In-vitro-diagnostic

According to the IVDR, an in vitro diagnostic medical device (IVD) is any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, device, software, or system intended for the examination of samples taken from the human body.

The samples are used to provide Information on physiological or pathological processes, physical or mental impairment, predispositions to a health condition or disease, the determination of the safety/tolerability of potential recipients, the probable effect of a treatment or the monitoring of therapeutic measures. According to the IVDR, sample containers are also considered IVDs (IVDR, Article 2 (2)).