the investigational device(s) in question conform(s) to the applicable general safety and performance requirements set out in Annex I apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects.
comhlíonann an fheiste imscrúdaitheach/na feistí imscrúdaitheacha atá i dtrácht na ceanglais feidhmíochta is infheidhme maidir le sábháilteacht ghinearálta a leagtar amach in Iarscríbhinn I seachas na gnéithe a chumhdaítear leis an imscrúdú cliniciúil agus, maidir leis na gnéithe sin, rinneadh gach réamhchúram chun sláinte agus sábháilteacht na n-ábhar a chosaint.