How often must the post-market surveillance plan be updated?

The post-market surveillance plan must be periodically reviewed and updated based on new data and feedback to ensure it remains effective and relevant. As new information emerges from the ongoing use of a medical device in the market—such as reports of adverse events, customer feedback, and advancements in technology or regulations—the surveillance plan needs to adapt accordingly. This proactive approach allows manufacturers to monitor device performance, ensure continued safety and effectiveness, and respond promptly to any emerging concerns.

Post-market surveillance is not a one-time obligation; rather, it represents a continuous commitment to patient safety and product accountability. Regular updates help in identifying trends or issues that may arise over time and allow for timely intervention to mitigate any potential risks to patients using the device. Therefore, the emphasis on periodic review and adaptation underscores the dynamic nature of medical device regulation and the importance of ongoing vigilance.