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

Injury. 2023 Oct:54 Suppl 5:110908. doi: 10.1016/j.injury.2023.110908. Epub 2023 Jun 20.

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, there are differences in the quality and quantity of clinical data required to obtain market approval. In both regions, it is possible to place a new device on the market based on the demonstration of equivalence to an already marketed device, but the MDR significantly increased the regulatory requirements for the equivalence pathway. While an approved medical device in the US in most cases only requires general post-market surveillance activities, manufacturers in the EU must continuously collect clinical data and submit specific reports to the Notified Bodies. In this article, we will compare the regulatory requirements between the US and Europe and provide an overview of similarities and differences.

Keywords: Equivalence Demonstration; Food and Drug Administration (FDA); Medical Device Regulation (MDR); Medical Devices; Regulatory Approval.

MeSH terms

  • Europe
  • Humans
  • Medical Device Legislation*
  • United States
  • United States Food and Drug Administration