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Vigilance - European authorities need a telematics system

This article was originally published in Clinica

Executive Summary

Great enthusiasm was expressed by representatives of the EEA Competent Authorities during a theoretical telematics demonstration of medical device vigilance reporting at the EUROMEDIES Workshop. The demonstration raised their hopes that a Europe-wide telematics network could be realised in the near future to support the increasing number of communications between the Commission, Competent Authorities, Notified Bodies and manufacturers as more and more products are CE-marked under the medical device Directives.

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