Systems or procedure packs shall be accompanied by the information referred to in Section 23 of Annex I. The statement referred to in paragraph 2 of this Article shall be kept at the disposal of the competent authorities, after the system or procedure pack has been put together, for the period that is applicable under Article 10(8) to the devices that have been combined.
Beidh an fhaisnéis dá dtagraítear i Roinn 23 d'Iarscríbhinn I ag gabháil leis na córais nó pacáistí gnáthamh. Coinneofar an ráiteas dá dtagraítear i mír 2 den Airteagal seo ar fáil do na húdaráis inniúla, tar éis don chóras nó don phacáiste gnáthamh a bheith curtha le chéile, ar feadh na tréimhse is infheidhme faoi Airteagal 10(8) maidir leis na feistí a cuireadh le chéile.