Unique Device Identification (UDI) System
En son güncellendiği tarih: 28 Ağu 2019
under the EU Medical Device Regulations 2017/745 and 2017/746
The existing regulatory framework on medical devices dates back to the 1990s and consists of three Directives. Two new Regulations (Regulation (EU) 745/2017 on medical devices and Regulation (EU) 746/2017 on In Vitro diagnostic medical devices) were adopted in April 2017 and entered into force on 25 May 2017. The general application dates of the two Regulations are 25 May 2020 for medical devices and 25 May 2022 for In Vitro diagnostic medical devices, though different timelines apply for certain specific provisions.