Regulatory Assessment of Premarket Approval of Medical Devices in US and EU

Abstract

The demand for medical devices globally has raised the attention of government regulatory bodies to ensure the safety and effectiveness of these products. Developed markets, such as the United States and European Union, have set up wellestablished regulatory systems for medical devices, which have consistently been amended to accommodate the changing requirements of safety and the trend of globalization. The way in which devices are regulated in the European Union is very different from that of United States, especially in terms of the clinical data required for premarket approval. This has introduced significant differences in time-to-market approval for both United States and European Union, particularly in the case of high-risk Class III and Class IIb implantable devices. Systems for approving new medical devices must provide pathways to market important innovations besides ensuring that patients are adequately protected. To achieve these goals, the United States and the European Union use a combination of premarket testing and postmarket vigilance but with some marked contrasts in their approaches. Features of both environments require reform, as well as continuing research to assess policy changes which will benefit device manufacturers to develop devices which can be marketed both in US and EU simultaneously