{"id":8232,"date":"2018-11-14T13:58:23","date_gmt":"2018-11-14T12:58:23","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8232"},"modified":"2023-01-24T15:05:21","modified_gmt":"2023-01-24T14:05:21","slug":"union-europea-cinco-directrices-sobre-la-implementacion-del-udi","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/11\/14\/union-europea-cinco-directrices-sobre-la-implementacion-del-udi\/","title":{"rendered":"UNI\u00d3N EUROPEA: cinco Directrices para la implementaci\u00f3n del UDI"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p><img decoding=\"async\" class=\"size-medium wp-image-8356 aligncenter\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/europe-300x300.png\" alt=\"\" width=\"300\" height=\"300\" \/>Publicadas el 10 de octubre de 2018 por el <em>Medical Devices Coordination Group<\/em> (MDCG), cinco Directrices proporcionan informaci\u00f3n para la implementaci\u00f3n del UDI (Identificaci\u00f3n \u00danica de Dispositivo) de acuerdo con los Reglamentos Europeos MDR (UE) 2017\/745 e IVDR (UE) 2017\/746.<\/p>\n<p>En particular, las Directrices abordan los siguientes temas:<\/p>\n<ul>\n<li><strong><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/31924\" target=\"_blank\" rel=\"noopener\">Sistemas y kit de procedimiento<\/a>:\u00a0<\/strong><span lang=\"EN-US\">asignaci\u00f3n\u00a0<\/span><span lang=\"EN-US\">UD<\/span><span lang=\"EN-US\">I\u00a0<\/span><span lang=\"EN-US\">e informaci\u00f3n relacionada que el Fabricante debe proporcionar a la base de datos <\/span><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/31925\"><span lang=\"EN-US\">EUDAMED<\/span><\/a><span lang=\"EN-US\">, de conformidad con el Art\u00edculo 29 (2) y la Parte B del Anexo VI del MDR;<\/span><\/li>\n<li><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/31926\" target=\"_blank\" rel=\"noopener\"><strong>Software en dispositivos m\u00e9dicos<\/strong><\/a><strong>:<\/strong> <span lang=\"EN-US\">las consideraciones espec\u00edficas para la clasificaci\u00f3n del software como dispositivo m\u00e9dico (solo el software disponible comercialmente y que constituye un dispositivo independiente est\u00e1n sujetos a los requisitos UDI) y la subsiguiente asignaci\u00f3n del UDI;<\/span><\/li>\n<li><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/31927\" target=\"_blank\" rel=\"noopener\"><strong>Responsabilidad de los operadores econ\u00f3micos\u00a0<\/strong><\/a><span lang=\"EN-US\">en materia de UDI en relaci\u00f3n con el Art\u00edculo 16 (1) del MDR y del IVDR, ofreciendo aclaraciones sobre situaciones en las que las obligaciones del Fabricante se aplican al Importador, al Distribuidor o a cualquier otra persona;<\/span><\/li>\n<li><strong><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/31928\" target=\"_blank\" rel=\"noopener\">Aspectos ling\u00fc\u00edsticos<\/a>\u00a0<\/strong><span style=\"font-size: 1rem;\">asociados con la base de datos UDI [5] en relaci\u00f3n con el Anexo VI, Parte A, Secci\u00f3n 2 y Parte B del MDR y del IVDR que ofrecen disposiciones que hacen que la informaci\u00f3n sea de acceso p\u00fablico y de f\u00e1cil interpretaci\u00f3n.<\/span><\/li>\n<\/ul>\n<p>Los Documentos mencionados suceden a las primeras Directrices sobre la nomenclatura de dispositivos m\u00e9dicos y el UDI publicadas en abril.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; Publicadas el 10 de octubre de 2018 por el Medical Devices Coordination Group (MDCG), cinco Directrices proporcionan informaci\u00f3n para la  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","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-8232","post","type-post","status-publish","format-standard","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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