{"id":3474,"date":"2025-04-24T08:00:22","date_gmt":"2025-04-24T08:00:22","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3474"},"modified":"2025-05-07T07:58:13","modified_gmt":"2025-05-07T07:58:13","slug":"udi-di-mandatory-from-may-26-2025-a-guide-for-manufacturers","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/udi-di-mandatory-from-may-26-2025-a-guide-for-manufacturers\/","title":{"rendered":"UDI-DI mandatory from May 26, 2025: A guide for manufacturers"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>An important deadline is coming up under the EU Medical Devices Regulations (MDR and IVDR), and it\u2019s all about your product labels.<br \/>\nFrom this date, manufacturers will be required to place the <b>UDI (Unique Device Identification) carrier<\/b> on:<\/p>\n<p>\ud83d\udd39<b> All Class I medical devices<\/b> (under MDR)<br \/>\n\ud83d\udd39 <b>Class B and Class C in vitro diagnostic devices <\/b>(under IVDR)<\/p>\n<p>The obligation applies to <b>all manufacturers<\/b>, regardless of whether a Notified Body is involved. It also applies to Software medical Devices. For many manufacturers, especially those working with Class I or self-certified devices, this may represent a significant regulatory shift.<\/p>\n<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/udi-di-mandatory-from-may-26-2025-a-guide-for-manufacturers\/#What_is_the_UDI\" >What is the UDI?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/udi-di-mandatory-from-may-26-2025-a-guide-for-manufacturers\/#How_it_works\" >How it works<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/udi-di-mandatory-from-may-26-2025-a-guide-for-manufacturers\/#Basic_UDI-DI_vs_UDI-DI\" >Basic UDI-DI vs. UDI-DI<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/udi-di-mandatory-from-may-26-2025-a-guide-for-manufacturers\/#Main_differences\" >Main differences<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/udi-di-mandatory-from-may-26-2025-a-guide-for-manufacturers\/#Why_is_this_important\" >Why is this important<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/cmcmedicaldevices.com\/es\/udi-di-mandatory-from-may-26-2025-a-guide-for-manufacturers\/#What_are_the_risks_of_non-compliance\" >What are the risks of non-compliance?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/cmcmedicaldevices.com\/es\/udi-di-mandatory-from-may-26-2025-a-guide-for-manufacturers\/#What_should_you_do_now\" >What should you do now?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/cmcmedicaldevices.com\/es\/udi-di-mandatory-from-may-26-2025-a-guide-for-manufacturers\/#Steps_to_take\" >Steps to take<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/cmcmedicaldevices.com\/es\/udi-di-mandatory-from-may-26-2025-a-guide-for-manufacturers\/#Need_support\" >Need support?<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"What_is_the_UDI\"><\/span>What is the UDI?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The UDI is a sequence of numbers and\/or letters following globally accepted standards. Its purpose is to allow clear identification of a specific medical device on the market.<\/p>\n<p>The UDI is composed by two elements the UDI-DI and the UDI-PI.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"How_it_works\"><\/span>How it works<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The <b>UDI-DI (Device identifier)<\/b> is specific to a manufacturer and a device model.<br \/><b><br \/>\nThe UDI-PI (Production Identifier)<\/b> includes information like lot number, manufacturing or expiration date, and serial number\u2014used for batch-level traceability.<\/p>\n<p>Together they form the UDI, which must be readable for both humans and \u201cmachines\u201d. To achieve this, Manufacturers must include the UDI Carrier on the label or on the device itself and on all higher levels of device packaging. The UDI Carrier typically looks like a barcode or QR accompanied by text.<\/p>\n<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Basic_UDI-DI_vs_UDI-DI\"><\/span>Basic UDI-DI vs. UDI-DI<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Main_differences\"><\/span>Main differences<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u2022 <b>Basic UDI-DI<\/b>: A code that groups together devices with the same intended purpose, risk class, and essential design and manufacturing characteristics. It appears in the Declaration of Conformity (DoC), certificates, and EUDAMED. It is independent of product labelling and does not appear on the commercial item.<br \/>\n\u2022 <b>UDI-DI<\/b>: A code that unambiguously identifies a device version. A different UDI-DI will be necessary for products with different trade names, sterilisation requirements, contra-indications or quantity of devices included in a package. It appears in the labelling of the devices and EUDAMED.<br \/>\nEach UDI-DI shall be associated with one, and only one, Basic UDI-DI.<\/p>\n<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Why_is_this_important\"><\/span>Why is this important<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b><br \/>\nThe Unique Device Identifier<\/b> System is designed to enhance the traceability, transparency, and safety of medical devices across the European market.<\/p>\n<p>Even if your device does not require certification from a Notified Body, <b>the obligation to implement the UDI system remains<\/b>. This includes both the generation of the codes and the proper use of identifiers across documentation, labelling, and registration platforms like EUDAMED.<\/p>\n<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_are_the_risks_of_non-compliance\"><\/span>What are the risks of non-compliance?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\n\u2022 <b>Loss<\/b> of CE marking<br \/>\n\u2022 <b>Inability to market<\/b> devices in the EU<br \/>\n\u2022 <b>Risk of product recalls<\/b> or enforcement actions<br \/>\n\u2022 <b>Reputational damage<\/b> and loss of distributor or customer trust<\/p>\n<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_should_you_do_now\"><\/span>What should you do now?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Steps_to_take\"><\/span>Steps to take<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\n1. <b>Verify <\/b>if your devices are affected by the UDI requirements<br \/>\n2. <b>Obtain <\/b>UDI and Basic UDI-DI codes from a recognized issuing entity (e.g., GS1, HIBCC, ICCBBA)<br \/>\n3.<b> Include<\/b> the UDI information in your labelling, packaging, and technical documentation<br \/>\n4.<b> Register<\/b> the UDI-DI and Basic UDI-DI in EUDAMED, once fully functional<br \/>\n5.<b> Ensure<\/b> full alignment with the requirements of MDR or IVDR<\/p>\n<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Need_support\"><\/span>Need support?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Implementing UDI isn\u2019t just about assigning codes. It means rethinking labelling workflows, ensuring consistent data entry across documents, and managing regulatory deadlines with precision.<\/p>\n<p>We assist manufacturers with:<\/p>\n<p><b><br \/>\n\u2022 Choosing the right issuing entity<br \/>\n\u2022 Assigning and structuring UDI and Basic UDI-DI<br \/>\n\u2022 Registering data in EUDAMED<br \/>\n\u2022 Ensuring complete documentation and labelling compliance<\/b><\/p>\n<p><b><br \/>\nWant to talk to an expert or receive a personalized plan? Get in touch with our team<\/b>, we\u2019re here to make compliance simple and strategic.<\/p><\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_margin-top:10px;--button_margin-bottom:10px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us for personalized support<\/span><\/a><\/div><div class=\"fusion-image-element \" style=\"text-align:center;--awb-max-width:600px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"2560\" height=\"1465\" alt=\"UDI-DI (1)\" title=\"UDI-DI (1)\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/04\/UDI-DI-1.jpg\" class=\"img-responsive wp-image-3472\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/04\/UDI-DI-1-200x114.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/04\/UDI-DI-1-400x229.jpg 400w, 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