{"id":33686,"date":"2025-02-18T16:32:12","date_gmt":"2025-02-18T15:32:12","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=33686"},"modified":"2025-06-16T16:38:27","modified_gmt":"2025-06-16T14:38:27","slug":"transicion-ivdr-australia-y-suiza-se-alinean-con-la-union-europea","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2025\/02\/18\/transicion-ivdr-australia-y-suiza-se-alinean-con-la-union-europea\/","title":{"rendered":"Transici\u00f3n IVDR: Australia y Suiza se alinean con la Uni\u00f3n Europea"},"content":{"rendered":"<h1><span lang=\"ES\">Transici\u00f3n IVDR: Australia y Suiza se alinean con la Uni\u00f3n Europea<\/span><\/h1>\n<p>En los \u00faltimos a\u00f1os, tanto Australia como Suiza han dado pasos importantes para armonizar sus normativas con la Uni\u00f3n Europea, en particular el <strong>Reglamento (UE) 2017\/746<\/strong> sobre productos sanitarios para diagn\u00f3stico in vitro (IVD). Estos esfuerzos reflejan una tendencia mundial hacia el <strong>cumplimiento del IVDR<\/strong>, que garantiza una mayor coherencia y seguridad en el sector de los productos sanitarios.<\/p>\n<h2>Ampliaci\u00f3n de los periodos transitorios para la plena aplicaci\u00f3n del Reglamento IVDR en la Uni\u00f3n Europea<\/h2>\n<p>El Reglamento (UE) 2017\/746 entr\u00f3 en vigor el 26 de mayo de 2017 y pas\u00f3 a ser aplicable el 26 de mayo de 2022, con un per\u00edodo transitorio inicial de cinco a\u00f1os. Para garantizar una transici\u00f3n fluida, se introdujeron <strong>disposiciones transitorias del IVDR<\/strong>, diferenciadas en funci\u00f3n de la clase de riesgo de los productos y de la certificaci\u00f3n que posean.<\/p>\n<p>La \u00faltima revisi\u00f3n del calendario se produjo con el <a href=\"https:\/\/www.trovanorme.salute.gov.it\/norme\/renderNormsanPdf?anno=2024&amp;codLeg=102506&amp;parte=1%20&amp;serie=S2\"><strong>Reglamento (UE) 2024\/1860 <\/strong><\/a>\u00a0publicado el <strong>9 de julio de 2024<\/strong> en el Diario Oficial de la Uni\u00f3n Europea, con el fin de dar a los fabricantes m\u00e1s tiempo para cumplir la normativa y evitar la escasez de productos sanitarios p\u00fablicos esenciales.<\/p>\n<h2><span lang=\"ES\">Australia ampl\u00eda el r\u00e9gimen transitorio para los IVD<\/span><\/h2>\n<p>En consonancia con los plazos europeos, el <strong>10 de enero de 2025<\/strong>, la Administraci\u00f3n de Productos Terap\u00e9uticos de Australia (TGA) anunci\u00f3 la ampliaci\u00f3n de las disposiciones transitorias para los IVD, lo que permite a los fabricantes <strong>seguir<\/strong> <strong>utilizando los certificados CE expedidos en virtud de la Directiva 98\/79\/CE (IVD)<\/strong> como prueba de conformidad, hasta las fechas siguientes:<\/p>\n<ul>\n<li><strong>1 de enero de 2028<\/strong>: para productos de la clase 4 de IVD (equivalente a la clase D en la UE).<\/li>\n<li><strong>1 de enero de 2029<\/strong>: para productos de la clase 3 de IVD (equivalente a la clase C en la UE).<\/li>\n<li><strong>1 de enero de 2030<\/strong>: para los productos IVD de clase 2 (equivalentes a los de clase B en la UE).<\/li>\n<\/ul>\n<p>Por lo tanto, los fabricantes que soliciten el registro de un dispositivo de DIV en el Registro Australiano de Productos Terap\u00e9uticos (ARTG) tienen ahora m\u00e1s opciones que explotar para cumplir el requisito de <em>Manufacturer Evidence<\/em> en apoyo de una solicitud.<\/p>\n<p>Estas medidas reducen la carga de obtener nuevas pruebas de conformidad. Adem\u00e1s, la TGA introdujo una opci\u00f3n para los fabricantes de IVD de clase 2 y 3, permitiendo el uso de la Declaraci\u00f3n de Conformidad (DoC) de IVD de la UE realizada antes del 26 de mayo de 2022 como <strong>Prueba del Fabricante<\/strong> hasta los plazos especificados.<\/p>\n<h2><span lang=\"ES\">Suiza adapta su legislaci\u00f3n al Reglamento IVDR de la UE <\/span><\/h2>\n<p>A partir <strong>del 1 de enero de 2025<\/strong>, Suiza ha actualizado <strong>la Ordenanza sobre productos sanitarios para diagn\u00f3stico in vitro (IvDO)<\/strong>, adapt\u00e1ndola a los recientes cambios introducidos en el IVDR de la UE. Las principales novedades son:<\/p>\n<ul>\n<li><strong>Pr\u00f3rroga de la validez de los certificados de IVDD <\/strong>hasta 2027, 2028 o 2029<\/li>\n<li>La implantaci\u00f3n gradual de <strong>EUDAMED<\/strong>, la base de datos europea de productos sanitarios.<\/li>\n<\/ul>\n<p>Estos cambios restablecen la equivalencia normativa con la UE, garantizando una mayor coherencia en la regulaci\u00f3n de los IVD.<\/p>\n<h2><span lang=\"ES\">Otros pa\u00edses siguen el ejemplo europeo<\/span><\/h2>\n<p>Adem\u00e1s de Australia y Suiza, otros pa\u00edses est\u00e1n tomando medidas para armonizar sus normativas sobre IVD con el Reglamento (UE) 2017\/746 sobre IVD de la Uni\u00f3n Europea.<\/p>\n<p>Estos avances confirman la tendencia mundial hacia la armonizaci\u00f3n de las normativas sobre productos sanitarios para diagn\u00f3stico in vitro, con el objetivo de garantizar unos elevados niveles de seguridad y calidad para los pacientes y los profesionales sanitarios de todo el mundo, y promover la difusi\u00f3n de productos sanitarios seguros.<\/p>\n<p><strong>&gt;&gt;&gt;<\/strong> Con un enfoque estrat\u00e9gico, los expertos en reglamentaci\u00f3n de Thema le ayudan a obtener el <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>marcado CE<\/strong><\/a> para productos sanitarios y productos sanitarios para diagn\u00f3stico in vitro, acelerando la entrada de su producto en el mercado europeo.<\/p>\n<p>FUENTES:<br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/dfd7a1c6-f319-4682-9bac-77bef1165818_en?filename=mdr_qna-ext-ivdr.pdf\">https:\/\/health.ec.europa.eu\/document\/download\/dfd7a1c6-f319-4682-9bac-77bef1165818_en?filename=mdr_qna-ext-ivdr.pdf<\/a><\/p>\n<p><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/news\/mitteilungen\/anpassung-verordnung-ivd.html\">https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/news\/mitteilungen\/anpassung-verordnung-ivd.html<\/a><\/p>\n<p><strong>M\u00e1s informaci\u00f3n sobre el calendario de aplicaci\u00f3n del IVDR (UE) 2017\/746 en la Uni\u00f3n Europea<\/strong>: <strong>\u201c<\/strong><a href=\"uropa.eu\/document\/download\/dfd7a1c6-f319-4682-9bac-77bef1165818_en?filename=mdr_qna-ext-ivdr.pdf\"><strong>Ampliaci\u00f3n de los periodos transitorios del IVDR\u201d<\/strong><\/a><\/p>\n<p>&nbsp;<\/p>\n<p><em>18\/02\/2025<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Transici\u00f3n IVDR: Australia y Suiza se alinean con la Uni\u00f3n Europea En los \u00faltimos a\u00f1os, tanto Australia como Suiza han dado  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33682,"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":[1660,1658,1659],"class_list":["post-33686","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es","tag-ivdr-es-2","tag-transicion-ivdr","tag-union-europea"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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