Reinforced rules for clinical investigations on devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices, including in vitro diagnostic medical devices.
Rangemad eeskirjad seadmete kliiniliste uuringute ning kliiniliste andmete kohta, mis on vajalikud meditsiiniseadmete, sh in vitro diagnostikameditsiiniseadmete turustamiseelse ja pideva turustamisjärgse hindamise jaoks;