{"id":4237,"date":"2025-09-18T20:55:05","date_gmt":"2025-09-18T20:55:05","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=4237"},"modified":"2025-09-29T10:52:09","modified_gmt":"2025-09-29T10:52:09","slug":"new-eu-manual-on-borderline-classification-of-medical-devices-and-ivds","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/new-eu-manual-on-borderline-classification-of-medical-devices-and-ivds\/","title":{"rendered":"New EU manual on borderline &#038; classification of medical devices and IVDs"},"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\"><article>\n<header><strong>The European Union has released the <strong>4th edition of the Manual on Borderline and Classification for Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)<\/strong>. This update provides practical, case-based guidance to help stakeholders determine whether a product falls under the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).<\/strong><\/header>\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\/new-eu-manual-on-borderline-classification-of-medical-devices-and-ivds\/#Purpose_and_scope\" >Purpose and scope<\/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\/new-eu-manual-on-borderline-classification-of-medical-devices-and-ivds\/#Selected_cases_from_the_2025_edition\" >Selected cases from the 2025 edition<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-manual-on-borderline-classification-of-medical-devices-and-ivds\/#COVID-19_nasal_spray\" >COVID-19 nasal spray<\/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\/new-eu-manual-on-borderline-classification-of-medical-devices-and-ivds\/#Rescue_bag_for_patient_transport\" >Rescue bag for patient transport<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-manual-on-borderline-classification-of-medical-devices-and-ivds\/#Root_canal_irrigation_solutions\" >Root canal irrigation solutions<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-manual-on-borderline-classification-of-medical-devices-and-ivds\/#Medical_calculators\" >Medical calculators<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-manual-on-borderline-classification-of-medical-devices-and-ivds\/#FeNO_measuring_device\" >FeNO measuring device<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-manual-on-borderline-classification-of-medical-devices-and-ivds\/#Why_this_update_matters\" >Why this update matters<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-manual-on-borderline-classification-of-medical-devices-and-ivds\/#Reference_and_call_to_action\" >Reference and call to action<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Purpose_and_scope\"><\/span>Purpose and scope<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Classification is not always straightforward. Misclassification can create regulatory uncertainty, distort the internal market, or compromise patient safety. Therefore, the manual clarifies borderline situations and explains how to apply classification rules consistently across EU member states.<\/p>\n<p>Although the manual is not legally binding, it records the consensus of national competent authorities and serves as a widely used reference in regulatory practice.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Selected_cases_from_the_2025_edition\"><\/span>Selected cases from the 2025 edition<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3 style=\"font-size: 28px;\" data-fusion-font=\"true\"><span class=\"ez-toc-section\" id=\"COVID-19_nasal_spray\"><\/span>COVID-19 nasal spray<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A nasal spray containing antibodies designed to inactivate SARS-CoV-2 is <strong>not<\/strong> classified as a medical device. Its principal action is immunological, which places it in the scope of medicinal products rather than devices.<\/p>\n<h3 style=\"font-size: 28px;\" data-fusion-font=\"true\"><span class=\"ez-toc-section\" id=\"Rescue_bag_for_patient_transport\"><\/span>Rescue bag for patient transport<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Rescue bags intended to protect and stabilise patients during emergency transport are classified as <strong>Class I medical devices<\/strong>. Their intended purpose aligns with the MDR definition of alleviating or compensating for injury or disability.<\/p>\n<h3 style=\"font-size: 28px;\" data-fusion-font=\"true\"><span class=\"ez-toc-section\" id=\"Root_canal_irrigation_solutions\"><\/span>Root canal irrigation solutions<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Solutions that include antimicrobial substances (for example sodium hypochlorite or chlorhexidine) may be classified as <strong>Class III medical devices<\/strong>. In those cases, the antimicrobial action is considered ancillary to the device\u2019s mechanical cleaning function.<\/p>\n<h3 style=\"font-size: 28px;\" data-fusion-font=\"true\"><span class=\"ez-toc-section\" id=\"Medical_calculators\"><\/span>Medical calculators<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Software that computes clinical scores (for example stroke risk or kidney function) qualifies as <strong>medical device software<\/strong>. Depending on the clinical significance of the output, such software is typically classed as <strong>Class IIa or higher<\/strong>.<\/p>\n<h3 style=\"font-size: 28px;\" data-fusion-font=\"true\"><span class=\"ez-toc-section\" id=\"FeNO_measuring_device\"><\/span>FeNO measuring device<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Devices that measure fractional exhaled nitric oxide (FeNO) to support asthma assessment are classified as <strong>in vitro diagnostic devices (IVDR)<\/strong>, because they analyse specimens derived from the human body.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Why_this_update_matters\"><\/span>Why this update matters<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>By offering clear examples and interpretation, the updated manual improves regulatory alignment across the EU. As a result, manufacturers gain greater predictability, regulatory authorities can act more consistently, and patient safety is reinforced. Moreover, clearer classification supports innovation and smoother market access.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Reference_and_call_to_action\"><\/span>Reference and call to action<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>For full details, read the official manual:<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/update-manual-borderline-and-classification-under-regulations-eu-2017745-and-2017746-september-2025-2025-09-12_en\" target=\"_blank\" rel=\"noopener noreferrer\"> <em>Manual on Borderline and Classification for Medical Devices and IVDs \u2013 Version 4 (September 2025)<\/em>.<\/a><\/p>\n<footer><\/footer>\n<p>&nbsp;<\/p>\n<\/article>\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 today<\/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\" title=\"new ch rep\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/09\/new-ch-rep.png\" alt class=\"img-responsive wp-image-4233\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/09\/new-ch-rep-200x113.png 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/09\/new-ch-rep-400x225.png 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/09\/new-ch-rep-600x338.png 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/09\/new-ch-rep-800x451.png 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/09\/new-ch-rep-1200x676.png 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/09\/new-ch-rep.png 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;4237&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;New EU manual on borderline \\u0026amp; 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Discover key cases, classification rules, and what this update means for manufacturers, regulators, and healthcare professionals.\" \/>\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\/new-eu-manual-on-borderline-classification-of-medical-devices-and-ivds\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New EU Manual on Borderline and Classification of Medical Devices and IVDs \u2013 September 2025\" \/>\n<meta property=\"og:description\" content=\"The EU has published the 4th edition of its Manual on Borderline and Classification for medical devices and IVDs (Sept 2025). 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