Manufacturers of class III devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Annex IX.
Beidh monaróirí feistí in aicme III, nach feistí saincheaptha nó feistí imscrúdaitheacha iad, faoi réir measúnú comhréireachta mar a shonraítear in Iarscríbhinn VIII.