Unique Device Identifiers (UDI)

Designation of new issuing entity for Unique Device Identifiers (UDI) in the field of medical devices

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/PDF/?uri=CELEX:32019D0939&from=EN

Last modification 06.11.2019

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