{"id":31240,"date":"2023-11-22T15:12:13","date_gmt":"2023-11-22T14:12:13","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=31240"},"modified":"2023-11-23T11:33:59","modified_gmt":"2023-11-23T10:33:59","slug":"europa-aprobada-la-directriz-mdcg-sobre-software-de-productos-sanitarios-en-combinacion-con-hardware","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/11\/22\/europa-aprobada-la-directriz-mdcg-sobre-software-de-productos-sanitarios-en-combinacion-con-hardware\/","title":{"rendered":"EUROPA: Aprobada la Directriz MDCG sobre Software de productos sanitarios en combinaci\u00f3n con hardware"},"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 octubre de 2023, el Grupo de Coordinaci\u00f3n de Productos Sanitarios (<strong>MDCG<\/strong>) aprob\u00f3 la directriz <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-10\/md_mdcg_2023-4_software_en.pdf\"><em>MDCG 2023-4 Medical Device Software (MDSW) \u2013 Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components<\/em><\/a> que trata sobre el Software de Productos Sanitarios (<strong>MDSW<\/strong>) destinado a funcionar en combinaci\u00f3n con hardware o componentes de hardware.<\/h2>\n<p>La directriz pretende aclarar la<strong> interacci\u00f3n entre el MDSW y el hardware<\/strong>, en concreto describe si el hardware o el componente de hardware, que funciona en combinaci\u00f3n con el MDSW, es un producto sanitario o un accesorio de un producto sanitario.<\/p>\n<p>El documento describe varios <strong>ejemplos<\/strong> de c\u00f3mo un MDSW y un hardware o componente de hardware funcionan en combinaci\u00f3n para lograr una <strong>finalidad m\u00e9dica<\/strong> y c\u00f3mo pueden<strong> introducirse en el<\/strong> <strong>mercado<\/strong>.<\/p>\n<p>La finalidad m\u00e9dica prevista por un MDSW s\u00f3lo puede lograrse mediante el uso de hardware o componentes de hardware que demuestren suficiente seguridad, rendimiento, precisi\u00f3n y fiabilidad a la luz de la finalidad prevista de un MDSW y del estado de la t\u00e9cnica.<\/p>\n<p>La directriz tambi\u00e9n contiene los tres escenarios posibles:<\/p>\n<ul>\n<li><strong>Escenario 1<\/strong>: El hardware o componente de hardware se comercializa como accesorio del MDSW.<\/li>\n<li><strong>Escenario 2<\/strong>: El hardware o componente de hardware se comercializa como producto sanitario independiente.<\/li>\n<li><strong>Escenario 3<\/strong>: El hardware o componente de hardware es parte integrante del producto de consumo general, no es un producto sanitario ni un accesorio de un dispositivo y no tiene finalidad m\u00e9dica.<\/li>\n<\/ul>\n<p>Tambi\u00e9n se dan ejemplos de estos posibles escenarios:<\/p>\n<ul>\n<li>Sensor integrado en un parche cut\u00e1neo que proporciona datos de entrada a una aplicaci\u00f3n MDSW incluida en el escenario 2.<\/li>\n<li>Sensor integrado en un smartphone o wearable conectado a una aplicaci\u00f3n MDSW en un smartphone o wearable que forma parte del escenario 1.<\/li>\n<\/ul>\n<p>En cuanto a la comercializaci\u00f3n, los fabricantes de MDSW deben demostrar el <strong>cumplimiento<\/strong> del MDR (UE) 2017\/745, incluidos los requisitos generales de seguridad y rendimiento. En concreto, el fabricante debe verificar, validar y demostrar la seguridad, reproducibilidad y compatibilidad del hardware con el que funciona el MDSW en <strong>combinaci\u00f3n<\/strong>, incluidas todas las distintas configuraciones y variantes.<\/p>\n<p>En cuanto a la gesti\u00f3n de riesgos y la vigilancia posterior a la comercializaci\u00f3n, el fabricante de MDSW debe supervisar y evaluar sistem\u00e1ticamente toda la informaci\u00f3n procedente del mercado <strong>a lo largo de la vida \u00fatil del MDSW<\/strong>, as\u00ed como para el hardware o componente de hardware que pueda afectar a la seguridad y el rendimiento del MDSW.<\/p>\n<p>El aumento del uso de programas inform\u00e1ticos en productos sanitarios est\u00e1 llevando a los organismos reguladores a comprometerse a proporcionar orientaciones que ayuden a los fabricantes a producir dispositivos que cumplan cada vez m\u00e1s los requisitos de seguridad y rendimiento para salvaguardar la vida de los usuarios finales.<\/p>\n<p><strong>&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>, <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\/\">asistencia para <\/a>\u00a0la\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>\u00a0y<\/a> 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>Representante europeo autorizado<\/strong><\/a>, Thema puede ayudarle a aplicar los requisitos del Reglamento 2023\/607 para aprovechar la pr\u00f3rroga y el 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\/2023-10\/md_mdcg_2023-4_software_en.pdf\">MDCG 2023-4 Medical Device Software (MDSW) \u2013 Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":31225,"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-31240","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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