Deficiencies of the EU Medical Device Regulation when applying its own rules.

Abstract

The EU Medical Device Regulation (MDR) was developed to improve the safety of medical devices as well as the smooth functioning of the market in this field. Since it entered into force in 2017, there have been continuous debates about the actual success thereof. However, no consequent analysis was provided until now. In this paper, we contribute to this endeavor. We analyzed whether the MDR meets appropriate standards that it requires for the development of medical products. In other words, we r