EC Medical Devices Vigilance Systems and Post Marketing Surveillance

While the premarket approval process has been delegated by most of the competent authorities to the private sector, competent authorities have kept the responsibility for the surveillance of their market. Because of this situation, there is transfer of resource and energy to the monitoring of market including the vigilance system within each member state. The evaluation of incidents notified by the manufacturers and users represents a key source of information. Combined with sophisticated exchange of information between EU member states, and also with other countries like the U.S., Japan, Canada, or Australia, this provides a unique insight of the performance of devices in the post production phase.