{"id":34760,"date":"2025-10-22T12:27:34","date_gmt":"2025-10-22T10:27:34","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34760"},"modified":"2025-10-22T16:20:57","modified_gmt":"2025-10-22T14:20:57","slug":"eu-updated-borderline-and-classification-manual-for-medical-devices-according-to-mdr-and-ivdr","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/10\/22\/eu-updated-borderline-and-classification-manual-for-medical-devices-according-to-mdr-and-ivdr\/","title":{"rendered":"EU: Updated Borderline and Classification Manual for Medical Devices according to MDR and IVDR"},"content":{"rendered":"<p style=\"text-align: right;\"><strong><em>Translated with AI<\/em><\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>In September 2025, the <strong>Borderline and Classification Working Group (BCWG)<\/strong>, an advisory group established by the European Commission, published <strong>Revision 4<\/strong> of the <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\"><strong>Manual on Classification and Borderline Products<\/strong><\/a> in accordance with Regulations MDR (EU) 2017\/745 (MDR) and IVDR (EU) 2017\/746.<\/p>\n<p>The manual supports manufacturers in the complex task of correctly <strong>qualifying and classifying<\/strong> a borderline product, clarifying its regulatory framework. This update presents numerous practical cases and shared interpretations that guide the manufacturer towards the most appropriate classification.<\/p>\n<h3><strong>Borderline Devices and Mechanism of Action<\/strong><\/h3>\n<p>Borderline products are those products that, by their nature, <strong>do not clearly belong to a specific sector <\/strong>and it is therefore difficult to establish which reference legislation applies. A product is considered <strong>Borderline<\/strong> when its <strong>intended use<\/strong> or its <strong>Mechanism of Action (MOA) <\/strong>places it in a border area between different regulatory frameworks.<\/p>\n<p>The Manual reiterates that <strong>correct qualification<\/strong> depends on the <strong>product&#8217;s principal intended action<\/strong>, in accordance with Article 2 of the MDR:<\/p>\n<ul>\n<li><strong>Medical Device (MD):<\/strong> the principal action is achieved by physical or mechanical means, for example by a barrier, support, or absorption effect.<\/li>\n<li><strong>Medicinal Product:<\/strong> the principal action is achieved by pharmacological, immunological, or metabolic means.<\/li>\n<\/ul>\n<p>Correct qualification becomes particularly complex in cases where a device contains <strong>active substances<\/strong>. The Manual, in line with the <a href=\"https:\/\/www.thema-med.com\/en\/2024\/11\/22\/aggiornamento-della-linea-guida-mdcg-2022-5-rev-1-chiarificazioni-sui-prodotti-borderline-tra-dispositivi-medici-e-medicinali\/\"><strong>MDCG 2022-5<\/strong><\/a> guidance, provides practical examples to distinguish between prevalent mechanical action (MD) and prevalent pharmacological\/metabolic action (medicinal product).<\/p>\n<h3><strong>The Sections of the Manual<\/strong><\/h3>\n<p>The document is articulated in two main sections, which reflect the logical process of regulation:<\/p>\n<p><strong>Section 1 \u2013 MDR Regulation (EU) 2017\/745<\/strong><\/p>\n<ul>\n<li><strong>Qualification of borderline devices:<\/strong> analyses the boundaries with other product categories, such as medicinal products, <em>in vitro<\/em> diagnostic devices (IVD), biocidal products, cosmetics, foodstuffs, or Personal Protective Equipment (PPE).<\/li>\n<li><strong>Classification of medical devices:<\/strong> provides examples of application and interpretation of the classification rules (MDR Annex VIII) for risk classes I, IIa, IIb, and III.<\/li>\n<\/ul>\n<p><strong>Section 2 \u2013 IVDR Regulation (EU) 2017\/746<\/strong><\/p>\n<ul>\n<li>Deals with the <strong>qualification and classification<\/strong> of <em>in vitro<\/em> diagnostic devices, from low-risk categories (Class A) to high-risk ones (Class D), highlighting the risk criteria.<\/li>\n<li>Includes practical cases of IVDR borderline devices, for example, combined products or test kits with active chemical components, clarifying when they fall within the scope of the IVDR or other regulations.<\/li>\n<\/ul>\n<h3><strong>Key Points of the Update \u2013 Version 4<\/strong><\/h3>\n<ul>\n<li><strong>Case studies and reasoning for qualification and classification:<\/strong> Revision 4 significantly enriches the case studies, presenting solved practical cases for which the BCWG group&#8217;s interpretative reasoning is set out. This allows <strong>manufacturers<\/strong> to understand the logic behind the correct qualification and classification of the device and to apply it by analogy to similar products.<\/li>\n<li><strong>Alignment with <\/strong><a href=\"https:\/\/www.thema-med.com\/en\/2024\/11\/22\/aggiornamento-della-linea-guida-mdcg-2022-5-rev-1-chiarificazioni-sui-prodotti-borderline-tra-dispositivi-medici-e-medicinali\/\"><strong>MDCG 2022-5<\/strong><\/a><strong> for medicinal product\/MD borderline devices:<\/strong> formalises the alignment with the guidance that defines the distinction between a medical device and a medicinal product, clarifying the criteria for products containing active substances.<\/li>\n<li><strong>Clarifications on the boundaries with other regulatory frameworks (cosmetics, biocidal products, PPE, foodstuffs):<\/strong> the guidance provides further clarifications on the regulatory boundaries between medical devices and other categories of products, such as cosmetics, biocidal products, PPE, and foodstuffs.<\/li>\n<\/ul>\n<p>\ud83d\udc49 Thema offers integrated support for managing the regulatory compliance and quality of borderline devices, particularly those supported by a drug with an ancillary function. For more information contact <a href=\"mailto:sales@complifegroup.com\">sales@complifegroup.com<\/a><\/p>\n<p><strong>SOURCE: <\/strong><\/p>\n<ul>\n<li><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\">https:\/\/health.ec.europa.eu\/latest-updates\/update-manual-borderline-and-classification-under-regulations-eu-2017745-and-2017746-september-2025-2025-09-12_en<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Translated with AI &nbsp; In September 2025, the Borderline and Classification Working Group (BCWG), an advisory group established by the European  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":34792,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-34760","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU: Updated Borderline and Classification Manual for Medical Devices according to MDR and IVDR - Thema Med<\/title>\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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