According to Art. 3 MedDO medical devices are instruments, apparatus, appliances, software, implants, reagents, materials or other objects that are intended by their manufacturer for use in human beings; that do not achieve their principal intended action in or on the human body either by pharmacological, immunological or metabolic means, but which action can be assisted by such means; and that serve to fulfil one or more of the following specific medical purposes either alone or in combination, e.g. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, injuries or handicaps; investigation, replacement or modification of the anatomy or of a physiological or pathological process or condition; or the acquisition of information by means of in vitro investigation of samples obtained from the human body, including donated organs, blood or tissue.
Medical devices also include contraceptive or fertility-enhancing products, and items intended specifically to clean, disinfect or sterilise medical devices. Art. 3 para. 2 MedDO
Medical device accessory means any article that is not a medical device in its own right, but which is intended by its manufacturer to be used together with one or more particular medical devices. Art. 3 para. 3 MedDO
Other products within the scope of the MedDO are defined in Art. 1 of the ordinance.