Post-Market Surveillance (PMS) Study
Medical Device Manufacturers plan, establish, document, implement, maintain, and update a Post-Market Surveillance (PMS) system for each medical device in a manner that is proportional to the device’s risk classification and appropriate to the type of device. This system should also be incorporated into the Quality Management System.
Post-Market Surveillance (PMS) refers to a collection of processes and activities used to monitor the safety and performance of a medical device.
These activities are designed to generate information related to the device’s usage in order to quickly identify design and/or use problems and accurately characterize the device’s behavior and clinical outcomes in the real world. The need for PMS arises immediately after the commercialization of the medical device.
With MDR, significant changes have been made to PMS processes, which were previously based on MDD. We believe that some of the most important changes introduced by the MDR are related to PMS. Along with the new approach, critical reporting by medical device manufacturers has been incorporated into the PMS processes.
Critical Reporting Related to PMS
- PMS Reporting
- Periodic Safety Update Report (PSUR)
- Post-Market Clinical Follow-up (PMCF) Reporting
- Safety and Clinical Performance Summary (SSCP)
- Trend Reporting
- Vigilance/Alertness