{"id":3422,"date":"2025-03-31T11:53:35","date_gmt":"2025-03-31T11:53:35","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3422"},"modified":"2025-03-31T12:07:05","modified_gmt":"2025-03-31T12:07:05","slug":"ivd-classification-whats-new-in-the-latest-mdcg-2020-16-rev-4-guidance","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/ivd-classification-whats-new-in-the-latest-mdcg-2020-16-rev-4-guidance\/","title":{"rendered":"IVD Classification: What\u2019s new in the latest MDCG 2020-16 Rev.4 guidance?"},"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>In March 2025, the <b>Medical Device Coordination Group (MDCG)<\/b> released an update to its guidance <b>MDCG 2020-16 Rev.4<\/b>, focused on the classification of <b>in vitro diagnostic medical devices (IVDs)<\/b> under <b>Regulation (EU) 2017\/746 (IVDR)<\/b>.<br \/>\nThis document plays a crucial role for <b>IVD manufacturers<\/b> who aim to ensure regulatory compliance while maintaining access to the European market.<\/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-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/ivd-classification-whats-new-in-the-latest-mdcg-2020-16-rev-4-guidance\/#Why_this_update_matters\" >Why this update matters<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/ivd-classification-whats-new-in-the-latest-mdcg-2020-16-rev-4-guidance\/#Whats_changed_in_Rev4\" >What\u2019s changed in Rev.4?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/ivd-classification-whats-new-in-the-latest-mdcg-2020-16-rev-4-guidance\/#Practical_examples_to_support_interpretation\" >Practical examples to support interpretation<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/ivd-classification-whats-new-in-the-latest-mdcg-2020-16-rev-4-guidance\/#Final_thoughts\" >Final thoughts<\/a><\/li><\/ul><\/nav><\/div>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"Why_this_update_matters\"><\/span>Why this update matters<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Classification is more than just a technical formality. It directly influences the<b> entire regulatory pathway<\/b>, including whether a Notified Body is required, the <b>scope and complexity of the technical documentation, post-market obligations<\/b> such as PSURs and vigilance, and ultimately, the time and costs associated with market access.<br \/>\nIn short, <b>accurate classification<\/b> helps manufacturers minimise risks, avoid unnecessary delays, and streamline the route to <b>CE marking<\/b>.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"Whats_changed_in_Rev4\"><\/span>What\u2019s changed in Rev.4?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The 2025 revision introduces several<b> practical updates<\/b> compared to the previous version. These include<b> revised examples<\/b> for classification <b>Rules 1, 4(a), and 6<\/b>, an updated explanatory note for <b>Rule 3(m)<\/b> concerning <b>neonatal screening<\/b>, and <b>editorial changes<\/b> to Annexes 1 and 2.<br \/>\nThe guidance also provides <b>clearer definitions<\/b> of key terms such as \u201ckit,\u201d \u201cmonitoring,\u201d and \u201cscreening,\u201d while placing greater emphasis on the importance of the <b>intended purpose<\/b>, which refers to the use as declared by the manufacturer.<br \/>\nThis aspect is particularly crucial. The way the <b>intended purpose is described<\/b> in <b>the technical documentation, instructions for use<\/b>, and <b>promotional materials<\/b> can significantly affect the device\u2019s classification. If the wording is <b>unclear or inconsistent<\/b>, the product may be classified under a <b>higher-risk category<\/b>, leading to <b>more demanding regulatory requirements<\/b>.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"Practical_examples_to_support_interpretation\"><\/span>Practical examples to support interpretation<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>To assist manufacturers in applying the classification rules correctly, the updated guidance includes a variety of <b>practical examples<\/b>. These are especially useful for differentiating between<b> Class C and Class D devices<\/b> and for understanding how the rules apply to <b>infectious disease tests, genetic tests, companion diagnostics, and software-based IVDs<\/b>.<br \/>\nFor those navigating the complex IVDR framework, this document offers valuable clarification and helps ensure a more consistent interpretation of the classification system.<\/p>\n<p><a href=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/03\/md_mdcg_2020_guidance_classification_ivd-md_en.pdf\"><b><u>You can download the full MDCG 2020-16 Rev.4 guidance here.<\/u><\/b><\/a><\/p>\n<p>At <b>CMC Medical Devices<\/b>, we assist manufacturers seeking to enter the European market with their IVDs by offering support in representation, registration, and global compliance strategy. If you are preparing your documentation or exploring the steps required under the IVDR, we invite you to discover our dedicated service: <b><u><a href=\"https:\/\/cmcmedicaldevices.com\/services\/consulting-ivdr\/\" target=\"_blank\" rel=\"noopener noreferrer\">Learn more about our IVDR support<\/a><\/u><\/b>.<\/p>\n<p>&nbsp;<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"Final_thoughts\"><\/span>Final thoughts<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>For <b>IVD manufacturers<\/b> looking to remain competitive within the EU, this revised version of<b> MDCG 2020-16 is essential reading<\/b>. It offers not only updated regulatory insights but also practical tools to help avoid misclassification and plan compliance efforts more effectively.<\/p>\n<p>We are committed to supporting manufacturers by sharing timely updates and useful resources. <b>If you are working on IVD registration or simply wish to stay informed, follow our channels to stay up to date with the latest developments.<\/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=\"--button_margin-top:10px;--button_margin-bottom:10px;\" 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=\"2560\" height=\"1465\" alt=\"New eu ivd guidance\" title=\"New eu ivd guidance\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/03\/New-eu-ivd-guidance.png\" class=\"img-responsive wp-image-3416\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/03\/New-eu-ivd-guidance-200x114.png 200w, 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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":[1],"tags":[],"class_list":["post-3422","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>IVD Classification: What\u2019s new in the latest MDCG 2020-16 Rev.4 guidance? | 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\/ivd-classification-whats-new-in-the-latest-mdcg-2020-16-rev-4-guidance\/\" \/>\n<meta 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