clearly document the outcome of its assessment in a pre-clinical and clinical evaluation assessment report as part of the EU type examination report referred to in point (i);
a dhoiciméadú go soiléir an toradh a bhí ar an measúnú i dtuarascáil ar an meastóireacht chliniciúil agus réamhchliniciúil mar chuid den tuarascáil ar scrúdú cineáil AE dá dtagraítear i bpointe (i);