Regulatory Focus™ > News Articles > Vigilance Reporting for Medical Devices in the EU

Vigilance Reporting for Medical Devices in the EU

Posted 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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