{"id":34407,"date":"2025-07-10T12:25:54","date_gmt":"2025-07-10T10:25:54","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34407"},"modified":"2025-07-11T12:16:53","modified_gmt":"2025-07-11T10:16:53","slug":"what-is-the-udi-for-medical-devices-and-ivds-and-what-is-it-for","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/what-is-the-udi-for-medical-devices-and-ivds-and-what-is-it-for\/","title":{"rendered":"What is the UDI for Medical Devices and IVDs, and what is it for?"},"content":{"rendered":"

Unique Device Identification (UDI)<\/strong> is a global identification system designed to enhance the traceability <\/strong>and security<\/strong> of medical devices and in vitro diagnostic medical devices. The UDI consists of a series of alphanumeric codes that enable the unique identification of each device, facilitating monitoring throughout the supply chain.<\/p>\n

The UDI code consists of two distinct parts:<\/p>\n

    \n
  • UDI-DI (Device Identifier)<\/strong><\/li>\n<\/ul>\n

    The UDI-DI<\/strong> is the unique identifier assigned to a specific device model<\/strong>.<\/p>\n

    This identifier remains unchanged for all devices<\/strong> sharing the same model, configuration and intended use. Any significant change to the device, such as a change in size, type or packaging, requires the assignment of a new UDI-DI.<\/p>\n

      \n
    • UDI-PI (Production Identifier)<\/strong><\/li>\n<\/ul>\n

      The UDI-PI<\/strong> is the identifier for the individual production unit<\/strong> of a device.<\/p>\n

      It includes, where appropriate, the following elements:<\/p>\n

        \n
      • Lot or serial number<\/li>\n
      • Software identifier (if applicable)<\/li>\n
      • Date of manufacture<\/li>\n
      • Expiry date<\/li>\n<\/ul>\n

        The UDI-PI varies <\/strong>for each piece and each production batch.<\/p>\n

        Key features of the UDI<\/h2>\n
          \n
        • Dual format<\/strong>: the UDI appears on the device label either in human-readable format or in AIDC (Automatic Identification and Data Capture) format, e.g. a linear barcode or a 2D code (e.g. a Data Matrix).<\/li>\n
        • Scannability<\/strong>: it is designed to be easily read and scanned by healthcare professionals, distributors and regulatory authorities.<\/li>\n
        • Registration in <\/strong>EUDAMED<\/strong>: the UDI-DI must be registered in the European database EUDAMED. This registration associates the UDI-DI with key information on the device.<\/li>\n<\/ul>\n<\/div>
          <\/span><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[892,1910],"tags":[1927,1640,1926,1894,1737,1928,1931,1929,1930],"class_list":["post-34407","post","type-post","status-publish","format-standard","hentry","category-faq-en","category-udi-in-medical-devices","tag-in-vitro-diagnostic-devices","tag-ivd-en-2","tag-medical-device-identification","tag-medical-device-traceability-en","tag-medical-devices-en","tag-udi-en-2","tag-udi-ivd-en","tag-udi-di-en","tag-udi-pi-en"],"acf":[],"yoast_head":"\nWhat is the UDI for Medical Devices and IVDs and What is it for?<\/title>\n<meta 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