“For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device…The post-market surveillance system shall be suited to actively and systematically gathering, recording and analyzing relevant data on the quality, performance, and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.”
EU MDR, Article 83, Post-market Surveillance System of the Manufacturer