Cases in which paragraph 4 is not applied by virtue of paragraph 6 shall be justified in the clinical evaluation report by the manufacturer and in the clinical evaluation assessment report by the notified body.
I gcásanna nach gcuirtear mír 4 i bhfeidhm de bhua mhír 6, tabharfar údar leis sin sa tuarascáil ón monaróir ar an meastóireacht chliniciúil agus sa tuarascáil mheasúnaithe ón gcomhlacht dá dtugtar fógra ar an meastóireacht chliniciúil.