{"id":15417,"date":"2020-08-20T14:23:15","date_gmt":"2020-08-20T12:23:15","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=15417"},"modified":"2020-08-20T14:23:15","modified_gmt":"2020-08-20T12:23:15","slug":"ivdr-2017-746-regulacion-ue","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2020\/08\/20\/ivdr-2017-746-regulacion-ue\/","title":{"rendered":"\u00bfCu\u00e1l es el Reglamento de productos sanitarios para diagn\u00f3stico in vitro IVDR (UE) 2017\/746 y cuando se aplica?"},"content":{"rendered":"\n<p>El<strong> Reglamento de productos sanitarios para diagn\u00f3stico <em>in vitro <\/em>IVDR (UE) 2017\/746 <\/strong>regula la comercializaci\u00f3n, la puesta a disposici\u00f3n y la puesta en servicio de productos sanitarios para diagn\u00f3stico <em>in vitro <\/em>en el mercado europeo. El IVDR se public\u00f3 el 5 de mayo de 2017 y entr\u00f3 en vigor el 26 de mayo de 2017, reemplazando la directive 98\/79\/CE de la Uni\u00f3n Europea sobre productos sanitarios para diagn\u00f3stico <em>in vitro.<\/em><\/p>\n\n\n\n<p>La plena aplicaci\u00f3n del Reglamento IVDR (UE) estaba programada para el 26 de mayo de 2022, pero como consecuencia de los retrasos y dificultades del sector, amplificados por las consecuencias de la pandemia de COVID-19, el Consejo de la Uni\u00f3n Europea y el Parlamento Europeo &#8211; con una enmienda publicada el 15 de diciembre de 2021 &#8211; han cambiado el calendario y han autorizado una <strong>introducci\u00f3n gradual<\/strong> del Reglamento IVDR (UE) 2017\/746.<\/p>\n\n\n\n<p>Se han establecido<strong> nuevos periodos de transici\u00f3n <\/strong>para<strong> la\naplicaci\u00f3n del reglamento <\/strong>seg\u00fan las<strong> clases de riesgo de los productos\nsanitario DIV.<\/strong><\/p>\n\n\n\n<p>De esta manera, muchos operadores del sector tienen m\u00e1s tiempo para cumplir\nel Reglamento, pero la fecha de comienzo de la plena aplicaci\u00f3n del Reglamento\n(<strong>el 26 de mayo de 2022<\/strong>) no se modifica, empezando por los <strong>productos DIV\nno est\u00e9riles de la clase A<\/strong>.<\/p>\n\n\n\n<p>Los pr\u00f3ximos plazos para cumplir con el IVDR (UE) 2017\/746 son los siguientes:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>el\n26 de mayo de 2025<\/strong> en el\ncaso de los productos de mayor riesgo (<strong>clase D<\/strong>);<\/li><li><strong>el\n26 de mayo de 2026<\/strong> en el\ncaso de los productos de la <strong>clase C<\/strong>;<\/li><li><strong>el\n26 de mayo de 2027<\/strong> en el\ncaso de los productos de la <strong>clase B<\/strong> y los de la <strong>clase A <\/strong>introducidos\nen el mercado <strong>en condiciones est\u00e9riles.<\/strong><\/li><\/ul>\n\n\n\n<p>Para los <strong>productos sanitarios para diagn\u00f3stico <em>in vitro <\/em>con el marcado CE <\/strong>que<strong> no necesitan la intervenci\u00f3n <\/strong>de un<strong> organismo notificado, <\/strong>el Reglamento<strong> IVDR (UE) 2017\/746 se aplica <\/strong>desde el<strong> 26 de mayo de 2022. <\/strong><\/p>\n\n\n\n<p><strong><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/\">Descubre los servicios de asesoramiento estrat\u00e9gico-regulador Thema<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El Reglamento de productos sanitarios para diagn\u00f3stico in vitro IVDR (UE) 2017\/746 regula la comercializaci\u00f3n, la puesta a disposici\u00f3n y la  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[891,1019],"tags":[],"class_list":["post-15417","post","type-post","status-publish","format-standard","hentry","category-faq-es","category-ivdr-es-faq-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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