the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan, and the procedures put in place to ensure compliance with the obligations resulting from the provisions on vigilance set out in Articles 87 to 92,
an doiciméadacht maidir le córas faireachais iarmhargaidh an mhonaróra agus, i gcás inarb infheidhme, an plean don phlean MLCI, na nósanna imeachta a cuireadh ar bun chun comhlíonadh na n-oibleagáidí atá mar thoradh ar na forálacha maidir le faireachas a thig as Airteagal 87 go hAirteagal 92 a áirithiú