Posts tagged with "UDI"

04. December 2019
The European Commission published a series of documents further clarifying the UDI specifications for each of the four European UDI Issuing Entities.

01. October 2019
The regulation that was published by the NMPA and that came into force 2019-10-01 just specifies that UDI regulations are applicable for medical devices as of that date - BUT - the details are missing ! This is the wording of the most important article: 第十八条 本规则自2019年10月1日起施行。分类实施的具体步骤另行制定并 公布。 Article 18 These Rules shall come into force on October 01, 2019. The specific steps for the implementation of the classification will be...

11. June 2019
In addition to the three UDI issuing entities already mentioned in the MDR Article 120,12 the EU Commission just announced a fourth entity. Following the COMMISSION IMPLEMENTING DECISION (EU) 2019/939 dated June 6th 2019 there will be the following four issuing entities for the UDI codes: (a) GS1 AISBL (b) Health Industry Business Communications Council (HIBCC) (c) ICCBBA (d) Informationsstelle für Arzneispezialitäten — IFA GmbH

29. January 2019
MDCG today published another guidance explaining more details on the Basic UDI-DI that will be relevant for the EUDAMED Database Manufacturer's Declaration of Conformity And the Technical Documentation MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI The core information included is: The Basic UDI-DI code value shall have maximum 25 characters A check digit/character must be part of the Basic UDI-DI Further guidance concerning the UDI was already published by MDCG...

10. October 2018
5 new guidance documents concerning the implementation of the UDI in Europe published by MDCG