Summary
This guide presents a framework for classifying medical devices based on their nature, class, and intended territory of operation. It outlines the regulatory pathways and documentation requirements necessary for achieving authorization and market approval. The document details three main classes of medical devices: Class I, which includes low-risk devices such as surgical instruments and hospital beds; Class II, encompassing moderate-risk devices like syringes and insulin pumps; and Class III, which consists of high-risk devices such as ventilators and pacemakers. Each class is associated with specific control requirements and approval processes, including General Controls and Pre-Market Approval (PMA). The guide further explains the classification criteria established by the Medical Device Regulation (MDR) and categorizes software as medical devices (SaMD), distinguishing between hardware and software classifications. It also defines the significance of SaMD in healthcare decision-making and the risks associated with different classes.
