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

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.