Summary

This book presents the current issues concerning information exchange in the field of Medical Device Vigilance and expands on the influences and trends introduced by the application of telematic technologies. The need for appropriate reporting systems in order to collect information concerning adverse incidents, has been recognised world-wide. Many countries have already established their own vigilance systems for medical devices. Within the EU a series of Directives and guidelines have been put into force, in order to provide the legal framework for the implementation of a medical device vigilance system through which Member States will be able to exchange information. The book consists of two parts. The first part provides an extensive overview of the activities and initiatives undertaken, by all parties involved in the medical device vigilance, in the EU and world-wide. The second part of the book, deals with the telematics aspects concerning the medical device vigilance, as they have been negotiated within the framework of EUROMEDIES (European Medical Device Information System) Concerted Action of DGXIII. This Action has facilitated a common approach to the relevant regulatory information exchange, based on consensus of all actors involved; this has subsequently provided the basis for the elaboration of the requirements for a telematics facility that would serve the purposes of this exchange. The project's results are expected to be adopted for the implementation of the vigilance system in the European Union.