{"id":34396,"date":"2025-07-10T12:22:21","date_gmt":"2025-07-10T10:22:21","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34396"},"modified":"2025-07-10T14:56:07","modified_gmt":"2025-07-10T12:56:07","slug":"what-are-the-mandatory-deadlines-for-adopting-the-udi-system","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/what-are-the-mandatory-deadlines-for-adopting-the-udi-system\/","title":{"rendered":"What are the mandatory deadlines for adopting the UDI system?"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container 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:1144px;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:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>The timing of UDI implementation varies depending on the risk class of the device, as set out in the MDR (EU) Regulations 2017\/745 for medical devices and IVDR (EU) 2017\/746 for in vitro diagnostic medical devices.<\/p>\n<p>The application dates are as follows:<\/p>\n<p><strong>For Medical Devices (MDR (EU) 2017\/745):<\/strong><\/p>\n<ul>\n<li><strong>Applying UDI on device labels:<\/strong>\n<ul>\n<li>For <strong>Class III and implantable devices<\/strong>, the deadline was May 26, 2021.<\/li>\n<li>For <strong>Class IIa and Class IIb<\/strong>: the deadline was May 26, 2023.<\/li>\n<li>For <strong>Class I<\/strong>: the deadline is May 26, 2025.<\/li>\n<\/ul>\n<\/li>\n<li><strong>Direct Marking of Medical Devices<\/strong>\n<ul>\n<li>For <strong>Class III and implantable devices<\/strong>, the deadline was May 26, 2023.<\/li>\n<li>For <strong>Class IIa and Class IIb<\/strong>: the deadline is May 26, 2025.<\/li>\n<li>For <strong>Class I<\/strong>: the deadline is May 26, 2027.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>For In Vitro Diagnostic Medical Devices (IVDR (EU) 2017\/746):<\/strong><\/p>\n<ul>\n<li><strong>Applying UDI on device labels:<\/strong>\n<ul>\n<li>For <strong>Class D IVD<\/strong>: the deadline was May 26, 2021.<\/li>\n<li>For <strong>Class C and Class B<\/strong>: the deadline was May 26, 2023.<\/li>\n<li>For <strong>Class A<\/strong>: the deadline is May 26, 2025.<\/li>\n<\/ul>\n<\/li>\n<li><strong>Direct Marking of Medical Devices<\/strong>\n<ul>\n<li>For <strong>Class D IVD<\/strong>: the deadline was May 26, 2023.<\/li>\n<li>For <strong>Class C and Class B<\/strong>: the deadline is May 26, 2025.<\/li>\n<li>For <strong>Class A<\/strong>: the deadline is May 26, 2027.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><div class=\"fusion-image-element \" style=\"--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=\" 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\/><\/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":[],"class_list":["post-34396","post","type-post","status-publish","format-standard","hentry","category-faq-en","category-udi-in-medical-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>What are the mandatory deadlines for adopting the UDI system? - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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