{"id":31531,"date":"2026-02-13T09:42:15","date_gmt":"2026-02-13T12:42:15","guid":{"rendered":"https:\/\/sobelconsult.com\/mdr-and-ivdr-under-review\/"},"modified":"2026-10-24T06:39:59","modified_gmt":"2026-10-24T09:39:59","slug":"mdr-and-ivdr-under-review","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/es\/mdr-and-ivdr-under-review\/","title":{"rendered":"Noticias: MDR e IVDR en revisi\u00f3n, QMSR en vigor y m\u00e1s"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">En los \u00faltimos meses, el sector regulador se ha centrado cada vez m\u00e1s en temas relacionados con la MDR y la IVDR.<\/p>\n\n<p class=\"wp-block-paragraph\">En la \u00faltima edici\u00f3n de Sobel News, cubrimos un <a href=\"https:\/\/sobelconsult.com\/es\/regulatory-impacts-of-the-eu-mdr-ivdr\/\">estudio encargado por la Uni\u00f3n Europea que analiza el impacto de la MDR y la IVDR<\/a> en el mercado de productos sanitarios de la regi\u00f3n.<\/p>\n\n<p class=\"wp-block-paragraph\">Ahora, a finales de enero, Bruselas acogi\u00f3 <strong>debates sobre posibles revisiones del MDR y el IVDR.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Esta actualizaci\u00f3n, junto con importantes novedades normativas en Estados Unidos y China, es el tema central de este art\u00edculo.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-mdr-and-ivdr-under-review-in-the-european-union\"><strong>MDR e IVDR en revisi\u00f3n en la Uni\u00f3n Europea<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">Las autoridades reguladoras de la Uni\u00f3n Europea han presentado <a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2026\/1\/eu-officials-detail-proposed-mdr,-ivdr-revisions\"><strong>propuestas iniciales para revisar el MDR y el IVDR<\/strong><\/a> (Reglamento de Productos Sanitarios y Reglamento de Diagn\u00f3stico In Vitro).<\/p>\n\n<p class=\"wp-block-paragraph\">El objetivo es ajustar las operaciones normativas para reducir los retos a los que se enfrentan los fabricantes durante los procesos de certificaci\u00f3n y mantenimiento.<\/p>\n\n<p class=\"wp-block-paragraph\">Los debates incluyen mejoras en la previsibilidad normativa y posibles ampliaciones de los plazos en situaciones concretas. Tambi\u00e9n abordan los ajustes de los requisitos que afectan a la disponibilidad del producto en el mercado europeo. <\/p>\n\n<p class=\"wp-block-paragraph\">Desde su implantaci\u00f3n, las MDR y las IVDR han aumentado significativamente los requisitos t\u00e9cnicos y de documentaci\u00f3n para los fabricantes, reforzando las normas de seguridad y rendimiento.<\/p>\n\n<p class=\"wp-block-paragraph\">Sin embargo, este marco ha introducido retos, como el aumento de los costes reglamentarios, la complejidad del proceso y la capacidad limitada de los organismos notificados.<\/p>\n\n<p class=\"wp-block-paragraph\">B\u00e1sicamente, las revisiones propuestas pretenden mejorar la eficacia reguladora sin comprometer los objetivos fundamentales.<\/p>\n\n<p class=\"wp-block-paragraph\">Para los fabricantes, los cambios en las MDR y las IVDR pueden afectar a la planificaci\u00f3n reglamentaria, las prioridades del mercado y los plazos del ciclo de vida de los productos.<\/p>\n\n<p class=\"wp-block-paragraph\">Se trata de un tema que se espera que siga siendo muy relevante en los pr\u00f3ximos meses.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-qmsr-c-omes-into-force-in-the-united-states\"><strong>Entra en vigor<\/strong><strong>el QMSR<\/strong><strong>en Estados Unidos<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">En <a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2026\/2\/qmsr-is-live-expert-says-new-rule-may-be-challengi\"><strong>Ha entrado en vigor el nuevo Reglamento del Sistema de Gesti\u00f3n de la Calidad (QMSR) de la FDA,<\/strong><\/a> alineando los requisitos del sistema de calidad de los productos sanitarios con la norma ISO 13485.<\/p>\n\n<p class=\"wp-block-paragraph\">La actualizaci\u00f3n representa un paso importante hacia la armonizaci\u00f3n normativa internacional.<\/p>\n\n<p class=\"wp-block-paragraph\">En la pr\u00e1ctica, introduce ajustes relevantes en las expectativas de cumplimiento para los fabricantes que operan en el mercado estadounidense, <strong>exigiendo <\/strong><a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-usa\/medical-device-quality-consulting\/\"><strong>actualizaciones de los procedimientos internos, la documentaci\u00f3n y los procesos de auditor\u00eda.<\/strong><\/a><\/p>\n\n<figure class=\"wp-block-image aligncenter size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"733\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/FDA-ISO-13485-harmonization.jpg\" alt=\"Manos masculinas sujetando una tableta. Elementos gr&#xE1;ficos que representan un Sistema de Calidad. \" class=\"wp-image-19982\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/FDA-ISO-13485-harmonization.jpg 1000w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/FDA-ISO-13485-harmonization-300x220.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/FDA-ISO-13485-harmonization-768x563.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<h2 class=\"wp-block-heading\" id=\"h-china-launches-plan-to-strengthen-quality-systems-in-the-cosmetics-industry\"><strong>China lanza un plan para reforzar los sistemas de calidad en la industria cosm\u00e9tica<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">Las autoridades reguladoras chinas anunciaron un <a href=\"https:\/\/cisema.com\/en\/cosmetics-quality-system-action-plan\/\">plan de acci\u00f3n 2026-2028<\/a> destinado a <strong>reforzar los sistemas de calidad de los fabricantes de cosm\u00e9ticos.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">La iniciativa incluye una mayor supervisi\u00f3n basada en el riesgo, un control m\u00e1s estricto de las materias primas y una vigilancia continua del cumplimiento durante todo el ciclo de vida del producto.<\/p>\n\n<p class=\"wp-block-paragraph\">Sin duda, esto indica un claro aumento de las expectativas normativas para las empresas que fabrican o exportan al mercado chino.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-publishes-draft-guidance-for-cosmetics\"><strong>La FDA publica un borrador de directrices sobre cosm\u00e9ticos<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">La FDA ha publicado <a href=\"https:\/\/www.fda.gov\/media\/190681\/download\">un proyecto de directrices <strong>en el que se describen las expectativas actualizadas en materia de seguridad y reglamentaci\u00f3n<\/strong><\/a><strong> aplicables a los productos cosm\u00e9ticos.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">El documento <strong>refuerza la necesidad de una documentaci\u00f3n t\u00e9cnica s\u00f3lida, un mantenimiento adecuado de los registros y unas pr\u00e1cticas reforzadas de seguimiento posterior a la comercializaci\u00f3n.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Aunque todav\u00eda son preliminares, las orientaciones indican la futura direcci\u00f3n normativa y permiten a las empresas iniciar los primeros ajustes de sus procesos de cumplimiento.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-quality-traceability-and-regulatory-oversight\"><strong>Calidad, trazabilidad y supervisi\u00f3n reglamentaria<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">Los debates en torno al MDR y el IVDR, combinados con la implantaci\u00f3n del QMSR en Estados Unidos y las nuevas iniciativas reguladoras en China y el sector cosm\u00e9tico estadounidense, demuestran que el entorno regulador mundial sigue avanzando hacia modelos m\u00e1s s\u00f3lidos de calidad, trazabilidad y supervisi\u00f3n.<\/p>\n\n<p class=\"wp-block-paragraph\">Para los fabricantes y las empresas con actividad internacional, vigilar estos cambios e integrar la inteligencia normativa en la estrategia empresarial es esencial para reducir los riesgos, mantener el cumplimiento y mantener la competitividad en unos mercados cada vez m\u00e1s exigentes.<\/p>\n\n<p class=\"wp-block-paragraph\">Tanto si el tema es MDR e IVDR, tendencias normativas sobre cosm\u00e9ticos o nuevas publicaciones de las autoridades reguladoras, en el bolet\u00edn de Sobel encontrar\u00e1s las actualizaciones m\u00e1s importantes del sector.<\/p>\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/sobelconsult.com\/es\/?popup=810\">Suscr\u00edbete gratuitamente a Sobel News Round Up<\/a> y mantente informado sobre las novedades que puedan afectar a tu empresa en los sectores de productos sanitarios, IVD y cosm\u00e9ticos.<\/p>\n\n<p class=\"wp-block-paragraph\">Construir una estrategia reguladora de \u00e9xito requiere estar preparado para las continuas actualizaciones reguladoras globales.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Actualizaciones globales sobre el MDR y el IVDR, el QMSR en EE.UU. y los nuevos requisitos normativos para los cosm\u00e9ticos en China y el mercado estadounidense.<\/p>\n","protected":false},"author":12,"featured_media":31529,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_angie_page":false,"page_builder":"","footnotes":"","_members_access_role":[],"_members_access_error":""},"categories":[140],"tags":[530],"market":[502,498],"content_type":[518],"class_list":["post-31531","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-productos-sanitarios","tag-sistemas-de-calidad-es","market-ee-uu","market-europa-es","content_type-noticias-es"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v28.1) - 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