For ongoing safety evaluation of a medical device, which document is typically used?

The document typically used for the ongoing safety evaluation of a medical device is the clinical evaluation report. This report plays a crucial role in assessing the clinical data associated with a device, which includes ongoing studies, post-market surveillance, and any new information that may affect the device's safety and effectiveness. It synthesizes evidence regarding the safety and performance of the device, helping to ensure that it continues to meet regulatory requirements and does not pose a risk to patients.

The clinical evaluation report is essential for maintaining the market approval of the device and must be updated regularly as new data becomes available, which is a key part of ongoing safety evaluation. It provides an evidence-based framework for evaluating if the benefits of continuing to use the device outweigh any risks identified through accumulated data.

The other options serve important functions but do not focus specifically on the ongoing assessment of safety. For example, design control files are primarily related to the design and development stages of a device, the risk management file addresses potential hazards and mitigation strategies during the risk assessment phase, and quality system records are more aligned with the overall compliance of manufacturing and quality processes rather than the continual evaluation of device safety.