The clinical evidence and its assessment in the performance evaluation report shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer's PMPF plan in accordance with Part B of this Annex, as part of the performance evaluation and the post-market surveillance system referred to in Article 10(9).
Déanfar an fhianaise chliniciúil agus an measúnú uirthi sin, rud a bheidh sa tuarascáil ar an meastóireacht feidhmíochta, a nuashonrú feadh shaolré na feiste lena mbaineann le sonraí a gheofar ó chur chun feidhme phlean MLFI an mhonaróra i gcomhréir le Cuid B den Iarscríbhinn seo, mar chuid den mheastóireacht feidhmíochta agus den chóras faireachais iarmhargaidh dá dtagraítear in Airteagal 10(9).