The Medical Device Handbook For Europe

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. Cover 1 Title Page 5 Copyright 6 ABOUT THE AUTHOR 7 TABLE OF CONTENTS 9 List of Figures 15 List of Tables 17 List of Boxes 19 List of Abbreviations 21 Preface 25 Chapter 1 Introduction to Medical Devices 27 1.1. What is a Medical Device? 28 1.2. Understanding the History of Medical Devices 30 1.3. The Influence of Technology Trends on Medical Device Development 34 1.4. The Global Medical Device Market 36 1.5. Understanding the Differences Between Medicines and Medical Devices 40 Chapter 2 Introduction to the Medical Device Market 45 2.1. Incidents that Influenced Changes to the Regulatory Field for Medical Devices 46 2.2. Pip Breast Implant Scandal 47 2.3. Overview of Events in the Pip Scandal 48 2.4. What Happened to Pip? 49 2.5. Changes to the Medical Device Regulations (MDRS) as A Result of Pip 50 2.6. The Depuy Hip Replacement Recall 51 2.7. Overview of Events In The Dupuy Scandal 52 2.8. Reactions to Published Data on Dupuy Hip Replacement Scandal 53 2.9. Inadequate Vaginal Mesh 54 2.10. The Implant Files 56 2.11. Why is the ICIJ Making This Data Public? 57 2.12. How Did the ICIJ Create the Database and Screen Data? 58 2.13. How Is Information Listed Within the Database? 62 Chapter 3 Developing a Medical Device 99 3.1. Understanding the Phases of Medical Device Development 100 3.2. Choosing a Medical Device 103 3.3. Lack of Information 104 3.4. Attractive Technology 105 3.5. Personal Preference 105 3.6. Costing of Medical Devices 106 3.7. Lack of a Single Nomenclature 107 3.8. Solutions to Overcoming Barriers Experienced When Choosing a Medical Device 107 3.9. Common Questions That Could Be Asked When Choosing A Medical Device 108 3.10. Assessment of Costs 109 3.11. Improving Marketing Practices 109 3.12. Using Medical Devices 110 3.13. Inappropriate Design 110 3.14. Limited Management 113 3.15. Lack of Training 113 3.16. Maintenance Problems 114 3.17. Phases in the Life Span of Medical Devices 115 3.18. What Happens After the Device Is Placed on the Market? 119 Chapter 4 Standards and Regulations 121 4.1. What Are Standards? 122 4.2. Types of Standard Specifications 122 4.3. The Purpose of Standards 123 4.4. Types of Standards 124 4.5. Development Process of Standards 124 4.6. Key Principles in the Development of ISO Standards (As Defined By ISO) 124 4.7. Conformity Assessment With Standards 126 4.8. National and International Standard Systems 127 4.9. Identification of Standards 128 4.10. The Use of Standards In Medical Device Regulations (MDRS) 128 4.11. The Global Harmonized Task Force (GHTF) 129 4.12. Nomenclature of Medical Devices 130 4.13. The Global Medical Devices Nomenclature System (GMDNS) 131 4.14. Development of GMDN 132 4.15. Understanding the Purpose of GMDN 133 4.16. Compilation of the Initial GMDN Nomenclature Database 133 4.17. Understanding The Structure of the Global Medical Device Nomenclature (GMDN) System 134 4.18. Understanding the Coding System Used for GMDN 139 4.19. Services Provided By the GMDN Agency 140 4.20. Benefits of the Global Medical Device Nomenclature (GMDN) System 141 4.21. How to Use GMDN Codes? 142 4.22. Application of the GMDN to International Use 143 4.23. Final Documents Arising From GHTF 143 4.24. International Medical Devices Regulators Forum (IMDRF) 145 4.25. Goals of the IMDRF 146 Chapter 5 Regulating Medical Devices 147 5.1. Design and Implementation of National Medical Device Regulatory Systems 148 5.2. Why Are Regulatory Controls for Medical Devices So Complicated? 149 5.3. Ensuring Safety of Medical Devices 151 5.4. Phases in the Life Span of Medical Devices 151 5.5. Who is Responsible for Ensuring the Safety of Medical Devices? 155 5.6. Understanding the Role of Each Participant/Stakeholder In Medical Device Safety 155 5.7. Understanding The Stages of Regulatory Control 158 5.8. General Development Phases of National Regulatory Authorities 158 5.9. Responsibilities of National Regulatory Authorities 160 5.10. Principles of Good Regulatory Practice 164 5.11. A Simple Guide to Regulating Medical Devices 165 5.12. Optimizing the Use of Regulatory Resources 176 5.13. How to Increase Knowledge of the Medical Device Sector? 177 5.14. How to Establish a Basic Regulatory Program? 180 5.15. How to Draft a Comprehensive Policy/Guideline on Medical Device Management 182 5.16. Medical Device Product Control 182 Chapter 6 Regulating Medical Devices in Europe 187 6.1. How are Medical Devices Regulated in Europe? 188 6.2. Overview of the CE Marking Process 190 6.3. Simplified Process for CE Marking of Medical Devices in Europe 196 Chapter 7 The Medical Device Directive (MDD 93/42/EEC) 203 7.1. What Is The Medical Device Directive (MDD)? 204 7.2. Understanding the MDD: Let’s Take a Closer Look 204 7.3. Classification Rules Under The MDD 204 7.4. How To Comply with the Medical Device Directive (MDD) 93/42/EEC 211 7.5. Understanding Which Products are Within the Scope of The Medical Device Directive (MDD) 93/42/Eec 213 7.6. Understanding Which Products Are Not Covered By The Medical Device Directive (MDD) 219 7.7. Purpose of the Medical Device Directive (MDD) 93/42/Eec 219 7.8. Scope of the Medical Device Directive (MDD) 93/42/Eec 219 Chapter 8 Transitioning From the MDD to the MDR 223 8.1. What is the Medical Device Regulation (EU MDR 2017/745 or MDR)? 224 8.2. Major Differences Between the Medical Device Directive (MDD) 93/42/EEC and Medical Device Regulation (MDR) 2017/745 224 Chapter 9 Classification of Medical Devices in Europe 227 9.1. Class I Medical Devices 228 9.2. Class IIA Medical Devices 229 9.3. Class IIB Medical Devices 230 9.4. Class III Medical Devices 231 9.5. EU Guidelines on Medical Device Classification 232 9.6. Factors Influencing Device Classification Schemes 236 9.7. Initial Classification Rules As Defined by the Global Harmonization Task Force (GHTF) 238 9.8. Understanding the Rules Governing Guidelines for the Classification of Medical Devices According to Meddev 2.4/1 243 9.9. Understanding Classification Rules Under the New MDR 2017/745 263 9.10. Understanding How Categories of Medical Devices Are Defined Under MDR 263 9.11. Comparison of Classification Rules Between The MDD and MDR 275 Chapter 10 Safety and Performance of Medical Devices 279 Chapter 11 Biocompatibility Testing 285 11.1. What Is Biocompatibility? 286 11.2. Do Medical Device Companies Really Need Biocompatibility Testing Data? 286 11.3. How To Determine if a Manufacturer Must Test Their Device And Which Tests Apply 302 11.4. Key Concepts of Material Characterization and Analytical Testing of Biomaterials 305 11.5. Biomaterials and Medical Devices 308 11.6. Biocompatibilityand Toxicology of Biomaterials 309 11.7. Mechanical and Performance Requirements 310 11.8. Regulating Biomaterials 311 11.9. Understanding the Difference Between in Vivo and in Vitro Testing 312 11.10. Testing With Glp 313 11.11. Sample Preparation: Determining The Surface Area Of Your Device 315 11.12. Choosing the Appropriate Extraction Media and Extraction Conditions 319 11.13. Selecting Suitable Reference Materials (RMS) and Experimental Controls 323 11.14. Developing a Biological Evaluation Plan (BEP) 324 11.15. Re-Evaluation of Biocompatibility Data 326 11.16. Template of a Biological Evaluation Report 329 Chapter 12 Easy Review Questions Around Biocompatibility Testing 331 12.1. What is the First Thing to Be Aware of When Considering Biocompatibility? 332 12.2. How Long Does Biocompatibility Testing Take? 332 12.3. How Much Does Biocompatibility Testing Cost? 332 12.4. What Should Manufacturers Know Before Starting Biocompatibility Discussions? 332 12.5. How Does Regulatory Requirements Impact Biocompatibility Testing? 333 12.6. How Do You Choose A Suitable Biocompatibility Testing Facility? 333 Chapter 13 Economic Operators 335 13.1. Introduction to Economic Operators 336 13.2. What is an Economic Operator? 336 13.3. Who Controls Economic Operators? 337 13.4. Do Economic Operators Need a Quality Management System (QMS)? 338 Chapter 14 Person Responsible for Regulatory Compliance 351 14.1. Person Responsible for Regulatory Compliance (PRRC) 352 14.2. Qualifications of the PRRC 352 14.3. Can One Person Be the PRRC for a Manufacturer and its Authorized Representative? 358 Bibliography 359 Index 365 Back Cover 370