What is the purpose of post-market surveillance for medical devices?

Post-market surveillance plays a critical role in ensuring that medical devices remain safe and effective once they are available in the market. This ongoing monitoring process involves collecting data on the performance of the device and any adverse effects that may arise during its use in a real-world setting.

The primary objective is to detect any potential problems that were not identified during pre-market clinical trials and to assess whether the device continues to meet safety and effectiveness standards as it is used by the general population. Through this surveillance, regulatory authorities, manufacturers, and healthcare providers can gain valuable insights that may lead to adjustments in usage guidelines, device modifications, or even recalls if necessary.

This process is essential for patient safety and helps to maintain public trust in medical devices. In contrast, while preparing devices for market introduction, gathering funding for research and development, and evaluating market competition are important aspects of the medical device lifecycle, they do not pertain to the ongoing assessment of devices once they are approved and in use.