1. A Medical Device (MD) is any instrument, apparatus, machine, appliance, implant, reagent for in vitro use, software, material, or similar item intended by the manufacturer for medical purposes, such as diagnosing, preventing, monitoring, treating, or alleviating diseases or conditions. Examples include patient monitors, ventilators, X-ray machines, and BP monitors. In-Vitro Diagnostics (IVD), on the other hand, are medical instruments and accessories used to perform tests on biological samples (blood, urine, tissues, etc.) to detect diseases, infections, or conditions outside the body (in vitro). Common examples include blood glucose monitors, alcohol analyzers, and urine analyzers. In India, both MDs and IVDs are regulated as drugs under the Drugs and Cosmetics Act. The Indian Medical Device Rules (IMDR), 2017 classifies medical devices into four categories based on their risk level: Class A (low risk) includes devices like syringes, stethoscopes, and bandages; Class B (moderate risk) includes devices like infusion pumps, X-ray machines, and ECGs; Class C (high risk) includes devices like dialysis units, ventilators, and cardiac stents; and Class D (extremely high risk) includes devices like artificial heart valves, mechanical ventilators, and CT scanners. These classifications ensure that devices are regulated according to their potential risk to patient safety.