News New medtech regulations

Status of designation of UDI issuing agencies in Europe

Posted on 30.01.2019

The deadline for the UDI issuing agencies to apply for designation in accordance with Article 27(2) of Regulation (EU) 2017/745 (MDR) and Article 24(2) of Regulation (EU) 2017/746 (IVDR) expired on Friday, 25 January 2019. After the assessment of the received applications, an Implementing Act on the designation of UDI issuing entity/ies will be published - according to DG GROW’s implementation rolling plan latest by 26 May 2019. In the meantime, the MDCG approved guiding principles for issuing entities on Basic UDI-DI were also published.