open access: Regulation of Medical Devices in the United States and European Union — NEJM (comparing differences pro's/con's)

Conclusions

Systems for approving new medical devices must provide pathways to market for important innovations while also ensuring that patients are adequately protected. To achieve these goals, the United States and 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.