"in vitro diagnostic medical device" as defined in the EU Regulation 2017/746 on in vitro diagnostic medical devices is "a medical device intended by the manufacturer as a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, software or system, whether used alone or in combination, for the in vitro examination of specimens, including blood and tissue donations, derived from the human body and intended solely or principally to provide information on any of the following:

a) about physiological or pathological processes or conditions,

b) about congenital physical or mental impairments,

c) on the predisposition to a particular health condition or disease,

d) to determine the safety and tolerability of potential recipients,

e) the likely effect of a treatment or the likely reactions to it, or,

f) the definition or monitoring of therapeutic measures.

Sample containers shall be considered as in vitro diagnostic medical devices".