The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer's PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.
Déanfar an mheastóireacht chliniciúil agus an doiciméadacht a ghabhann léi a nuashonrú feadh shaolré na feiste lena mbaineann le sonraí cliniciúla a gheofar ó phlean MLCI an mhonaróra a chur chun feidhme i gcomhréir le Cuid B d'Iarscríbhinn XIV agus ón bplean faireachais iarmhargaidh dá dtagraítear in Airteagal 84.