Vigilance Reporting for Medical Devices in the EU

| 01 September 2009

Manufacturers putting medical devices on the market in the European Union (EU) must have a vigilance system in place for collecting and evaluating reported incidents and taking corrective action if necessary to prevent the recurrence of such incidents. The main purpose of a medical device vigilance system is to improve protection of patients' and other users' health and safety by reducing the likelihood that a device incident will recur.1 At a higher level, the vigilance system is an integral part of a postmarket surveillance (PMS) system.

 

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