By way of derogation from Section 5, by virtue of the EU declaration of conformity the manufacturer shall be deemed to ensure and to declare that the class IIa devices in question are manufactured in conformity with the technical documentation referred to in Annexes II and III and meet the requirements of this Regulation which apply to them.
De mhaolú ar Roinn 5, de bhua dhearbhú comhréireachta AE measfar go n-áirithíonn agus go ndearbhaíonn an monaróir go monaraítear na feistí in aicme IIa i gcomhréir leis an doiciméadacht theicniúil dá dtagraítear in Iarscríbhinn II agus in Iarscríbhinn III agus go gcomhlíonann siad na ceanglais sin de chuid an Rialacháin seo a bhfuil feidhm acu maidir leo.