{"id":31397,"date":"2023-12-15T16:31:15","date_gmt":"2023-12-15T15:31:15","guid":{"rendered":"https:\/\/www.thema-med.com\/2023\/12\/15\/italia-applicazione-regolamento-607-a-banca-dati-ministeriale-2\/"},"modified":"2023-12-15T16:36:56","modified_gmt":"2023-12-15T15:36:56","slug":"italia-applicazione-regolamento-607-a-banca-dati-ministeriale-2","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/12\/15\/italia-applicazione-regolamento-607-a-banca-dati-ministeriale-2\/","title":{"rendered":"EUROPA: Aceleraci\u00f3n necesaria para las certificaciones MDR e IVDR de la CE"},"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 noviembre, el Grupo de Coordinaci\u00f3n de Productos Sanitarios (<strong>MDCG<\/strong>) aprob\u00f3 la <strong>revisi\u00f3n de<\/strong> la directriz <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-11\/mdcg_2022-11_en.pdf\">MDCG 2022-11, <em>Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements<\/em><\/a>. En concreto, se ha modificado la secci\u00f3n \u201c<em>Call to manufacturers to transition to the Regulations and submit their applications for certification without further delay<\/em>\u201d, en la que se anima a los fabricantes a <strong>solicitar la certificaci\u00f3n CE <\/strong>de conformidad con MDR o IVDR para sus productos sanitarios sin m\u00e1s demora, pero tambi\u00e9n se ha a\u00f1adido una nueva secci\u00f3n \u201c<em>Call to notified bodies to streamline the certification process\u201d <\/em>en la que se invitan a los organismos notificados a <strong>agilizar el \u00a0proceso decertificaci\u00f3n<\/strong>.<\/h2>\n<p>El MDCG reconoce los esfuerzos de los numerosos fabricantes que ya han adaptado su Sistema de Gesti\u00f3n de la Calidad a la normativa europea. Sin embargo, los datos facilitados por los Organismos Notificados en junio de 2023 muestran <strong>un progreso limitado en cuanto a solicitudes presentadas y certificados expedidos<\/strong>. De hecho, frente a los m\u00e1s de 24.000 certificados expedidos en virtud de las Directivas 90\/385\/CEE y 93\/42\/CEE, solo se presentaron unas 13.000 solicitudes de MDR y se expidieron unos 3.900 certificados. Adem\u00e1s, unos 1.000 de estos \u00faltimos est\u00e1n relacionados con actualizaciones.<\/p>\n<p>En consecuencia, los fabricantes prefieren transferir dispositivos para incluirlos en el mismo certificado en distintos momentos. Sin embargo, este planteamiento podr\u00eda crear <strong>problemas en la planificaci\u00f3n<\/strong> y la <strong>capacidad de los organismos notificados<\/strong>. Adem\u00e1s, sus datos muestran que la mayor\u00eda de las solicitudes de los fabricantes est\u00e1n <strong>incompletas<\/strong>, lo que provoca m\u00e1s retrasos en el proceso de certificaci\u00f3n.<\/p>\n<p>Por lo tanto, para mejorar la eficacia del proceso y garantizar una transici\u00f3n fluida, el MDCG insta a los fabricantes a <strong>aprovechar al m\u00e1ximo el<\/strong> <strong>tiempo adicional<\/strong> que concede el Reglamento 2023\/607, presentando las solicitudes de evaluaci\u00f3n de la conformidad con la debida antelaci\u00f3n.<\/p>\n<p>En la directriz, el MDCG tambi\u00e9n insta a los organismos notificados a <strong>agilizar el proceso de certificaci\u00f3n<\/strong>. De hecho, es esencial que simplifiquen sus procedimientos y realicen todos los esfuerzos necesarios para mejorar sus actividades de evaluaci\u00f3n de la conformidad en t\u00e9rminos de transparencia, calendario, previsibilidad y coherencia.<\/p>\n<p>En conclusi\u00f3n, se insta a los fabricantes a intensificar sus esfuerzos para efectuar la transici\u00f3n lo antes posible y a <strong>no retrasar<\/strong>m\u00e1s la presentaci\u00f3n de solicitudes, ya que esto podr\u00eda provocar atascos en el trabajo de los organismos notificados y posibles <strong>fallos de<\/strong> los productos en el mercado. Precisamente por estas razones, los Organismos Notificados han recomendado encarecidamente presentar las solicitudes <strong>antes de finales de 2023<\/strong>. Por su parte, se pide a los organismos notificados que <strong>ayuden<\/strong> <strong>adecuadamente<\/strong> <strong>a<\/strong> los fabricantes con orientaciones normativas e informaci\u00f3n t\u00e9cnica sobre c\u00f3mo solicitar los procedimientos de evaluaci\u00f3n de la conformidad, a fin de acelerar el proceso de certificaci\u00f3n y evitar las solicitudes incompletas, que se han identificado como una de las causas m\u00e1s importantes de los retrasos.<\/p>\n<p><strong>&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>, apoyo a 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>\u00a0<\/a>y si es 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 proporcionar apoyo en la implementaci\u00f3n de los requisitos del Reglamento de Dispositivos M\u00e9dicos MDR (UE) 2017\/745 y el Reglamento de Dispositivos de Diagn\u00f3stico In Vitro IVDR (UE) 2017\/746.<\/p>\n<p><strong>Fuente<\/strong><\/p>\n<p><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-11\/mdcg_2022-11_en.pdf\">MDCG 2022-11, Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":31388,"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-31397","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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