{"id":8860,"date":"2019-02-18T10:42:19","date_gmt":"2019-02-18T09:42:19","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8860"},"modified":"2023-01-26T11:57:17","modified_gmt":"2023-01-26T10:57:17","slug":"ue-ee-uu-y-la-ue-se-comprometen-a-cerrar-la-brecha-normativa-en-relacion-al-udi-para-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2019\/02\/18\/ue-ee-uu-y-la-ue-se-comprometen-a-cerrar-la-brecha-normativa-en-relacion-al-udi-para-dispositivos-medicos\/","title":{"rendered":"UE: EE. UU. Y la UE se comprometen a cerrar la brecha normativa en relaci\u00f3n al UDI para dispositivos m\u00e9dicos"},"content":{"rendered":"\r\n<p>Tras una declaraci\u00f3n conjunta firmada el 25 de julio de 2018 por los Presidentes Juncker (Comisi\u00f3n Europea) y Trump (Estados Unidos), el 30 de enero de 2018 se public\u00f3 un <a href=\"http:\/\/trade.ec.europa.eu\/doclib\/docs\/2019\/january\/tradoc_157651.pdf\">informe <\/a>que ofrece una visi\u00f3n general del trabajo realizado por el Grupo de Trabajo Ejecutivo de los EE. UU. (EWG) -UE.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-8855\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/02\/eu-usa-collaboration-fill-regulatory-gap-udi-specifications-single-audit-report-1024x536.jpg\" alt=\"\" \/>\r\n<figcaption><em>Compromiso de los EE. UU. Y la UE para cerrar la brecha normativa en UDI para dispositivos m\u00e9dicos<\/em><\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<p>Con la intenci\u00f3n de facilitar el comercio transatl\u00e1ntico, la UE y los EE. UU. Se comprometen a cooperar, en sinergia con los esfuerzos del <em>International Medical Device Regulators Forum <\/em>(IMDRF), para mejorar la identificaci\u00f3n y el monitoreo de los dispositivos m\u00e9dicos colocados en el mercado. Sus esfuerzos concertados est\u00e1n dirigidos a garantizar la alineaci\u00f3n de las especificaciones de la base de datos electr\u00f3nica para los <em><strong>Unique Device Identifiers<\/strong><\/em> (UDI) y el desarrollo de un plan de pruebas de compatibilidad bilateral para el UDI.<\/p>\r\n\r\n\r\n\r\n<p>Adem\u00e1s, los Estados Unidos actualmente aplican sistemas reguladores para dispositivos m\u00e9dicos distintos de la UE, que a menudo involucran pruebas duplicadas de los productos, lo que causa un acceso retrasado a los dispositivos m\u00e9dicos, as\u00ed como un mayor costo para los pacientes.<\/p>\r\n\r\n\r\n\r\n<p>Por este motivo, la UE se compromete activamente a utilizar los<strong> informes de auditor\u00eda \u00fanicos<\/strong> (una iniciativa desarrollada por el IMDRF) \u00abde una manera compatible con los requisitos legislativos de la UE\u00bb. Aunque no sin desaf\u00edos, este compromiso es ciertamente bien recibido y alcanzable.<\/p>\r\n\r\n\r\n\r\n<p>Los Estados Unidos son miembros del <em>Medical Device Single Audit Program<\/em> (MDSAP), operativo desde 2017, un programa que permite a las Organizaciones de Auditor\u00eda realizar una <strong>auditor\u00eda \u00fanica<\/strong>, que cumple simult\u00e1neamente con m\u00faltiples jurisdicciones regulatorias relacionadas con los sistemas de gestiones de calidad (<em>Quality Management Systems<\/em>, QMS) y a las buona pratica di fabbricazione (<em>Good Manufacturing Practices,<\/em>GMP) requeridas por los fabricantes de dispositivos m\u00e9dicos. Sin embargo, las diferencias reglamentarias actuales limitan el uso de MDSAP en una escala mayor, incluida la UE.<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Tras una declaraci\u00f3n conjunta firmada el 25 de julio de 2018 por los Presidentes Juncker (Comisi\u00f3n Europea) y Trump (Estados Unidos),  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23460,"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-8860","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>UE: EE. UU. 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