Guidance

  • 2019-2 Guidance on application of UDI rules to devices incorporating medicinal substance, human tissues and cells (MDCG)
  • 2019-1 Guiding principles for issuing entities rules on Basic UDI-DI (MDCG)
  • 2018-8 Guidance on content of the certificates, voluntary certificate transfers (MDCG)
  • Draft guidance on Basic UDI-DI and changes to UDI-DI (MDCG)
  • Guidance on UDI for systems and procedure packs (MDCG and Annex)
  • Preliminary Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices