{"id":35462,"date":"2026-03-27T12:58:21","date_gmt":"2026-03-27T11:58:21","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=35462"},"modified":"2026-03-30T15:55:23","modified_gmt":"2026-03-30T13:55:23","slug":"dos-reglamentos-delegados-de-la-ue-amplian-la-lista-wet-del-mdr","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2026\/03\/27\/dos-reglamentos-delegados-de-la-ue-amplian-la-lista-wet-del-mdr\/","title":{"rendered":"Dos Reglamentos Delegados de la UE ampl\u00edan la lista WET del MDR"},"content":{"rendered":"<p style=\"text-align: right;\"><em><strong>Traducido con IA<\/strong><\/em><\/p>\n<p>El 20 de marzo de 2026, la Comisi\u00f3n Europea adopt\u00f3 dos reglamentos delegados, <a href=\"https:\/\/data.consilium.europa.eu\/doc\/document\/ST-7573-2026-INIT\/it\/pdf\"><strong>C (2026) 1809<\/strong><\/a> y <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=PI_COM:C%282026%291798\"><strong>C (2026) 1798<\/strong><\/a>, que modifican el Reglamento (UE) 2017\/745 (MDR) <strong>ampliando la lista de Well-Established Technologies (WET)<\/strong>.<\/p>\n<p>Estos actos reducen la carga burocr\u00e1tica y financiera para tecnolog\u00edas con seguridad probada y dise\u00f1o estable, introduciendo exenciones <strong>espec\u00edficas al requisito de investigaci\u00f3n cl\u00ednica para los productos implantables y de Clase III,<\/strong> adem\u00e1s de procedimientos simplificados de evaluaci\u00f3n t\u00e9cnica por muestreo para los productos de Clase IIb.<\/p>\n<p>Ambos reglamentos entrar\u00e1n en vigor <strong>20 d\u00edas despu\u00e9s de su publicaci\u00f3n<\/strong> en el Diario Oficial de la Uni\u00f3n Europea (DOUE).<\/p>\n<h3><strong>Reglamento C (2026) 1798: exenci\u00f3n de investigaciones cl\u00ednicas<\/strong><\/h3>\n<p>El reglamento sustituye \u00edntegramente la lista mencionada en el <strong>Art. 61(6)(b) del MDR<\/strong>, incluyendo <strong>nuevos productos que pueden considerarse WET<\/strong>. Adem\u00e1s de los productos ya presentes, tales como suturas, grapas, tornillos y placas, en la lista figuran ahora tipos adicionales de productos, de los que se ofrecen algunos ejemplos desglosados por \u00e1rea cl\u00ednica:<\/p>\n<ul>\n<li><strong>Cardiovascular:<\/strong> cat\u00e9teres (port, de bal\u00f3n, recubiertos), gu\u00edas, electrodos, snares.<\/li>\n<li><strong>Ortopedia y cirug\u00eda:<\/strong> sustitutos \u00f3seos, anclajes, clavos, sistemas de fijaci\u00f3n espinal, espirales y part\u00edculas embolizantes.<\/li>\n<li><strong>Odontolog\u00eda:<\/strong> implantes dentales, coronas, carillas, aparatos de ortodoncia.<\/li>\n<li><strong>Neurocirug\u00eda y otros:<\/strong> drenajes ventriculares, shunts, sondas de alimentaci\u00f3n, instrumentos quir\u00fargicos reutilizables, marcadores radiopacos.<\/li>\n<\/ul>\n<p><strong>El Reglamento aclara que la exenci\u00f3n afecta exclusivamente a la<\/strong> <strong>obligaci\u00f3n de realizar investigaciones cl\u00ednicas<\/strong>; se mantiene el requisito de <strong>planificar, realizar y documentar una evaluaci\u00f3n cl\u00ednica <\/strong>completa durante todo el ciclo de vida del producto. En la pr\u00e1ctica, seg\u00fan el Art. 61(6)(b) del MDR, el fabricante puede <strong>evitar las investigaciones cl\u00ednicas<\/strong> previas a la <strong>comercializaci\u00f3n<\/strong> solo si existe una evaluaci\u00f3n cl\u00ednica basada en <strong>datos cl\u00ednicos suficientes<\/strong> y cumple con las <strong>Especificaciones Comunes (CS)<\/strong> aplicables (Art. 61(9) del MDR).<\/p>\n<p><strong>En resumen:<\/strong> si los productos son WET, no se requieren nuevas investigaciones cl\u00ednicas pre-comercializaci\u00f3n (Art. 61(6)(b)), pero sigue siendo obligatoria la <strong>evaluaci\u00f3n cl\u00ednica <\/strong>basada en datos cl\u00ednicos suficientes (Art. 61(4)).<\/p>\n<h3><strong>Reglamento C (2026) 1809: simplificaci\u00f3n de la evaluaci\u00f3n t\u00e9cnica<\/strong><\/h3>\n<p>De conformidad con el <strong>Art\u00edculo 52(4) del MDR<\/strong>, la Comisi\u00f3n ha ampliado la lista de productos sanitarios <strong>implantables de Clase IIb<\/strong> exentos de la evaluaci\u00f3n de la documentaci\u00f3n t\u00e9cnica para cada producto individual. Los Organismos Notificados podr\u00e1n proceder por <strong>muestreo (sampling basis)<\/strong>, evaluando solo una selecci\u00f3n representativa de los expedientes dentro de una familia de productos.<\/p>\n<p>Entre los nuevos productos de Clase IIb a\u00f1adidos: c\u00e1nulas, cat\u00e9teres, sondas de alimentaci\u00f3n, rellenos y sustitutos \u00f3seos, marcadores radiopacos, sistemas de fijaci\u00f3n vertebral posterior, implantes dentales y dispositivos de ortodoncia.<\/p>\n<h3><strong>\u00bfQu\u00e9 hacer ahora?<\/strong><\/h3>\n<p>Para beneficiarse de las exenciones, los fabricantes deben verificar si sus productos figuran en las nuevas listas y si cumplen los requisitos de la gu\u00eda <strong>MDCG 2020-6<\/strong> para Well-Established Technologies:<\/p>\n<ul>\n<li><strong>Dise\u00f1o com\u00fan y estable:<\/strong> estructura y materiales ampliamente utilizados, con cambios evolutivos limitados.<\/li>\n<li><strong>Perfil de seguridad conocido:<\/strong> historial de uso sin problemas de seguridad sist\u00e9micos ni retiradas recurrentes.<\/li>\n<li><strong>Est\u00e1ndar de cuidado:<\/strong> prestaciones que representen la pr\u00e1ctica cl\u00ednica consolidada para la indicaci\u00f3n espec\u00edfica.<\/li>\n<\/ul>\n<p><strong>&gt;&gt;&gt; Thema<\/strong> ofrece servicios de <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">consultor\u00eda estrat\u00e9gico-regulatoria<\/a> para apoyar a los fabricantes en el mapeo de su cartera de productos y en la definici\u00f3n de la estrategia m\u00e1s eficaz para acceder a las nuevas exenciones y procedimientos simplificados WET.<\/p>\n<p><strong>FUENTES:<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/webgate.ec.europa.eu\/regdel\/#\/delegatedActs\/2643?lang=en\">C(2026) 1798<\/a><\/li>\n<li><a href=\"https:\/\/data.consilium.europa.eu\/doc\/document\/ST-7573-2026-INIT\/it\/pdf\">C(2026) 1809<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Traducido con IA El 20 de marzo de 2026, la Comisi\u00f3n Europea adopt\u00f3 dos reglamentos delegados, C (2026) 1809 y C  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":35455,"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-35462","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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