Where the manufacturer of the device concerned considers that the incident is not a serious incident or is an expected undesirable side-effect, which will be covered by trend reporting in accordance with Article 88, it shall provide an explanatory statement.
I gcás ina meastar do mhonaróir na feiste lena mbaineann nach teagmhas tromchúiseach é an teagmhas nó gur fo-éifeacht neamh-inmhianaithe a mbeifí ag súil léi é a bheidh cumhdaithe leis an tuairisciú treochtaí i gcomhréir le hAirteagal 88, tabharfaidh sé ráiteas míniúcháin.