Tasks of the BfArM
in the area of medical devices
The tasks of BfArM in the field of medical devices result in particular from the Medical Device Regulation (MDR) (EU) 2017/745, the Medical Device Law Implementation Act, the “Medizinprodukterecht-Durchführungsgesetz” (MPDG), the Medical Devices Act “Medizinproduktegesetz” (MPG) and the further implementing legal ordinances. In addition, the BfArM performs tasks from the Fifth Book of the German Social Code (“Sozialgesetzbuch”) (SGB V), for Digital Health Applications (“Digitale Gesundheitsanwendungen”) (DiGA).