{"id":380,"date":"2026-08-11T10:09:56","date_gmt":"2026-08-11T08:09:56","guid":{"rendered":"https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/"},"modified":"2026-08-27T11:37:12","modified_gmt":"2026-08-27T09:37:12","slug":"udi-unique-device-identification-explained","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/udi-unique-device-identification-explained\/","title":{"rendered":"UDI: Unique Device Identification Explained"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Every device in Europe now needs a unique, machine-readable identity. The UDI system underpins traceability, recalls and the entire EUDAMED database &mdash; and getting the structure right is a common stumbling block.<\/strong><\/p>\n<p>The Unique Device Identification system has two parts on the product: the <strong>UDI-DI<\/strong> (Device Identifier), the static code identifying the issuing entity, manufacturer and product reference; and the <strong>UDI-PI<\/strong> (Production Identifier), the dynamic part carrying lot or batch number, serial number, and manufacturing or expiry date.<\/p>\n<h2>The Basic UDI-DI<\/h2>\n<p>Sitting above these is the <strong>Basic UDI-DI<\/strong> &mdash; an EU-specific grouping identifier that links devices sharing the same intended purpose, risk class and essential design characteristics. It never appears on the label; instead it is the key reference used across the declaration of conformity, certificates, clinical evaluation, PSUR and EUDAMED. Manufacturers frequently misunderstand its role.<\/p>\n<h2>Issuing entities<\/h2>\n<p>UDIs are assigned through one of four Commission-designated issuing entities &mdash; <strong>GS1, HIBCC, ICCBBA and IFA<\/strong> &mdash; whose designations were renewed in 2024 to run until 2029. Most manufacturers work with GS1.<\/p>\n<h2>Where the UDI goes<\/h2>\n<p>The UDI carrier &mdash; a barcode plus a human-readable form &mdash; must appear on the device label and on all higher levels of packaging. Reusable devices that require reprocessing also need <strong>direct marking<\/strong> on the device itself.<\/p>\n<h2>The timeline<\/h2>\n<p>UDI carrier placement applied from 26 May 2021 for Class III and implantables, 26 May 2023 for Class IIa and IIb, and 26 May 2025 for Class I, with direct-marking obligations following two years after each date. Registration of UDI data in EUDAMED becomes obligatory with the platform&#8217;s mandatory date in May 2026.<\/p>\n<h2>How PQRA helps<\/h2>\n<p>PQRA advises on UDI structure, Basic UDI-DI grouping, labelling and registration in EUDAMED.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Get your UDI right &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Every device in Europe now needs a unique, machine-readable identity. The UDI system underpins traceability, recalls and the entire EUDAMED database &mdash; and getting the structure right is a common stumbling block. The Unique Device Identification system has two parts on the product: the UDI-DI (Device Identifier), the static code identifying the issuing entity, manufacturer [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":393,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[9,14],"tags":[],"class_list":["post-380","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-base","category-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>UDI: Unique Device Identification Explained - PQRA<\/title>\n<meta name=\"description\" content=\"Every device in Europe now needs a unique, machine-readable identity. The UDI system underpins traceability, recalls and the entire EUDAMED database\u2026\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.pqra.gr\/el\/udi-unique-device-identification-explained\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UDI: Unique Device Identification Explained - PQRA\" \/>\n<meta property=\"og:description\" content=\"Every device in Europe now needs a unique, machine-readable identity. The UDI system underpins traceability, recalls and the entire EUDAMED database\u2026\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.pqra.gr\/el\/udi-unique-device-identification-explained\/\" \/>\n<meta property=\"og:site_name\" content=\"PQRA\" \/>\n<meta property=\"article:published_time\" content=\"2026-08-11T08:09:56+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-27T09:37:12+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/08\/md-udi.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"630\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u03a3\u03c5\u03bd\u03c4\u03ac\u03c7\u03b8\u03b7\u03ba\u03b5 \u03b1\u03c0\u03cc\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u0395\u03ba\u03c4\u03b9\u03bc\u03ce\u03bc\u03b5\u03bd\u03bf\u03c2 \u03c7\u03c1\u03cc\u03bd\u03bf\u03c2 \u03b1\u03bd\u03ac\u03b3\u03bd\u03c9\u03c3\u03b7\u03c2\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 \u03bb\u03b5\u03c0\u03c4\u03cc\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#\\\/schema\\\/person\\\/31e1a03125e7281efaddd7278681af2c\"},\"headline\":\"UDI: Unique Device Identification Explained\",\"datePublished\":\"2026-08-11T08:09:56+00:00\",\"dateModified\":\"2026-08-27T09:37:12+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/\"},\"wordCount\":284,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.pqra.gr\\\/wp-content\\\/uploads\\\/2026\\\/08\\\/md-udi.png\",\"articleSection\":[\"Knowledge Base\",\"Medical Devices\"],\"inLanguage\":\"el\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/\",\"url\":\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/\",\"name\":\"UDI: Unique Device Identification Explained - PQRA\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.pqra.gr\\\/wp-content\\\/uploads\\\/2026\\\/08\\\/md-udi.png\",\"datePublished\":\"2026-08-11T08:09:56+00:00\",\"dateModified\":\"2026-08-27T09:37:12+00:00\",\"description\":\"Every device in Europe now needs a unique, machine-readable identity. The UDI system underpins traceability, recalls and the entire EUDAMED database\u2026\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/#breadcrumb\"},\"inLanguage\":\"el\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"el\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.pqra.gr\\\/wp-content\\\/uploads\\\/2026\\\/08\\\/md-udi.png\",\"contentUrl\":\"https:\\\/\\\/www.pqra.gr\\\/wp-content\\\/uploads\\\/2026\\\/08\\\/md-udi.png\",\"width\":1200,\"height\":630},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/udi-unique-device-identification-explained\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.pqra.gr\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"UDI: Unique Device Identification Explained\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#website\",\"url\":\"https:\\\/\\\/www.pqra.gr\\\/\",\"name\":\"PQRA\",\"description\":\"Your trusted partner in Pharma\",\"publisher\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.pqra.gr\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"el\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#organization\",\"name\":\"PQRA\",\"url\":\"https:\\\/\\\/www.pqra.gr\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"el\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/www.pqra.gr\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/pqra-logo-white.png\",\"contentUrl\":\"https:\\\/\\\/www.pqra.gr\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/pqra-logo-white.png\",\"width\":594,\"height\":362,\"caption\":\"PQRA\"},\"image\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#\\\/schema\\\/person\\\/31e1a03125e7281efaddd7278681af2c\",\"name\":\"admin\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"el\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/656b750ec6bc02db9de84dc3080e82be722c7777ef23ff04d6e8e7a0ac541a45?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/656b750ec6bc02db9de84dc3080e82be722c7777ef23ff04d6e8e7a0ac541a45?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/656b750ec6bc02db9de84dc3080e82be722c7777ef23ff04d6e8e7a0ac541a45?s=96&d=mm&r=g\",\"caption\":\"admin\"},\"sameAs\":[\"https:\\\/\\\/www.pqra.gr\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"UDI: Unique Device Identification Explained - PQRA","description":"Every device in Europe now needs a unique, machine-readable identity. The UDI system underpins traceability, recalls and the entire EUDAMED database\u2026","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.pqra.gr\/el\/udi-unique-device-identification-explained\/","og_locale":"el_GR","og_type":"article","og_title":"UDI: Unique Device Identification Explained - PQRA","og_description":"Every device in Europe now needs a unique, machine-readable identity. The UDI system underpins traceability, recalls and the entire EUDAMED database\u2026","og_url":"https:\/\/www.pqra.gr\/el\/udi-unique-device-identification-explained\/","og_site_name":"PQRA","article_published_time":"2026-08-11T08:09:56+00:00","article_modified_time":"2026-08-27T09:37:12+00:00","og_image":[{"width":1200,"height":630,"url":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/08\/md-udi.png","type":"image\/png"}],"author":"admin","twitter_card":"summary_large_image","twitter_misc":{"\u03a3\u03c5\u03bd\u03c4\u03ac\u03c7\u03b8\u03b7\u03ba\u03b5 \u03b1\u03c0\u03cc":"admin","\u0395\u03ba\u03c4\u03b9\u03bc\u03ce\u03bc\u03b5\u03bd\u03bf\u03c2 \u03c7\u03c1\u03cc\u03bd\u03bf\u03c2 \u03b1\u03bd\u03ac\u03b3\u03bd\u03c9\u03c3\u03b7\u03c2":"1 \u03bb\u03b5\u03c0\u03c4\u03cc"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/#article","isPartOf":{"@id":"https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/"},"author":{"name":"admin","@id":"https:\/\/www.pqra.gr\/#\/schema\/person\/31e1a03125e7281efaddd7278681af2c"},"headline":"UDI: Unique Device Identification Explained","datePublished":"2026-08-11T08:09:56+00:00","dateModified":"2026-08-27T09:37:12+00:00","mainEntityOfPage":{"@id":"https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/"},"wordCount":284,"commentCount":0,"publisher":{"@id":"https:\/\/www.pqra.gr\/#organization"},"image":{"@id":"https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/#primaryimage"},"thumbnailUrl":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/08\/md-udi.png","articleSection":["Knowledge Base","Medical Devices"],"inLanguage":"el","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/","url":"https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/","name":"UDI: Unique Device Identification Explained - PQRA","isPartOf":{"@id":"https:\/\/www.pqra.gr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/#primaryimage"},"image":{"@id":"https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/#primaryimage"},"thumbnailUrl":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/08\/md-udi.png","datePublished":"2026-08-11T08:09:56+00:00","dateModified":"2026-08-27T09:37:12+00:00","description":"Every device in Europe now needs a unique, machine-readable identity. The UDI system underpins traceability, recalls and the entire EUDAMED database\u2026","breadcrumb":{"@id":"https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/#breadcrumb"},"inLanguage":"el","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/"]}]},{"@type":"ImageObject","inLanguage":"el","@id":"https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/#primaryimage","url":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/08\/md-udi.png","contentUrl":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/08\/md-udi.png","width":1200,"height":630},{"@type":"BreadcrumbList","@id":"https:\/\/www.pqra.gr\/udi-unique-device-identification-explained\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.pqra.gr\/"},{"@type":"ListItem","position":2,"name":"UDI: Unique Device Identification Explained"}]},{"@type":"WebSite","@id":"https:\/\/www.pqra.gr\/#website","url":"https:\/\/www.pqra.gr\/","name":"PQRA","description":"Your trusted partner in Pharma","publisher":{"@id":"https:\/\/www.pqra.gr\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.pqra.gr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"el"},{"@type":"Organization","@id":"https:\/\/www.pqra.gr\/#organization","name":"PQRA","url":"https:\/\/www.pqra.gr\/","logo":{"@type":"ImageObject","inLanguage":"el","@id":"https:\/\/www.pqra.gr\/#\/schema\/logo\/image\/","url":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/07\/pqra-logo-white.png","contentUrl":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/07\/pqra-logo-white.png","width":594,"height":362,"caption":"PQRA"},"image":{"@id":"https:\/\/www.pqra.gr\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.pqra.gr\/#\/schema\/person\/31e1a03125e7281efaddd7278681af2c","name":"admin","image":{"@type":"ImageObject","inLanguage":"el","@id":"https:\/\/secure.gravatar.com\/avatar\/656b750ec6bc02db9de84dc3080e82be722c7777ef23ff04d6e8e7a0ac541a45?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/656b750ec6bc02db9de84dc3080e82be722c7777ef23ff04d6e8e7a0ac541a45?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/656b750ec6bc02db9de84dc3080e82be722c7777ef23ff04d6e8e7a0ac541a45?s=96&d=mm&r=g","caption":"admin"},"sameAs":["https:\/\/www.pqra.gr"]}]}},"_links":{"self":[{"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/posts\/380","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/comments?post=380"}],"version-history":[{"count":1,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/posts\/380\/revisions"}],"predecessor-version":[{"id":394,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/posts\/380\/revisions\/394"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/media\/393"}],"wp:attachment":[{"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/media?parent=380"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/categories?post=380"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/tags?post=380"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}