{"id":34433,"date":"2025-07-10T12:20:05","date_gmt":"2025-07-10T10:20:05","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34433"},"modified":"2025-07-10T15:01:36","modified_gmt":"2025-07-10T13:01:36","slug":"como-debe-figurar-el-udi-en-la-etiqueta-y-el-embalaje-del-producto","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/como-debe-figurar-el-udi-en-la-etiqueta-y-el-embalaje-del-producto\/","title":{"rendered":"\u00bfC\u00f3mo debe figurar el UDI en la etiqueta y el embalaje del producto?"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>El c\u00f3digo UDI debe aplicarse en lugares espec\u00edficos para garantizar la m\u00e1xima accesibilidad y legibilidad:<\/p>\n<ul>\n<li><strong>En <\/strong><strong>todos los niveles del envase<\/strong>: en la etiqueta del <strong>envase<\/strong> <strong>primario <\/strong>(el primer envoltorio que entra en contacto directo con el dispositivo o producto) y en el <strong>envase secundario <\/strong>(el envoltorio exterior que contiene uno o varios envases primarios).<\/li>\n<li><strong>Directamente en el propio aparato<\/strong> <strong>(marcado UDI permanente<\/strong>): si es t\u00e9cnicamente factible y si el aparato est\u00e1 destinado a la reutilizaci\u00f3n. En este caso, se suele utilizar un c\u00f3digo DataMatrix grabado de forma permanente.<\/li>\n<\/ul>\n<p>Con respecto al embalaje terciario, que se utiliza normalmente para el env\u00edo, no hay obligaci\u00f3n de notificar el UDI del dispositivo individual, aunque puede contener c\u00f3digos UDI de agregaci\u00f3n.<\/p>\n<p><strong>El UDI debe aparecer en dos formatos complementarios:<\/strong><\/p>\n<ul>\n<li><strong>AIDC (Automatic Identification and Data Capture)<\/strong>: formato legible por esc\u00e1neres y sistemas automatizados (por ejemplo, DataMatrix, c\u00f3digo de barras lineal).<\/li>\n<li><strong>HRI (Human Readable Interpretation)<\/strong>: formato de texto claro legible por humanos.<\/li>\n<\/ul>\n<p><strong>Excepciones y normas adicionales:<\/strong><\/p>\n<ul>\n<li><strong>Espacio <\/strong><strong>limitado<\/strong>: si el espacio de la etiqueta es demasiado peque\u00f1o, s\u00f3lo se requiere el formato AIDC.<\/li>\n<li><strong>Dispositivos para uso fuera de centros sanitarios <\/strong>(por ejemplo, asistencia domiciliaria): para estos dispositivos, la parte legible por humanos (HRI) es siempre obligatoria, incluso si esto impidiera la inclusi\u00f3n del formato escaneable (AIDC).<\/li>\n<li><strong>Jerarqu\u00eda de embalaje<\/strong>: si el UDI no puede colocarse en la unidad de embalaje por falta de espacio, puede colocarse en el nivel de embalaje inmediatamente superior, que debe tener su propio UDI \u00fanico.<\/li>\n<li><strong>Productos <\/strong><strong>desechables de clase I y IIa (productos sanitarios) y de clase A y B (IVD) embalados individualmente<\/strong>: para estos productos, no se requiere el soporte de UDI en el embalaje de la unidad individual, siempre que el soporte de UDI se coloque en el siguiente nivel superior de embalaje y pueda ser f\u00e1cilmente identificado y recuperado por el usuario.<\/li>\n<li><strong>Dispositivos destinados \u00fanicamente a la venta al por menor<\/strong>: el UDI en formato AIDC no es obligatorio si se sustituye por un c\u00f3digo de barras est\u00e1ndar EAN\/UPC.<\/li>\n<li><strong>Transparencia del<\/strong> <strong>envase:<\/strong> si el UDI ya es claramente legible o escaneable a trav\u00e9s del envase, no hay necesidad de un soporte UDI adicional en el envase.<\/li>\n<\/ul>\n<p>Para m\u00e1s detalles, v\u00e9ase la Secci\u00f3n 4 del Anexo VI Parte C de los Reglamentos MDR e IVDR.<\/p>\n<p><strong><em>Ejemplos de colocaci\u00f3n de UDI en productos sanitarios<\/em><\/strong><\/p>\n<\/div><div class=\"fusion-image-element \" style=\"--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1920\" height=\"1080\" title=\"4ES\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/4ES.png\" alt class=\"img-responsive wp-image-34435\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/4ES-200x113.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/4ES-400x225.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/4ES-600x338.png 600w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/4ES-800x450.png 800w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/4ES-1200x675.png 1200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/4ES.png 1920w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"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":[891,1911],"tags":[],"class_list":["post-34433","post","type-post","status-publish","format-standard","hentry","category-faq-es","category-udi-en-productos-sanitarios"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u00bfC\u00f3mo debe figurar el UDI en la etiqueta y el embalaje del producto? 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