'` in vitro diagnostični medicinski pripomoček` pomeni vsak medicinski pripomoček, ki je reagent, reagenčni izdelek, komplet, instrument, oprema ali sistem in se uporablja sam ali v kombinaciji, proizvajalec pa ga je namenil za uporabo in vitro za preiskavo vzorcev, odvzetih človeškemu telesu z namenom pridobitve informacij o njegovem fiziološkem stanju, zdravju oziroma bolezni ali prirojeni anomaliji;
'device used for in vitro diagnosis' means any device which is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof;