For companion diagnostics the notified body shall in particular for every device consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X.
I gcás feistí diagnóiseacha coimhdeachta, rachaidh an comhlacht dá dtugtar fógra, go háirithe i gcás gach feiste, i gcomhairle le húdarás inniúil, arna ainmniú ag na Ballstáit i gcomhréir le Treoir 2001/83/CE nó leis an EMA, de réir mar is infheidhme, i gcomhréir leis an nós imeachta a leagtar amach i bpointe (k) de Roinn 3 d'Iarscríbhinn X.