Post Market Surveillance System

Post Market Surveillance System relies on reactive data gathering. Manufacturers collect and report adverse events from a device post-market, often using manual methods. These adverse events are either directly reported to the manufacturer or they could be reported to Regulatory bodies like FDA in the US (MAUDE database), MHRA in the UK, Health Canada in Canada etc. 

Post Market Surveillance System 

The FDA has government authorization to require post-market surveillance for class II and class III medical devices that meet one of four criteria:

Failure of the device would be reasonably likely to have a serious adverse health consequence. The device is intended to be implanted in the human body for over one year. The device is intended to be a life-sustaining of life-supporting device used outside of a user facility.

Post Market Surveillance Plan

A postmarket surveillance plan is a systematic process that is designed for the monitoring of a specific device. Note that each individual device requires its own PMS plan. Though the plans for different devices may have a lot of similarities, you cannot simply reuse a PMS plan from one device to another. Your PMS plan must define which data should be surveilled, how it should be collected, and how you will investigate or determine reportable trends.

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