EU: MDCG publishes additional UDI guidelines

The Medical Device Coordination Group (MDCG) within the European Union has published new guidance documents relating to the UDI, which has been introduced as part of the MDR and IVDR, on the EU websites.

The five new documents, added in October 2018, deal with specific features of systems and procedure packs as well as the associated data elements, the UDI for software as a medical device, clarification regarding the responsibilities in conjunction with Article 16 (transfer of manufacturer's obligations), as well as provisional considerations regarding language rules for the UDI database.

The documents can be found here.

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