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Vigilance Institute and the manufacturer or the authorized representative shall organize a system ofvigilance with the aim of collecting and assessing data related to the safety of use of the medicaldevice as well as other data of importance for estimating the benefit and risk ratio of using themedical device in order to protect the health of the populationhttp://cinmed.me/wp-content/uploads/2022/12/MedDevice-840x630-1.jpg