Full text of EU MDR (Medical Device Regulation)
EU MDR Chapter 3 Article 28

Article 28 – UDI database

  1. The Commission, after consulting the MDCG shall set up and manage a UDI database to validate, collate, process and make available to the public the information mentioned in Part B of Annex VI.
  2. When designing the UDI database, the Commission shall take into account the general principles set out in Section 5 of Part C of Annex VI. The UDI database shall be designed in particular such that no UDI-PIs and no commercially confidential product information can be included therein.
  3. The core data elements to be provided to the UDI database, referred to in Part B of Annex VI, shall be accessible to the public free of charge.
  4. The technical design of the UDI database shall ensure maximum accessibility to information stored therein, including multi-user access and automatic uploads and downloads of that information. The Commission shall provide for technical and administrative support to manufacturers and other users of the UDI database.


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