In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7, in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the procedure specified in Section 5.4 of Annex IX or Section 6 of Annex X, as applicable, shall also apply.
De bhreis ar na nósanna imeachta is infheidhme de bhun mhíreanna 3, 4, 6, 7 nó 8, i gcás feistí atá comhdhéanta de shubstaintí nó de theaglamaí substaintí atá beartaithe lena dtabhairt isteach i gcorp an duine trí oscailt colainne nó a chuirtear ar an gcraiceann agus a ionsúitear nó a scaiptear go logánta i gcorp an duine, beidh feidhm freisin ag an nós imeachta a shonraítear i Roinn 5.4 d'Iarscríbhinn IX nó i Roinn 6 d'Iarscríbhinn X, de réir mar is infheidhme.