Medical devices are preparations, instruments or other items used for medical purposes, including detecting, preventing, monitoring, treating or alleviating disease. Unlike drugs, however, they do not intervene in the body's own processes, such as the immune system or metabolism. The medical devices include, for example, bandages, hearing aids, condoms or the contraceptive spiral. Production and distribution are regulated by the Medical Devices Act.
Medical devices must comply with the requirements of the Medical Devices Act, which are the result of European directives. These ensure the perfect quality of the product and the safety of patients, users and third parties. A defined "conformity assessment procedure" requires the manufacturer to demonstrate that he has complied with the essential requirements Medical devices that are marketable under the new European legislation in one Member State of the European Union are also marketable in the other Member States.