Comparison of the international regulations for medical devices-USA versus Europe.

Abstract

In May 2021, the new Medical Device Regulation in the EU came into force. While the US has a centralized governmental authority, the Food and Drug Administration (FDA), the EU implemented a system of different Notified Bodies responsible for the approval process of medical devices. Both regions have a similar system to classify medical devices based on their overall risks but specific devices, like joint prostheses, are classified differently in the US and the EU. Depending on the risk class, th