Contents:

Chapter 1 - - Introduction. 1 Medical devices 2 Plan of research 2.1 Regulating medical devices 2.2 Community regulation and structure for medical devices 2.3 US regulation and structure for medical devices: in a search for alternatives 3 In search for a new model for regulating medical devices in the Community 4 Content of this study Chapter 2 - EC Measures and Medical Devices. 1 Introduction 2 General regulatory framework 2.1 Introduction 2.2 Technical harmonisation 2.2.1 Essential requirements 2.2.2 Developing European standards 2.3 Presumption of conformity 3 Directives on medical devices 3.1 Scope 3.1.1 General Product Safety Directive 3.1.2 Definition of medical device 3.1.3 Active implantable medical devices 3.1.4 In vitro diagnostic medical devices 3.1.5 Medical device or medicinal product? 3.1.6 Medical devices incorporating human blood and human plasma derivatives 3.1.7 Human tissue: a medical device? 3.1.8 Software 3.1.9 Personal protective equipment 3.1.10 Special medical devices 3.2 Manufacturer and authorised representative 3.3 Classification 3.3.1 Classification according to the MDD 3.3.2 Classification according to the IVDD 3.4 Conformity assessment procedure in the directives 3.4.1 Notified Bodies 3.4.2 Global Approach 3.4.3 Modules in directives 3.4.4 CE-marking 3.4.5 Special medical devices 3.5 Placing on the market and putting into service 3.6 Post-production issues 3.6.1 Market surveillance 3.6.2 Post-Marketing Surveillance System 3.6.2.1 Medical Device Vigilance System 3.6.2.2 Adverse incident reporting 3.6.2.3 Duty of competent authority 3.6.3 European Databank for medical devices 3.7 Exceptions in the Directives on medical devices 3.7.1 Safeguard clause 3.7.2 Particular health monitoring measures 3.7.2.1 French pre-market approval system for high risk devices 4 Conclusion Chapter 3 - Executing the Community Medical Devices Regime. 1 Introduction 2 Legislative and implementing or executive acts 3 Essential and ancillary elements 4 Comitology 4.1 The Comitology Decision of 1987 4.2 Comitology Decision of 1999 and pending proposal 4.3 Committee on Medical Devices 5 Scientific committees 5.1 Scientific Committee on Medicinal Products and Medical Devices 5.2 Scientific advice 6 Medical device structure: non-legally based 7 Recent developments 8 Conclusion Chapter 4 - Community Agencies. 1 Introduction 2 Agencies 3 Categorisation 3.1 Formal approach 3.2 Functional approach 3.2.1 Type of tasks 3.2.2 The nature of their powers 3.2.2.1 Non-delegation 3.2.2.2 Reconsidering the Meroni cases, the institutional balance and the EC-Treaty 4 Concerns regarding the delegation of powers 5 Preference for the delegation of powers 6 Recent developments 6.1 Executive agencies 6.2 The White paper on European Governance and agencies 7 Conclusion Chapter 5 - Laws on Regulating Medical Devices in the United States. 1 Introduction 2 Historical and statutory background 3 Legal analysis of regulatory framework 3.1 Scope 3.1.1 Medical devices 3.1.2 Therapeutic intent? 3.1.3 Objective intent 3.1.4 Medical software 3.1.5 In vitro diagnostic devices 3.1.6 Medical device or drugs 3.1.7 Special devices 3.2 Classification 3.2.1 Pre and post-amendment medical devices 3.2.2 Classification procedures 3.2.3 Reclassification 3.4 Pre-marketing requirements 3.4.1 Pre-market notification 3.4.1.1 Third-Party Review Pilot Program 3.4.2 Pre-market approval 3.5 Post-market control and other requirements 3.5.1 Registration of manufacturers and medical devices 3.5.2 The Medical Device Reporting (MDR) 4 Creating policy in general and individual cases 4.1 Rule-making in the medical device field 5 Recent developments: medical device users fee programme 6 Conclusion Chapter 6 - US Agency: The Food and Drug Administration. 1 Introduction 2 Food and Drug Administration 2.1 Introduction: American agencies 2.2 History and structure 3 Control mechanisms 3.1 Introduction 3.2 Branches 3.2.1 Congress 3.2.2 The President 3.2.2.1 Power of appointment and removal 3.2.2.2 Opinion in writing 3.2.3 The judiciary 3.2.1 Judicial review: acts of Congress 3.2.2 Judicial review: actions of agencies 4 Conclusion Chapter 7 - Conclusions and Recommendations. 1 Shortcomings in the Community framework for medical devices 2 Exploring the EC and US system 2.1 Substantive 2.1.1 Two level approach 2.1.2 Medical device definition 2.1.3 Intended purpose 2.1.4 Demarcation 2.1.5 Classification and reclassification 2.1.6 Pre-marketing 2.1.7 Post-marketing 2.2 Institutional 2.2.1 Legislative power to create an agency 2.2.2 Categorisation agencies 2.2.3 Organisation structure 2.2.4 Executing the regulatory regime for medical devices 3 European Medical Device Agency 4 A proposed model 4.1 Legal basis 4.2 Enabling regulation 4.2.1 Objectives 4.2.2 Decision-making 4.2.2.1 Introduction 4.2.2.2 Procedural safeguards 4.2.2.3 Access to documents 4.2.3 Network of national authorities and notified bodies 4.2.4 Advice for revising legislation, and advice on alleged infringements of Community law 4.3 Other control mechanisms 4.3.1 The Board and the Executive Director: appointment and removal 4.3.2 Parliamentary and executive power 4.3.3 Judicial review 4.4 Contribution of this study Bibliography Table of Cases Abbreviations Index Samenvatting

Reviews

Clinica 1082, November 7, 2003: "Ms Franks research has given her a perceptive insight into the workings of the medical device industry." The European Commissions medical expert Antonio Lacerda, was impressed by her work and described it as "pioneering" and "very thorough". The Regulatory Affairs Journal, 2004, p. 3-5: "a comprehensive work"; "Ms Frank covers a number of issues that are extremely relevant today"; "In conclusion, the book may become a valuable reference. It raises a number of important issues". Jason Bright (Barlow, Lyde & Gilbert; London, UK) in Journal of Medical Device Regulation, 2005, 2(4), 76: "there is no doubt that this book would be an extremely valuable addition to any manufacturer’s library." Christopher Hodges in 128 MEDICAL LAW REVIEW [2005]: "stimulating book"; "This work is to be commended in exploring new and important ground."