in the case of reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use. 8. Manufacturers of custom-made devices shall follow the procedure set out in Annex XIII and draw up the statement set out in Section 1 of that Annex before placing such devices on the market.
Leanfaidh monaróirí feistí saincheaptha an nós imeachta a leagtar amach in Iarscríbhinn XI agus déanfaidh siad an ráiteas a leagtar amach san Iarscríbhinn sin a tharraingt suas sula gcuirfidh siad feistí den sórt sin ar an margadh.