In the case of devices for self-testing or near-patient testing, the application shall also include the aspects referred to in point (b) of Section 5.1.
I gcás feistí le haghaidh féintástála nó le haghaidh tástáil neas-othair, áireofar san iarratas freisin na gnéithe dá dtagraítear i bpointe (b) de Roinn 5.1.