The manufacturer shall undertake to institute and keep up to date a post-market surveillance plan, including a PMCF plan, and the procedures ensuring compliance with the obligations of the manufacturer resulting from the provisions on vigilance and post-market surveillance system set out in Chapter VII.
Gabhfaidh an monaróir air féin plean faireachais iarmhargaidh a thionscnamh agus a choinneáil nuashonraithe, lena n-áirítear plean don Mheasúnú Leantach Cliniciúil Iarmhargaidh (MLCI), agus na nósanna imeachta lena n-áirithítear comhlíonadh oibleagáidí an mhonaróra atá mar thoradh ar na forálacha maidir le aireachas agus córas faireachais iarmhargaidh a leagtar amach i gCaibidil VII.