{"id":3561,"date":"2025-05-07T12:29:40","date_gmt":"2025-05-07T12:29:40","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3561"},"modified":"2025-05-07T12:29:40","modified_gmt":"2025-05-07T12:29:40","slug":"dnv-joins-the-ivdr-framework-as-a-notified-body-a-new-option-for-ivd-manufacturers","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/dnv-joins-the-ivdr-framework-as-a-notified-body-a-new-option-for-ivd-manufacturers\/","title":{"rendered":"DNV joins the IVDR framework as a Notified Body: A new option for IVD manufacturers"},"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\/dnv-joins-the-ivdr-framework-as-a-notified-body-a-new-option-for-ivd-manufacturers\/#DNV_designated_as_IVDR_Notified_Body\" >DNV designated as IVDR Notified Body<\/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\/dnv-joins-the-ivdr-framework-as-a-notified-body-a-new-option-for-ivd-manufacturers\/#Why_DNVs_designation_matters_for_the_IVDR_framework\" >Why DNV\u2019s designation matters for the IVDR framework<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/dnv-joins-the-ivdr-framework-as-a-notified-body-a-new-option-for-ivd-manufacturers\/#Choosing_the_right_Notified_Body_for_your_IVD_strategy\" >Choosing the right Notified Body for your IVD strategy<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/dnv-joins-the-ivdr-framework-as-a-notified-body-a-new-option-for-ivd-manufacturers\/#A_positive_development_for_IVD_compliance_in_the_EU\" >A positive development for IVD compliance in the EU<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"DNV_designated_as_IVDR_Notified_Body\"><\/span>DNV designated as IVDR Notified Body<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\nThe list of IVDR Notified Bodies continues to grow, and as of <strong>April 30, 2025<\/strong>, <strong>DNV Product Assurance<\/strong>, based in Norway, has officially joined the system. Added to the <strong>NANDO database<\/strong> under number <strong>NB 2460<\/strong>, DNV becomes the <strong>17th Notified Body designated under Regulation (EU) 2017\/746<\/strong> on in vitro diagnostic medical devices (IVDR).\n<\/p>\n<p>\nThis new designation comes at a strategic time for the IVD industry, as manufacturers face critical deadlines and a complex certification process. The inclusion of DNV increases the capacity for IVDR conformity assessments and offers manufacturers an additional route to <strong>CE marking for IVDs<\/strong>.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Why_DNVs_designation_matters_for_the_IVDR_framework\"><\/span>Why DNV\u2019s designation matters for the IVDR framework<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\nEach new Notified Body is more than a number, it\u2019s a new opportunity for manufacturers to plan their <strong>IVDR certification pathway<\/strong> more efficiently.\n<\/p>\n<p>\nDNV brings a strong international reputation in certification, risk management, and regulatory compliance. Its entry into the IVDR system provides access to a new, credible partner at a time when <strong>Notified Body availability remains limited<\/strong> and the pressure on timelines is growing.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Choosing_the_right_Notified_Body_for_your_IVD_strategy\"><\/span>Choosing the right Notified Body for your IVD strategy<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\nSelecting a Notified Body is no longer just a procedural step, it\u2019s a strategic decision. With different timelines, areas of expertise, and capacities, each NB offers distinct advantages. DNV may be the right fit for:\n<\/p>\n<ul>\n<li>Manufacturers still seeking their first IVDR certification<\/li>\n<li>Companies looking for faster timelines or available assessment slots<\/li>\n<li>Businesses valuing a globally recognized conformity assessment body<\/li>\n<\/ul>\n<p>\nIn short, DNV offers a fresh option for <strong>navigating IVDR compliance<\/strong> with greater flexibility and potentially fewer delays.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"A_positive_development_for_IVD_compliance_in_the_EU\"><\/span>A positive development for IVD compliance in the EU<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\nWith the <strong>2025 IVDR deadlines<\/strong> approaching\u2014especially for <strong>Class D devices and legacy IVDs<\/strong>\u2014every new Notified Body strengthens the European regulatory system and eases the burden on both manufacturers and regulators.\n<\/p>\n<p>\nDNV\u2019s designation signals that the system is growing, becoming more resilient, and opening more space for IVD manufacturers to operate strategically.<\/p>\n<p><strong>Need help selecting the right Notified Body or building your IVDR strategy?<br \/><\/strong><br \/>\nOur team supports IVD manufacturers in aligning regulatory steps with product and market goals, so you can reach CE certification smoothly, on time, and with full compliance.<\/p>\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:20px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us for more information<\/span><\/a><\/div><div class=\"fusion-image-element \" 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this<\/span>\n    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"footnotes":""},"categories":[],"tags":[],"class_list":["post-3561","post","type-post","status-publish","format-gallery","hentry","post_format-post-format-gallery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>DNV joins the IVDR framework as a Notified Body: A new option for IVD manufacturers | CMC Medical Devices<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cmcmedicaldevices.com\/es\/dnv-joins-the-ivdr-framework-as-a-notified-body-a-new-option-for-ivd-manufacturers\/\" \/>\n<meta property=\"og:locale\" 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