the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative.
an oibleagáid atá ar an ionadaí údaraithe imeachta tar éis fhoirceannadh an tsainordaithe aon ghearáin nó aon tuairiscí ó ghairmithe cúraim sláinte, ó othair nó ó úsáideoirí maidir le teagmhais amhrasta a bhaineann le feiste ar ainmníodh é ina ionadaí údaraithe di a chur ar aghaidh chuig an monaróir nó chuig an ionadaí údaraithe inteachta.