{"id":17759,"date":"2024-08-06T09:52:36","date_gmt":"2024-08-06T07:52:36","guid":{"rendered":"https:\/\/eudamed.com\/?p=17759"},"modified":"2026-07-07T18:57:53","modified_gmt":"2026-07-07T16:57:53","slug":"eudamed-and-the-master-udi","status":"publish","type":"post","link":"https:\/\/eudamed.com\/index.php\/2024\/08\/06\/eudamed-and-the-master-udi\/","title":{"rendered":"EUDAMED and the Master UDI"},"content":{"rendered":"\r\n<h1 class=\"reader-article-header__title wp-block-heading\" dir=\"ltr\"><span data-scaffold-immersive-reader-title=\"\">EUDAMED and the Master UDI<\/span><\/h1>\r\n\r\n\r\n\r\n<p class=\"article-editor-content__paragraph article-editor-content__has-focus wp-block-paragraph\">The European Commission and the EUDAMED team have released a new version of EUDAMED to Production. This includes a significant change: the implementation of the Master UDI.<\/p>\r\n<p class=\"article-editor-content__paragraph\">This has a significant impact on the level of data required by the Lens and Spectacle manufacturers. This is the rule as published in the <a class=\"article-editor-content__link article-editor-content__link\" href=\"https:\/\/webgate.ec.europa.eu\/eudamed-play-help\/en\/files\/UDI%20Devices%20-%20business%20rules.pdf\" rel=\"noopener noreferrer\" target=\"_blank\">business rules document<\/a>.<\/p>\r\n<div class=\"article-editor-content__horizontal-rule-container\" contenteditable=\"false\"><hr class=\"article-editor-content__horizontal-rule\" \/>\r\n<div class=\"article-editor-content__horizontal-rule-delete-button-container\">\u00a0<\/div>\r\n<\/div>\r\n<p class=\"article-editor-content__paragraph\"><em>BR-UDID-731: Master UDI-DI<\/em><\/p>\r\n<p class=\"article-editor-content__paragraph\">Master UDI-DI is an identifier of a group of highly individualised products\/devices presenting specific similarities with respect to defined clinically relevant parameters. It is applicable with REGULATION (EU) 2017\/745 on medical devices only.<\/p>\r\n<p class=\"article-editor-content__paragraph\">The following special device types require the registration of Master UDI-DI:<\/p>\r\n<ul>\r\n<li>Standard soft contact lenses<\/li>\r\n<li>Standard Rigid Gas Permeable (RGP) contact lenses<\/li>\r\n<li>Made to order soft contact lenses<\/li>\r\n<li>Made to order Rigid Gas Permeable (RGP) contact lenses<\/li>\r\n<\/ul>\r\n<p>&nbsp;<\/p>\r\n<ul>\r\n<li class=\"article-editor-content__paragraph\">A Master UDI-DI is an alphanumeric code. The system will ensure:<br \/>There are no duplicates of a Master UDI-DI code.<\/li>\r\n<\/ul>\r\n<p>&nbsp;<\/p>\r\n<ul>\r\n<li class=\"article-editor-content__paragraph\">At the registration of a Master UDI-DI for the GS1 issuing entity, the system will also:<br \/>Validate the format of the Master UDI-DI code when registering Master UDI-DI for the following special device types:\r\n<ul>\r\n<li>Standard soft contact lenses<\/li>\r\n<li>Standard Rigid Gas Permeable (RGP) contact lenses<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<ul>\r\n<li class=\"article-editor-content__paragraph\">for the following special device types the format of the UDI-DI for the GS1 issung entity will be applied\r\n<ul>\r\n<li class=\"article-editor-content__paragraph\">Made to order soft contact lenses<\/li>\r\n<li class=\"article-editor-content__paragraph\">Made to order Rigid Gas Permeable (RGP) contact lenses<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<div class=\"article-editor-content__horizontal-rule-container\" contenteditable=\"false\"><hr class=\"article-editor-content__horizontal-rule\" \/>\r\n<div class=\"article-editor-content__horizontal-rule-delete-button-container\">\u00a0<\/div>\r\n<\/div>\r\n<p class=\"article-editor-content__paragraph\"><strong>Note: Selecting any of these special device types requires the registration of a Master UDI-DI as per rule BR-UDID-731: Master UDI-DI<\/strong><\/p>\r\n<p class=\"article-editor-content__paragraph\">A comment I received from the European Commission:<\/p>\r\n<p class=\"article-editor-content__paragraph\">When the Issuing Entity is GS1:<\/p>\r\n<ul class=\"article-editor-content__bullet-list\">\r\n<li class=\"article-editor-content__list-item\">\r\n<p class=\"article-editor-content__paragraph\">The MASTER UDI-DI has the same format as the GMN code &#8211; <a class=\"article-editor-content__link article-editor-content__link\" href=\"https:\/\/www.gs1belu.org\/en\/global-model-number-gmn\" rel=\"noopener noreferrer\" target=\"_blank\">https:\/\/www.gs1belu.org\/en\/global-model-number-gmn<\/a><\/p>\r\n<\/li>\r\n<li class=\"article-editor-content__list-item\">\r\n<p class=\"article-editor-content__paragraph\">The UDI DI is the GTIN code.<\/p>\r\n<\/li>\r\n<\/ul>\r\n<div class=\"article-editor-content__horizontal-rule-container\" contenteditable=\"false\"><hr class=\"article-editor-content__horizontal-rule\" \/>\r\n<div class=\"article-editor-content__horizontal-rule-delete-button-container\">\u00a0<\/div>\r\n<\/div>\r\n<p class=\"article-editor-content__paragraph\">This new addition has quite an impact on the data EUDAMED requires. So what does it mean for you?<\/p>\r\n<h3 class=\"article-editor-content__heading\">Data Requirements Changes for Master UDI<\/h3>\r\n<p class=\"article-editor-content__paragraph\"><strong>Note<\/strong>: Orthopedic is no longer an available option.<\/p>\r\n<p class=\"article-editor-content__paragraph\">By default, in EUDAMED, DIs will be considered as Master UDIs if any of the above \u201cSpecial Device Type\u201d options are selected. As a result, the requirements\/abilities for adding other information differ from those for adding a normal UDI DI.<\/p>\r\n<p class=\"article-editor-content__paragraph\">It is also possible to add a secondary Master UDI from another issuing entity using the normal Secondary UDI fields; these will be validated as Master UDIs. Again, this is automatically done based on the selection of the specific \u2018Special Device Type\u2019 options.<\/p>\r\n<p class=\"article-editor-content__paragraph\">Under the new business rule <em>BR-UDID-729<\/em> the following data is not required for Master UDIs<\/p>\r\n<p class=\"article-editor-content__paragraph\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Unit of Use<\/p>\r\n<p class=\"article-editor-content__paragraph\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 DI Direct Marking UDI-DI<\/p>\r\n<p class=\"article-editor-content__paragraph\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 List of CMR Substances associated to Device<\/p>\r\n<p class=\"article-editor-content__paragraph\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 List of Endocrine Substances associated to Device<\/p>\r\n<p class=\"article-editor-content__paragraph\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Related Device (Legacy- Regulation) New Device<\/p>\r\n<p class=\"article-editor-content__paragraph\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 List of Medicinal product substances associated to the Device<\/p>\r\n<p class=\"article-editor-content__paragraph\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Tissues and cells &#8211; presence of human tissues or cells, or their derivates<\/p>\r\n<p class=\"article-editor-content__paragraph\">\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Tissues and cells &#8211; presence of animal tissues or cells, or their derivates<\/p>\r\n<p class=\"article-editor-content__paragraph\">For the \u2018Intended purpose other than medical (Annex XVI)\u2019 field only a Yes or No is allowed with none of the available Annex XVI options allowed, again this is only for Master UDIs.<\/p>\r\n<p class=\"article-editor-content__paragraph\">Container Packages will also reflect the Master UDIs<\/p>\r\n<p class=\"article-editor-content__paragraph\">We do not expect these changes to be reflected in EUDAMED Production until much later in the year, either towards the end of Q4 2024 or early in Q1 2025.<\/p>\r\n<p class=\"article-editor-content__paragraph\">For any affected companies, we can assist with your EUDAMED requirements. Although this requirement will not be released into Production for several months, you should make your required preparations now.<\/p>\r\n<p class=\"article-editor-content__paragraph\">If you are looking for expert EUDAMED advice, machine-to-machine (M2M), premium support, training, and data submission management, please do come and talk to us at <a class=\"article-editor-content__link article-editor-content__link\" href=\"mailto:support@eudamed.com\" rel=\"noopener noreferrer\">support@eudamed.com<\/a><\/p>\r\n<p class=\"article-editor-content__paragraph\"><strong>About EirMed<\/strong><\/p>\r\n<p class=\"article-editor-content__paragraph\">EirMed Ltd is a leading provider of EUDAMED and regulatory submission solutions for the medical technology (MedTech) industry worldwide. With a commitment to excellence and innovation, EirMed offers comprehensive solutions tailored to meet clients&#8217; evolving needs in regulatory data submissions and data management.<\/p>\r\n\r\n\r\n\r\n<p class=\"wp-block-paragraph\">If you are looking for expert EUDAMED advice, premium support, training, and data submission management, please do come and talk to us.<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>EUDAMED and the Master UDI The European Commission and the EUDAMED team have released a new version of EUDAMED to Production. This includes a significant change: the implementation of the&#8230;<\/p>\n","protected":false},"author":2,"featured_media":11749,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","_exactmetrics_skip_tracking":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[6,4],"tags":[],"class_list":["post-17759","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mdreudamed","category-news"],"jetpack_sharing_enabled":true,"jetpack_featured_media_url":"https:\/\/eudamed.com\/wp-content\/uploads\/2018\/05\/WBJEE-Medical-scaled.jpg","_links":{"self":[{"href":"https:\/\/eudamed.com\/index.php\/wp-json\/wp\/v2\/posts\/17759","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eudamed.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eudamed.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eudamed.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/eudamed.com\/index.php\/wp-json\/wp\/v2\/comments?post=17759"}],"version-history":[{"count":7,"href":"https:\/\/eudamed.com\/index.php\/wp-json\/wp\/v2\/posts\/17759\/revisions"}],"predecessor-version":[{"id":18460,"href":"https:\/\/eudamed.com\/index.php\/wp-json\/wp\/v2\/posts\/17759\/revisions\/18460"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eudamed.com\/index.php\/wp-json\/wp\/v2\/media\/11749"}],"wp:attachment":[{"href":"https:\/\/eudamed.com\/index.php\/wp-json\/wp\/v2\/media?parent=17759"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eudamed.com\/index.php\/wp-json\/wp\/v2\/categories?post=17759"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eudamed.com\/index.php\/wp-json\/wp\/v2\/tags?post=17759"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}