As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by ensuring, among other things, that data generated in clinical investigations are reliable and robust and that the safety of the subjects participating in a clinical investigation is protected.
Maidir le hAirteagal 168(4)(c) CFAE, socraítear sa Rialachán seo ardchaighdeáin cháilíochta agus sábháilteachta d'fheistí leighis trína áirithiú, maille le nithe eile, go mbeidh na sonraí a ghinfear in imscrúduithe cliniciúla iontaofa agus láidir agus go gcosnófar sábháilteacht na n-ábhar d'imscrúdú cliniciúil.