{"id":3132,"date":"2024-11-28T11:33:49","date_gmt":"2024-11-28T11:33:49","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3132"},"modified":"2025-07-29T11:21:57","modified_gmt":"2025-07-29T11:21:57","slug":"eudamed-roll-out-everything-you-need-to-know-for-medical-device-compliance","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/eudamed-roll-out-everything-you-need-to-know-for-medical-device-compliance\/","title":{"rendered":"Eudamed modules: Key steps for medical device compliance"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background 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:1248px;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:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/eudamed-roll-out-everything-you-need-to-know-for-medical-device-compliance\/#What_is_Eudamed_and_why_is_it_important\" >What is Eudamed and why is it important?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/eudamed-roll-out-everything-you-need-to-know-for-medical-device-compliance\/#The_key_Eudamed_modules_and_their_impact_on_manufacturers\" >The key Eudamed modules and their impact on manufacturers<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/eudamed-roll-out-everything-you-need-to-know-for-medical-device-compliance\/#1_Actor_registration_Actor_module\" >1. Actor registration (Actor module)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/eudamed-roll-out-everything-you-need-to-know-for-medical-device-compliance\/#2_UDIDevice_registration_UDIDEV_Module\" >2. UDI\/Device registration (UDI\/DEV Module)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/eudamed-roll-out-everything-you-need-to-know-for-medical-device-compliance\/#3_Notified_Bodies_and_certificates_NBCRF_module\" >3. Notified Bodies and certificates (NB\/CRF module)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/cmcmedicaldevices.com\/es\/eudamed-roll-out-everything-you-need-to-know-for-medical-device-compliance\/#4_Post-Market_Surveillance_and_vigilance_PMSVGL_module\" >4. Post-Market Surveillance and vigilance (PMS\/VGL module)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/cmcmedicaldevices.com\/es\/eudamed-roll-out-everything-you-need-to-know-for-medical-device-compliance\/#5_Clinical_investigations_and_performance_studies_CIPS_module\" >5. Clinical investigations and performance studies (CI\/PS module)<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/cmcmedicaldevices.com\/es\/eudamed-roll-out-everything-you-need-to-know-for-medical-device-compliance\/#Eudamed_roll-out_timeline\" >Eudamed roll-out timeline<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/cmcmedicaldevices.com\/es\/eudamed-roll-out-everything-you-need-to-know-for-medical-device-compliance\/#Why_early_registration_is_critical\" >Why early registration is critical<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/cmcmedicaldevices.com\/es\/eudamed-roll-out-everything-you-need-to-know-for-medical-device-compliance\/#Stay_ahead_of_Eudameds_implementation\" >Stay ahead of Eudamed\u2019s implementation<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"What_is_Eudamed_and_why_is_it_important\"><\/span>What is Eudamed and why is it important?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>Eudamed<\/strong> is the European database for medical devices, designed to improve <strong>transparency, traceability, and regulatory oversight<\/strong> across the EU market. By centralizing data related to <strong>medical device registration, post-market surveillance, and clinical investigations<\/strong>, <strong>Eudamed<\/strong> enhances patient safety and strengthens regulatory compliance.<\/p>\n<p>The introduction of <strong>Eudamed modules<\/strong> under <strong>Regulation (EU) 2024\/1860<\/strong> follows a <strong>phased approach<\/strong>, ensuring each module becomes mandatory only after its full review and confirmation of functionality, which is expected <strong>six months<\/strong> after official publication in the <strong>Official Journal of the European Union (OJEU)<\/strong>. This structure is defined within the official <b>Eudamed implementation plan<\/b>.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"The_key_Eudamed_modules_and_their_impact_on_manufacturers\"><\/span>The key Eudamed modules and their impact on manufacturers<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The <strong>Eudamed roll-out<\/strong> consists of six essential <strong>modules<\/strong>, each playing a critical role in regulatory compliance for medical devices. Manufacturers, importers, and authorized representatives must understand and integrate these modules into their operations to comply with <strong>MDR and IVDR<\/strong> regulations.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"1_Actor_registration_Actor_module\"><\/span>1. Actor registration (Actor module)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The <strong>Actor module<\/strong> requires all economic operators\u2014including manufacturers, importers, and authorized representatives\u2014to <strong>register in Eudamed<\/strong>. This is a prerequisite for accessing other <strong>Eudamed modules<\/strong>, such as <strong>UDI\/device registration and vigilance reporting<\/strong>.<\/p>\n<p>Manufacturers must obtain a <strong>Single Registration Number (SRN)<\/strong> through the <strong>Actor module<\/strong> before placing devices on the EU market. <strong>Early registration<\/strong> is highly recommended to avoid delays when this module becomes mandatory.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"2_UDIDevice_registration_UDIDEV_Module\"><\/span>2. UDI\/Device registration (UDI\/DEV Module)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The <strong>UDI\/Device module<\/strong> ensures that each medical device is properly <strong>identified and tracked<\/strong> throughout its lifecycle. The <strong>Unique Device Identifier (UDI)<\/strong> is essential for medical device traceability, enhancing safety and simplifying <strong>post-market surveillance<\/strong>.<\/p>\n<p>Manufacturers must ensure their devices are registered with a <strong>valid UDI<\/strong> before the <strong>UDI\/DEV module<\/strong> becomes mandatory, as non-compliance could lead to regulatory penalties and market access issues.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"3_Notified_Bodies_and_certificates_NBCRF_module\"><\/span>3. Notified Bodies and certificates (NB\/CRF module)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The <strong>Notified Bodies and Certificates module<\/strong> allows for the <strong>registration and monitoring<\/strong> of certificates issued by <strong>notified bodies<\/strong>. This module is crucial for ensuring ongoing compliance with <strong>EU medical device regulations<\/strong>.<\/p>\n<p>Manufacturers should ensure that their certifications are properly registered in this module, particularly when updates or modifications are made.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"4_Post-Market_Surveillance_and_vigilance_PMSVGL_module\"><\/span>4. Post-Market Surveillance and vigilance (PMS\/VGL module)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Post-market surveillance (PMS) and vigilance reporting are <strong>mandatory requirements<\/strong> under <strong>MDR and IVDR<\/strong>. The <strong>PMS\/VGL module<\/strong> facilitates the <strong>submission of adverse event reports, serious incidents, trend analyses, and corrective actions<\/strong>.<\/p>\n<p>To comply with EU regulations, manufacturers must integrate their <strong>post-market surveillance systems<\/strong> with Eudamed to enable efficient safety reporting.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"5_Clinical_investigations_and_performance_studies_CIPS_module\"><\/span>5. Clinical investigations and performance studies (CI\/PS module)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The <strong>CI\/PS module<\/strong> supports the <strong>submission and monitoring of clinical investigations<\/strong> and <strong>performance studies<\/strong>. Manufacturers conducting <strong>clinical trials<\/strong> within the EU must register their studies before they can proceed.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Eudamed_roll-out_timeline\"><\/span>Eudamed roll-out timeline<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Each <strong>Eudamed module<\/strong> will become mandatory <strong>six months after<\/strong> its confirmation of functionality is published in the <strong>Official Journal of the European Union (OJEU)<\/strong>. This timeline gives manufacturers a crucial window to complete their <strong>Actor registration<\/strong> and <strong>UDI\/device registrations<\/strong> before they become mandatory.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Why_early_registration_is_critical\"><\/span>Why early registration is critical<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>Early registration<\/strong> is one of the key strategies to ensure <strong>smooth compliance<\/strong> with <strong>Eudamed modules<\/strong>. Voluntary registration is already open for some modules, including the <strong>Actor module<\/strong> and <strong>UDI\/Device module<\/strong>.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Stay_ahead_of_Eudameds_implementation\"><\/span>Stay ahead of Eudamed\u2019s implementation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The phased roll-out of <strong>Eudamed modules<\/strong> under <strong>Regulation (EU) 2024\/1860<\/strong> marks a pivotal development in the <strong>medical device industry<\/strong> within the EU. Understanding the <strong>mandatory registration process<\/strong>, key Eudamed modules, and implementation timeline is crucial for manufacturers to maintain <strong>compliance and secure market access<\/strong>.<\/p>\n<p>For expert guidance on <strong>Eudamed modules<\/strong> and regulatory compliance, <strong>contact us today<\/strong>. We are here to support you in achieving full compliance with EU medical device regulations.<\/p>\n<div><\/div>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_margin-top:10px;--button_margin-bottom:10px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us <\/span><\/a><\/div><div class=\"fusion-image-element \" 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