uniform application of the requirements regarding the clinical evidence/data needed to demonstrate compliance with the general safety and performance requirements set out in Annex I.
le cur i bhfeidhm aonfhoirmeach na gceanglas maidir leis an bhfianaise chliniciúil/na sonraí cliniciúla, is gá chun a thaispeáint gur comhlíonadh na ceanglais ghinearálta sábháilteachta agus feidhmíochta a leagtar amach in Iarscríbhinn I.