What is Post-market surveillance (PMS)?

The 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. PMS system shall be an integral part of the manufacturer's quality management system.

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.

If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with vigilance system.

MDR has increased the post-market requirements for manufacturers and their obligation to proactively collect data and document and report the analysis of these post-market activities and data.

1. Post-Market Surveillance Report(PMSR)

Manufacturers of class I devices shall prepare a post-market surveillance report summarizing the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the competent authority upon request.

2. Periodic safety update report(PSUR)

Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarizing the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken.