{"id":3999,"date":"2025-07-31T11:03:59","date_gmt":"2025-07-31T11:03:59","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3999"},"modified":"2025-07-31T11:03:59","modified_gmt":"2025-07-31T11:03:59","slug":"a-new-vision-for-eu-governance-in-the-medical-device-sector-the-notified-bodies-perspective","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/a-new-vision-for-eu-governance-in-the-medical-device-sector-the-notified-bodies-perspective\/","title":{"rendered":"A new vision for EU governance in the medical device sector: the Notified Bodies\u2019 perspective"},"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\"><p><b>The European medical device regulatory framework is at a pivotal moment<\/b>. Fragmentation, inconsistent implementation, and complex administrative procedures are undermining the intended goals of safety, innovation, and timely market access. In response, <b>a collective of Notified Bodies<\/b>, represented by NBCG-Med and Team-NB, <b>has issued a proposal to reshape governance in the sector<\/b>.<\/p>\n<p>The document outlines a forward-looking model built on stronger coordination, centralized support, and sustainable infrastructure, while preserving the vital role of Notified Bodies in ensuring clinical, technical, and regulatory integrity.<\/p>\n<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\/a-new-vision-for-eu-governance-in-the-medical-device-sector-the-notified-bodies-perspective\/#The_proposal_a_central_Medical_Device_Coordination_Office_MDCO\" >The proposal: a central Medical Device Coordination Office (MDCO)<\/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\/a-new-vision-for-eu-governance-in-the-medical-device-sector-the-notified-bodies-perspective\/#Notified_Bodies_assessors_and_strategic_partners\" >Notified Bodies: assessors and strategic partners<\/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\/a-new-vision-for-eu-governance-in-the-medical-device-sector-the-notified-bodies-perspective\/#Special_Pathways_and_Early_Advice_structured_support_for_innovation\" >Special Pathways and Early Advice: structured support for innovation<\/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\/a-new-vision-for-eu-governance-in-the-medical-device-sector-the-notified-bodies-perspective\/#Toward_a_more_cohesive_and_evidence-based_system\" >Toward a more cohesive and evidence-based system<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"The_proposal_a_central_Medical_Device_Coordination_Office_MDCO\"><\/span>The proposal: a central Medical Device Coordination Office (MDCO)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>At the core of the proposed model is the creation of an EU-level authority: the <strong>Medical Device Coordination Office (MDCO)<\/strong>. This structure would not replace existing bodies but streamline and reinforce them. Its responsibilities would include:<\/p>\n<ul>\n<li>Coordinating designation, monitoring, and reassessment of Notified Bodies;<\/li>\n<li>Overseeing classification and qualification decisions;<\/li>\n<li>Developing technical and clinical guidance, including Common Specifications;<\/li>\n<li>Managing consultation procedures with expert panels, EU reference labs, and other authorities;<\/li>\n<li>Facilitating special pathways and early advice for high-priority or innovative devices;<\/li>\n<li>Maintaining a centralized repository of scientific and clinical evidence;<\/li>\n<li>Acting as the secretariat for MDCG and its working groups.<\/li>\n<\/ul>\n<p>The MDCO is envisioned as a single, coherent point of coordination\u2014improving consistency and reducing duplication across the EU regulatory landscape.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Notified_Bodies_assessors_and_strategic_partners\"><\/span>Notified Bodies: assessors and strategic partners<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>Notified Bodies are positioned not only as conformity assessment entities, but as essential contributors to the regulatory ecosystem<\/b>. With more than 6,200 professionals across the EU\u2014including over 3,700 technical experts and 900 clinicians\u2014their insight is deeply rooted in real-world practice.<\/p>\n<p>Their involvement in early dialogue, guidance development, and classification decisions is seen as crucial for bridging the gap between regulation and clinical and technological realities. The proposal also emphasizes expanding the strategic role of <strong>NBCG-Med<\/strong>, the formal coordination platform for Notified Bodies, to support harmonized implementation and contribute to high-level planning.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Special_Pathways_and_Early_Advice_structured_support_for_innovation\"><\/span>Special Pathways and Early Advice: structured support for innovation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Among the most notable elements of the proposal is the creation of two flexible regulatory mechanisms:<\/p>\n<ul>\n<li><strong>Special Pathways<\/strong>, designed for devices targeting unmet needs (e.g., paediatric, orphan, or breakthrough technologies), allowing for adapted pre-market requirements and reinforced post-market surveillance<\/li>\n<li><strong>Early Advice Pathway<\/strong>, enabling manufacturers to request formal scientific and clinical input at an early stage, with oversight from MDCO-coordinated expert groups<\/li>\n<\/ul>\n<p>Both processes would be governed by a dedicated working group made up of national competent authority experts, ensuring consistent decision-making across the EU.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Toward_a_more_cohesive_and_evidence-based_system\"><\/span>Toward a more cohesive and evidence-based system<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The final recommendation advocates the development of a centralized, MDCO-managed repository of clinical and scientific evidence. This would <b>facilitate proportionate assessments<\/b>, <b>support the work of expert panels<\/b>, and <b>ensure a shared foundation for regulatory decisions<\/b>.<\/p>\n<p>By leveraging the established expertise of Notified Bodies and enhancing central coordination, this governance model aims to deliver <b>a more responsive, transparent, and innovation-oriented EU medical device framework<\/b>, without compromising scientific rigour or patient safety.<\/p>\n<p><strong>Need guidance on navigating EU regulatory developments? Contact us for tailored support.<\/strong><\/p>\n<p><img decoding=\"async\" class=\"emoji\" role=\"img\" draggable=\"false\" src=\"https:\/\/s.w.org\/images\/core\/emoji\/16.0.1\/svg\/1f449.svg\" alt=\"\ud83d\udc49\"> <a href=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/NB-Perspective-on-Future-Governance-in-EU-medical-device-sector-20250728.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><u><b>Read the full document here<\/b><\/u><\/a><\/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\">Reach out to our team<\/span><\/a><\/div><div class=\"fusion-image-element \" 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class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 142.5px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            5\/5 - (5 votos)    <\/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":[1],"tags":[],"class_list":["post-3999","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","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>EU medical device governance: the Notified Bodies\u2019 vision<\/title>\n<meta name=\"description\" content=\"A forward-looking perspective on EU medical device governance, as outlined by the Notified Bodies in their latest strategic document.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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