Based on its assessment of the clinical evidence, the notified body shall consider the clinical evaluation and the benefit-risk determination, and whether specific milestones need to be defined to allow the notified body to review updates to the clinical evidence that result from post-market surveillance and PMCF data.
Bunaithe ar a mheasúnú ar an bhfianaise chliniciúil, measfaidh an comhlacht dá dtugtar fógra an mheastóireacht chliniciúil agus an cinneadh maidir le tairbhe-riosca, agus más gá garspriocanna sonracha a shainiú chun go mbeidh an comhlacht dá dtugtar fógra in ann athbhreithniú a dhéanamh ar nuashonruithe ar an bhfianaise chliniciúil atá mar thoradh ar fhaireachas iarmhargaidh agus ar shonraí MLCI.