Glossary Term
Post-Market Surveillance (PMS)
Definition
Post-market surveillance (PMS) refers to the ongoing monitoring and assessment of a medical device or pharmaceutical product after it has been approved and introduced to the market. The primary purpose of PMS is to ensure that a device continues to meet safety, efficacy, and performance standards in real-world clinical use. This surveillance involves collecting data on adverse events, device malfunctions, patient outcomes, and long-term effectiveness to identify any emerging risks or trends. PMS is a critical component of regulatory compliance and helps manufacturers take corrective actions, such as recalls or safety warnings, if necessary.
Relevance to the MedTech Industry
The aim of PMS is to ensure the continued safety and performance of medical devices or drugs after they have been commercialized. It provides critical insights into how a product performs outside the controlled environment of clinical trials, allowing for early detection of issues that may not have been apparent during pre-market studies. PMS also supports regulatory compliance, enhances patient safety, and informs further improvements in the product lifecycle.
Additional Information & Related Terms
Related Terms
Clinical Post-Market Follow-up (PMCF): A specific subset of PMS focused on the ongoing clinical evaluation of a medical device’s safety and performance after market release.
Adverse Event Reporting System (AERS): A system that collects and monitors reports of adverse events associated with medical devices and drugs, often part of post-market surveillance.
Risk Management: A process of identifying, assessing, and mitigating risks associated with the use of medical devices or pharmaceuticals, including during post-market phases.
Field Safety Notice (FSN): A communication sent to healthcare providers and patients when a device or drug needs to be corrected, recalled, or modified after post-market surveillance identifies safety issues.
Regulatory Compliance: The process of adhering to laws and regulations set by health authorities like the FDA, EMA, or other regulatory bodies, which include requirements for post-market surveillance.