The Importance of Validating New in vitro Medical Devices

Abstract

Currently, technological innovations are increasingly gaining ground in all fields, and especially in medicine, the validation process is one of the essential requirements for the approval of new medical devices (MDs) and in vitro diagnostic devices (IVDs). For a new device to be introduced into the market, it must meet specific requirements, and it is in this context that validation emerges. All IVDs and MDs must be approved by the National Health Surveillance Agency (ANVISA) or the relevant health authority of the country to ensure that the device is safe and effective for the population, and that its use will cause minimal harm compared to the benefits it can bring. In this context of Health Technology Assessment (HTA), this study aims to highlight, through a literature review, the importance of the validation process for IVDs and its impact on the market and the healthcare network.