When the manufacturer fulfils the obligations laid down in Section 1, it shall draw up and keep an EU declaration of conformity in accordance with Article 17 and Annex IV for the device covered by the conformity assessment procedure.
Nuair a chomhlíonann an monaróir na hoibleagáidí a leagtar síos le Roinn 1, tarraingeoidh sé suas agus coinneoidh sé dearbhú comhréireachta AE i gcomhréir le hAirteagal 17 agus le hIarscríbhinn IV don fheiste a chumhdaítear faoin nós imeachta um measúnú comhréireachta.