Updated: Feb 1, 97
EUROMEDIES

European Medical device Information Exchange System

Project Code: A2122 Project value: 300 KECU EC contribution: 300 KECU No of partners: 23 No of countries 11 Duration: 20 months

Contact: Prof. Nicolas Pallikarakis INBIT Institute of Biomedical Technology Ellinos Stratiotou 50A GR-26441 Patras, Greece Tel.: +30-61-65.28.15 / 65.28.51 Fax: +30-61-65.01.16

Over the past two decades, an exploding number of new technologies and applications has been introduced into the medical field, opening up amazing possibilities for diagnosis and therapy, but also raising questions of their appropriateness, safety and effectiveness. The E.U. shares today about 1/3 of the medical devices world market, which grows by almost 10% per year. A fragmentation of the European market, however, exists due to inconsistencies in national regulations imposing technical, physical and financial barriers. The main objective of EUROMEDIES Concerted Action was the investigation of the requirements for a centralised or distributed database, containing relevant regulatory data and incident reports, pertaining to medical devices, as well as telematics means for the exchange of this information between Member States and the Commission. Each Competent Authority is responsible for developing its own organisational structure and telematics means in order to respond to the requirements of the Medical Device Vigilance System, but all parties need to he part of a trans-European network and a standard way for transmission of the information is needed.

	Copyright 1997 © EHTO All rights reserved This server is the only official EHTO WWW knowledge repository. Mail suggestions to: webmaster@ehto.org