In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics, the notified body shall consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council [25] or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX.
Sa bhreis ar na nósanna imeachta dá dtagraítear sa chéad fhomhír agus sa dara fomhír, i gcás feistí diagnóiseacha coimhdeachta, rachaidh an comhlacht dá dtugtar fógra i gcomhairle le húdarás inniúil, arna ainmniú ag na Ballstáit i gcomhréir le Treoir 2001/83/CE ó Pharlaimint na hEorpa agus ón gComhairle [25], nó leis an EMA, de réir mar is infheidhme, i gcomhréir leis an nós imeachta a leagtar amach i Roinn 5.2 d'Iarscríbhinn IX.