Guide to Post-Market Surveillance (PMS) of Medical Devices in USA & EU


As a regulatory leader, your responsibility doesn’t end with market approval, it begins there. This sentiment echoes across boardrooms and regulatory strategy meetings as post-market surveillance (PMS) becomes a critical pillar of lifecycle management in medical devices. In the times where real-world performance, patient safety, and global compliance are under the spotlight, PMS is a strategic advantage.

According to global regulatory experts, the ability to predict, monitor, and act on post-market data is fast becoming a benchmark for excellence in medical device oversight. While the U.S. FDA and the European Union (EU) both prioritize PMS, their frameworks reflect two distinct philosophies: the FDA’s reactive yet data-driven model versus the EU’s proactive, lifecycle-integrated system under MDR 2017/745.

For companies with global aspirations, understanding these nuances in 2025 is essential to safeguarding brand reputation, achieve compliance, and maintain market access.

Understanding Post-Market Surveillance (PMS)

Post-Market Surveillance refers to the ongoing and systematic collection, analysis, and interpretation of data related to a medical device after it is placed on the market. It helps in identifying risks, evaluating benefit–risk ratios, and supporting regulatory actions such as safety communications, recalls, or labeling updates. PMS is also a fundamental input into the manufacturer’s Corrective and Preventive Action (CAPA) and Quality Management System (QMS) processes.

Read in detail about US and EU requirements here: https://resource.ddregpharma.com/insights/post-market-surveillance-pms-in-medical-devices-usa-eu-requirements/

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