Title Page -- Contents -- Part A -- Chapter 1: Medical Device Incident Reporting World-Wide -- The European Legislation on Medical Devices -- Medical Devices Vigilance: The European Approach -- Medical Device Vigilance at FDA -- The Australian Medical Device Vigilance System -- Medical Device Accident Reporting: Does it Improve Patient Safety? -- Chapter 2: Data Exchange using Telematics -- Requirements Specification for a Harmonized Medical Device Vigilance Information Exchange System -- Security Aspects for Medical Device Vigilance Information Exchange -- The EUROMEDIES EDI Prototype System -- Data Exchange in the European Pharmacovigilance -- Data Exchange in Metrology -- Chapter 3: Medical Device Directives Implementation Activities -- Finland's Competent Authority Initiatives -- France's Competent Authority Initiatives -- Germany's Competent Authority Initiatives -- Ireland's Competent Authority Initiatives -- The Netherlands' Competent Authority Activities -- Spain's Competent Authority Initiatives -- Sweden's Competent Authority Initiatives -- Activities in Other European Countries -- Chapter 4: Nomenclature Issues and Points of View of Notified Bodies and Manufacturers -- The Universal Medical Device Nomenclature System -- The CEN/TC 257/SC1 - Nomenclature -- Notified Body Needs of Information Exchange -- National Handling of Medical Devices Vigilance Reports and the Use of Registers -- Experience of BSI as a Notified Body -- Medical Technology Manufacturers' View of a European Data Exchange -- EUCOMED's Position -- CEN/TC 251 Medical Informatics & EAN and HIBC Coding -- Part B. Towards a European Medical Devices Information Exchange System -- Section I: Medical Device Surveillance World-wide -- Section II: The EUROMEDIES Concerted Action Outcomes -- List of Abbreviations -- Author Index