Medical Device Vigilance

The principal purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, users and others 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.

Current Directives and Quality standards require Member States to take the necessary steps to ensure that any information is brought to their knowledge when a device does not perform as intended, leading to injury, death or recall of the product. Such activities may be conducted by manufacturers proactively via post-market surveillance (PMS) or reactively via vigilance.

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