The marketing of medical devices and approval of pharmaceuticals requires compliance with the highest standards of quality, safety, and efficacy. Research examines how to achieve an optimal balance between safety, efficacy, and innovation under changing technological conditions. With the increasing importance of artificial intelligence in medical software products, real-world data applications, and personalised medicine, new regulatory challenges emerge. These require continuous adaptation of legal regulations and assessment methods, focusing on governance between state actors, regulatory authorities, and industry.