{"id":2642,"date":"2020-11-09T09:30:25","date_gmt":"2020-11-09T12:30:25","guid":{"rendered":"https:\/\/noticias.gs1.org.ar\/?p=2642"},"modified":"2020-11-09T09:30:25","modified_gmt":"2020-11-09T12:30:25","slug":"una-novedad-europea-el-basic-udi-di","status":"publish","type":"post","link":"https:\/\/codigon.gs1.org.ar\/index.php\/2020\/11\/09\/una-novedad-europea-el-basic-udi-di\/","title":{"rendered":"Una novedad europea: el Basic UDI-DI"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large is-style-default\"><img loading=\"lazy\" decoding=\"async\" width=\"840\" height=\"472\" src=\"https:\/\/codigon.gs1.org.ar\/wp-content\/uploads\/2020\/11\/UDI-UE.jpg\" alt=\"\" class=\"wp-image-2644\" srcset=\"https:\/\/codigon.gs1.org.ar\/wp-content\/uploads\/2020\/11\/UDI-UE.jpg 840w, https:\/\/codigon.gs1.org.ar\/wp-content\/uploads\/2020\/11\/UDI-UE-300x169.jpg 300w, https:\/\/codigon.gs1.org.ar\/wp-content\/uploads\/2020\/11\/UDI-UE-768x432.jpg 768w\" sizes=\"auto, (max-width: 840px) 100vw, 840px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Junto al UDI para dispositivos m\u00e9dicos y diagn\u00f3sticos in-vitro, la reglamentaci\u00f3n UE ha introducido para la comercializaci\u00f3n en Europa un nuevo identificador: el Basic UDI-DI, que no se reporta sobre la etiqueta del producto, sino sobre la documentaci\u00f3n t\u00e9cnica relacionada con el producto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Qu\u00e9 se identifica con el Basic UDI-DI? Su definici\u00f3n oficial es la de \u201cidentificador primario de una familia de dispositivos. Es la llave principal para la registraci\u00f3n en la base de datos EUDAMED y se cita en los certificados relacionados y en las declaraciones de conformidad UE\u201d. En otros t\u00e9rminos, identifica un grupo de dispositivos con caracter\u00edsticas similares. \u201cPor ejemplo \u2013 explica Giada Necci, especialista de GS1 Italia \u2013 jeringas con agujas de 10-12 \u00f3 14mm, en t\u00e9rminos de UDI-DI, tienen cada una un c\u00f3digo identificador propio, pero de hecho son el mismo producto con caracter\u00edsticas similares, o como dice el reglamento UE \u201cdispositivos con el mismo destino de uso, la misma clase de riesgo y caracter\u00edsticas esenciales de proyecci\u00f3n y fabricaci\u00f3n\u201d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cTenemos que pensar \u2013 agrega Giada Necci \u2013 que EUDAMED (la base de datos europea en la que son registrados todos los dispositivos), ser\u00e1 un cuerpo de base de datos que servir\u00e1 para administrar la vida de cada producto desde la entrada en el comercio hasta el monitoreo post venta, esto \u00faltimo con una finalidad estad\u00edstica sobre c\u00f3mo funciona en el mercado. Para esta finalidad en EUDAMED se proceder\u00e1 principalmente por clase de dispositivos con caracter\u00edsticas similares\u201d.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">GS1 desarroll\u00f3 una nueva clave est\u00e1ndar para respaldar la asignaci\u00f3n del Basic UDI-DI. Es el GMN \u2013 Global Model Number. El generador de GMN que representa el Basic UDI-DI, ayuda a construirlo, a calcular la copia relativa de caracter\u00edsticas de control o a verificarlo.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">El GMN no sirve para identificar una unidad comercial, sino relaciona las unidades comerciales de los dispositivos m\u00e9dicos identificados con GTINs, con las actividades precedentes y sucesivas a la introducci\u00f3n del producto en el mercado (certificados, declaraciones de conformidad, vigilancia, control del mercado e investigaci\u00f3n cl\u00ednica). Para representarlo gr\u00e1ficamente se puede utilizar el c\u00f3digo de barras GS1-128 \u00f3 el c\u00f3digo bidimensional GS1 DataMatrix, pero en este momento no el reglamento no requiere representar el Basic UDI-DI en el envase de los productos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Si bien el vencimiento de la entrada en vigor del reglamento europeo 745\/2017 fue postergada hasta mayo 2021, las empresas que deben producir documentaci\u00f3n t\u00e9cnica de un nuevo dispositivo, o que deben renovar aquella vencida, asignan ya el Basic UDI que es un nuevo c\u00f3digo con el cual las empresas se est\u00e1n familiarizando.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Para m\u00e1s informaci\u00f3n sobre el Basic UDI-DI se puede acceder al documento a trav\u00e9s de las l\u00edneas gu\u00edas de Medtech Europe, la asociaci\u00f3n de categor\u00eda europea para la industria de tecnolog\u00edas m\u00e9dicas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Fuente: GS1 Italia<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Junto al UDI para dispositivos m\u00e9dicos y diagn\u00f3sticos in-vitro, la reglamentaci\u00f3n UE ha introducido para la comercializaci\u00f3n en Europa un nuevo identificador: el Basic UDI-DI, que no se reporta sobre&hellip; <\/p>\n","protected":false},"author":2,"featured_media":2644,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_wpcom_ai_launchpad_first_post":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[6],"tags":[],"class_list":["post-2642","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-estandares-gs1"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - 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