Post-market Surveillance

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As World Health Organization (WHO) states the aim of the post-market surveillance (reactive post-market surveillance after an issue has occurred; proactive post-market surveillance to scan for potential issues) of in vitro diagnostic medical devices is to ensure that they continue to meet the same quality, safety and performance requirements as when they were first released to market.

WHO schematizes the general steps of post-market surveillance of in vitro diagnostic medical devices as follows:  

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