whether to provide a scientific opinion on the clinical evaluation assessment report of the notified body based on the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the medical indication or indications and the PMCF plan.
ar cheart tuairim eolaíoch a chur ar fáil maidir leis an tuarascáil mheasúnaithe ar an meastóireacht chliniciúil ón gcomhlacht dá dtugtar fógra, bunaithe ar an bhfianaise chliniciúil a chuireann an monaróir ar fáil, go háirithe maidir le tairbhe-riosca a chinneadh, le comhsheasmhacht na fianaise sin leis an tásc nó leis na tásca leighis agus le plean MLCI.