Prior to putting into service a device that is not placed on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
Sula gcuirfear feiste i seirbhís nach feiste í a chuirtear ar an margadh, tabharfaidh monaróirí faoi mheasúnú ar chomhréireacht na feiste sin, i gcomhréir leis na nósanna imeachta um measúnú comhréireachta a leagtar amach in Iarscríbhinn IX go hIarscríbhinn XI.