decide, based on the results of its assessment of the clinical evaluation and risk management, whether the post-market surveillance plan, including the PMCF plan, is adequate,
cinneadh a dhéanamh, bunaithe ar thorthaí a chuid measúnaithe ar an meastóireacht chliniciúil agus ar an mbainistiú riosca, an bhfuil an plean faireachais iarmhargaidh, lena n-áirítear an plean MLCI, leordhóthanach,