Starting May 26th, 2021 (the MDR (EU) 2017/745 application date), medical device manufacturers will have to apply the MDR requirements for post-market surveillance (PMS), vigilance, registration of operators economic and devices.

The current infographic provides manufacturers an overview of a proactive and systematic post-market surveillance process, in line with the requirements of ISO 13485:2016 regarding the quality management system for Medical Devices and EN ISO 14971:2012 for production and post-production activities.

The post-market surveillance includes all those activities that the manufacturer must prepare to implement an adequate system to actively and systematically collect, record and analyze the relevant information on the quality, performance and safety of the medical device during the entire life cycle of the device itself, in order to implement preventive and corrective actions.

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