In the case of devices referred to in the first subparagraph of Article 1(8), the quality, safety and usefulness of the substance which, if used separately, would be considered to be a medicinal product within the meaning of point (2) of Article 1 of Directive 2001/83/EC, shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC, as required by the applicable conformity assessment procedure under this Regulation.
I gcás feistí dá dtagraítear sa chéad fhomhír d'Airteagal 1(8), fíorófar, ar analach, cáilíocht, sábháilteacht agus fónamh na substainte a mheasfaí a bheith, dá mbeadh sí in úsáid ar leithligh, ina táirge íocshláinte de réir bhrí phointe (2) d'Airteagal 1 de Threoir 2001/83/CE, trí úsáid a bhaint as na modhanna a shonraítear in Iarscríbhinn I a ghabhann le Treoir 2001/83/CE, mar a cheanglaítear leis an nós imeachta um measúnú comhréireachta is infheidhme faoin Rialachán seo.