‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
ciallaíonn “gabhálas feiste leighis” earra a bheartaíonn an monaróir lena úsáid, cé nach feiste leighis é féin, maille le feiste leighis áirithe amháin nó roinnt feistí leighis áirithe chun gur féidir an fheiste leighis nó na feistí leighis a úsáid i gcomhréir leis an gcríoch nó leis na críocha a beartaíodh di nó dóibh nó chun cabhrú go sonrach agus go díreach le feidhmíocht leighis na feiste nó na bhfeistí leighis maidir leis an gcríoch nó leis na críocha a beartaíodh di nó dóibh;