The term medical device covers the entirety of all products that serve the medical purpose of treating human diseases. The type and function of the products range from implants and visual aids to human medical instruments and in-vitro diagnostics to X-ray equipment and software solutions. Guidelines and requirements placed on various medical devices are regulated by the Medical Devices Act. Medical devices are classified by law based on their vulnerability to the human body, as well as the producer’s intended purpose in terms of recommended treatment duration and place of use. Further included is whether the product is an active medical device, whether it contains biological materials from animals or humans, and whether it is a reusable product. A distinction is made in four classes:
- Class I corresponds to medical devices that do not present methodological risks and whose duration of use is limited to a maximum of one hour
- Class IIa includes products that carry a low risk of application and the product is used in the body with a maximum treatment period of 30 days
- Class IIb includes medical devices that have an increased methodological risk and are used for long-term application.
- Class III describes medical devices with a high hazard potential and high methodological risk, intended for long-term drug delivery or for direct use on the CNS, CCS or heart.