They are defined in the Regulation as all kinds of tools, tools, equipment, software, accessories or other materials, including manufactured for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of the disease or diagnosis, monitoring, treatment, alleviation or relief of injury or disability, or for the purpose of investigating, changing or replacing an anatomical or physiological function, or for contraception, can be used alone or together, manufactured by its manufacturer especially for diagnostic and/or therapeutic purposes and software necessary for the medical device to perform its intended function.