
23.3.5;20.3.5
National Specificities in Germany and Austria: Safety Officer and MD Consultants;243
23.3.6;20.3.6
Obligation of the Manufacturer: Product Surveillance;244
23.3.7;20.3.7
Tasks of the Higher Federal Authority;245
23.3.8;20.3.8
Official Measures;245
23.3.9;20.3.9
Possible Consequences of Incidents;246
23.4;20.4 Requirements of the Quality System (MDD, Annex II, 3)
;247
23.5;20.5
Statistics;248
23.6;20.6
Summary;248
23.7;20.7
Test Your Knowledge;250
23.8;20.8
References;250
24;Chapter 21: Change Management/Lifecycle Management/
Product Modification;254
24.1;21.1
Learning Objective;254
24.2;21.2
Introduction;254
24.3;21.3
Lifecycle of a Medical Device;254
24.4;21.4
Reasons for Modification;255
24.5;21.5 Product Development/Product Lifecycle –
Exemplary Description;256
24.6;21.6
Types of Modifications;262
24.7;21.7
Change Notification;263
24.8;21.8
Modifications that are Subject to Approval;265
24.9;21.9
Approach of Implementing Modifications on CE-marked Medical Devices;266
24.10;21.10
Risk Assessment of Modifications;267
24.11;21.11
Summary;267
24.12;21.12
Test Your Knowledge;268
24.13;21.13
References;269
25;Chapter 22: MDD Revision;270
25.1;22.1
Learning Objective;270
25.2;22.2 What will be New? What will Prevail? ...
and Why?;270
25.3;22.3
What Kind of Influence will the New Regulation have on the Notified Bodies?;272
25.4;22.4
Summary;274
25.5;22.5
References;274
26;Chapter 23: Final Case Study with Sample Solutions;276
26.1;23.1
Learning Objective;276
26.2;23.2
Case Study: Approval of a Medical Device;276
26.3;23.3
Preliminary Remarks;276
26.4;23.4
The Project;276
26.5;23.5
Case Task;287
26.6;23.6
Sample Solution;295
27;Chapter 24: Glossary;330

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