{"id":34422,"date":"2025-07-10T12:15:45","date_gmt":"2025-07-10T10:15:45","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34422"},"modified":"2025-07-10T14:58:31","modified_gmt":"2025-07-10T12:58:31","slug":"cuales-son-los-requisitos-para-el-registro-udi-de-sistemas-y-kits-de-procedimientos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/cuales-son-los-requisitos-para-el-registro-udi-de-sistemas-y-kits-de-procedimientos\/","title":{"rendered":"\u00bfCu\u00e1les son los requisitos para el registro UDI de sistemas y kits de procedimientos?"},"content":{"rendered":"<p>De conformidad con el art\u00edculo 29, apartado 2, del RDC (UE) 2017\/745, antes de comercializar un <strong>sistema<\/strong> o <strong>conjunto de procedimientos<\/strong> con arreglo al<strong>art\u00edculo 22, apartados 1 o 3<\/strong> -siempre que no se trate de un producto a medida-, el <strong>fabricante <\/strong>est\u00e1 obligado a:<\/p>\n<ul>\n<li><strong>Asignar un c\u00f3digo UDI-DI B\u00e1sico<\/strong>, siguiendo las normas establecidas <strong>por el organismo emisor autorizado<\/strong> (por ejemplo, GS1, HIBCC, ICCBBA);<\/li>\n<li><strong>Registrar el UDI-DI b\u00e1sico<\/strong> en la base de datos europea <strong>EUDAMED<\/strong>, junto con los dem\u00e1s datos esenciales del aparato.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>De conformidad con el art\u00edculo 29, apartado 2, del RDC (UE) 2017\/745, antes de comercializar un sistema o conjunto de procedimientos  [&#8230;]<\/p>\n","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-34422","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>\u00bfCu\u00e1les son los requisitos para el registro UDI de sistemas y kits de procedimientos? 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