Manufacturers of class B devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Sections 4.4 to 4.8 of that Annex for at least one representative device per category of devices.
Beidh monaróirí feistí in aicme B, seachas feistí le haghaidh staidéar feidhmíochta, faoi réir measúnú comhréireachta mar a shonraítear i gCaibidil I agus i gCaibidil III d'Iarscríbhinn IX, agus lena n-áirítear measúnú ar an doiciméadacht theicniúil a shonraítear i Roinn 4.4 go Roinn 4.8 den Iarscríbhinn sin a bhaineann le feiste ionadaíoch amháin ar a laghad le haghaidh gach catagóra feistí cineálacha.