What is an investigational device?

An investigational product is a product that is evaluated for its health and safety aspects as part of clinical trials. In contrast, medicinal products are more commonly referred to as investigational medicinal products. An investigational device can therefore be a medical device that has not yet been placed on the market, which may or may not bear the CE marking, and which is assessed within or outside its intended purpose. The term is defined in the EU MDR 2017/745 and in the MPDG. Medical devices without an intended medical purpose are currently (12/2023) not yet subject to the MDR. Some test objects cannot be easily and clearly assigned to the categories "medical device" or "medicinal product". In cases of doubt, the classification is decided by the authorities. Special legal requirements apply to test products.