Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Article 20.
I gcás inar léiríodh go raibh na ceanglais is infheidhme á gcomhlíonadh, de réir an nós imeachta um measúnú comhréireachta, déanfaidh monaróirí feistí, nach feistí saincheaptha nó imscrúdaitheacha iad, dearbhú comhréireachta AE a tharraingt suas i gcomhréir le hAirteagal 19 agus déanfaidh siad an mharcáil comhréireachta CE a cheangal díobh i gcomhréir le hAirteagal 20.