In Vitro Diagnostic Regulation refers to the set of rules and guidelines established to ensure the safety and effectiveness of diagnostic tests performed outside the human body. These regulations govern the development, manufacturing, and marketing of in vitro diagnostic devices (IVDs), which are used to detect diseases, conditions, or infections by analyzing samples such as blood or tissue. The primary goal of these regulations is to protect public health by ensuring that IVDs meet specific quality standards. Regulatory bodies, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), oversee the approval process, requiring rigorous testing and validation before these devices can be marketed to healthcare providers and patients.