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New version applies from 25/05/2017. 124 provisions change. Later versions: 24/04/2020, 11/03/2023, 20/03/2023, 09/07/2024, 10/01/2025, 01/01/2026, 19/07/2026. Article 28 changes in this version: compare with the current text.

Article 28 - UDI database

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.

Official text · consolidated version 05/05/2017 (no longer in force) Open full page ↗
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