Post-Market Surveillance: Monitoring Medical Devices After Approval

Abstract

Post-market surveillance (PMS) is a critical process in the lifecycle of medical devices, occurring after the devices have received regulatory approval and are made available to the public. While pre-market approval focuses on safety and effectiveness in controlled settings, PMS aims to monitor the real-world performance of medical devices to identify any adverse events or long-term issues that may not have been evident during clinical trials. This ongoing monitoring helps to detect rare or delayed side effects, ensure continued safety, and inform potential regulatory actions. Effective PMS systems incorporate various strategies such as adverse event reporting, patient registries, and post-market clinical studies, with regulatory bodies like the FDA and EMA playing a pivotal role in overseeing and enforcing compliance. The goal is to ensure that medical devices continue to meet the necessary safety standards throughout their use in the market, providing both the public and healthcare professionals with ongoing confidence in the devices' safety and performance.