Technological development, over the last two decades has had a tremendous impact on the health care sector. Advances in medical device technology and manufacturing practice have led to a significant impact on the accuracy and efficacy of medical procedures and a remarkable influence on health care services at all associated levels. This evolution, driven by intense and productive applied biomedical research, as well as the rapid progress in health care telematics, is expected to dramatically change the shape of health care delivery within the next decade.

These innovations are also causing a shift of focus to technology assessment and risk management, provided by governmental agencies and regulatory bodies. New improved methods are implemented in equipment design and manufacturing practice, with emphasis on reliability and safety for both patients and users. Monitoring systems for adverse incidents are also introduced, to provide surveillance for safety during use.

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 user reporting 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 implementation of the medical device directives has resulted in a considerable amount of information to be exchanged between Competent Authorities, Notified Bodies, Manufacturers, Users and the Commission. The potential of utilising telematics to facilitate a harmonised approach to regulatory information exchange, in order to increase the effectiveness and efficacy of the relevant procedures, has been investigated within the framework of EUROMEDIES (European Medical Device Information Exchange System), a Concerted Action supported by DG XIII under the AIM (Advanced Informatics in Medicine) programme. The most important consensus statements, which have emerged, concern the elaboration of the data model and the basic data set to be exchanged amongst the involved parties, the definition of the necessary mechanisms for data security, integrity and confidentiality as well as the identification of Electronic Data Interchange (EDI) technology as the most appropriate means to meet the relevant requirements.

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. It consists of two parts. The first 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 main objective is to provide and disseminate information to the international community, on the actions planned, in progress or already implemented, in order to facilitate collaboration and promote global harmonisation. The issues concerned were extensively discussed during the second Euromedies workshop, in September 1995, in Athens and the first part is primarily based on the relevant contributions. 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 Concerted Action. 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, expected to be used in the implementation of the vigilance system in the European Union.

The positive results achieved through this action have to be attributed to the high level of expertise, but also to the good willingness of all participants and contributors. Of course, the positions expressed in their papers do not necessarily engage their organisations, reflecting their own points of view. I would like to express my deep appreciation for their efforts. Nicolas Pallikarakis Associate Professor, University of Patras