{"id":4012,"date":"2025-08-07T11:43:12","date_gmt":"2025-08-07T11:43:12","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=4012"},"modified":"2025-08-07T11:50:34","modified_gmt":"2025-08-07T11:50:34","slug":"mdr-and-ivdr-certification-key-insights-from-the-14th-nb-survey","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/mdr-and-ivdr-certification-key-insights-from-the-14th-nb-survey\/","title":{"rendered":"MDR and IVDR Certification: Key Insights from the 14th NB Survey"},"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 availability of medical devices in the EU is closely linked to the certification capacity of Notified Bodies (NBs)<\/b>. To monitor this dynamic, the <b><u><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/updated-notified-bodies-survey-certifications-and-applications-2025-08-01_en\" target=\"_blank\" rel=\"noopener noreferrer\">European Commission launched a recurring survey<\/a> collecting<\/u><\/b> data from all designated NBs under the MDR and IVDR.<\/p>\n<p>The <strong>14th NB survey<\/strong>, published on <strong>25 July 2025<\/strong>, offers updated figures on:<\/p>\n<ul>\n<li><b>The number of applications submitted and certificates issued<\/b><\/li>\n<li><b>Timeframes for certification<\/b><\/li>\n<li><b>Common reasons for application refusal<\/b><\/li>\n<li><b>Collaboration with EU Reference Laboratories (EURLs) for high-risk IVDs<\/b><\/li>\n<li><b>Trends in the certification of devices with no medical purpose<\/b><\/li>\n<\/ul>\n<p>This extensive monitoring effort is part of the European Commission\u2019s strategy to evaluate the availability of certified devices on the EU market and to support the effective implementation of MDR and IVDR.<\/p>\n<p><strong>You can download the full survey report here: <\/strong><a href=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/md_nb_survey_certifications_applications_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><b><u>Download the 14th NB Survey \u2013 July 2025 (PDF)<\/u><\/b><\/a><br \/><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2025-07\/2025_nb-survey_certifications_applications_en.pdf\" target=\"_blank\"><br \/>\n  <\/a><\/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\/mdr-and-ivdr-certification-key-insights-from-the-14th-nb-survey\/#MDR_High_application_volumes_growing_backlogs\" >MDR: High application volumes, growing backlogs<\/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\/mdr-and-ivdr-certification-key-insights-from-the-14th-nb-survey\/#IVDR_Class_D_and_EURL_collaboration_still_limited\" >IVDR: Class D and EURL collaboration still limited<\/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\/mdr-and-ivdr-certification-key-insights-from-the-14th-nb-survey\/#Key_Takeaways_for_Manufacturers\" >Key Takeaways for Manufacturers<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"MDR_High_application_volumes_growing_backlogs\"><\/span>MDR: High application volumes, growing backlogs<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>As of February 2025:<\/p>\n<ul>\n<li><strong>28,489 applications<\/strong> for MDR certification had been lodged.<\/li>\n<li>Only <strong>12,177 certificates<\/strong> were issued.<\/li>\n<li>Over <strong>5,000 applications<\/strong> concerned changes to existing MDR certificates.<\/li>\n<\/ul>\n<p>Despite the high number of written agreements signed (18,476), <strong>application refusals reached 650<\/strong>, with the main reasons being incomplete documentation and applications falling outside the scope of the NB\u2019s designation.<\/p>\n<p>Notably, <strong>more than 50% of the time required for certification<\/strong> is attributed to the manufacturer\u2019s side, mostly due to document revision delays.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"IVDR_Class_D_and_EURL_collaboration_still_limited\"><\/span>IVDR: Class D and EURL collaboration still limited<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>For in vitro diagnostic devices:<\/p>\n<ul>\n<li><strong>2,395 applications<\/strong> were submitted<\/li>\n<li><strong>1,490 certificates<\/strong> were issued by February 2025<\/li>\n<\/ul>\n<p>Among these:<\/p>\n<ul>\n<li><strong>765 applications<\/strong> and <strong>466 certificates<\/strong> concerned Class D devices<\/li>\n<li>Only <strong>3 out of 14 NBs<\/strong> had issued Class D certificates under EURL oversight<\/li>\n<\/ul>\n<p>The majority of applications requiring EURL consultation involve infectious diseases such as hepatitis and respiratory viruses.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Key_Takeaways_for_Manufacturers\"><\/span>Key Takeaways for Manufacturers<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li><strong>Prepare complete and accurate documentation<\/strong> before submission: over 60% of applications are still considered incomplete.<\/li>\n<li><strong>Expect long timelines<\/strong>: the median time to obtain a QMS+Product certificate ranges from 13 to 18 months.<\/li>\n<li><strong>Understand the NB\u2019s designation scope<\/strong>: submitting outside of scope is among the top reasons for refusal.<\/li>\n<\/ul>\n<p><b style=\"\">Are you navigating MDR or IVDR certification?<br \/><\/b><br \/>\n  We help you understand the current certification landscape and guide you in preparing a compliant technical documentation.<\/p>\n<p>  <strong>Contact us today to simplify your EU market access.<\/strong><\/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 \" 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=\"1640\" height=\"924\" alt=\"14th NB Survey Certifications, Delays and Critical Issues in MDR and IVDR\" title=\"14th NB Survey Certifications, Delays and Critical Issues in MDR and IVDR\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/14th-NB-Survey-Certifications-Delays-and-Critical-Issues-in-MDR-and-IVDR.jpg\" class=\"img-responsive wp-image-4019\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/14th-NB-Survey-Certifications-Delays-and-Critical-Issues-in-MDR-and-IVDR-200x113.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/14th-NB-Survey-Certifications-Delays-and-Critical-Issues-in-MDR-and-IVDR-400x225.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/14th-NB-Survey-Certifications-Delays-and-Critical-Issues-in-MDR-and-IVDR-600x338.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/14th-NB-Survey-Certifications-Delays-and-Critical-Issues-in-MDR-and-IVDR-800x451.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/14th-NB-Survey-Certifications-Delays-and-Critical-Issues-in-MDR-and-IVDR-1200x676.jpg 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/14th-NB-Survey-Certifications-Delays-and-Critical-Issues-in-MDR-and-IVDR.jpg 1640w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div>\n\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-center kksr-valign-bottom\"\n    data-payload='{&quot;align&quot;:&quot;center&quot;,&quot;id&quot;:&quot;4012&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;bottom&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;7&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;5&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;Rate this&quot;,&quot;legend&quot;:&quot;5\\\/5 - (7 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;MDR and IVDR Certification: Key Insights from the 14th NB Survey&quot;,&quot;width&quot;:&quot;142.5&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div 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            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24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            5\/5 - (7 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":[],"tags":[],"class_list":["post-4012","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>14th Notified Body Survey: MDR and IVDR key findings<\/title>\n<meta name=\"description\" content=\"The 14th Notified Body survey reveals key data on MDR and IVDR certifications, application delays, Class D IVDs and rejection reasons.\" \/>\n<meta name=\"robots\" content=\"index, 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