{"id":3309,"date":"2025-02-21T12:32:27","date_gmt":"2025-02-21T12:32:27","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3309"},"modified":"2025-02-21T12:32:27","modified_gmt":"2025-02-21T12:32:27","slug":"new-notified-bodies-for-mdr-ivdr-cncps-and-nsai-strengthen-eu-certification","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/new-notified-bodies-for-mdr-ivdr-cncps-and-nsai-strengthen-eu-certification\/","title":{"rendered":"New Notified Bodies for MDR &#038; IVDR: CNCps and NSAI strengthen EU Certification"},"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>The <b>European certification system<\/b> continues to expand with the recent designation of <b>two new Notified Bodies (NBs)<\/b>:<\/p>\n<li><b>CNCps (Spain)<\/b> \u2013 Now designated for <b>IVDR (EU Regulation 2017\/746)<\/b>, increasing certification capacity for <b>in vitro diagnostic devices<\/b>.<\/li>\n<li><b>NSAI (Ireland)<\/b> \u2013 Becomes the <b>11th NB worldwide<\/b> for <b>MDR<\/b> <b>(EU Regulation 2017\/745)<\/b> certification, reinforcing market access for MedTech companies.<\/li>\n<p><b>Why is this important for medical device and IVD manufacturers?<\/b><br \/>\n<span style=\"color: var(--awb-text-color); font-family: var(--awb-text-font-family); font-size: var(--awb-font-size); font-style: var(--awb-text-font-style); font-weight: var(--awb-text-font-weight); letter-spacing: var(--awb-letter-spacing); text-align: var(--awb-content-alignment); text-transform: var(--awb-text-transform); background-color: var(--awb-bg-color-hover);\"><br \/>\nWith MDR and IVDR now fully in effect, obtaining <\/span><span style=\"color: var(--awb-text-color); font-family: var(--awb-text-font-family); font-size: var(--awb-font-size); font-style: var(--awb-text-font-style); letter-spacing: var(--awb-letter-spacing); text-align: var(--awb-content-alignment); text-transform: var(--awb-text-transform); background-color: var(--awb-bg-color-hover);\"><b>CE certification<\/b><\/span><span style=\"color: var(--awb-text-color); font-family: var(--awb-text-font-family); font-size: var(--awb-font-size); font-style: var(--awb-text-font-style); font-weight: var(--awb-text-font-weight); letter-spacing: var(--awb-letter-spacing); text-align: var(--awb-content-alignment); text-transform: var(--awb-text-transform); background-color: var(--awb-bg-color-hover);\"> is a top priority. The increase in Notified Bodies helps ease bottlenecks and delays, ensuring a smoother approval process.<\/span><\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_87_1 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-4'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-notified-bodies-for-mdr-ivdr-cncps-and-nsai-strengthen-eu-certification\/#CNCps_Expanding_IVDR_Certification_Capacity\" >CNCps: Expanding IVDR Certification Capacity<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-notified-bodies-for-mdr-ivdr-cncps-and-nsai-strengthen-eu-certification\/#NSAI_Strengthening_MDR_Certification\" >NSAI: Strengthening MDR Certification<\/a><\/li><\/ul><\/nav><\/div>\n<h4><span class=\"ez-toc-section\" id=\"CNCps_Expanding_IVDR_Certification_Capacity\"><\/span><b>CNCps: Expanding IVDR Certification Capacity<br \/>\n<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>The <b>Centro Nacional de Certificaci\u00f3n de Productos Sanitarios (CNCps)<\/b> has now been officially designated as <b>Notified Body 0318 for IVDR<\/b>, strengthening Spain&#8217;s role in medical device certification.<\/p>\n<p><b>What does this mean for IVD manufacturers?<\/b><\/p>\n<ul>\n<li>CNCps can now <b>certify in vitro diagnostic devices<\/b>, including infectious disease tests, oncology biomarkers, and neonatal screening tools.<\/li>\n<li>This designation helps <b>mitigate potential shortages of certified IVDs<\/b>, ensuring a more efficient market supply.<\/li>\n<li>Manufacturers can <b>submit certification applications through the CNCps platform starting March 1, 2025<\/b>.<\/li>\n<\/ul>\n<p><u><b style=\"color: #062b21;\"><a href=\"https:\/\/cmcmedicaldevices.com\/services\/consulting-ivdr\/\" target=\"_blank\" rel=\"noopener noreferrer\">Need IVDR certification for your IVD device? Discover how we can help.<\/a><br \/>\n<\/b><\/u><\/p>\n<h4><span class=\"ez-toc-section\" id=\"NSAI_Strengthening_MDR_Certification\"><\/span><b>NSAI: Strengthening MDR Certification<\/b><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>The <b>National Standards Authority of Ireland (NSAI)<\/b> has now been officially designated as a <b>Notified Body for MDR<\/b>, further positioning Ireland as a key MedTech hub.<\/p>\n<p><b>What does this mean for medical device manufacturers?<\/b><\/p>\n<ul>\n<li>NSAI will assist companies in <b>obtaining CE certification for medical devices<\/b>, focusing on quality and safety.<\/li>\n<li>The increased certification capacity <b>supports both SMEs and multinational companies<\/b> in navigating MDR requirements.<\/li>\n<li>Ireland is already a strategic <b>MedTech hub<\/b>, with over <b>450 companies<\/b>, <b>60% of which are locally owned<\/b>.<\/li>\n<\/ul>\n<p><a href=\"https:\/\/cmcmedicaldevices.com\/services\/consulting-mdr\/\" target=\"_blank\" rel=\"noopener noreferrer\"><b><u>Need MDR certification for your medical device? Let us guide you.<\/u><\/b><\/a><\/p>\n<p><b>Looking for expert MDR or IVDR certification support? Contact us for a consultation!<\/b><\/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=\"--awb-margin-top:10px;--awb-margin-bottom:10px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Contact us for more information<\/span><\/a><\/div><div class=\"fusion-image-element\" style=\"text-align:center;--awb-max-width:600px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"2560\" height=\"1465\" alt=\"New notified bodies\" title=\"New notified bodies\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/02\/New-notified-bodies.png\" class=\"img-responsive wp-image-3305\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/02\/New-notified-bodies-200x114.png 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/02\/New-notified-bodies-400x229.png 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/02\/New-notified-bodies-600x343.png 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/02\/New-notified-bodies-800x458.png 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/02\/New-notified-bodies-1200x687.png 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/02\/New-notified-bodies.png 2560w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/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-3309","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 v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New Notified Bodies for MDR &amp; 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