{"id":1938,"date":"2019-11-29T11:51:00","date_gmt":"2019-11-29T11:51:00","guid":{"rendered":"http:\/\/localhost\/vistaar.ai\/?p=1938"},"modified":"2025-12-03T09:05:30","modified_gmt":"2025-12-03T09:05:30","slug":"an-overview-of-european-unique-device-identification-system","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/an-overview-of-european-unique-device-identification-system\/","title":{"rendered":"An Overview of European Unique Device Identification System"},"content":{"rendered":"\n<p class=\"has-black-color has-text-color has-link-color wp-elements-4eff81f69f448ff8d2931aa3059244d0 wp-block-paragraph\">The EU Medical Device Regulations (EU 2017\/745 and EU 2017\/746) introduce a comprehensive Unique Device Identification (UDI) system designed to uniquely and consistently identify medical devices throughout the global supply chain. The core elements of the system are defined in Articles 27\u201331, Chapter III, and Annex VI of the regulations, with additional guidance expected from EU authorities.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The UDI system applies to all medical devices except custom-made devices and those intended solely for performance studies or investigations. It is aligned with internationally recognized standards and harmonized definitions used by major regulatory partners.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Basic UDI-DI<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The regulations introduce the \u201cBasic UDI-DI,\u201d a numeric or alphanumeric code used to group devices that share the same intended purpose, risk class, and essential design and manufacturing characteristics.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Key points include:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>It acts as the primary access key to device information in EUDAMED.\u00a0<\/li>\n\n\n\n<li>It must be referenced in certificates, declarations of conformity, technical documentation, and summary of safety and clinical performance documents.\u00a0<\/li>\n\n\n\n<li>It links devices within the same family but does not appear on labels, packaging, or any trade items.\u00a0<\/li>\n\n\n\n<li>Each Basic UDI-DI must uniquely identify the entire device group it represents.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">What Is the Unique Device Identification (UDI)?<\/h3>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-f9250aee46f932b28e1a1305bac77b3a wp-block-paragraph\">The UDI system, described in Part C of Annex VI of the EU MDR, consists of a globally standardized series of characters enabling precise identification of a specific device. The UDI on the device comprises two elements:<\/p>\n\n\n\n<ul class=\"wp-block-list has-black-color has-text-color has-link-color wp-elements-40c02bb57306665fa132e74fc282d87c\">\n<li><strong>Device Identifier (UDI-DI):<\/strong>&nbsp;The UDI-DI is a unique numeric or alphanumeric code that identifies a specific medical device within the product \u2018family\u2019. As per Part B of Annex VI of the EU MDR, a new UDI-DI required in case of a change of name\/trade name, version\/model, use, sterilization requirements, change of quantity in packaging, new indications\/warnings. Higher UDI-DIs are linked to the \u201cBasic UDI-DI\u201d; for example, single pack and six pack would have a different UDI-DI but the same \u201cBasic UDI-DI\u201d, same devices but in different language packaging would each have their own UDI-DI, etc.<\/li>\n\n\n\n<li><strong>Production Identifier (UDI-PI):<\/strong>&nbsp;The UDI-PI that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI of the EU MDR. The UDI-PI contains a variable code related to production data of the device, such as lot\/batch number, expiry date, manufacturing date, etc.<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table\"><table style=\"color:#000;\"><tbody style=\"color:#000;\"><tr><td><strong>UDI-DI = Device Identifier<\/strong><\/td><td><strong>UDI-PI = Production Identifier<\/strong><\/td><\/tr><tr><td>Unique numeric alphanumeric code specifies to a model of device i.e. GTIN.<\/td><td>Numeric alphanumeric code that identifies the unit of device production (=batch identifier) and, if applicable, the packaged devices.<\/td><\/tr><tr><td>Used as the &#8216;access key&#8217; to information stored in a UDI database<\/td><td>Different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date. Serial number mandatory for active implantable devices.<\/td><\/tr><tr><td>Must be referenced in Declaration of Conformity<\/td><td>&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-5edb12b09433fae420fd5a218b8b2650\">UDI Carrier<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">According to the EU MDR, the UDI carrier must be placed on the device label or packaging and all higher levels of packaging (excluding shipping containers). This requirement does not imply aggregation, as parent\u2013child packaging relationships are not mandatory.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Reusable devices must have the UDI carrier directly on the device, and implant device UDIs must be visible before implantation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Acceptable machine-readable formats include:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Linear barcode (concatenated or non-concatenated)\u00a0<\/li>\n\n\n\n<li>Data matrix\u00a0<\/li>\n\n\n\n<li>RFID (with an additional printed barcode required)\u00a0<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Deadlines for EUDAMED UDI Registration<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Mandatory UDI data submission deadlines:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Medical devices: 26 November 2021\u00a0<\/li>\n\n\n\n<li>In vitro diagnostic devices: 26 November 2023\u00a0<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">These apply only if EUDAMED is fully functional by the date of application; otherwise, deadlines shift to 24 months after functionality becomes available.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Voluntary early registration:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Medical devices: from 26 May 2020\u00a0<\/li>\n\n\n\n<li>IVDs: from 26 May 2022\u00a0<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-fd51a18b0ed9ed64d39c5ec753bf37ca wp-block-paragraph\">Once EUDAMED becomes fully functional, device registration (per Article 29 of MDR and Article 26 of IVDR) is required before reporting any serious incidents involving those devices in EUDAMED.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>EU\u2019s UDI DI is a unique identification code, clubbing the medical devices with a similar purpose, which helps in recognizing them in the global platform.<\/p>\n","protected":false},"author":1,"featured_media":1877,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[645],"tags":[],"class_list":["post-1938","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - 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