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)
d) Informationsstelle für Arzneispezialitäten – IFA GmbH
The above Decision can be downloaded here: