UDI Guidance given by the European MDCG

5 new guidance documents concerning the implementation of the UDI in Europe published by MDCG

The Medical device coordination group (MDCG) publishes 4 guidance documents on the implementation of the Unique device identification (UDI) under the new European regulatory framework.


Todays publication list includes:


  • MDCG 2018-3
    • Guidance on UDI for systems and procedure packs
  • MDCG 2018 -04 Annex
    • UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs
  • MDCG 2018 -05
    • UDI Assignment to Medical Device Software
  • MDCG 2018 -06
    • Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Medical Devices Regulation 2017/746
  • MDCG 2018 -07
    • Provisional considerations regarding the language issues associated with the UDI database (Annex VI, Part A Section 2 and Part B of the Medical Devices Regulation 2017/745 and the In-Vitro Diagnostic Medical Device Regulation 2017/745