chapter 1 Introduction -- chapter 2 The transformation in the European Community -- chapter 3 The current situation: the EC Medical Devices Directive -- chapter 4 The current situation: Regulations in USA and Japan— a comparison with the Medical Devices Directive -- chapter 5 The current situation: regulatory developments in other countries -- chapter 6 The place of quality systems -- chapter 7 The use of product standards -- chapter 8 The question of effectiveness -- chapter 9 Key factors—post-market controls -- chapter 10 Proposals and prospects for a global regulatory system for medical devices -- chapter 11 Overview and look to the future.