Medical device CE marking

MDCG endorses 5 new documents


The European Commission has issued 5 new MDCG endorsed documents:

  • MDCG 2018-3   Guidance on UDI for systems and procedure packs
  • MDCG 2018-4   Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs
  • MDCG 2018-5   UDI Assignment to Medical Device Software
  • MDCG 2018-6   Clarifications of UDI related responsibilities in relation to Article 16
  • MDCG 2018-7   Provisional considerations regarding language issues associated with the UDI database

The guidances can be downloaded here: library