{"id":68100,"date":"2025-06-23T12:07:58","date_gmt":"2025-06-23T10:07:58","guid":{"rendered":"https:\/\/gs1.se\/uncategorized\/new-labeling-requirement-for-contact-lenses-from-2025\/"},"modified":"2025-06-23T14:16:47","modified_gmt":"2025-06-23T12:16:47","slug":"new-labeling-requirement-for-contact-lenses-from-2025","status":"publish","type":"post","link":"https:\/\/gs1.se\/en\/news\/new-labeling-requirement-for-contact-lenses-from-2025\/","title":{"rendered":"New labeling requirement for contact lenses from 2025"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1820\" height=\"1024\" src=\"https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2025\/06\/udi-kontaktlinser-16-9-1820x1024.jpg\" alt=\"\" class=\"wp-image-68083\" srcset=\"https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2025\/06\/udi-kontaktlinser-16-9-1820x1024.jpg 1820w, https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2025\/06\/udi-kontaktlinser-16-9-300x169.jpg 300w, https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2025\/06\/udi-kontaktlinser-16-9-768x432.jpg 768w, https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2025\/06\/udi-kontaktlinser-16-9-1536x864.jpg 1536w, https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2025\/06\/udi-kontaktlinser-16-9-2048x1152.jpg 2048w, https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2025\/06\/udi-kontaktlinser-16-9-640x360.jpg 640w, https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2025\/06\/udi-kontaktlinser-16-9-1024x576.jpg 1024w, https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2025\/06\/udi-kontaktlinser-16-9-1280x720.jpg 1280w\" sizes=\"auto, (max-width: 1820px) 100vw, 1820px\" \/><\/figure>\n\n\n\n<p><strong>Medical devices with a high degree of customization, such as contact lenses, are now subject to a new EU regulation aimed at simplifying and streamlining product identification within the framework of the Medical Device Regulation (MDR). The regulation introduces a new type of product identifier, the Master UDI-DI, which must be applied to contact lenses starting from November 9, 2025.<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-is-a-master-udi-di-and-why-is-it-needed\">What is a Master UDI-DI and why is it needed?<\/h2>\n\n\n\n<p>Contact lenses are available in a wide range of variants and configurations, with many parameters that vary in value. Assigning a unique UDI-DI to each configuration, in line with standard requirements, would result in an unreasonably high number of registrations\u2014potentially complicating traceability rather than enhancing it.<\/p>\n\n\n\n<p>To address this, the Master UDI-DI is being introduced\u2014an identifier that sits between the Basic UDI-DI and individual UDI-DIs. It is used during registration in EUDAMED and is combined with the UDI-PI to generate each product\u2019s complete UDI. This allows for a more manageable registration process without compromising traceability or patient safety.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-applies-today-and-what-lies-ahead\">What applies today and what lies ahead?<\/h2>\n\n\n\n<p>Currently, contact lenses are included, with a provisional implementation date of 9 November 2025 (subject to revision). At the same time, extensive work is underway within the EU to develop guidance and regulations to also include spectacle frames, prescription lenses, and ready-made reading glasses. This work is expected to be completed within approximately one year.<\/p>\n\n\n\n<p>Products within these categories that fall under the MDR will not be able to be registered in EUDAMED without an assigned Master UDI-DI.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-does-this-mean-for-you-as-a-manufacturer\">What does this mean for you as a manufacturer?<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>If you use AIDC scanning in your process, ensure that your system can read the new information, including the Master UDI-DI.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Contact your software provider to ensure that your system is updated and compatible.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Please note that during a transition period, products with and without a Master UDI-DI will coexist on the market. Therefore, your system needs to be able to handle both variants.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-changes-can-be-expected-on-the-labels\">What changes can be expected on the labels?<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"63\" data-end=\"119\">Do you already use AIDC (e.g., GS1 DataMatrix)?<\/strong><br>Then the Master UDI-DI will be added to the existing code.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"182\" data-end=\"206\">Do you not use AIDC?<\/strong><br>Then you need to add a GS1 DataMatrix containing all UDI information, including the Master UDI-DI.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The labeling must also include human-readable information (HRI).<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-two-new-application-identifiers\">Two new application identifiers<\/h2>\n\n\n\n<p>GS1 has introduced two new application identifiers as part of the Master UDI-DI requirement, which are as follows:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"63\" data-end=\"96\">AI (8014) <\/strong>for standard lenses<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><p data-start=\"63\" data-end=\"157\"><strong data-start=\"99\" data-end=\"157\">AI (03) <\/strong>for made-to-order lenses (MtO \u2013 Made to Order)<\/p><\/li>\n<\/ul>\n\n\n\n<p>This means that although the information in the 2D code is essentially the same, the new Master UDI-DI will be encoded within it.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-example-of-labeling-with-master-udi-di\">Example of labeling with Master UDI-DI<\/h3>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p>The label includes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"63\" data-end=\"102\" data-is-last-node=\"\">GTIN (01): <\/strong>Global Trade Item Number<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"63\" data-end=\"107\">Manufacture and expiry dates <\/strong>(11) &amp; (17)<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"110\" data-end=\"141\">Batch or serial number <\/strong>(10)<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"144\" data-end=\"203\" data-is-last-node=\"\">Master UDI-DI <\/strong>(8014): Identifies the contact lens group<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"598\" height=\"375\" src=\"https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2025\/06\/image.jpg\" alt=\"\" class=\"wp-image-68079\" srcset=\"https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2025\/06\/image.jpg 598w, https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2025\/06\/image-300x188.jpg 300w\" sizes=\"auto, (max-width: 598px) 100vw, 598px\" \/><\/figure>\n<\/div>\n<\/div>\n\n\n<section class=\"section-facts p-3 mb-5 mt-4 gs1-background-color-ui-1 ml-n3 mr-n3\">\n\n  <div class=\"row\">\n    <div class=\"col mb-3\">\n      <h3>Read more<\/h3>\n      <p><ul>\n<li><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX%3A32017R0745\" target=\"_blank\" rel=\"noopener\">EU-f\u00f6rordning 2017\/745 om medicintekniska produkter<\/a><\/li>\n<li><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32023R2197\">Delegerad f\u00f6rordning (EU) 2023\/2197 om UDI f\u00f6r kontaktlinser<\/a><\/li>\n<li><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf\" target=\"_blank\" rel=\"noopener\">MDCG 2024-14: V\u00e4gledning f\u00f6r implementering av MUDI f\u00f6r kontaktlinser<\/a><\/li>\n<\/ul>\n<\/p>\n          <\/div>\n\n<\/section>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h2 class=\"wp-block-heading\" id=\"h-contact\">Contact<\/h2>\n\n\n\n<p>For more information and advice, you are welcome to contact Olivia by filling out the form below.<\/p>\n\n\n<p>[contact-form-7 id=&#8221;a63b18d&#8221; title=&#8221;Submit Health Care (EN)&#8221;]<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"515\" height=\"515\" src=\"https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2024\/01\/olivia-karringer-square.png\" alt=\"\" class=\"wp-image-52387\" srcset=\"https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2024\/01\/olivia-karringer-square.png 515w, https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2024\/01\/olivia-karringer-square-300x300.png 300w, https:\/\/gs1.se\/wp-content\/uploads\/sites\/2\/2024\/01\/olivia-karringer-square-150x150.png 150w\" sizes=\"auto, (max-width: 515px) 100vw, 515px\" \/><figcaption class=\"wp-element-caption\">Olivia Karringer, Client Manager, GS1 Sweden<\/figcaption><\/figure>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>As of November 9, 2025, a Master UDI-DI will be required for contact lenses under a new EU regulation aimed at simplifying identification within the MDR framework.<\/p>\n","protected":false},"author":84,"featured_media":68084,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"33447,17658,58302,54128,33082,56070","_relevanssi_noindex_reason":"","footnotes":""},"categories":[113],"tags":[72],"class_list":["post-68100","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>New labeling requirement for contact lenses from 2025 &#187; 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