IVD Regulation

IVD Regulation refers to rules governing in vitro diagnostic medical devices, which are tests used on samples like blood or tissue to diagnose diseases. These regulations ensure that such tests are safe, effective, and reliable before they reach the market. They set standards for manufacturing, clinical testing, and labeling, helping to protect public health. Compliance with these regulations is essential for manufacturers to ensure that their products meet quality and performance requirements, ultimately safeguarding patients who rely on these diagnostic tools for accurate health information.