Medical devices are classified into different categories depending on their intended purpose and the degree of risk to the patient. The classification system helps determine the appropriate level of regulatory review and control required to ensure the safety and effectiveness of the device. Classification systems can vary from country to country but generally have similar principles. Here is a general overview of the classification system:
Class I medical devices:
These are low-risk devices that are not intended to be used for invasive purposes and are generally considered to have the lowest potential risk to patients. Examples of Class I medical devices include dressings, stethoscopes, and tongue depressors.
Class II medical devices:
These are medium-risk devices that are frequently used for diagnostic or treatment purposes. They may pose a greater risk compared to Class I devices and require a higher level of regulatory control. Class II medical devices include, for example, electric wheelchairs, surgical gloves, and X-ray equipment.
Class III medical devices:
These are high-risk products that are often used for life-sustaining or life-supporting purposes, as well as pose a significant risk of illness or injury to patients. These products require the most extensive testing and clinical evaluation before they can be marketed. These include pacemakers, heart valves, and implantable defibrillators.
In addition to these classes, there are further classifications in some countries, such as Class IV in Canada. This class includes diagnostic and therapeutic devices with a very high increased risk for patients. Classification thus varies from country to country.