“Post-market surveillance means […] a systematic procedure to proactively collect and review experience […] for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.” (Art. 2 (60), EU MDR)
“1. 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. That system shall be an integral part of the manufacturer’s quality management system referred to in Article 10(9).
2.The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing 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.! (Art. 83, No. 1, f., EU MDR)« Back to Glossary Index