the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body, and
gur thaispeáin an monaróir go bhfuil an fheiste mhodhnaithe coibhéiseach leis an bhfeiste a cuireadh ar an margadh, i gcomhréir le Roinn 3 d'Iarscríbhinn XIV agus go ndearna an comhlacht dá dtugtar fógra an taispeáint sin a fhormhuiniú, agus