What does "compliance" mean in the context of medical device regulations?

In the context of medical device regulations, "compliance" primarily refers to adherence to relevant regulations, standards, and guidelines that are established by regulatory authorities. This includes following laws, rules, and policies that govern how medical devices are developed, tested, manufactured, and marketed. Ensuring compliance is vital for maintaining the safety and effectiveness of medical devices, as well as for protecting public health. It encompasses a broad range of activities, including quality management systems, risk management processes, clinical evaluations, and proper labeling.

This understanding of compliance is crucial for manufacturers because it determines whether a medical device is legally allowed to be marketed and sold. Non-compliance can lead to significant repercussions, including fines, recalls, or bans on products.