Medical device

Objects or substances that are used to cure or prevent disease. Medical devices may be objects that do not come into direct contact with the body or skin, such as syringes, but also substances and devices that are introduced into the body, such as catheters that are inserted into the veins for endovenous therapy. From the safety point of view, it is important to distinguish between medical devices and medicinal products (medicines), as the requirements for marketing authorisation (permission to bring on to the market) and safety monitoring are very differently regulated. The requirements for medical devices are generally less stringent. It is therefore often disputed in court whether a product is truly a medical device or whether it is not, in fact, a hidden medicinal product.

Medicinal products have pharmacological effects, that is to say, their effects are due to interactions with the cells in the body. Basically, medical devices may have only a purely physical effect and not react with the body. This distinction is not easy to understand and often not completely clear. In any case, a medicinal product is more intensively scrutinised by the authorities.