Manufacturers of class IIa 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 for each category of devices.
Beidh monaróirí feistí in aicme IIb, seachas feistí saincheaptha nó feistí imscrúdaitheacha, 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 ii Roinn 4 de nIarscríbhinn sin, a bhaineann le feiste ionadaíoch amháin ar a laghad le haghaidh gach catagóir feiste.