In relation to clinical data from clinical investigations included within the clinical evaluation, the notified body in question shall ensure that the conclusions drawn by the manufacturer are valid in the light of the approved clinical investigation plan.
Maidir le sonraí cliniciúla ó imscrúduithe cliniciúla a áirítear sa mheastóireacht chliniciúil, áiritheoidh an comhlacht dá dtugtar fógra atá i gceist go bhfuil na conclúidí a bhain an monaróir amach bailí i bhfianaise an phlean fhormheasta don imscrúdú cliniciúil.