‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
ciallaíonn “feiste leighis” aon uirlis, aon ghaireas, aon fhearas, aon bhogearra, aon ionchlannán, aon ábhar imoibrithe nó aon earra eile a bheartaíonn an monaróir lena úsáid/lena húsáid ina aonar/ina haonar nó i gcomhcheangal le ní eile, ag an duine, chun ceann amháin nó níos mó de na críocha sonracha leighis seo a leanas a chomhlíonadh: