On the following pages, the BfArM provides links to laws and ordinances relating to medical device law and to other competent authorities. In addition, information on the tasks of the BfArM is listed and the process for placing medical devices on the market is explained.

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).