Reimbursement of medical devices in Germany

Abstract

In the conversion of the European directives, the German Medical Devices Law (Medizinproduktegesetz, MPG) regulates as a priority the safe marketing of an extremely heterogeneous group of products that was previously subject to the responsibility of various other legal areas. The MPG is structured similarly to the German Drug Law (Arzneimittelgesetz, AMG), and as a result of numerous exceptions it is difficult to obtain an overview. Although the costs of medical devices are to a large extent borne by the statutory health insurance (Gesetzliche Krankenversicherung, GKV), up to now they have not been covered by the social legislation. In this article, the regulations of the MPG are presented, the gaps in the social legislation and the reimbursement procedures for medical devices in outpatient statutory health care are described by means of the example of products formerly regarded as medicinal products and aids.