Sozialrechtlicher Nutzen und medizinprodukterechtliche Konformität

Where do the reformed European medical device regime and statutory health technology assessment (HTA) under the Fifth Book of the German Social Security Code intersect? In the context of the new European Medical Devices Regulation and recent social law reforms, the requirements for the reimbursement of new technologies under the German statutory health insurance system have shifted. Focused on the interface between regulatory and reimbursement requirements, the thesis analyses whether and to what extent a product's conformity with medical device law defines the notion of benefit of new diagnosis and treatment methods within the meaning of staturory health insurance.