Where the expert panel finds that the level of clinical evidence is not sufficient or otherwise gives rise to serious concerns about the benefit-risk determination, the consistency of that evidence with the intended purpose, including the medical indication(s), and with the PMCF plan, the notified body shall, if necessary, advise the manufacturer to restrict the intended purpose of the device to certain groups of patients or certain medical indications and/or to impose a limit on the duration of validity of the certificate, to undertake specific PMCF studies, to adapt the instructions for use or the summary of safety and performance, or to impose other restrictions in its conformity assessment report, as appropriate.
I gcás ina gcinnfidh an painéal saineolaithe nach leor leibhéal na fianaise cliniciúla nó go dtagann údair imní chun cinn leis faoin gcinneadh maidir le tairbhe-riosca, comhsheasmhacht na fianaise sin leis an gcríoch a beartaíodh don fheiste, lena n-áirítear an tásc/na tásca leighis agus le plean MLCI, déanfaidh an comhlacht dá dtugtar fógra, más gá, a mholadh don mhonaróir an chríoch a beartaíodh don fheiste a shrianadh do ghrúpaí áirithe othar nó do thásc nó do tásca áirithe leighis, agus/nó teorainn a chur le tréimhse bailíochta an deimhnithe, staidéir shonracha MLCI a dhéanamh, oiriúnú a dhéanamh ar na treoracha úsáide nó ar an achoimre ar shábháilteacht agus ar fheidhmíocht, nó srianta eile a fhorchur ina thuarascáil ar mheasúnú comhréireachta, mar is iomchuí.