{"id":31503,"date":"2024-01-18T15:16:43","date_gmt":"2024-01-18T14:16:43","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=31503"},"modified":"2024-01-19T09:56:35","modified_gmt":"2024-01-19T08:56:35","slug":"europa-se-publica-la-directriz-del-mdcg-sobre-productos-no-destinados-para-fines-medicos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/01\/18\/europa-se-publica-la-directriz-del-mdcg-sobre-productos-no-destinados-para-fines-medicos\/","title":{"rendered":"EUROPA: Se publica la directriz del MDCG sobre productos no destinados para fines m\u00e9dicos"},"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>El pasado mes de diciembre, el <strong>Grupo de Coordinaci\u00f3n de Productos Sanitarios<\/strong> <strong>(MDCG<\/strong>) public\u00f3 la directriz <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>, que trata sobre la <strong>demostraci\u00f3n de equivalencia<\/strong> basada en datos de un producto existente, a efectos del marcado CE y bajo el MDR (UE) 2017\/745.<\/h2>\n<p>La directriz es aplicable a los <strong>productos no destinados para fines m\u00e9dicos<\/strong> (enumerados en el Anexo XVI del Reglamento europeo) y los <strong>productos de doble uso en su finalidad no m\u00e9dica<\/strong>.<\/p>\n<p>En general, el <strong>MDR (UE) 2017\/745<\/strong> establece que los datos para la evaluaci\u00f3n cl\u00ednica de un producto pueden ser los mismos que para otro producto que pueda demostrarse que es equivalente a \u00e9l. Sin embargo, este no es el caso de los productos <strong>sin finalidad m\u00e9dica. <\/strong>De hecho -seg\u00fan el <strong>Reglamento (UE) 2022\/2346 <\/strong>de la Comisi\u00f3n Europea por el que se establecen especificaciones comunes para los productos sin finalidad m\u00e9dica enumerados en el MDR (UE) 2017\/745- <strong>la equivalencia entre un producto sanitario y un producto sin finalidad m\u00e9dica no puede demostrarse <\/strong>si todos los resultados disponibles de las investigaciones cl\u00ednicas se refieren exclusivamente al producto sanitario.<\/p>\n<p>La directriz aclara que, para demostrar la equivalencia entre un producto sin finalidad m\u00e9dica y un producto sanitario, el fabricante debe tener en cuenta las caracter\u00edsticas t\u00e9cnicas, biol\u00f3gicas y cl\u00ednicas de los productos, de conformidad con el Reglamento europeo.<\/p>\n<p>Sin embargo, a diferencia de las caracter\u00edsticas t\u00e9cnicas y biol\u00f3gicas, las caracter\u00edsticas <strong>cl\u00ednicas<\/strong> no pueden compararse directamente, es decir, <strong>no es posible comparar un producto sin finalidad m\u00e9dica y un producto sanitario desde el punto de vista cl\u00ednico<\/strong>. Por ejemplo, la caracter\u00edstica \u00abgravedad y estadio similares de la enfermedad\u00bb se define y est\u00e1 disponible para el producto sanitario, pero no para el producto sin finalidad m\u00e9dica.<\/p>\n<p>En cambio, la <strong>equivalencia entre un producto sin finalidad m\u00e9dica y un producto de doble uso <\/strong>puede demostrarse comparando \u00fanicamente las <strong>caracter\u00edsticas de uso no m\u00e9dico<\/strong> de ambos productos. Adem\u00e1s, en caso de que se demuestre la equivalencia, la <strong>evaluaci\u00f3n<\/strong> <strong>cl\u00ednica<\/strong> del producto sin finalidad m\u00e9dica solo deber\u00e1 basarse en los <strong>datos cl\u00ednicos del<\/strong> <strong>producto de doble uso<\/strong>.<\/p>\n<p>El aumento del uso de productos sin finalidad m\u00e9dica est\u00e1 llevando a los organismos reguladores a comprometerse a proporcionar orientaciones que ayuden a los fabricantes a fabricar dispositivos que cumplan cada vez m\u00e1s los requisitos de seguridad y rendimiento para salvaguardar la vida de los usuarios finales y de los pacientes.<\/p>\n<p><strong>&gt;&gt;&gt;<\/strong>\u00a0A trav\u00e9s de los servicios de <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>Consultor\u00eda estrat\u00e9gica-normativa<\/strong>, <\/a>asistencia para la\u00a0<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>certificaci\u00f3n CE<\/strong><\/a> y, si necesario, <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>Rapresentante Europeo Autorizado<\/strong><\/a>, Thema puede ayudarle a aplicar los requisitos del Reglamento de Productos Sanitarios MDR (UE) 2017\/745.<\/p>\n<p><strong>Fuente <\/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":31482,"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":[3],"tags":[],"class_list":["post-31503","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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