{"id":8942,"date":"2023-10-23T12:36:52","date_gmt":"2023-10-23T17:36:52","guid":{"rendered":"https:\/\/casusconsulting.com\/?p=8942"},"modified":"2024-05-07T11:13:19","modified_gmt":"2024-05-07T16:13:19","slug":"eu-commission-updated-eudamed-timeline_deadline-2027","status":"publish","type":"post","link":"https:\/\/casusconsulting.com\/eu-commission-updated-eudamed-timeline_deadline-2027\/","title":{"rendered":"Commission Publishes New EUDAMED Timeline: Delayed Until at Least 2027"},"content":{"rendered":"\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"ub_call_to_action wp-block-ub-call-to-action-block\"  id=\"ub_call_to_action_0bccc64b-ffcc-4968-a3a2-881594aa738b\">\n                <div class=\"ub_call_to_action_headline\">\n                    <h3 class=\"ub_call_to_action_headline_text\">Please read our April 25, 2024 post for the most current information.<\/h3><\/div>\n                <div class=\"ub_call_to_action_content\">\n                    <p class=\"ub_cta_content_text\">EUDAMED will now likely become mandatory sometime toward the end of 2025. <\/p><\/div>\n                <div class=\"ub_call_to_action_button\">\n                    <a href=\"https:\/\/casusconsulting.com\/eu-parliament-votes-to-extend-ivdr-legacy-device-transition-period-and-rollout-eudamed\/\" target=\"_self\" rel=\"noopener noreferrer\"\n                        class=\"ub_cta_button\">\n                        <p class=\"ub_cta_button_text\">Click Here<\/p><\/a><\/div><\/div>\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-4 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:5%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:85%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-table-of-contents-block ub_table-of-contents\" data-showtext=\"show\" data-hidetext=\"hide\" data-scrolltype=\"auto\" id=\"ub_table-of-contents-4d46720b-3022-4666-9f09-ba140a396c98\" data-initiallyhideonmobile=\"false\"\n                    data-initiallyshow=\"true\"><div class=\"ub_table-of-contents-header-container\"><div class=\"ub_table-of-contents-header\">\n                    <div class=\"ub_table-of-contents-title\">Table of Contents<\/div><\/div><\/div><div class=\"ub_table-of-contents-extra-container\"><div class=\"ub_table-of-contents-container ub_table-of-contents-1-column \"><ul><li><a href=https:\/\/casusconsulting.com\/eu-commission-updated-eudamed-timeline_deadline-2027\/#0-the-update->The Update<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-commission-updated-eudamed-timeline_deadline-2027\/#1-until-eudamed-is-mandatory->Until EUDAMED is Mandatory<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-commission-updated-eudamed-timeline_deadline-2027\/#2-additional-resources->Additional Resources<\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n<div style=\"height:5px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>As Casus originally&nbsp;<strong><a href=\"https:\/\/casusconsulting.com\/eudamed-update-mid-2025-implementation-date\/\" target=\"_blank\" rel=\"noreferrer noopener\">reported on 28 August 2023<\/a><\/strong>, the EU Commission had removed the EUDAMED timeline from the website. Further, based on the most recent EUDAMED Working Group meeting minutes, EUDAMED appeared to be further postponed.<\/p>\n\n\n\n<p>The EU Commission has now officially confirmed the delay by posting a new draft EUDAMED timeline to its website, available:\u00a0<strong><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-10\/md_eudamed_roadmap_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">HERE<\/a><\/strong><\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-95f799cb2062145561a033473a90a763\" id=\"0-the-update-\"><strong>The Update<\/strong><\/h2>\n\n\n\n<p>Based on the updated timeline, it does not appear that EUDAMED will be deemed fully functional until at least Q2 2027, followed by the transition period. &nbsp;<\/p>\n\n\n\n<p>The new draft timeline indicates that:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li>All six modules will not be ready to undergo an independent audit until Q4 2026\n<ul>\n<li>The hold-up is for the Clinical Investigation &amp; Performance Studies module, which is not expected to be \u201caudit-ready\u201d until Q3 2026<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>The audit is expected to be successfully concluded by Q2 2027<\/li>\n\n\n\n<li>After the successful audit, use of EUDAMED will be published in the Official Journal of the EU (OJEU)<\/li>\n\n\n\n<li>Then, the transition periods commence:\n<ul>\n<li>Six months for the Actor, Vigilance, Market Surveillance, and Clinical Investigation &amp; Performance Studies, i.e., mandatory in Q4 2027<\/li>\n\n\n\n<li>24 months for the UDI\/Device Registration and Notified Body &amp; Certificates, i.e., mandatory in Q2 2029<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"582\" src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/10\/EUDAMED-delay_timeline-1024x582.png\" alt=\"\" class=\"wp-image-8943\" srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/10\/EUDAMED-delay_timeline-1024x582.png 1024w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/10\/EUDAMED-delay_timeline-300x171.png 300w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/10\/EUDAMED-delay_timeline-768x437.png 768w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/10\/EUDAMED-delay_timeline-257x146.png 257w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/10\/EUDAMED-delay_timeline-50x28.png 50w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/10\/EUDAMED-delay_timeline-132x75.png 132w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/10\/EUDAMED-delay_timeline-960x546.png 960w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/10\/EUDAMED-delay_timeline.png 1175w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-bfeb5bbaecd79a1dff557457ffcccfe0\" id=\"1-until-eudamed-is-mandatory-\"><strong>Until EUDAMED is Mandatory<\/strong><\/h2>\n\n\n\n<p>ntil the above steps occur, EUDAMED is voluntary. Instead, the registration requirements outlined in the old Directives (MDD\/AIMDD\/IVDD) continue to prevail.<\/p>\n\n\n\n<p>That said, please note that some Competent Authorities are already making some parts of EUDAMED compulsory. For example, the Irish Competent Authority&nbsp;<strong><a href=\"https:\/\/www.hpra.ie\/homepage\/medical-devices\/registration\" target=\"_blank\" rel=\"noreferrer noopener\">requests<\/a><\/strong>&nbsp;that Class I medical device and IVD notifications be conducted in EUDAMED instead of directly to them. So even though EUDAMED is voluntary per the MDR\/IVDR, the best practice is to verify requirements with your individual Competent Authority.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-23e9394216c11023b46799f6e03ea546\" id=\"2-additional-resources-\"><strong>Additional Resources<\/strong><\/h2>\n\n\n\n<p>Related to general registration and timing:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-2 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li><strong><a href=\"https:\/\/casusconsulting.com\/tools-and-templates\/important-dates-europe-uk-and-switzerland\/\" target=\"_blank\" rel=\"noreferrer noopener\">Timeline of Important Dates in Europe, the UK and Switzerland<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/casusconsulting.com\/eu-registration-requirements\/\" target=\"_blank\" rel=\"noreferrer noopener\">EU Registration Requirements<\/a><\/strong><\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p>Related to voluntarily registering in EUDAMED:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-3 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li><strong><a href=\"https:\/\/casusconsulting.com\/eudamed_basics\/\" target=\"_blank\" rel=\"noreferrer noopener\">EUDAMED Basics<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/casusconsulting.com\/registering-your-company-in-eudamed\/\" target=\"_blank\" rel=\"noreferrer noopener\">How to Complete the Actor Registration<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/casusconsulting.com\/registering-devices-in-eudamed\/\" target=\"_blank\" rel=\"noreferrer noopener\">How to Complete the UDI\/Device Registration<\/a><\/strong><\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The EU Commission published a new draft EUDAMED timeline on its website. It is now delayed until at least Q2 2027. Read for more details.<\/p>\n","protected":false},"author":4,"featured_media":8944,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ub_ctt_via":"","footnotes":""},"categories":[6],"tags":[],"cp_meta_data":{"_edit_lock":["1715098400:4"],"_edit_last":["4"],"_tve_js_modules_gutenberg":["a:0:{}"],"_thumbnail_id":["8944"],"_wp_page_template":["default"],"hefo_before":["0"],"hefo_after":["0"],"mfn-post-hide-content":["0"],"mfn-post-layout":["no-sidebar"],"mfn-post-sidebar":["0"],"mfn-post-sidebar2":["0"],"mfn-post-template":["intro"],"mfn-post-slider":["0"],"mfn-post-slider-layer":["0"],"mfn-post-full-width":["0"],"mfn-post-hide-title":["0"],"mfn-post-remove-padding":["0"],"mfn-post-intro":["a:1:{s:9:\"post-meta\";s:1:\"1\";}"],"mfn-post-hide-image":["0"],"jbp-single-post":["a:3:{s:8:\"override\";s:1:\"0\";s:22:\"single_template_custom\";s:1:\"0\";s:5:\"nonce\";s:10:\"f00fc8b222\";}"],"_wpb_vc_js_status":["true"],"cmplz_hide_cookiebanner":[""],"mfn-meta-seo-title":["Oct 2023: EUDAMED Postponed Until at Least 2027"],"mfn-meta-seo-description":["The EU Commission published a new draft EUDAMED timeline on its website. It is now delayed until at least Q2 2027. Read for more details."],"_genesis_title":["Oct 2023: EUDAMED Postponed Until at Least 2027"],"_genesis_description":["The EU Commission published a new draft EUDAMED timeline on its website. It is now delayed until at least 2027. Read for more details."],"_wp_old_slug":["eu-commission-updated-eudamed-timeline_deadline-2026"],"_cmplz_scanned_post":["1"]},"featured_image_src":"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/10\/shutterstock_2250922991-scaled.jpg","author_info":{"display_name":"annmarie","author_link":"https:\/\/casusconsulting.com\/author\/annmarie\/"},"_links":{"self":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/8942"}],"collection":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/comments?post=8942"}],"version-history":[{"count":20,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/8942\/revisions"}],"predecessor-version":[{"id":12137,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/8942\/revisions\/12137"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media\/8944"}],"wp:attachment":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media?parent=8942"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/categories?post=8942"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/tags?post=8942"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}