Manufacturers of class A devices, other than devices for performance study, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical documentation set out in Annexes II and III.
Dearbhóidh monaróirí feistí in aicme A, seachas feistí le haghaidh staidéar feidhmíochta, comhréireacht a gcuid táirgí trí dhearbhú comhréireachta AE dá dtagraítear in Airteagal 17 a eisiúint, tar éis dóibh an doiciméadacht theicniúil a leagtar amach in Iarscríbhinn II agus in Iarscríbhinn III a tharraingt suas.