{"id":3890,"date":"2025-07-11T11:01:19","date_gmt":"2025-07-11T11:01:19","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3890"},"modified":"2025-07-18T09:35:07","modified_gmt":"2025-07-18T09:35:07","slug":"when-is-the-master-udi-di-mandatory-for-contact-lenses-and-spectacle-frames","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/when-is-the-master-udi-di-mandatory-for-contact-lenses-and-spectacle-frames\/","title":{"rendered":"When is the Master UDI-DI mandatory for contact lenses and spectacle frames?"},"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><strong>The Master UDI-DI will become mandatory for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles from September 2028, and for contact lenses from 9 November 2026. These deadlines are defined in MDCG 2025-7 and the relevant Delegated Regulations.<\/strong><\/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\/when-is-the-master-udi-di-mandatory-for-contact-lenses-and-spectacle-frames\/#Master_UDI-DI_requirements_under_the_MDR\" >Master UDI-DI requirements under the MDR<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/when-is-the-master-udi-di-mandatory-for-contact-lenses-and-spectacle-frames\/#UDI_labelling_requirements\" >UDI labelling requirements<\/a><\/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\/when-is-the-master-udi-di-mandatory-for-contact-lenses-and-spectacle-frames\/#EUDAMED_registration_module\" >EUDAMED registration module<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/when-is-the-master-udi-di-mandatory-for-contact-lenses-and-spectacle-frames\/#Master_UDI-DI_for_contact_lenses\" >Master UDI-DI for contact lenses<\/a><\/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\/when-is-the-master-udi-di-mandatory-for-contact-lenses-and-spectacle-frames\/#Master_UDI-DI_for_spectacle_frames_lenses_and_reading_glasses\" >Master UDI-DI for spectacle frames, lenses, and reading glasses<\/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\/when-is-the-master-udi-di-mandatory-for-contact-lenses-and-spectacle-frames\/#Voluntary_implementation_before_the_deadline\" >Voluntary implementation before the deadline<\/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\/when-is-the-master-udi-di-mandatory-for-contact-lenses-and-spectacle-frames\/#Use_of_Master_UDI-DI_in_vigilance_and_PMS\" >Use of Master UDI-DI in vigilance and PMS<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/cmcmedicaldevices.com\/es\/when-is-the-master-udi-di-mandatory-for-contact-lenses-and-spectacle-frames\/#Key_deadlines\" >Key deadlines<\/a><\/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\/when-is-the-master-udi-di-mandatory-for-contact-lenses-and-spectacle-frames\/#Need_help\" >Need help?<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Master_UDI-DI_requirements_under_the_MDR\"><\/span>Master UDI-DI requirements under the MDR<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The <b>Medical Device Coordination Group (MDCG) <\/b>published <b>MDCG 2025-7 <\/b>to clarify the timelines for implementing the <b>Master UDI-DI for optical devices<\/b> such as <b>contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles<\/b>. All these products are considered class I medical devices under the MDR and must comply with specific deadlines.<\/p>\n<p>Read the full document here:<br \/>\n<u><b><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2025-7-position-paper-timelines-implementation-master-udi-di-contact-lenses-and-spectacle-2025-07-10_en\" target=\"_blank\" rel=\"noopener noreferrer\">MDCG 2025-7 \u2013 Timelines of the implementation of Master UDI-DI<\/a><\/b><\/u><\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"UDI_labelling_requirements\"><\/span>UDI labelling requirements<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>According to Article 123(3)(f) of the MDR<\/b>, the <b>UDI labelling requirements<\/b> apply as follows:<\/p>\n<ul>\n<li><b>From 26 May 2023 for class IIa and IIb devices<\/b><\/li>\n<li><b>From 26 May 2025 for class I devices<\/b>, including spectacle frames, lenses, and reading glasses<\/li>\n<\/ul>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"EUDAMED_registration_module\"><\/span>EUDAMED registration module<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>According to <b>Regulation (EU) 2024\/1860<\/b> and the latest <b>EUDAMED timeline<\/b>, the UDI\/device registration module will become mandatory from the first quarter of 2026. <b>This is expected to happen six months after the European Commission publishes the notice confirming the module\u2019s full functionality in the Official Journal of the European Union<\/b>.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Master_UDI-DI_for_contact_lenses\"><\/span>Master UDI-DI for contact lenses<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Based on <b>Commission Delegated Regulation (EU) 2023\/2197<\/b>, the Master UDI-DI becomes mandatory <b>for contact lenses from 9 November 2026<\/b>. <b>Products placed on the market before this date are exempt from the obligation to include the Master UDI-DI on the label<\/b>.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Master_UDI-DI_for_spectacle_frames_lenses_and_reading_glasses\"><\/span>Master UDI-DI for spectacle frames, lenses, and reading glasses<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The Delegated Regulation of 12 June 2025 establishes that the Master UDI-DI must be implemented <b>for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles by September 2028<\/b>.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Voluntary_implementation_before_the_deadline\"><\/span>Voluntary implementation before the deadline<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>Manufacturers can choose to implement the Master UDI-DI before the mandatory deadline<\/b>. In such cases, the identifier must appear on the label and be registered in EUDAMED. Voluntary implementation is encouraged to streamline processes and prepare for upcoming regulatory obligations.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Use_of_Master_UDI-DI_in_vigilance_and_PMS\"><\/span>Use of Master UDI-DI in vigilance and PMS<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>When the vigilance and post-market surveillance module of EUDAMED becomes mandatory<\/b> (expected Q3 2026), <b>the assigned Master UDI-DI must be used in incident reporting, even if the full implementation deadline has not yet passed<\/b>. This requirement applies to both contact lenses and spectacle devices.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Key_deadlines\"><\/span>Key deadlines<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>UDI labelling<\/strong><br \/>\nClass IIa and IIb devices: <b>from 26 May 2023<\/b><br \/>\nClass I devices (including spectacle frames, lenses, and reading glasses): <b>from 26 May 2025;<\/b><\/p>\n<p><strong>EUDAMED device registration<\/strong><br \/>\nExpected from <b>Q1 2026<\/b>, <b>six months after publication of functionality notice in the Official Journal of the European Union;<\/b><\/p>\n<p><strong>Master UDI-DI for contact lenses<\/strong><br \/>\nMandatory from <b>9 November 2026<\/b><br \/>\n<b><br \/>\nNot required for products placed on the market before this date<\/b>;<\/p>\n<p><strong>Master UDI-DI for spectacle frames, lenses, and reading glasses<\/strong><br \/>\nMandatory <b>from September 2028.<\/b><\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Need_help\"><\/span>Need help?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>If you are a manufacturer and need support, we are here to help.<br \/>\n<b style=\"background-color: rgba(0, 0, 0, 0);\">Contact us to ensure your devices are compliant with the latest EU regulatory timelines.<\/b><\/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:20px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Get in touch with us today<\/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=\"1640\" height=\"924\" alt=\"Master UDI-DI for optical devices\" title=\"Master UDI-DI for optical devices\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Master-UDI-DI-for-optical-devices.jpg\" class=\"img-responsive wp-image-3886\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Master-UDI-DI-for-optical-devices-200x113.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Master-UDI-DI-for-optical-devices-400x225.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Master-UDI-DI-for-optical-devices-600x338.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Master-UDI-DI-for-optical-devices-800x451.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Master-UDI-DI-for-optical-devices-1200x676.jpg 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Master-UDI-DI-for-optical-devices.jpg 1640w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div>\n\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-center kksr-valign-bottom\"\n    data-payload='{&quot;align&quot;:&quot;center&quot;,&quot;id&quot;:&quot;3890&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;bottom&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;6&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;5&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;Rate this&quot;,&quot;legend&quot;:&quot;5\\\/5 - (6 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;When is the Master UDI-DI mandatory for contact lenses and spectacle frames?&quot;,&quot;width&quot;:&quot;142.5&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 142.5px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            5\/5 - (6 votos)    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3890","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","post_format-post-format-gallery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Master UDI-DI deadlines for contact lenses and spectacle frames<\/title>\n<meta name=\"description\" content=\"Learn when the Master UDI-DI becomes mandatory for contact lenses and spectacle frames under MDR. 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