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Vigilance

The purpose of the Medical Device Vigilance System is to improve the protection of health and safety by reducing the likelihood of reoccurrence of incidents related to the use of a medical device. Therefore, the Medical Devices Directives provide that adverse incidents are evaluated and, where appropriate, information is disseminated in the form of a National Competent Authority Report (NCAR) with the objective of preventing repetition of such incidents through the adoption of appropriate field safety corrective actions.

The provisions on Vigilance of the Medical Devices Directives are completed by general guidelines on vigilance which are intended for facilitating and harmonising the implementation of the EU Directives on Medical Devices by manufacturers and Competent Authorities.

Vigilance MEDDEV 2-12/1pdf(911 kB) Choose translations of the previous link 

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