Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for in vitro diagnostic medical devices in the Union.
Beidh duine amháin ar a laghad ar fáil go buan agus go leanúnach d'ionadaithe údaraithe le bheith freagrach as comhlíonadh rialála, ar duine é a mbeidh an saineolas riachtanach aige maidir leis na ceanglais rialála le haghaidh feistí leighis diagnóiseacha in vitro san Aontas.