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Devices look on as Italy strengthens vigilance:

This article was originally published in Clinica

Executive Summary

Europe's medical devices industry will look closely at developments among its pharmaceutical counterparts, following the launch by the Italian health ministry of its national "weblinked sentinel" pharmacovigilance network. The project, which involves 1,000 family doctors, is linked to the EU-wide post-market initiative headed by the European Medicines Evaluation Agency. In the medical devices industry, too, there have been tentative moves at EU level to tighten post-market surveillance - an initiative led by the UK Medical Devices Agency. France, however, is alone in Europe in having established a formal device-related reporting network at local level, involving the official designation of incident reporters.

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