The In Vitro Diagnostic Directive (IVDD) is a European Union regulation that governs the safety and performance of medical devices used for in vitro diagnostics. This includes tests and devices that analyze samples such as blood, urine, or tissue to diagnose diseases or conditions. The directive ensures that these products meet specific quality standards before they can be marketed in the EU. The IVDD aims to protect public health by requiring manufacturers to demonstrate the reliability and accuracy of their diagnostic devices. Compliance with the directive involves rigorous testing, quality control, and adherence to labeling requirements, ensuring that healthcare providers and patients can trust the results of these diagnostic tools.