A signed statement by the natural or legal person responsible for the manufacture of the device for performance study that the device in question conforms to the general safety and performance requirements laid down in Annex I apart from the aspects covered by the clinical performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.
Ráiteas sínithe ag an duine nádúrtha nó dlítheanach atá freagrach as monarú na feiste le haghaidh staidéar feidhmíochta lena gcuirtear in iúl go gcomhlíonann an fheiste atá i gceist na ceanglais ghinearálta sábháilteachta agus feidhmíochta a leagtar síos in Iarscríbhinn I, seachas na gnéithe a chumhdaítear faoin staidéar ar fheidhmíocht chliniciúil agus, maidir leis na gnéithe sin, go ndearnadh gach réamhchúram chun sláinte agus sábháilteacht an ábhair a chosaint.