{"id":7585,"date":"2026-06-09T11:59:49","date_gmt":"2026-06-09T06:29:49","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=7585"},"modified":"2026-06-09T11:59:49","modified_gmt":"2026-06-09T06:29:49","slug":"regulation-eu-2024-1860","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/eg-en\/regulation-eu-2024-1860\/","title":{"rendered":"Regulation (EU) 2024\/1860: Extension of IVDR Transitional Period and New Provisions"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7585\" class=\"elementor elementor-7585\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-104b0f01 e-flex e-con-boxed e-con e-parent\" data-id=\"104b0f01\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-48ab55c3 elementor-widget elementor-widget-heading\" data-id=\"48ab55c3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Regulation (EU) 2024\/1860: Extension of IVDR Transitional Period and New Provisions<\/h1>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-42b96d5 e-flex e-con-boxed e-con e-parent\" data-id=\"42b96d5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-8520250 e-con-full e-flex e-con e-child\" data-id=\"8520250\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2b8453ae elementor-widget elementor-widget-heading\" data-id=\"2b8453ae\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Extension of IVDR Transitional Period\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-35f1a1ac elementor-widget elementor-widget-text-editor\" data-id=\"35f1a1ac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The Regulation (EU) 2024\/1860, which amends Regulations (EU) 2017\/745 (MDR) and (EU) 2017\/746 (IVDR), has been published in the Official Journal of the European Union (OJEU). This legislation aims to ensure the continuity of supply for in vitro diagnostic devices on the European market. It also revises provisions related to the mandatory use of EUDAMED for devices that comply with one of the regulations or were placed on the market under previous directives (legacy devices). Additionally, the regulation introduces a requirement for manufacturers and all economic operators in the supply chain to declare any supply disruptions or risks of such disruptions.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-52aa95d e-con-full e-flex e-con e-child\" data-id=\"52aa95d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5d17fe12 e-con-full e-flex e-con e-child\" data-id=\"5d17fe12\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2d08c042 elementor-widget elementor-widget-heading\" data-id=\"2d08c042\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Looking for Consultant?<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3dc4b228 elementor-widget elementor-widget-wpforms\" data-id=\"3dc4b228\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/eg-en\/wp-json\/wp\/v2\/posts\/7585\" data-token=\"08115cc9be9ad5588cc368d2a2d40326\" data-token-time=\"1781371287\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div><div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Paragraph Name Text<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; 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This extension aims to prevent shortages of critical medical devices.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Phased Rollout of Eudamed: The European database on medical devices (Eudamed) will be introduced in stages as its electronic systems become operational. This phased approach will minimize disruption for manufacturers and notified bodies.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a2dbf14 elementor-widget elementor-widget-heading\" data-id=\"a2dbf14\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Do You Need Help Understanding This New Amendment and Its Details or Support in Implementing the New Regulation?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fdb2a70 elementor-widget elementor-widget-text-editor\" data-id=\"fdb2a70\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Operon Strategist is poised to assist manufacturers in navigating the latest regulatory updates introduced by the European Commission. With the extension of compliance deadlines for legacy in vitro diagnostic (IVD) devices and the phased rollout of EUDAMED, our expert consultants will provide comprehensive support to ensure your products meet the updated <a href=\"https:\/\/operonstrategist.com\/in-vitro-diagnostic-medical-device-regulation\/\">IVDR requirements<\/a>. We will help you apply with a designated notified body, secure necessary agreements well in advance, and manage the timely submission of compliance documentation. Additionally, our team will guide you through the new notification requirements to prevent device shortages, ensuring smooth communication with relevant authorities. By partnering with Operon Strategist, manufacturers can confidently adapt to the new regulatory landscape, maintaining compliance and market access in the European Union.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Extension of IVDR Transitional Period The Regulation (EU) 2024\/1860, which amends Regulations (EU) 2017\/745 (MDR) and (EU) 2017\/746 (IVDR), has been published in the Official Journal of the European Union (OJEU). This legislation aims to ensure the continuity of supply for in vitro diagnostic devices on the European market. It also revises provisions related to [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10890,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-7585","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/7585","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/comments?post=7585"}],"version-history":[{"count":1,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/7585\/revisions"}],"predecessor-version":[{"id":10891,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/7585\/revisions\/10891"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media\/10890"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media?parent=7585"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/categories?post=7585"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/tags?post=7585"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}