{"id":2654,"date":"2020-11-09T10:07:14","date_gmt":"2020-11-09T13:07:14","guid":{"rendered":"https:\/\/noticias.gs1.org.ar\/?p=2654"},"modified":"2020-11-09T10:07:14","modified_gmt":"2020-11-09T13:07:14","slug":"eudamed-la-base-de-datos-europea-para-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/gs1.navetrece.com.ar\/index.php\/2020\/11\/09\/eudamed-la-base-de-datos-europea-para-dispositivos-medicos\/","title":{"rendered":"EUDAMED, la base de datos europea para dispositivos m\u00e9dicos"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<figure class=\"wp-block-image size-large is-style-default\"><img loading=\"lazy\" decoding=\"async\" width=\"840\" height=\"472\" src=\"https:\/\/gs1.navetrece.com.ar\/wp-content\/uploads\/2020\/11\/EUDAMED.jpg\" alt=\"\" class=\"wp-image-2656\" srcset=\"https:\/\/gs1.navetrece.com.ar\/wp-content\/uploads\/2020\/11\/EUDAMED.jpg 840w, https:\/\/gs1.navetrece.com.ar\/wp-content\/uploads\/2020\/11\/EUDAMED-300x169.jpg 300w, https:\/\/gs1.navetrece.com.ar\/wp-content\/uploads\/2020\/11\/EUDAMED-768x432.jpg 768w\" sizes=\"auto, (max-width: 840px) 100vw, 840px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ser\u00e1 el \u201ccuadro viviente\u201d de todos los dispositivos m\u00e9dicos disponibles en el mercado europeo, y el Cat\u00e1logo electr\u00f3nico a disposici\u00f3n de todos los interesados.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EUDAMED, es uno de los pilares del reglamento europeo para la identificaci\u00f3n un\u00edvoca de dispositivos m\u00e9dicos (UDI), que entrar\u00e1 en vigencia en mayo de 2021, el banco europeo de datos para dispositivos m\u00e9dicos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Se trata de un proyecto \u201cque no sirve s\u00f3lo para catalogar los dispositivos m\u00e9dicos, sino es un instrumento m\u00e1s amplio para el monitoreo del ciclo de vida de cada dispositivo m\u00e9dico, formado a diferencia del que se usa en EEUU, por seis m\u00f3dulos: operadores econ\u00f3micos, UDI y dispositivos, Organismos notificados y certificados, vigilancia, investigaciones cl\u00ednicas y estudios de comportamiento y vigilancia del mercado, cada uno de los cuales sirve para actividades espec\u00edficas\u201d, explica Giada Necci, especialista en nuevas soluciones de GS1 Italia.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Uno de estos m\u00f3dulos es el Cat\u00e1logo Electr\u00f3nico UDI, que contempla todos los dispositivos m\u00e9dicos comercializados y comerciables en Europa, cuya consulta est\u00e1 abierta a todos los stakeholders interesados en un producto espec\u00edfico: empresas, entes reguladores, actores de la cadena como hospitales para la investigaci\u00f3n de dispositivos a prohibir. As\u00ed, EUDAMED se convierte en la referencia oficial para todos los dispositivos m\u00e9dicos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>Qu\u00e9 ser\u00e1 necesario registrar en EUDAMED?<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Las informaciones (datos descriptivos) a incluir en el banco de datos son aquellos centrales presentes en todas las bases de datos del mundo UDI y en aquellas locales, relacionadas a territorios espec\u00edficos (Europa, USA, y otros territorios que poco a poco se sumar\u00e1n).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En lo que respecta a los dispositivos m\u00e9dicos para comercializar dentro de la Uni\u00f3n Europea, estar\u00e1n registrados en la base de datos EUDAMED:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">1 \u2013 Los c\u00f3digos UDI-DI, que identifican un dispositivo espec\u00edfico o referencia.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2 \u2013 Los c\u00f3digos UDI-DI de base, es decir las identificaciones primarias de una familia de dispositivos, que identifican un grupo de dispositivos con las mismas caracter\u00edsticas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>Cu\u00e1l es la funci\u00f3n de EUDAMED?<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">El nuevo banco de datos EUDAMED mejorar\u00e1 la transparencia y la coordinaci\u00f3n de las informaciones sobre dispositivos disponibles en el mercado europeo con el objetivo de la seguridad. De esta forma \u2013 aclara Giada Necci \u2013 servir\u00e1 para gestionar la no conformidad de un producto o las documentaciones vencidas. Si bien mejora los procesos de trazabilidad, EUDAMED no es un instrumento espec\u00edfico para la trazabilidad de los productos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>Cu\u00e1ndo estar\u00e1 operativo el banco de datos?<\/em><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Seg\u00fan la Comisi\u00f3n Europea, EUDAMED estar\u00e1 operativo s\u00f3lo cuando todo el sistema y sus diversos m\u00f3dulos hayan alcanzado la plena funcionalidad, y hayen superado una auditor\u00eda independiente. Por esto, el lanzamiento ser\u00e1 realizado conjuntamente para dispositivos m\u00e9dicos y dispositivos m\u00e9dicos in vitro, para la fecha originaria prevista para estos \u00faltimos en mayo 2022.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sin embargo, seg\u00fan rumores circulantes en el sector, algunos m\u00f3dulos de EUDAMED estar\u00e1n disponibles antes: el relacionado con los operadores econ\u00f3micos para comienzos de 2021; y tambi\u00e9n el m\u00f3dulo UDI deber\u00eda estar disponible antes de 2022.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ser\u00e1 el \u201ccuadro viviente\u201d de todos los dispositivos m\u00e9dicos disponibles en el mercado europeo, y el Cat\u00e1logo electr\u00f3nico a disposici\u00f3n de todos los interesados. EUDAMED, es uno de los pilares&hellip; <\/p>\n","protected":false},"author":2,"featured_media":2656,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[6],"tags":[],"class_list":["post-2654","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 v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EUDAMED, la base de datos europea para dispositivos m\u00e9dicos - C\u00f3digo N \u2022 GS1<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/gs1.navetrece.com.ar\/index.php\/2020\/11\/09\/eudamed-la-base-de-datos-europea-para-dispositivos-medicos\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EUDAMED, la base de datos europea para dispositivos m\u00e9dicos - C\u00f3digo N \u2022 GS1\" \/>\n<meta property=\"og:description\" content=\"Ser\u00e1 el \u201ccuadro viviente\u201d de todos los dispositivos m\u00e9dicos disponibles en el mercado europeo, y el Cat\u00e1logo electr\u00f3nico a disposici\u00f3n de todos los interesados. 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