{"id":33178,"date":"2024-10-18T11:20:45","date_gmt":"2024-10-18T09:20:45","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/10\/18\/pubblicata-linea-guida-mdcg-2024-11-per-la-qualificazione-degli-ivd\/"},"modified":"2024-10-18T14:15:58","modified_gmt":"2024-10-18T12:15:58","slug":"pubblicata-linea-guida-mdcg-2024-11-per-la-qualificazione-degli-ivd","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/10\/18\/pubblicata-linea-guida-mdcg-2024-11-per-la-qualificazione-degli-ivd\/","title":{"rendered":"Publicada la directriz 2024-11 del MDCG para la cualificaci\u00f3n de los IVD"},"content":{"rendered":"<p style=\"text-align: right;\">18\/10\/2024<\/p>\n<h2>El 8 de octubre de 2024, el Grupo de Coordinaci\u00f3n de Productos Sanitarios (MDCG) de la Comisi\u00f3n Europea public\u00f3 la directriz <a href=\"https:\/\/health.ec.europa.eu\/document\/download\/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf\"><strong>MDCG 2024-11<\/strong><\/a><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf\"><strong> &#8211; Guidance on qualification of in vitro diagnostic medical devices<\/strong><\/a> para la <strong>cualificaci\u00f3n de<\/strong> <strong>productos sanitarios para diagn\u00f3stico in vitro (IVD<\/strong>).<\/h2>\n<p>El objetivo de este documento es aclarar qu\u00e9 productos entran en el \u00e1mbito de aplicaci\u00f3n del <strong>Reglamento IVDR (UE) 2017\/746 <\/strong>sobre productos sanitarios para diagn\u00f3stico in vitro (IVD), es decir, c\u00f3mo un producto puede calificarse como <strong>dispositivo IVD<\/strong> o <strong>accesorio de un IVD<\/strong>. Como indica la propia gu\u00eda, \u00abpara ser considerado un IVD o un accesorio de un IVD, el producto debe ajustarse a la definici\u00f3n del <strong>art\u00edculo 2<\/strong>, <strong>apartado 2,<\/strong> o del <strong>art\u00edculo 2, apartado 4, del Reglamento sobre IVD<\/strong>, respectivamente\u00bb. La cualificaci\u00f3n depende de la <strong>finalidad prevista <\/strong>por el fabricante\u00bb.<br \/>\nEl documento de orientaci\u00f3n sustituye y en gran medida incorpora las directrices anteriores de MEDDEV, incluido en particular <strong>MEDDEV 2.14\/1, Rev. 2 de 2012<\/strong>, que fue crucial para la cualificaci\u00f3n de los IVD en virtud de la Directiva 98\/79\/CE. La nueva gu\u00eda MDCG ya est\u00e1 disponible con referencia al Reglamento IVDR y tiene en su mayor parte el mismo contenido que MEDDEV con <strong>algunas modificaciones<\/strong>.<\/p>\n<p>MDCG 2024-11 no solo actualiza el contenido de las directrices anteriores, sino que tambi\u00e9n incluye nuevas secciones para reflejar la evoluci\u00f3n del sector y la inclusi\u00f3n de nuevas tecnolog\u00edas. En particular:<\/p>\n<ul>\n<li><strong>Secci\u00f3n 2.8<\/strong> sobre el software asociado a los IVD. Seg\u00fan la directriz 2024-11 del MDCG, un programa inform\u00e1tico puede considerarse un IVD si se utiliza para proporcionar informaci\u00f3n derivada de una prueba diagn\u00f3stica en muestras biol\u00f3gicas (por ejemplo, sangre, orina, tejidos), analiza o interpreta datos obtenidos de un dispositivo IVD, se utiliza para apoyar decisiones cl\u00ednicas sobre la salud de un paciente (por ejemplo, identificaci\u00f3n de pat\u00f3genos, seguimiento de biomarcadores). El documento aborda los criterios de cualificaci\u00f3n de los productos que utilizan <strong>programas inform\u00e1ticos aut\u00f3nomos<\/strong>, aclarando que <strong>un programa inform\u00e1tico<\/strong> puede considerarse <strong>IVD<\/strong> aunque <strong>\u00abno analice directamente muestras humanas\u00bb<\/strong>, siempre que procese informaci\u00f3n pertinente para el diagn\u00f3stico. Se trata de un nuevo punto para la regulaci\u00f3n de programas inform\u00e1ticos cada vez m\u00e1s complejos y avanzados, como los basados en inteligencia artificial o aprendizaje autom\u00e1tico.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li><strong>La secci\u00f3n 2.11<\/strong> aclara la clasificaci\u00f3n de las pruebas utilizadas para <strong>controlar la producci\u00f3n <\/strong>de otros productos, como los medicamentos. Seg\u00fan esta secci\u00f3n, las pruebas utilizadas para controlar los procesos de producci\u00f3n de productos que no sean IVD, como medicamentos o productos qu\u00edmicos, no deben considerarse productos sanitarios para diagn\u00f3stico in vitro (IVD). Esta secci\u00f3n elimina las ambig\u00fcedades relativas a la cualificaci\u00f3n de las pruebas utilizadas en los procesos de producci\u00f3n. <strong>No todas las pruebas de diagn\u00f3stico relacionadas con la producci\u00f3n de productos m\u00e9dicos se consideran<\/strong> <strong>IVD<\/strong>; solo las que se ajustan a la definici\u00f3n de IVD, tal como se establece en el Reglamento IVD, pueden clasificarse como tales. Por lo tanto, los fabricantes deben ser conscientes de que las pruebas utilizadas exclusivamente para el control de calidad en los procesos de producci\u00f3n no necesitan cumplir con el Reglamento IVDR (UE) 2017\/746.<\/li>\n<\/ul>\n<p>Adem\u00e1s, se han <strong>eliminado algunas secciones obsoletas<\/strong> de la directriz, como la comparaci\u00f3n entre los dispositivos de PCR (Polymerase Chain Reaction) de uso general y los IVD. Esto refleja la evoluci\u00f3n de las pr\u00e1cticas reguladoras y las tecnolog\u00edas en los a\u00f1os transcurridos desde la introducci\u00f3n del IVDR.<\/p>\n<p>Adem\u00e1s, <strong>se actualizaron los ejemplos pr\u00e1cticos<\/strong> y se introdujeron algunos casos concretos, lo que mejor\u00f3 la adecuaci\u00f3n de las directrices al estado actual de la tecnolog\u00eda.<\/p>\n<p>En resumen, el MDCG 2024-11 moderniza y ampl\u00eda el contenido del MEDDEV 2.14\/1 para adecuarlo al nuevo marco normativo, incorporando nuevas tecnolog\u00edas y aclarando categor\u00edas de productos relevantes, como el software como IVD.<\/p>\n<p>Estas nuevas directrices tienen como objetivo proporcionar una mayor claridad a los fabricantes en el proceso de cualificaci\u00f3n IVD y facilitar una transici\u00f3n m\u00e1s suave a los requisitos del Reglamento IVDR (UE) 2017\/746.<\/p>\n<p><strong>&gt;&gt;&gt;<\/strong> Con sus servicios de <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-svizzero\/\"><strong>consultor\u00eda estrat\u00e9gica-regulatoria<\/strong><\/a>, Thema le acompa\u00f1a en todas las etapas de la comercializaci\u00f3n de productos sanitarios para diagn\u00f3stico in vitro, desde la cualificaci\u00f3n del producto hasta la gesti\u00f3n post-comercializaci\u00f3n, en cumplimiento de los requisitos del Reglamento IVDR (UE) 2017\/746.<\/p>\n<p><strong>FUENTES:<\/strong><br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf\"><strong>MDCG 2024-11<\/strong><\/a><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf\"><strong>\u2014Guidance on qualification of in vitro diagnostic medical devices<\/strong><\/a><\/p>\n<p><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/10322\/attachments\/1\/translations\"><strong>Guidance document &#8211; In vitro diagnostic medical devices &#8211; Borderline and Classification issues. A guide for manufacturers and notified bodies &#8211; MEDDEV 2.14\/1 rev. 2<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>18\/10\/2024 El 8 de octubre de 2024, el Grupo de Coordinaci\u00f3n de Productos Sanitarios (MDCG) de la Comisi\u00f3n Europea public\u00f3 la  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33166,"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-33178","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 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Publicada la directriz 2024-11 del MDCG para la cualificaci\u00f3n de los IVD - 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