However, if those devices are placed on the market in sterile condition, the manufacturer shall apply the procedures set out in Annex IX or in Annex XI.
Mar sin féin, má chuirtear na feistí sin ar an margadh agus bail steiriúil orthu, déanfaidh an monaróir na nósanna imeachta a leagtar amach in Iarscríbhinn IX nó in Iarscríbhinn XI a chur i bhfeidhm.