Medical devices are instruments, apparatus, appliances, substances or preparations made from substances or other articles, used alone or in combination, including the software necessary for the medical device's proper application intended by the manufacturer to be used for human beings, by virtue of their functions, mainly for the purpose of
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation or compensation of injuries or handicaps,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception
and which - contrary to medicinal products - do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which might be assisted in their function by such means.
Medical devices are also products as defined above
- which contain a substance or preparation made from substances or are coated by the same which, when used separately, can be considered a medicinal product according to the Medicinal Products Act and which, in complementing the functions of the device, can have an action on the human body,
- which contain as one of their ingredients a substance which, when used separately is regarded as an ingredient of a medicinal product or a medicinal product made from human blood or blood plasma within the meaning of Article 1 of Council Directive 89/381/EEC of 14th June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma (O.J. EC No. L 181, p. 44) and complementing the device, can have an action on the human body.
Examples for medical devices are medical-technical devices, implants, products used for injection, infusion, transfusion and dialysis, dental products, instruments, dressings, contraceptives and in vitro diagnostics.
In vitro diagnostic medical devices are medical devices intended to be used, alone or in combination with others, as a reagent, reagent product, calibrator material, control material, kit, instrument, apparatus, equipment or system, according to the intended purpose specified by the manufacturer, for the in vitro examination of specimens derived from the human body, including blood and tissue donations, purely or mainly with a view to providing information
- on physiological or pathological conditions,
- congenital abnormalities, or
- to investigate the safety of or tolerance by potential recipients, or
- to monitor therapeutic measures.
Specimen containers are regarded as in vitro diagnostic medical devices. Products for general laboratory use are not considered to be in vitro diagnostics unless, due to their features, they are to be used specifically for in vitro diagnosis in accordance with the manufacturer's intended purpose.
Accessories for medical devices are articles, substances, preparations made from substances as well as software which do not in themselves constitute medical devices but are intended by the manufacturer to be used in combination with a medical device so as to enable the latter to be used for its intended purpose as specified by the manufacturer. Invasive medical devices intended for use in taking samples from human bodies for in vitro testing as well as medical devices intended for sample removal, which come into direct contact with the human body, are not deemed to be accessories for in vitro diagnostic devices.