The European Commission has published a guidance document for the unique device identification (UDI) system. Within this document, you can find answers to frequently asked questions as well as important links to further guidance and information.
The document can be found here:
In addition to the three issuing entities defined in Article 120 (12) of Regulation (EU) 2017/745 (MDR) and in Article 110 (10) of Regulation (EU) 2017/746 (IVDR), in its Implementing Decision of 6 June 2019 the European Commission has designated a further issuing entity for implementing a system of Unique Device Identifiers (UDI) in the field of medical devices.
The list of issuing entities tasked with implementing a system of UDI in application of MDR and a system of UDI in application of IVDR is therefore now as follows:
a) GS1 AISBL
b) Health Industry Business Communications Council (HIBCC)
c) ICCBBA
d) Informationsstelle für Arzneispezialitäten – IFA GmbH
The above Decision can be downloaded here:
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L_202402120&qid=1722864595853
