{"id":32403,"date":"2024-04-17T11:07:30","date_gmt":"2024-04-17T09:07:30","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/04\/17\/europa-termine-ultimo-per-implementare-sistema-qualita-e-application-mdr\/"},"modified":"2024-04-18T15:57:34","modified_gmt":"2024-04-18T13:57:34","slug":"europa-termine-ultimo-per-implementare-sistema-qualita-e-application-mdr","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2024\/04\/17\/europa-termine-ultimo-per-implementare-sistema-qualita-e-application-mdr\/","title":{"rendered":"EUROPA: Plazo final para implantar el sistema de calidad y la solicitud del MDR"},"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 20 de marzo de 2023 se public\u00f3 en el Diario Oficial de la Uni\u00f3n Europea &#8211; EUR-Lex el <strong>Reglamento<\/strong> <strong>2023\/607<\/strong> (<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=uriserv%3AOJ.L_.2023.080.01.0024.01.ENG&amp;toc=OJ%3AL%3A2023%3A080%3ATOC\">Reglamento (UE) 2023\/607 del Parlamento Europeo y del Consejo, de 15 de marzo de 2023, por el que se modifican los Reglamentos (UE) 2017\/745 y (UE) 2017\/746 en lo que respecta a las disposiciones transitorias relativas a determinados productos sanitarios y a productos sanitarios para diagn\u00f3stico in vitro<\/a>) que formaliza y hace inmediatamente ejecutiva la pr\u00f3rroga hasta 2027-2028 del per\u00edodo transitorio previsto en el art. 120 MDR (UE) 2017\/745.<\/h2>\n<p>La propuesta de aplazamiento de los plazos se presenta con el objetivo general de garantizar que los pacientes sigan teniendo acceso a una amplia gama de productos, asegurando al mismo tiempo la transici\u00f3n al nuevo marco reglamentario y permitiendo que los productos que se han comercializado, y siguen estando disponibles, permanezcan en el mercado.<\/p>\n<p>Asimismo, cabe recordar que la <strong>ampliaci\u00f3n<\/strong> s\u00f3lo es v\u00e1lida para <strong>los dispositivos heredados<\/strong>, es decir, los que requieren o requerir\u00e1n la intervenci\u00f3n de un organismo notificado. En cuanto a los productos de la clase I (en autodeclaraci\u00f3n) que seguir\u00e1n si\u00e9ndolo, el MDR ya se aplica plenamente a partir del 26\/05\/2021.<\/p>\n<p>El Reglamento 2023\/607 estipulaba que los productos sanitarios con un certificado CE o una declaraci\u00f3n CE de conformidad AIMDD o MDD expedidos antes del 26 de mayo de 2021 y a\u00fan no caducados podr\u00e1n comercializarse o ponerse en servicio hasta determinadas fechas en las siguientes condiciones:<\/p>\n<ul>\n<li>debe mantenerse el cumplimiento de la Directiva 90\/385\/CEE o de la Directiva 93\/42\/CEE, seg\u00fan proceda;<\/li>\n<li>el producto no debe ser objeto de cambios significativos en cuanto a su dise\u00f1o y uso previsto;<\/li>\n<li>los productos no deben presentar un riesgo inaceptable para la salud o la seguridad de los pacientes, usuarios o terceros;<\/li>\n<li>antes del 26 de mayo de 2024, el fabricante deber\u00e1 haber implantado un sistema de gesti\u00f3n de la calidad conforme al MDR;<\/li>\n<li>antes del 26 de mayo de 2024, el fabricante o su representante autorizado deber\u00e1 haber presentado una solicitud de certificaci\u00f3n MDR, y antes del 26 de septiembre de 2024, el Organismo Notificado y el Fabricante deber\u00e1n haber firmado una propuesta\/acuerdo por escrito.<\/li>\n<\/ul>\n<p>Por consiguiente, antes del pr\u00f3ximo <strong>26 de mayo<\/strong>, el fabricante deber\u00e1 haber implantado un sistema de gesti\u00f3n de la calidad conforme al MDR y una solicitud de certificaci\u00f3n MDR.<\/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 MDR (UE) 2017\/745.<\/p>\n<p><strong>Fuente<\/strong><\/p>\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=uriserv%3AOJ.L_.2023.080.01.0024.01.ENG&amp;toc=OJ%3AL%3A2023%3A080%3ATOC\">Reglamento (UE) 2023\/607 del Parlamento Europeo y del Consejo, de 15 de marzo de 2023, por el que se modifican los Reglamentos (UE) 2017\/745 y (UE) 2017\/746 en lo que respecta a las disposiciones transitorias para determinados productos sanitarios y productos sanitarios para diagn\u00f3stico in vitro<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32364,"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-32403","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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