Navigation and service

You are here:Legal Framework

Legal Framework

The BfArM has compiled links both to laws and ordinances in connection with the legislation on medical devices as well as to further competent authorities and bodies.

Furthermore, information on the BfArM's tasks and on the process surrounding the marketing of medical devices is provided. This is a process in which the BfArM is not involved (as opposed to the licensing of medicinal products). In order to be placed on the market, medical devices require a CE mark and a corresponding declaration of conformity. Depending on the risk potential this is either done by the manufacturer and/or by a notified body. The notified bodies also issue CE marks with which the medical devices are then basically marketable in the entire European Economic Area.