As the medical device landscape continues to evolve, so does the regulatory framework in Europe. Through this process many gaps and scarcity of skills and expertise have also been identified. For this reason, there was an increasing need to update the current medical device directive (MDD 93/42/EEC) being used within the European Union. This in turn led to the development and release of the Medical Device Regulation (EU MDR 2017/745). The release of the new Medical Device Regulation (EU MDR 2017/745) in 2017 marked the start of a three-year transition period for various Economic Operators along the supply chain. This volume aims to provide a simple overview of the medical device industry in Europe with particular focus on the main aspects covered in the new European Medical Device Regulation. Important concepts such as essential phases in a device lifecycle, complying to standards and regulations, the CE mark process and classification of medical devices in Europe are covered.
Author(s): Shalinee Naidoo
Publisher: Arcler Press
Year: 2022
Language: English
Pages: 367
City: Burlington
Cover
Title Page
Copyright
ABOUT THE AUTHOR
TABLE OF CONTENTS
List of Figures
List of Tables
List of Boxes
List of Abbreviations
Preface
Chapter 1 Introduction to Medical Devices
1.1. What is a Medical Device?
1.2. Understanding the History of Medical Devices
1.3. The Influence of Technology Trends on Medical Device Development
1.4. The Global Medical Device Market
1.5. Understanding the Differences Between Medicines and Medical Devices
Chapter 2 Introduction to the Medical Device Market
2.1. Incidents that Influenced Changes to the Regulatory Field for Medical Devices
2.2. Pip Breast Implant Scandal
2.3. Overview of Events in the Pip Scandal
2.4. What Happened to Pip?
2.5. Changes to the Medical Device Regulations (MDRS) as A Result of Pip
2.6. The Depuy Hip Replacement Recall
2.7. Overview of Events In The Dupuy Scandal
2.8. Reactions to Published Data on Dupuy Hip Replacement Scandal
2.9. Inadequate Vaginal Mesh
2.10. The Implant Files
2.11. Why is the ICIJ Making This Data Public?
2.12. How Did the ICIJ Create the Database and Screen Data?
2.13. How Is Information Listed Within the Database?
Chapter 3 Developing a Medical Device
3.1. Understanding the Phases of Medical Device Development
3.2. Choosing a Medical Device
3.3. Lack of Information
3.4. Attractive Technology
3.5. Personal Preference
3.6. Costing of Medical Devices
3.7. Lack of a Single Nomenclature
3.8. Solutions to Overcoming Barriers Experienced When Choosing a Medical Device
3.9. Common Questions That Could Be Asked When Choosing A Medical Device
3.10. Assessment of Costs
3.11. Improving Marketing Practices
3.12. Using Medical Devices
3.13. Inappropriate Design
3.14. Limited Management
3.15. Lack of Training
3.16. Maintenance Problems
3.17. Phases in the Life Span of Medical Devices
3.18. What Happens After the Device Is Placed on the Market?
Chapter 4 Standards and Regulations
4.1. What Are Standards?
4.2. Types of Standard Specifications
4.3. The Purpose of Standards
4.4. Types of Standards
4.5. Development Process of Standards
4.6. Key Principles in the Development of ISO Standards (As Defined By ISO)
4.7. Conformity Assessment With Standards
4.8. National and International Standard Systems
4.9. Identification of Standards
4.10. The Use of Standards In Medical Device Regulations (MDRS)
4.11. The Global Harmonized Task Force (GHTF)
4.12. Nomenclature of Medical Devices
4.13. The Global Medical Devices Nomenclature System (GMDNS)
4.14. Development of GMDN
4.15. Understanding the Purpose of GMDN
4.16. Compilation of the Initial GMDN Nomenclature Database
4.17. Understanding The Structure of the Global Medical Device Nomenclature (GMDN) System
4.18. Understanding the Coding System Used for GMDN
4.19. Services Provided By the GMDN Agency
4.20. Benefits of the Global Medical Device Nomenclature (GMDN) System
4.21. How to Use GMDN Codes?
4.22. Application of the GMDN to International Use
4.23. Final Documents Arising From GHTF
4.24. International Medical Devices Regulators Forum (IMDRF)
4.25. Goals of the IMDRF
Chapter 5 Regulating Medical Devices
5.1. Design and Implementation of National Medical Device Regulatory Systems
5.2. Why Are Regulatory Controls for Medical Devices So Complicated?
5.3. Ensuring Safety of Medical Devices
5.4. Phases in the Life Span of Medical Devices
5.5. Who is Responsible for Ensuring the Safety of Medical Devices?
5.6. Understanding the Role of Each Participant/Stakeholder In Medical Device Safety
5.7. Understanding The Stages of Regulatory Control
5.8. General Development Phases of National Regulatory Authorities
5.9. Responsibilities of National Regulatory Authorities
5.10. Principles of Good Regulatory Practice
5.11. A Simple Guide to Regulating Medical Devices
5.12. Optimizing the Use of Regulatory Resources
5.13. How to Increase Knowledge of the Medical Device Sector?
5.14. How to Establish a Basic Regulatory Program?
5.15. How to Draft a Comprehensive Policy/Guideline on Medical Device Management
5.16. Medical Device Product Control
Chapter 6 Regulating Medical Devices in Europe
6.1. How are Medical Devices Regulated in Europe?
6.2. Overview of the CE Marking Process
6.3. Simplified Process for CE Marking of Medical Devices in Europe
Chapter 7 The Medical Device Directive (MDD 93/42/EEC)
7.1. What Is The Medical Device Directive (MDD)?
7.2. Understanding the MDD: Let’s Take a Closer Look
7.3. Classification Rules Under The MDD
7.4. How To Comply with the Medical Device Directive (MDD) 93/42/EEC
7.5. Understanding Which Products are Within the Scope of The Medical Device Directive (MDD) 93/42/Eec
7.6. Understanding Which Products Are Not Covered By The Medical Device Directive (MDD)
7.7. Purpose of the Medical Device Directive (MDD) 93/42/Eec
7.8. Scope of the Medical Device Directive (MDD) 93/42/Eec
Chapter 8 Transitioning From the MDD to the MDR
8.1. What is the Medical Device Regulation (EU MDR 2017/745 or MDR)?
8.2. Major Differences Between the Medical Device Directive (MDD) 93/42/EEC and Medical Device Regulation (MDR) 2017/745
Chapter 9 Classification of Medical Devices in Europe
9.1. Class I Medical Devices
9.2. Class IIA Medical Devices
9.3. Class IIB Medical Devices
9.4. Class III Medical Devices
9.5. EU Guidelines on Medical Device Classification
9.6. Factors Influencing Device Classification Schemes
9.7. Initial Classification Rules As Defined by the Global Harmonization Task Force (GHTF)
9.8. Understanding the Rules Governing Guidelines for the Classification of Medical Devices According to Meddev 2.4/1
9.9. Understanding Classification Rules Under the New MDR 2017/745
9.10. Understanding How Categories of Medical Devices Are Defined Under MDR
9.11. Comparison of Classification Rules Between The MDD and MDR
Chapter 10 Safety and Performance of Medical Devices
Chapter 11 Biocompatibility Testing
11.1. What Is Biocompatibility?
11.2. Do Medical Device Companies Really Need Biocompatibility Testing Data?
11.3. How To Determine if a Manufacturer Must Test Their Device And Which Tests Apply
11.4. Key Concepts of Material Characterization and Analytical Testing of Biomaterials
11.5. Biomaterials and Medical Devices
11.6. Biocompatibilityand Toxicology of Biomaterials
11.7. Mechanical and Performance Requirements
11.8. Regulating Biomaterials
11.9. Understanding the Difference Between in Vivo and in Vitro Testing
11.10. Testing With Glp
11.11. Sample Preparation: Determining The Surface Area Of Your Device
11.12. Choosing the Appropriate Extraction Media and Extraction Conditions
11.13. Selecting Suitable Reference Materials (RMS) and Experimental Controls
11.14. Developing a Biological Evaluation Plan (BEP)
11.15. Re-Evaluation of Biocompatibility Data
11.16. Template of a Biological Evaluation Report
Chapter 12 Easy Review Questions Around Biocompatibility Testing
12.1. What is the First Thing to Be Aware of When Considering Biocompatibility?
12.2. How Long Does Biocompatibility Testing Take?
12.3. How Much Does Biocompatibility Testing Cost?
12.4. What Should Manufacturers Know Before Starting Biocompatibility Discussions?
12.5. How Does Regulatory Requirements Impact Biocompatibility Testing?
12.6. How Do You Choose A Suitable Biocompatibility Testing Facility?
Chapter 13 Economic Operators
13.1. Introduction to Economic Operators
13.2. What is an Economic Operator?
13.3. Who Controls Economic Operators?
13.4. Do Economic Operators Need a Quality Management System (QMS)?
Chapter 14 Person Responsible for Regulatory Compliance
14.1. Person Responsible for Regulatory Compliance (PRRC)
14.2. Qualifications of the PRRC
14.3. Can One Person Be the PRRC for a Manufacturer and its Authorized Representative?
Bibliography
Index
Back Cover
