‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
ciallaíonn “feiste leighis dhiagnóiseach in vitro” aon fheiste leighis ar imoibrí, táirge imoibrithe, calabróir, ábhar rialaithe, fearas, uirlis, gaireas, píosa trealaimh, bogearraí nó córas í, a úsáidtear ina haonar nó i gcomhcheangal le rud eile agus atá beartaithe a úsáid in vitro ag an monaróir chun eiseamail a scrúdú, lena n-áirítear deonú fola agus fíochán, arna ndíorthú ó chorp an duine, go heisiach nó go príomha chun faisnéis maidir le haon cheann amháin nó níos mó díobh seo a leanas a sholáthar: