{"id":27982,"date":"2023-06-07T14:00:51","date_gmt":"2023-06-07T12:00:51","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27982"},"modified":"2023-06-06T13:24:54","modified_gmt":"2023-06-06T11:24:54","slug":"reino-unido-la-mhra-actualiza-sus-directrices-sobre-vigilancia","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/06\/07\/reino-unido-la-mhra-actualiza-sus-directrices-sobre-vigilancia\/","title":{"rendered":"REINO UNIDO: La MHRA actualiza sus directrices sobre vigilancia"},"content":{"rendered":"<h2>El 24 de abril, la <strong><em>Agencia Reguladora de Medicamentos y Productos Sanitarios del Reino Unido (MHRA)<\/em><\/strong> actualiz\u00f3 la directriz <a href=\"https:\/\/www.gov.uk\/government\/collections\/medical-devices-guidance-for-manufacturers-on-vigilance?utm_medium=email&amp;utm_campaign=govuk-notifications-topic&amp;utm_source=4ca4b2d5-3072-47ae-b9b1-5727f889b390&amp;utm_content=immediately#full-publication-update-history\"><strong><em>Medical devices: guidance for manufacturers on vigilance<\/em><\/strong><\/a> en el sitio web oficial del gobierno. El objetivo de esta directriz es informar a los fabricantes, a la persona responsable (UKRP) y al representante autorizado con sede en Irlanda del Norte sobre lo que deben hacer a la hora de notificar incidentes adversos y las consiguientes medidas correctivas que deben tomarse.<\/h2>\n<p>El Fabricante, el UKRP y el Representante Autorizado con sede en Irlanda del Norte est\u00e1n obligados a informar a la MHRA de cualquier <strong>incidente adverso<\/strong> y de las <strong>Acciones Correctivas de Seguridad de Campo (FSCA)<\/strong>, incluidos los <strong>Informes Peri\u00f3dicos Resumidos (PSR)<\/strong> y <strong>los Informes de Tendencias<\/strong>. Una vez notificados, UKRP debe analizar los incidentes y llevar a cabo las acciones correctivas previamente declaradas. Adem\u00e1s, debe enviar los PSR a la MHRA a trav\u00e9s del <strong>portal MORE<\/strong>, recientemente activado.<\/p>\n<p>En cuanto a los <strong>criterios<\/strong> para notificar incidentes adversos, deben notificarse a la MHRA si<\/p>\n<ul>\n<li>el acontecimiento ha causado la muerte o un deterioro grave de la salud de un paciente, usuario u otra persona;<\/li>\n<li>se cree que el Producto Sanitario es una de las causas del incidente ocurrido;<\/li>\n<li>se haya producido un accidente relacionado con un Producto Sanitario, incluidas las situaciones ocurridas durante la realizaci\u00f3n de pruebas con el producto.<\/li>\n<\/ul>\n<p>En cuanto a los <strong>plazos de notificaci\u00f3n<\/strong>, el fabricante, el UKRP y el representante autorizado con sede en Irlanda del Norte deben informar inmediatamente a la MHRA. Concretamente, en el caso de una amenaza grave para la salud p\u00fablica, deben informar a la MHRA a m\u00e1s tardar 2 d\u00edas despu\u00e9s de tener conocimiento del incidente, a m\u00e1s tardar 10 d\u00edas en caso de fallecimiento o deterioro grave, y a m\u00e1s tardar 30 d\u00edas para cualquier otro acontecimiento adverso. El calendario de los informes de PSR y de tendencias debe acordarse previamente con la MHRA.<\/p>\n<p>Por \u00faltimo, cada <strong>informe<\/strong> debe ir acompa\u00f1ado de una <strong>acci\u00f3n correctiva<\/strong> de seguridad. Ejemplos de acciones correctivas pueden ser la devoluci\u00f3n de un Producto Sanitario al proveedor, es decir, retirada del mercado, inspecci\u00f3n del producto, modificaci\u00f3n del producto, destrucci\u00f3n del producto, adaptaci\u00f3n por parte del comprador del cambio del fabricante o cambio de dise\u00f1o, y cambios en el uso del producto o seguimiento de pacientes, usuarios u otros declarados por el fabricante.<\/p>\n<p>&gt;&gt; Si desea comercializar Productos Sanitarios en el Reino Unido, Thema puede ayudarle con el servicio de <strong><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">Consulencia Estrat\u00e9gico-Reguladora<\/a><\/strong>, puede ser su <strong><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/servicio-de-uk-responsible-person-uk-rp\/\">Persona Responsable en el Reino Unido (UKRP)<\/a><\/strong> y puede apoyarle en el <strong>registro de productos<\/strong> en la MHRA.<\/p>\n<p>Mant\u00e9ngase al d\u00eda de la normativa brit\u00e1nica sobre productos sanitarios: \u00a1suscr\u00edbase al <strong><a href=\"https:\/\/www.thema-med.com\/es\/newsletter-3\/\">bolet\u00edn!<\/a><\/strong><\/p>\n<p>Fuentes:<\/p>\n<p><a href=\"https:\/\/www.gov.uk\/government\/collections\/medical-devices-guidance-for-manufacturers-on-vigilance?utm_medium=email&amp;utm_campaign=govuk-notifications-topic&amp;utm_source=4ca4b2d5-3072-47ae-b9b1-5727f889b390&amp;utm_content=immediately#full-publication-update-history\">Directriz MHRA Medical devices: guidance for manufacturers on vigilance<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 24 de abril, la Agencia Reguladora de Medicamentos y Productos Sanitarios del Reino Unido (MHRA) actualiz\u00f3 la directriz Medical devices:  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":27953,"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-27982","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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