The COVID-19 crisis has created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/745.
Zbog krize uzrokovane bolešću COVID-19 došlo je do izvanrednih okolnosti koje zahtijevaju znatna dodatna sredstva i povećanu dostupnost životno važnih medicinskih proizvoda, a koje nisu bile razumno predvidljive u vrijeme donošenja Uredbe (EU) 2017/745.