The documentation shall contain the performance evaluation report, which includes the reports on the scientific validity, the analytical and the clinical performance, as referred to in Annex XIII, together with an assessment of those reports.
Beidh an tuarascáil ar an meastóireacht feidhmíochta sa doiciméadacht, lena n-áirítear na tuarascálacha maidir le bailíocht eolaíoch, an fheidhmíocht anailíseach agus chliniciúil, dá dtagraítear in Iarscríbhinn XIII, i dteannta measúnú ar na tuarascálacha sin.