{"id":29786,"date":"2023-08-02T11:38:28","date_gmt":"2023-08-02T09:38:28","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=29786"},"modified":"2023-08-04T12:11:08","modified_gmt":"2023-08-04T10:11:08","slug":"europa-revision-de-la-ampliacion-de-la-linea-qa-mdr","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/08\/02\/europa-revision-de-la-ampliacion-de-la-linea-qa-mdr\/","title":{"rendered":"EUROPA: revisi\u00f3n de la ampliaci\u00f3n de la l\u00ednea Q&#038;A MDR"},"content":{"rendered":"<h2>El 18 de julio de 2023, la Comisi\u00f3n Europea public\u00f3 en el Diario Oficial de la Uni\u00f3n Europea una <strong>actualizaci\u00f3n<\/strong> de la <strong>gu\u00eda de preguntas y respuestas (Q&amp;A)<\/strong> titulada \u00ab<em><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-07\/mdr_proposal_extension-q-n-a.pdf\">Rev. 1 &#8211; Q&amp;A on practical aspects related to the implementation of Regulation (EU) 2023\/607<\/a><\/em>\u00bb para aclarar determinados aspectos contenidos en el Reglamento 2023\/607.<\/h2>\n<p>Se describen los cambios e innovaciones m\u00e1s significativos entre la primera edici\u00f3n y la rev.1:<\/p>\n<ul>\n<li>Se facilitar\u00e1n <strong>diagramas de flujo<\/strong> para ayudar a los fabricantes a comprender si un producto se beneficia del per\u00edodo transitorio previsto en el art\u00edculo 120 del MDR.<\/li>\n<li>Un <strong>producto heredado<\/strong> y el correspondiente producto conforme al MDR pueden comercializarse en paralelo hasta que finalice el per\u00edodo de transici\u00f3n correspondiente.<\/li>\n<li>La excepci\u00f3n concedida en virtud del <strong>art\u00edculo 59<\/strong> o la aplicaci\u00f3n del <strong>art\u00edculo 97<\/strong> despu\u00e9s del <strong>20\/03\/2023<\/strong> no permite prorrogar el per\u00edodo transitorio.<\/li>\n<li>Un producto sanitario al que se le haya concedido una excepci\u00f3n en virtud del art\u00edculo 59 del MDR podr\u00e1 beneficiarse del periodo transitorio incluso sin el marcado CE si la retirada del marcado CE era una condici\u00f3n o consecuencia de la excepci\u00f3n concedida por la autoridad nacional competente en virtud del art\u00edculo 59 del MDR.<\/li>\n<li>En cuanto a la relaci\u00f3n entre el Fabricante y el Organismo Notificado, el Fabricante puede demostrar que ha presentado una solicitud de evaluaci\u00f3n de la conformidad y celebrado un acuerdo por escrito con un Organismo Notificado con una <strong>copia de los documentos pertinentes<\/strong>, adem\u00e1s de una carta de confirmaci\u00f3n o una autodeclaraci\u00f3n. Con respecto a la autodeclaraci\u00f3n, las asociaciones industriales EuromContact, EUROM VI y MedTech Europe a nivel europeo han desarrollado un <strong>modelo de declaraci\u00f3n<\/strong> del Fabricante y est\u00e1 disponible en sus sitios web, COCIR, EuromContact, EUROM VI y MedTech Europe.<\/li>\n<li>En lo que respecta a la <strong>vigilancia<\/strong>, el fabricante debe informar inmediatamente al Organismo Notificado si \u00e9ste a\u00fan no ha realizado la actividad para que pueda recuperarla.<\/li>\n<li>Si el fabricante retirara la solicitud de evaluaci\u00f3n de la conformidad o si se pusiera fin al acuerdo escrito entre el organismo notificado y el fabricante<strong>, dejar\u00edan de cumplirse<\/strong> las condiciones del art\u00edculo 120, apartado 3, letra e), del MDR y, por tanto, dejar\u00eda de aplicarse el per\u00edodo transitorio. Sin embargo, si el Fabricante celebrara simult\u00e1neamente un acuerdo escrito <strong>con otro Organismo Notificado<\/strong>, al que se transfiere la solicitud, las condiciones del art\u00edculo 120(3c)(e) seguir\u00edan cumpli\u00e9ndose y el per\u00edodo transitorio continuar\u00eda aplic\u00e1ndose.<\/li>\n<li><strong>Los cambios administrativos<\/strong> relacionados con la organizaci\u00f3n del Fabricante no se consideran cambios significativos y, en consecuencia, no tienen impacto en el periodo transitorio. Quedan excluidas las situaciones en las que el fabricante con certificado MDD\/AIMDD transfiere productos cubiertos por certificados MDD\/AIMDD a otro fabricante que pretende comercializar dichos productos bajo MDR, a menos que el fabricante con certificado MDD\/AIMDD y el fabricante con certificado MDR formen parte de la misma organizaci\u00f3n.<\/li>\n<\/ul>\n<p>Por consiguiente, la Comisi\u00f3n Europea prosigue sus actividades de clarificaci\u00f3n en la aplicaci\u00f3n del Reglamento 607 con vistas a facilitar a los fabricantes el uso de la extensi\u00f3n y, de este modo, seguir prestando asistencia al personal sanitario p\u00fablico y privado.<\/p>\n<p>&gt;&gt; A trav\u00e9s de sus <strong>servicios<\/strong> <strong>de<\/strong> <strong><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">consultor\u00eda estrat\u00e9gica-regulatoria<\/a><\/strong>, apoyo a la <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/apoyo-para-la-certificacion-ce\/\"><strong>certificaci\u00f3n CE<\/strong><\/a> y, si es necesario, <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/servicio-representante-autorizado-europeo\/\"><strong>representante europeo autorizado<\/strong><\/a>, Thema puede ayudarle a implementar los requisitos del Reglamento 2023\/607 para beneficiarse de la extensi\u00f3n y del Reglamento de Productos Sanitarios MDR (UE) 2017\/745.<\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/contactanos\/\">P\u00f3ngase en contacto con nosotros.<\/a><\/p>\n<p><strong>Fuente<\/strong><\/p>\n<p><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-07\/mdr_proposal_extension-q-n-a.pdf\">Rev. 1 &#8211; Q&amp;A on practical aspects related to the implementation of Regulation (EU) 2023\/607<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 18 de julio de 2023, la Comisi\u00f3n Europea public\u00f3 en el Diario Oficial de la Uni\u00f3n Europea una actualizaci\u00f3n de  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":29780,"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-29786","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 - 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