The EU Medical Device Regulation (MDR) was created to improve the safety of medical devices and the smooth functioning of the market. However, the analysis showed that the MDR contains significant shortcomings in the application of its own product development standards, including problems with transparency, clarity and traceability of requirements. The findings point to deficiencies in the implementation of risk management, validation steps and management structures. According to the research, the MDR would fail if its own rules, which it requires of medical device manufacturers, were applied to it. The main objectives of the MDR, such as the smooth functioning of the market and the security of the regulatory system, were consequently not addressed. The authors emphasize the need to improve the MDR-based regulatory system in order to eliminate these shortcomings and achieve a quality regulatory system.