Regulation (EU) 2017/745 significantly reinforces key elements of the existing regulatory approach in Council Directive 90/385/EEC and Council Directive 93/42/EEC, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance, whilst introducing provisions ensuring transparency and traceability regarding medical devices, to improve health and safety.
Uredbom (EU) 2017/745 znatno se poboljšavaju ključni elementi postojećeg regulatornog pristupa iz Direktive Vijeća 90/385/EEZ i Direktive Vijeća 93/42/EEZ, kao što su nadzor prijavljenih tijela, postupci ocjenjivanja sukladnosti, klinička ispitivanja i klinička procjena, vigilancija i nadzor tržišta, te se istodobno uvode odredbe za osiguravanje transparentnosti i sljedivosti u pogledu medicinskih proizvoda radi poboljšanja zdravlja i sigurnosti.