The European legal framework, including the Medical Device Regulation ("MDR") and the soon to come into force AI Regulation ("AI Regulation"), places strict requirements on the safety and performance of AI-based medical devices. The relationship between the Medical Device Regulation and the AI Regulation is characterized by supplementary certification requirements: While the MDR regulates the safety and performance of physical medical devices, the AI Regulation addresses specific risks and the data integrity of AI systems. Products that fall under both sets of regulations must meet the requirements of both regulations in order to be certified, which provides a double safety guarantee for both physical and software-related safety.