Manufacturers of class IIb devices, other than custom-made or investigational devices, 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 Section 4 of that Annex of at least one representative device per generic device group.
Beidh monaróirí feistí in aicme IIb, nach feistí saincheaptha nó feistí imscrúdaitheacha iad, 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, mar a shonraítear i Roinn 4 den Iarscríbhinn sin, a bhaineann le feiste ionadaíoch amháin ar a laghad le haghaidh gach grúpa feistí cineálacha.