The European Medical Devices Regulations

December 27, 2017

This paper addresses a number of areas, including: post-market surveillance (PMS) as an element of the management of clinical evidence throughout the device lifecycle; the PMS system, which is the comprehensive process used to collect, analyze and take action on PMS information; the PMS plan, which describes the application of the PMS system to a device or device family; preparation of a summary report of PMS information; complaint handling and reporting of vigilance; and, electronic submission of vigilance data and summary reports of PMS.

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