At the same time, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices in order to meet common safety concerns as regards such products.
Ag an am céanna, socraíonn an Rialachán seo ardchaighdeáin cháilíochta agus sábháilteachta d'fheistí leighis diagnóiseacha in vitro chun déileáil le gnáthcheisteanna sábháilteachta a bhaineann le táirgí den sórt sin.