To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements laid down in this Regulation should be based on clinical data that, for class III devices and implantable devices should, as a general rule, be sourced from clinical investigations that have been carried out under the responsibility of a sponsor.
Chun ardleibhéal sábháilteachta agus feidhmíochta a áirithiú, is le sonraí cliniciúla ba cheart a léiriú go bhfuil na ceanglais ghinearálta sábháilteachta agus feidhmíochta a leagtar síos sa Rialachán seo á gcomhlíonadh, agus na sonraí sin, i gcás feistí aicme III agus feistí so-ionchlannaithe, a theacht, de ghnáth, ó imscrúduithe cliniciúla a rinneadh faoi fhreagracht urraitheora.