Medical devices are preparations, instruments or other objects that serve medical purposes, including the detection, prevention, monitoring, treatment or alleviation of diseases.
Unlike medicines, however, they do not themselves interfere with the body’s processes, such as the immune system or metabolism. Medical devices include, for example, bandages, hearing aids, condoms and contraceptive coils.
Production and distribution are regulated by the Medical Devices Act.
Tested quality
Medical devices must meet the requirements contained in the Medical Devices Act, which are based on European directives. These ensure the perfect quality of the product as well as the safety of patients, users and third parties.
Through a defined “conformity assessment procedure”, the manufacturer must prove that he has complied with the essential requirements.
Medical devices that are marketable in one member state of the European Union under the new European law are also marketable in the other member states.
