The notified body shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the device in question or to the clinical condition in which it is utilised, for the purposes of that review;
Bainfidh an comhlacht dá dtugtar fógra úsáid as athbhreithneoirí feiste fostaithe ag a mbeidh saineolas cliniciúil leordhóthanach agus as saineolaithe cliniciúla seachtracha a bhfuil taithí dhíreach reatha acu maidir leis an bhfeiste atá i gceist nó maidir leis na mbail chliniciúil ina n-úsáidtear í, chun críocha an athbhreithnithe sin;