Medical device class is a concept used to distinguish between different medical device risk levels. Medical devices are categorized into three classes including Class I, II, and III. Class I medical devices usually refer to those products that are lower risk, such as some simple orthotics and biomaterials. class II medical devices are considered to be medium-risk products, such as medical gloves and dental fillings, and class III medical devices are those that are high-risk products, such as artificial joints and pacemakers.
Medical device classes provide a structured way to categorize medical devices. Depending on the device class, the approval process can vary. Lower classes may have a simpler approval process, while higher classes require more stringent testing. These regulations help protect the public from low-quality and dangerous products.
Medical device classes are risk assessments of medical devices. However, over the past decade, some medical device companies have exceeded the classifications of their devices, selling higher-grade products as lower-grade products to avoid stricter approvals. It is therefore important to ensure that all device companies are rigorously enforcing the approval processes set out in the different classes. Only then can the public be assured of safe and high-quality medical devices.