A signed statement by the natural or legal person responsible for the manufacture of the investigational device that the device in question conforms to the general safety and performance requirements 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 subject.
Ráiteas sínithe ag an duine nádúrtha nó dlítheanach atá freagrach as monarú na feiste imscrúdaithí lena gcuirtear in iúl go gcomhlíonann an fheiste i gceist na ceanglais ghinearálta sábháilteachta agus feidhmíochta, seachas na gnéithe a chumhdaítear faoin imscrúdú cliniciúil agus, maidir leis na gnéithe sin, go ndearnadh gach réamhchúram chun sláinte agus sábháilteacht an ábhair don imscrúdú a chosaint.