In addition to the procedure applicable pursuant to the first subparagraph, manufacturers of class III custom-made implantable devices shall be subject to the conformity assessment as specified in Chapter I of Annex IX.
De bhreis ar an nós imeachta is infheidmhe de bhun na chéad fhomhíre, beidh monaróirí feistí saincheaptha so-ionchlannaithe in aicme III faoi réir an mheasúnaithe comhréireachta freisin mar a shonraítear i gCaibidil I d'Iarscríbhinn IX.