When setting up the electronic system referred to in paragraph 1 of this Article, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of the Council [26] as concerns performance studies of companion diagnostics.
Agus an córas leictreonach dá dtagraítear i mír 1 den Airteagal seo á bhunú, áiritheoidh an Coimisiún go mbeidh sé idir-inoibritheach le bunachar sonraí AE le haghaidh trialacha cliniciúla ar tháirgí míochaine lena n-úsáid ag daoine a bunaíodh i gcomhréir le hAirteagal 81 de Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle [26] maidir le staidéir feidhmíochta ar fheistí diagnóiseacha coimhdeachta.