UDI Technical Documentation

Wednesday, December 4th, 2019, the European Commission published eight documents related to the technical specifications for unique device identifiers (UDIs). Four of the documents are related to Basic UDI-DI, one for each designating entity, and the other four deal with UDI human readable interpretation (HRI) formats and automatic identification and data capture (AIDC) carriers, again one for each designating entity. 

The issuing entities designated to operate a system for assignment of UDIs pursuant to Regulation 2017/745 and 2017/746 are:

  • GS1 AISBL 
  • Health Industry Business Communications Council (HIBCC) 
  • Informationsstelle für Arzneispezialitäten — IFA GmbH 

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.