Materiovigilance and Medical Devices

Abstract

The medical devices may have caused serious events for patients and could have contributed to healthcare costs. The post-market surveillance, as part of Medical Device Vigilance Systems, lead to improve the safety of patients and users by reducing the reoccurrence of the incidents. Furthermore, the existing incidents argue that it must continuously monitoring medical devices in use, in order to protect the patients’ health. The current regulations and guidance documents regarding medical devices focused on post market vigilance framework. were examined and discussed. The postmarket surveillance data was evaluated in order to synthesize and compare the EU state members for their active implication. In this context, Romanian regulations concerning medical devices are described and analyzed. This study aims to identify if Romania is harmonizing its medical device vigilance system with respect to those of the European Directives.