Which medical devices are classified as high risk?

Medical devices classified as high risk correspond to their potential impact on patient safety and health outcomes. Class III devices are those that typically sustain or support life, are implanted into the body, or present a potential unreasonable risk of illness or injury. Because of this higher level of risk associated with these devices, they undergo the most stringent regulatory controls. This includes premarket approval processes to demonstrate the device’s safety and efficacy through rigorous clinical testing.

In contrast, Class I devices are generally considered low risk and are subject to the least regulatory control. Class II devices present a moderate risk and require more regulatory controls than Class I but less than Class III. Class IV is not a standard classification used by regulatory bodies such as the FDA, which categorizes devices into only three classes (I, II, and III). This underscores the significant level of scrutiny and oversight that Class III devices require, justifying their classification as high risk.