Where the manufacturer of the device concerned considers that the incident is a serious incident, it shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the competent authority of the Member State in which that serious incident occurred and shall take the appropriate follow-up action in accordance with Article 84.
I gcás ina measann monaróir na feiste lena mbaineann gur teagmhas tromchúiseach é an teagmhas, tabharfaidh sé tuarascáil i gcomhréir le mír 1 go mír 5 den Airteagal seo maidir leis an teagmhas tromchúiseach sin d'údarás inniúil an Bhallstáit inar tharla an teagmhas tromchúiseach sin agus déanfaidh sé an ghníomhaíocht leantach iomchuí i gcomhréir le hAirteagal 84.