What is Post Market Surveillance?

Overview

Post Market Surveillance (PMS) refers to the monitoring and evaluation of medical devices after they have been placed on the market.

It involves collecting and analysing data to ensure the continued safety and effectiveness of the devices.

Importance of PMS

·        PMS is crucial in identifying any issues or risks that may arise post-sale of medical devices.

·        This helps manufacturers take appropriate actions to address any safety concerns promptly.

·        It also allows regulatory authorities to make informed decisions regarding the use of the devices.

Objectives of PMS

·        The primary goal of PMS is to monitor the performance of medical devices in real-world settings.

·        This includes detecting any adverse events or malfunctions that were not identified during pre-market testing.

·        It also involves assessing the long-term safety and efficacy of the devices.

Components of PMS

·        PMS typically includes the following components:

·        Post-market clinical follow-up studies.

·        These studies involve monitoring patients who have been implanted with a medical device.

·        Complaint handling and reporting.

·        Manufacturers must establish procedures for handling and reporting complaints related to their devices.

·        Periodic safety update reports.

·        Manufacturers are required to submit reports on the safety and performance of their devices at regular intervals.

Conclusion

In conclusion, Post Market Surveillance is a critical aspect of ensuring the safety and effectiveness of medical devices.

By monitoring devices post-sale, manufacturers can identify and address any issues that may arise, ultimately protecting patient safety.