Regulatory Requirements For Medical Devices And Vascular Ageing: An Overview

Abstract

The development and use of medical devices are subject to regulations and approval activities to enter the market. These are mandatory for manufacturers and have important implications for all involved professionals. In fact, the innovation process, starting from a clinical need, includes the identification of a solution and its implementation, and requires taking into account crucial aspects according to regulatory requirements in each phase. These include exemplary validation or risk management. The aim of this work is to provide an overview of some key aspects of regulation and their implementation in medical devices for vascular ageing assessment. In particular, regulatory scenarios in Europe, Australia and the United States of America are described and examples of marketed medical devices for vascular ageing assessment are provided. Strong and active links among industry, research, clinical experts and governments adds value for the community, requiring the ability to communicate between different skills and backgrounds: this multidisciplinary and multi-partner collaboration can speed up the innovation process and can increase the system's efficiency related to both social and ethical impact.

Medical Device Regulation: Should We Care About It?

“…The main aim of this process is to guarantee the introduction and maintenance of effective technologies that can be safely adopted by the users [ 3 ]. Many of the technologies developed and adopted for vascular ageing assessment are intended to be used for the monitoring and the prevention of vascular alterations and thus fall into the medical device framework [ 4 ]. Awareness of the basic concepts related to the approval to market and maintenance processes is a valuable background for the main involved stakeholders that can speed-up the innovation process in the field.…”

“…3 Risk based classification of medical devices according to EU Regulation. As reported in [ 4 ] many medical devices adopted for vascular ageing assessment fall at least in class IIa. Icons’ source for the picture: https://www.flaticon.com …”