{"id":33459,"date":"2024-12-18T11:32:38","date_gmt":"2024-12-18T10:32:38","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/12\/18\/mdcg-2024-14-guida-sullimplementazione-del-master-udi-di-per-le-lenti-a-contatto\/"},"modified":"2024-12-20T10:29:36","modified_gmt":"2024-12-20T09:29:36","slug":"mdcg-2024-14-guida-sullimplementazione-del-master-udi-di-per-le-lenti-a-contatto","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/12\/18\/mdcg-2024-14-guida-sullimplementazione-del-master-udi-di-per-le-lenti-a-contatto\/","title":{"rendered":"MDCG 2024-14: Orientaciones sobre la aplicaci\u00f3n del M\u00e1ster UDI-DI para lentes de contacto"},"content":{"rendered":"<p style=\"text-align: right;\">19\/12\/2024<\/p>\n<h2>El 26 de noviembre de 2024, el Grupo de Coordinaci\u00f3n de Productos Sanitarios (MDCG) public\u00f3 <strong>la Gu\u00eda MDCG 2024-14<\/strong>, un documento clave para los <strong>fabricantes de lentes de contacto<\/strong>. La gu\u00eda proporciona instrucciones operativas para implementar el c\u00f3digo <strong>Master Unique Device Identifier (M\u00e1ster UDI-DI)<\/strong>, introducido por <strong>el Reglamento Delegado (UE) 2023\/2197<\/strong> de 10 de julio de 2023. Esta herramienta est\u00e1 dise\u00f1ada para simplificar la identificaci\u00f3n de lentes de contacto, una categor\u00eda de dispositivos caracterizada por una gran variedad de combinaciones cl\u00ednicas y de dise\u00f1o.<\/h2>\n<h2><strong>Antecedentes y marco normativo <\/strong><\/h2>\n<p>El sistema UDI fue introducido por el Reglamento MDR (UE) 2017\/745, que exige que todos los productos sanitarios (excepto los fabricados a medida) se identifiquen mediante un UDI-DI b\u00e1sico, un UDI-DI y un UDI-PI. Adem\u00e1s, los fabricantes deben asegurarse de que los c\u00f3digos UDI aparecen en las etiquetas de los productos, en todos los niveles del embalaje exterior y en la base de datos europea Eudamed para garantizar la trazabilidad de los productos. En esencia, <strong>cada modelo espec\u00edfico <\/strong>de producto sanitario debe tener su propio UDI-DI.<\/p>\n<p>En el caso de las lentes de contacto, la gran variedad de modelos y combinaciones posibles implicar\u00eda manejar un gran n\u00famero de UDI-DI, lo que har\u00eda complejo el sistema. Para simplificar y superar estas dificultades, <strong>el Reglamento Delegado (UE) 2023\/2197<\/strong> introdujo el concepto de<strong> M\u00e1ster UDI &#8211; DI (MUDI),<\/strong> que permite<strong> agrupar lentes de contacto con caracter\u00edsticas similares, <\/strong>manteniendo la trazabilidad y seguridad del producto.<\/p>\n<p>Las actualizaciones se encuentran en las nuevas secciones de <strong>la parte C del anexo VI <\/strong>del Reglamento MDR:<\/p>\n<ul>\n<li>6,6. Dispositivos altamente personalizados<\/li>\n<li>6.1. Lentes de contacto<\/li>\n<li>6.1.1. Lentes de contacto est\u00e1ndar<\/li>\n<\/ul>\n<h2><strong>Lentes de contacto y M\u00e1ster UDI-DI<\/strong><\/h2>\n<p>Las lentes de contacto con la <strong>misma combinaci\u00f3n de par\u00e1metros cl\u00ednicos y de dise\u00f1o<\/strong> (por ejemplo, radio y di\u00e1metro de la base) deben agruparse bajo el mismo M\u00e1ster UDI-DI (MUDI).<\/p>\n<p>La Gu\u00eda <strong>MDCG 2024-14<\/strong> explica c\u00f3mo asignar el MUDI seg\u00fan el tipo de lente, <strong>est\u00e1ndar <\/strong>o <strong>personalizada<\/strong>.\u00a0 Por ejemplo, un UDI-DI debe asignarse a <strong>lentes de contacto est\u00e1ndar<\/strong> que tengan la misma combinaci\u00f3n de par\u00e1metros de dise\u00f1o, incluyendo al menos la curva base y el di\u00e1metro, es decir, el MUDI est\u00e1 vinculado a un grupo de par\u00e1metros de dise\u00f1o. El etiquetado debe incluir c\u00f3digos AIDC (Automatic Identification and Data Capture) y HRI (Human Readable Interpretation), conformes con las normas GS1, garantizando as\u00ed la trazabilidad completa de los dispositivos.<\/p>\n<p>El MUDI debe actualizarse en caso de <strong>cambios<\/strong> que puedan afectar a la identificaci\u00f3n del producto, como cambios en los par\u00e1metros de dise\u00f1o, cambios en el nombre comercial, versi\u00f3n o modelo, actualizaciones en el etiquetado (por ejemplo, producto desechable o esterilizaci\u00f3n).<\/p>\n<p>Los fabricantes deben incluir el UDI completo en <strong>los informes de vigilancia<\/strong>, como el Informe de Incidentes del Fabricante (MIR).<\/p>\n<h2><strong>Plazo de aplicaci\u00f3n<\/strong><\/h2>\n<p>El UDI-DI M\u00e1ster para lentes de contacto ser\u00e1 obligatorio a partir del <strong>9 de noviembre de 2025<\/strong>, pero los fabricantes pueden adoptarlo voluntariamente ya durante el periodo de transici\u00f3n.<\/p>\n<p>La<strong> Gu\u00eda 2024-14 del MDCG<\/strong> es una referencia esencial para los fabricantes de lentes de contacto, ya que proporciona un marco claro para implementar el UDI-DI M\u00e1ster y garantizar el cumplimiento de los requisitos del MDR.<\/p>\n<p>Para m\u00e1s detalles, consulte la directriz completa: <a href=\"https:\/\/health.ec.europa.eu\/document\/download\/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf\"><strong>MDCG 2024-14:<\/strong><\/a><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf\"><strong> Guidance on the implementation of the Master UDI-DI solution for contact lenses<\/strong><\/a><\/p>\n<p><strong>&gt;&gt;&gt;<\/strong> Prepararse con antelaci\u00f3n para la fecha l\u00edmite del 9 de noviembre de 2025 es crucial. Los expertos en normativa de Thema ofrecen <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>asistencia<\/strong><\/a> integral para lograr la conformidad del etiquetado de todos los productos sanitarios, incluidas las lentes de contacto.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>19\/12\/2024 El 26 de noviembre de 2024, el Grupo de Coordinaci\u00f3n de Productos Sanitarios (MDCG) public\u00f3 la Gu\u00eda MDCG 2024-14, un  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33414,"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-33459","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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