EU reference laboratories should be enabled to verify by laboratory testing the performance claimed by the manufacturer and the compliance of devices presenting the highest risk with the applicable CS, when such CS are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.
Ba cheart a chur ar chumas shaotharlanna tagartha AE a fhíorú, trí thástáil sa tsaotharlann, an fheidhmíocht atá á maíomh ag an monaróir agus comhlíonadh na bhfeistí lena ngabhann an riosca is airde, leis na SCanna is infheidhme, i gcás ina bhfuil na SCanna sin ar fáil, nó an gcomhlíonann siad réitigh eile arna roghnú ag an monaróir chun leibhéal sábháilteachta agus feidhmíochta is coibhéiseach, ar a laghad, a áirithiú.