Class I, II, III Medical Devices

Medical devices are classified into three categories based on their level of risk. Class I devices are low-risk items like bandages or stethoscopes, requiring minimal regulation. Class II devices pose moderate risk, such as blood glucose monitors, and need more oversight. Class III devices are high-risk tools like pacemakers, requiring the strictest regulation and extensive testing before approval. This classification helps ensure safety and effectiveness, with higher-risk devices undergoing more rigorous evaluation to protect patients.