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

Introduction: 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 raised the question of whether the MDR could be placed on the market if we were to apply the rules of the MDR to itself. Methods: For this purpose, the analysis was based on the MDR and its Recitals, Articles, and Annexes, as well as the components implementing the regulatory system based on it. We checked whether basic principles for product development and the setup of regulatory systems in the field of medical devices are fulfilled. We asked whether basic development steps for the MDR have been realized appropriately, according to these principles and standards. Results: The analysis showed that the MDR contains substantial deficiencies regarding a consequent implementation of product development standards. For example, this applies to core principles like transparency, clarity, and traceability of requirements, appropriate implementation of risk management and validation steps, or realization of governance structures. According to our findings, the MDR would fail when we applied its own rules. In particular, central goals of the MDR like the smooth functioning of the market and the safety of the regulatory system were not addressed consequently. Discussion: According to the high impact the MDR has on the medical device sector but also on the healthcare system in general, our analysis motivates improvements of the MDR-based regulatory system that take these deficiencies into account. This paper provides basic insights into the application of basic principles regarding the implementation of regulatory systems. This should be complemented by further evaluation steps regarding the actual performance of the MDR during its operational phase. Based on this, consequent steps for the actual improvement should be derived to finally achieve a high-quality regulatory system.