{"id":5750,"date":"2026-03-04T11:59:35","date_gmt":"2026-03-04T11:59:35","guid":{"rendered":"https:\/\/pharmanomos.ch\/traceability-of-medical-devices-what-is-udi-and-how-it-is-used-in-switzerland\/"},"modified":"2026-04-28T06:07:44","modified_gmt":"2026-04-28T06:07:44","slug":"traceability-of-medical-devices-what-is-udi-and-how-it-is-used-in-switzerland","status":"publish","type":"post","link":"https:\/\/pharmanomos.ch\/en\/traceability-of-medical-devices-what-is-udi-and-how-it-is-used-in-switzerland\/","title":{"rendered":"Traceability of Medical Devices: What is UDI and how it is used in Switzerland"},"content":{"rendered":"\n<p class=\"has-medium-font-size\"><strong>Medical device traceability<\/strong> is now one of the central elements of regulatory compliance in Switzerland. With the entry into force of the new Swiss regulations aligned with the European framework, the <strong>Unique Device Identification (UDI)<\/strong> system has become a mandatory tool to ensure unique identification, patient safety and post-marketing surveillance. <\/p>\n\n<p class=\"has-medium-font-size\">For manufacturing companies, manufacturers and importers active in the Swiss market, understanding and properly implementing<strong>UDI medical devices<\/strong> is not only a regulatory requirement, but a strategic factor in risk control and quality system robustness. In this context, the support of consultants specializing in regulatory and quality for the life sciences sector can make all the difference in the proper setup of the UDI project. <\/p>\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-large-font-size\">What is Unique Device Identification (UDI)<\/h2>\n\n<p class=\"has-medium-font-size\">The UDI is a unique identification system that allows each medical device to be distinguished by a standardized code that can be read in either human or machine readable format (barcode or DataMatrix).<\/p>\n\n<p class=\"has-medium-font-size\">The UDI system is regulated in Switzerland by the Swiss Agency for Therapeutic Products (Swissmedic) under the Medical Devices Ordinance (MDA), which implements the principles of Regulation (EU) 2017\/745 (MDR).<\/p>\n\n<p class=\"has-medium-font-size\">Official normative references:<\/p>\n\n<ul class=\"wp-block-list link-verde has-medium-font-size\">\n<li>ODmed text (RS 812.213): <a href=\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2020\/552\/it\">https:\/\/www.fedlex.admin.ch\/eli\/cc\/2020\/552\/it<\/a><\/li>\n\n\n\n<li>Swissmedic page on medical devices: <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/it\/home\/dispositivi-medici\/regolamentazione-dei-dispositivi-medici.html\">https:\/\/www.swissmedic.ch\/swissmedic\/it\/home\/dispositivi-medici\/regolamentazione-dei-dispositivi-medici.html<\/a><\/li>\n\n\n\n<li>Regulation (EU) 2017\/745 (MDR): <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/IT\/TXT\/?uri=CELEX%3A32017R0745\">https:\/\/eur-lex.europa.eu\/legal-content\/IT\/TXT\/?uri=CELEX%3A32017R0745<\/a><\/li>\n<\/ul>\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-large-font-size\">Structure of the UDI code<\/h2>\n\n<p class=\"has-medium-font-size\">UDI consists of two main elements:<\/p>\n\n<h3 class=\"wp-block-heading has-medium-font-size\">UDI-DI (Device Identifier)<\/h3>\n\n<p class=\"has-medium-font-size\">Static part identifying:<\/p>\n\n<ul class=\"wp-block-list has-medium-font-size\">\n<li>manufacturer<\/li>\n\n\n\n<li>device model<\/li>\n\n\n\n<li>specific version or configuration<\/li>\n<\/ul>\n\n<p class=\"has-medium-font-size\">The UDI-DI is also the key reference for registration in regulatory databases.<\/p>\n\n<h3 class=\"wp-block-heading has-medium-font-size\">UDI-PI (Production Identifier)<\/h3>\n\n<p class=\"has-medium-font-size\">Dynamic part that may include:<\/p>\n\n<ul class=\"wp-block-list has-medium-font-size\">\n<li>batch number<\/li>\n\n\n\n<li>serial number<\/li>\n\n\n\n<li>date of production<\/li>\n\n\n\n<li>expiration date<\/li>\n<\/ul>\n\n<p class=\"has-medium-font-size\">The combination of UDI-DI and UDI-PI enables complete traceability throughout the supply chain.<\/p>\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-large-font-size\">UDI and traceability medical devices CH<\/h2>\n\n<p class=\"has-medium-font-size\">In the Swiss context, <strong>medical device CH traceability<\/strong> becomes particularly relevant following full technical alignment with the European MDR and the need to ensure transparency and control even in the absence of the updated Mutual Recognition Agreement (MRA).<\/p>\n\n<p class=\"has-medium-font-size\">UDI enables:<\/p>\n\n<ul class=\"wp-block-list has-medium-font-size\">\n<li>Improving patient safety<\/li>\n\n\n\n<li>Facilitating safety recalls and corrective actions (FSCA)<\/li>\n\n\n\n<li>Strengthening post-market surveillance (PMS)<\/li>\n\n\n\n<li>Support regulatory audits and inspections<\/li>\n<\/ul>\n\n<p class=\"link-verde has-medium-font-size\">UDI data must be registered in the European EUDAMED database:<br\/><a href=\"https:\/\/ec.europa.eu\/tools\/eudamed\">https:\/\/ec.europa.eu\/tools\/eudamed<\/a><\/p>\n\n<p class=\"has-medium-font-size\">Although Switzerland does not operate an equivalent autonomous database, Swissmedic uses EUDAMED as a reference for regulatory cooperation.<\/p>\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-large-font-size\">Obligations for producers, manufacturers and importers<\/h2>\n\n<p class=\"has-medium-font-size\">According to ODmed, UDI is mandatory for most medical devices placed on the Swiss market.<\/p>\n\n<h3 class=\"wp-block-heading has-medium-font-size\">Manufacturer<\/h3>\n\n<ul class=\"wp-block-list has-medium-font-size\">\n<li>Assigns and maintains UDI<\/li>\n\n\n\n<li>Ensures consistency between label, technical documentation and registration in EUDAMED<\/li>\n\n\n\n<li>Integrates UDI into the quality management system (QMS)<\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading has-medium-font-size\">Importer<\/h3>\n\n<ul class=\"wp-block-list has-medium-font-size\">\n<li>Verify that the device reports the compliant UDI<\/li>\n\n\n\n<li>Check the manufacturer&#8217;s correct registration<\/li>\n\n\n\n<li>Keeps documentation for traceability<\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading has-medium-font-size\">Distributor<\/h3>\n\n<ul class=\"wp-block-list has-medium-font-size\">\n<li>Verify the presence of UDI<\/li>\n\n\n\n<li>Collaborates in the management of any recalls<\/li>\n<\/ul>\n\n<p class=\"has-medium-font-size\">For life sciences companies, this implies a structured integration of UDI into quality assurance and regulatory affairs processes.<\/p>\n\n<div class=\"wp-block-uagb-info-box uagb-block-3966eb25 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top wp-block-uagb-info-box--has-margin link-verde\"><div class=\"uagb-infobox-margin-wrapper\"><div class=\"uagb-ifb-content\"><div class=\"uagb-ifb-title-wrap\"><h3 class=\"uagb-ifb-title\">UDI and traceability: is your system really compliant?<\/h3><\/div><div class=\"uagb-ifb-separator\"><\/div><p class=\"uagb-ifb-desc\">Many critical issues related to UDI do not result from code assignment, but from management that is not integrated into the quality system, incomplete procedures, or misalignment between labeling, technical documentation, and EUDAMED.<br\/><br\/>A structured assessment allows you to identify any gaps with respect to ODmed and MDR, verify the correct assignment of UDI-DI, and ensure consistency between Regulatory, Quality, and Supply Chain.<br\/><br\/>Pharmanomos Sagl supports producers, manufacturers and importers in the life sciences sector in the compliant implementation of UDI medical devices in Switzerland, integrating regulatory and quality system requirements.<br\/><br\/><strong>Request a preliminary audit of your UDI system.<\/strong><\/p><div class=\"uagb-ifb-button-wrapper wp-block-button\"><a href=\"https:\/\/pharmanomos.ch\/en\/contact\/\" class=\"uagb-infobox-cta-link wp-block-button__link\" target=\"_blank\" rel=\"noopener noreferrer\" onclick=\"return true;\"><span class=\"uagb-inline-editing\">Verify your UDI compliance<\/span><\/a><\/div><\/div><\/div><\/div>\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-large-font-size\">How to implement UDI effectively<\/h2>\n\n<p class=\"has-medium-font-size\">The implementation of UDI in medical devices is not limited to the assignment of an identification code, but requires a structured organizational approach involving several business areas.<\/p>\n\n<p class=\"has-medium-font-size\">To ensure effective management that complies with regulatory requirements, there is a need to ensure consistency between device labeling, technical documentation, records in regulatory databases, and corporate information systems.<\/p>\n\n<p class=\"has-medium-font-size\">This process typically involves several business functions, including Regulatory Affairs, Quality Assurance, IT and Supply Chain, and must be integrated into the organization&#8217;s quality management system.<\/p>\n\n<p class=\"has-medium-font-size\">Proper implementation of UDI allows not only to meet regulatory obligations, but also to strengthen traceability systems, support post-market surveillance activities, and improve the management of recalls or safety corrective actions.<\/p>\n\n<p class=\"has-medium-font-size\">In this context, a structured view of traceability is a key element in ensuring regulatory compliance and transparency throughout the medical device lifecycle.<\/p>\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-large-font-size\">Frequent critical issues<\/h2>\n\n<p class=\"has-medium-font-size\">The main nonconformities found in audits include:<\/p>\n\n<ul class=\"wp-block-list has-medium-font-size\">\n<li>UDI-DI assigned inconsistently with product variants<\/li>\n\n\n\n<li>Failure to re-evaluate UDI when significant changes are made<\/li>\n\n\n\n<li>Misalignment between technical documentation and database<\/li>\n\n\n\n<li>Lack of integration into the quality system<\/li>\n<\/ul>\n\n<p class=\"has-medium-font-size\">A structured approach, guided by experienced regulatory and quality professionals for the pharmaceutical and medical device industries, enables the prevention of such critical issues and the transformation of regulatory obligation into a competitive advantage.<\/p>\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-large-font-size\">Conclusions<\/h2>\n\n<p class=\"has-medium-font-size\">The<strong>medical device UDI<\/strong> is now a pillar of regulatory compliance in Switzerland. It is not just a labeling requirement, but an integrated identification and traceability system that impacts quality, supply chain, and vigilance. <\/p>\n\n<p class=\"has-medium-font-size\">For manufacturers, manufacturers and importers active in the Swiss market, properly implementing <strong>medical devices CH traceability<\/strong> means ensuring safety, regulatory soundness and audit readiness.<\/p>\n\n<div class=\"wp-block-uagb-info-box uagb-block-a9db74d3 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top wp-block-uagb-info-box--has-margin link-verde\"><div class=\"uagb-infobox-margin-wrapper\"><div class=\"uagb-ifb-content\"><div class=\"uagb-ifb-title-wrap\"><h3 class=\"uagb-ifb-title\">Medical devices CH traceability: are you ready for an inspection?<\/h3><\/div><div class=\"uagb-ifb-separator\"><\/div><p class=\"uagb-ifb-desc\">UDI is not only a labeling requirement, but a central element of traceability and post-market surveillance. Errors in UDI management can surface during Swissmedic audits or inspections, with significant regulatory and reputational impacts. <br\/><br\/>A proactive approach makes it possible to strengthen compliance, reduce the risk of noncompliance, and structure a robust and sustainable quality system over time.<br\/><br\/>Pharmanomos Sagl &#8211; Experts in Regulatory and Quality for the Life Sciences Industry &#8211; offers specialized consulting for the pharmaceutical and medical device industry, supporting companies in complying with UDI and traceability requirements in Switzerland.<br\/><br\/><strong>Contact us for a customized regulatory assessment.<\/strong><\/p><div class=\"uagb-ifb-button-wrapper wp-block-button\"><a href=\"https:\/\/pharmanomos.ch\/en\/contact\/\" class=\"uagb-infobox-cta-link wp-block-button__link\" target=\"_blank\" rel=\"noopener noreferrer\" onclick=\"return true;\"><span class=\"uagb-inline-editing\">Talk to a UDI expert<\/span><\/a><\/div><\/div><\/div><\/div>\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical device traceability is now one of the central elements of regulatory compliance in Switzerland. With the entry into force of the new Swiss regulations aligned with the European framework, the Unique Device Identification (UDI) system has become a mandatory tool to ensure unique identification, patient safety and post-marketing surveillance. For manufacturing companies, manufacturers and [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5751,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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