the documentation on the manufacturer's post-market surveillance system, and, where applicable, on the PMPF plan, and the procedures put in place to ensure compliance with the obligations resulting from the provisions on vigilance set out in Articles 82 to 87,
an doiciméadacht maidir le córas faireachais iarmhargaidh an mhonaróra agus, i gcás inarb infheidhme, ar plean MLFI, agus na nósanna imeachta a cuireadh ar bun chun comhlíonadh na n-oibleagáidí atá mar thoradh ar na forálacha maidir le haireachas a leagtar amach in Airteagal 82 go hAirteagal 87 a áirithiú,