Clinical evaluations of those products shall be based on relevant data concerning safety, including data from post-market surveillance, PMCF, and, where applicable, specific clinical investigation.
Beidh meastóireachtaí cliniciúla ar na táirgí sin bunaithe ar shonraí ábhartha a bhaineann leis an tsábháilteacht, lena n-áirítear sonraí ón bhfaireachas iarmhargaidh, MLFI agus, i gcás inarb infheidhme, imscrúdú cliniciúil sonrach.