{"id":31501,"date":"2024-01-18T15:16:43","date_gmt":"2024-01-18T14:16:43","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=31501"},"modified":"2024-01-19T09:55:50","modified_gmt":"2024-01-19T08:55:50","slug":"europe-published-the-mdcg-guideline-on-products-without-an-intended-medical-purpose","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/01\/18\/europe-published-the-mdcg-guideline-on-products-without-an-intended-medical-purpose\/","title":{"rendered":"EUROPE: Published the MDCG Guideline on Products without an Intended Medical Purpose"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container 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:1144px;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:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>Last December, the <strong>Medical Device Coordination Group<\/strong> <strong>(MDCG<\/strong>) published the guideline <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-12\/mdcg_2023-6_en.pdf\"><em>MDCG 2023-6, Guidance on demonstration of equivalence for Annex XVI products A guide for manufacturers and notified bodies<\/em><\/a>, which deals with the <strong>demonstration of equivalence<\/strong> based on data from an existing device, for CE marking and under MDR (EU) 2017\/745.<\/h2>\n<p>The guideline applies to <strong>products without an intended medical purpose<\/strong> (listed in Anx. XVI of the European Regulation) and <strong>dual-purpose devices<\/strong><strong> in their non-medical purpose<\/strong>.<\/p>\n<p>In general, the <strong>MDR (EU) 2017\/745<\/strong> states that the data for the clinical evaluation of a device can be the same as for another device that can be shown to be equivalent to it. However, this is not the case for products without a medical purpose; in fact &#8211; according to European Commission <strong>Regulation (EU) 2022\/2346<\/strong> laying down common specifications for products without a medical purpose listed in MDR (EU) 2017\/745 &#8211; <strong>equivalence between a medical device and a product without an intended medical purpose cannot be demonstrated <\/strong>if all available results of clinical investigations relate exclusively to the medical device.<\/p>\n<p>The guideline clarifies that to demonstrate equivalence between a device with a non-medical intended purpose and a medical device, the manufacturer must take into account the technical, biological and clinical characteristics of the products, under the European Regulation.<\/p>\n<p>However, unlike technical and biological characteristics, <strong>clinical<\/strong> characteristics cannot be directly compared, i.e. <strong>it is not possible to compare a device without an intended medical purpose and a medical device from a clinical point<\/strong> <strong>of view<\/strong>. For example, the &#8216;similar severity and stage of disease&#8217; characteristic is defined and available for the medical device but not for the device without an intended medical purpose.<\/p>\n<p>In contrast, <strong>equivalence between a non-medical purpose device and a dual-purpose device <\/strong>can be demonstrated by comparing only the <strong>non-medical purpose characteristics<\/strong> of both devices. Furthermore, should equivalence be demonstrated, the <strong>clinical<\/strong> <strong>evaluation<\/strong> of the product without an intended medical purpose should only be based on the <strong>clinical data of the<\/strong> <strong>dual-purpose device<\/strong>.<\/p>\n<p>The increase in the use of products without an intended medical purpose is prompting regulators to commit to providing <strong>guidelines<\/strong> that can help manufacturers make devices that increasingly meet safety and performance requirements to safeguard the end-users and patients\u2019 health.<\/p>\n<p><strong>&gt;&gt;&gt;<\/strong>\u00a0Through the services of<strong>\u00a0<\/strong><a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>strategic-regulatory consulting<\/strong>, support <\/a>\u00a0to <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/supporto-alla-certificazione-ce-dispositivi-medici-ivd\/\"><strong>EC certification<\/strong><\/a>\u00a0and if necessary, <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/local-representative-mercati-esteri\/servizio-rappresentante-autorizzato-europeo\/\"><strong>European Authorised Representative<\/strong><\/a>, Thema can help you implement the requirements of the MDR (EU) 2017\/745.<\/p>\n<p><strong>Source <\/strong><\/p>\n<p><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-12\/mdcg_2023-6_en.pdf\">MDCG 2023-6, Guidance on demonstration of equivalence for Annex XVI products A guide for manufacturers and notified bodies<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":31481,"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-31501","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>EUROPE: Published the MDCG Guideline on Products without an Intended Medical Purpose - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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