Such notification shall take place through the electronic system referred to in Article 57 and shall include the summary of safety and clinical performance pursuant to Article 32, the assessment report by the notified body, the instructions for use referred to in Section 23.4 of Annex I, and, where applicable, the scientific opinion of the expert panels referred to in Section 5.1 of Annex IX or Section 6 of Annex X, as applicable. In the case of divergent views between the notified body and the expert panels, a full justification shall also be included.
Maidir le fógra den sórt sin, tabharfar é tríd an gcóras leictreonach dá dtagraítear in Airteagal 57 agus áireofar leis an achoimre ar an bhfeidhmíocht shábháilte agus chliniciúil de bhun Airteagal 32, an tuarascáil mheasúnaithe ón gcomhlacht dá dtugtar fógra, na treoracha le haghaidh úsáid a dtagraítear dóibh i Roinn 23.4 d'Iarscríbhinn I agus, i gcás inarb infheidhme, an tuairim eolaíoch ó phainéal na saineolaithe dá dtagraítear i Roinn 5.1 d'Iarscríbhinn IX nó i Roinn 6 d'Iarscríbhinn X, de réir mar is infheidhmeTabharfar údar iomlán i gcás barúlacha éagsúla idir an comhlacht dá dtugtar fógra agus painéil na saineolaithe.