{"id":25161,"date":"2022-12-15T09:31:32","date_gmt":"2022-12-15T08:31:32","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=25161"},"modified":"2022-12-15T09:32:11","modified_gmt":"2022-12-15T08:32:11","slug":"reino-unido-nuevas-formas-de-notificar-eventos-adversos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2022\/12\/15\/reino-unido-nuevas-formas-de-notificar-eventos-adversos\/","title":{"rendered":"Reino Unido: nuevas formas de notificar eventos adversos"},"content":{"rendered":"<h2>El 28 de octubre, la <strong>MHRA<\/strong> <em>(<\/em><a href=\"https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency\" target=\"_blank\" rel=\"noopener\"><strong><em>Medicines and Healthcare products Regulatory Agency<\/em><\/strong><\/a><em>)<\/em> anunci\u00f3 que, a partir del <strong>lunes 5 de diciembre de 2022<\/strong>, los eventos adversos relacionados con dispositivos m\u00e9dicos que se produzcan en el Reino Unido deber\u00e1n notificarse a trav\u00e9s del <strong>nuevo<\/strong> <a href=\"https:\/\/aic.mhra.gov.uk\/\" target=\"_blank\" rel=\"noopener\"><strong>portal MORE<\/strong><\/a>.<\/h2>\n<p>La notificaci\u00f3n y evaluaci\u00f3n de los eventos adversos y de las acciones correctivas (<a href=\"https:\/\/www.gov.uk\/guidance\/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices\" target=\"_blank\" rel=\"noopener\"><strong>FSCA \u2013 Field Safety Corrective Actions<\/strong><\/a>) relacionadas con Dispisitivos M\u00e9dicos se conoce como sistema de vigilancia y debe ser llevado a cabo, junto con los Informes Peri\u00f3dicos Resumidos \u2013 IRP <em>(Periodic Summary Reports \u2013 PSR)<\/em> y los <em>Trend Reports,<\/em> por el fabricante con sede en el Reino Unido o la <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/servicio-de-uk-responsible-person-uk-rp\/\" target=\"_blank\" rel=\"noopener\"><strong>UK Responsible Person<\/strong><\/a>.<\/p>\n<p>Los informes de vigilancia post-comercializaci\u00f3n de eventos adversos de Dispositivos M\u00e9dicos deben ser enviados a la MHRA por los usuarios registrados <strong>a trav\u00e9s del portal MORE<\/strong> con cargas de informes XML o a trav\u00e9s de formularios web dentro del portal o a trav\u00e9s de Interfaz de Programaci\u00f3n de Aplicaciones (API &#8211; <em>Application Programming Interface)<\/em> personalizada para el env\u00edo directo desde sistemas internos.<\/p>\n<p>El <strong>viejo portal<\/strong> pudo utilizarse hasta las 18.00 horas del <strong>viernes 2 de diciembre<\/strong>; a partir de ese momento, pas\u00f3 a ser de s\u00f3lo lectura. Seguir\u00e1 siendo posible acceder al viejo portal hasta el 30 de abril de 2023 para consultar los informes existentes: sin embargo, los documentos dejar\u00e1n de estar disponibles para su consulta despu\u00e9s de esta fecha; por lo tanto, recomendamos descargar el historial de la antigua cuenta <strong>antes del 30 de abril de 2023<\/strong> para evitar perder datos importantes.<\/p>\n<p>Tenga en cuenta que para acceder y utilizar el nuevo portal MORE, es necesario que el fabricante o UKRP con sede en el Reino Unido se <a href=\"https:\/\/aic.mhra.gov.uk\/\" target=\"_blank\" rel=\"noopener\"><strong>registre<\/strong><\/a> a trav\u00e9s de la MHRA y obtenga <strong>una nueva cuenta MORE<\/strong>.<\/p>\n<p>Si necesita apoyo para comercializar sus dispositivos m\u00e9dicos e IVD en el Reino Unido cumpliendo plenamente la normativa, elija a Thema como su <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/servicio-de-uk-responsible-person-uk-rp\/\" target=\"_blank\" rel=\"noopener\"><strong>UK Responsible Person (UKRP)<\/strong><\/a>. Adem\u00e1s de los servicios definidos por la normativa MHRA, estar\u00e1 siempre al d\u00eda de las \u00faltimas novedades normativas.<\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/contactanos-2\/\"><strong>Cont\u00e1ctanos<\/strong><\/a> para m\u00e1s informaci\u00f3n.<\/p>\n<p>Fuente: <a href=\"https:\/\/www.gov.uk\/government\/collections\/medical-devices-guidance-for-manufacturers-on-vigilance\" target=\"_blank\" rel=\"noopener\">https:\/\/www.gov.uk\/government\/collections\/medical-devices-guidance-for-manufacturers-on-vigilance<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 28 de octubre, la MHRA (Medicines and Healthcare products Regulatory Agency) anunci\u00f3 que, a partir del lunes 5 de diciembre  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":25144,"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-25161","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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