The European Commission has designated four organizations as Unique Device Identification (UDI) Issuing Agencies to support medical device and IVD manufacturers comply with new regulatory requirements applicable for Medical Devices under the Medical Devices Regulation (EU) 2017/745 (MDR) and In-Vitro Diagnostic Medical Devices (EU) 2017/746 (IVDR). These agencies will issue the unique codes necessary for UDI, described in MDR articles 27-28, Annex VI and IVDR articles 24-25, Annex VI.
List of issuing entities designated to operate a system for assignment of UDIs pursuant to Regulation (EU) 2017/745 and the Regulation (EU) 2017/746:
(a) GS1 AISBL
(b) Health Industry Business Communications Council (HIBCC)
(d) InformationsstellefürArzneispezialitäten – IFA GmbH
UDI will be used on the Declaration of Conformity, Certificates and labels for identification of the devices during distribution, use, incidents and Field Safety Corrective Actions (FSCA). This assignment will become effective on June 27, 2019 and will be valid for five years, after which designations will be reviewed by the European Commission and possibly renewed as per the Official Journal of the European Union (OJEU) of 7 June 2019, page 75.