The proposed amendment aims to ensure that the intended purpose of Regulation (EU) 2017/745, that is, to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which guarantees a high level of protection of public health and patient safety and the smooth functioning of the internal market for such devices, can be attained.
Predloženom izmjenom nastoji se postići predviđeni cilj Uredbe (EU) 2017/745, odnosno uspostava čvrstog, transparentnog, predvidljivog i održivog regulatornog okvira za medicinske proizvode kojim se jamči visoka razina zaštite javnog zdravlja i sigurnosti pacijenata te neometano funkcioniranje unutarnjeg tržišta za te proizvode.