The manufacturer shall demonstrate the clinical performance of the device in relation to all the parameters described in point (b) of Section 9.1. of Annex I, unless any omission can be justified as not applicable.
Léireoidh an monaróir feidhmíocht anailíseach na feiste maidir leis na paraiméadair uile a bhfuil tuairisc orthu i bpointe (b) de Roinn 9.1. d'Iarscríbhinn I, mura féidir bonn cirt a thabhairt maidir le haon rud a fágadh ar lár mar rud nach raibh infheidhme.