How often should regulatory professionals monitor compliance of marketed devices?

Monitoring compliance of marketed devices is essential throughout the entire product lifecycle, which includes the design, manufacturing, marketing, and post-marketing phases. Continuous monitoring helps ensure that devices remain in compliance with regulatory standards and that any changes in regulations, market conditions, or product performance are promptly addressed.

By adopting a continuous monitoring approach, regulatory professionals can identify and rectify any compliance issues proactively, ensuring patient safety and maintaining public trust in the medical device's efficacy and quality. It also allows for the gathering of real-world evidence and feedback that can inform necessary updates or modifications to the device or its usage.

In contrast, the other options would leave gaps in compliance assurance. Monitoring only when new devices are launched or only during inspections does not account for ongoing changes and risks that can arise throughout the lifecycle of a product, and relying solely on annual checks does not provide the vigilant oversight that ongoing compliance requires.