Introduction

The field of medical devices plays a pivotal role in modern healthcare, enabling clinicians to diagnose, monitor, and treat a wide range of medical conditions. However, not all medical devices are created equal, as they vary in terms of their potential risks and benefits. This chapter serves as an introductory exploration into the classification of medical devices based on their risk profiles, focusing on the distinction between significant and non-significant risk devices. It elucidates the criteria and factors that influence the classification of devices into these categories, emphasizing the importance of risk assessment, intended use, and patient population. Additionally, the chapter explores the regulatory pathways and requirements associated with each category, shedding light on the stringent processes significant risk devices must undergo to gain market approval.