{"id":9540,"date":"2026-02-25T10:57:53","date_gmt":"2026-02-25T02:57:53","guid":{"rendered":"https:\/\/regask.com\/?p=9540"},"modified":"2026-02-25T10:57:53","modified_gmt":"2026-02-25T02:57:53","slug":"la-mhr-del-reino-unido-actualiza-las-directrices-de-registro-de-dispositivos-medicos-con-los-cambios-en-irlanda-del-norte-la-transicion-de-eudamed-y-las-tarifas-anuales","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/uk-mhra-updates-medical-device-registration-guidance-with-northern-ireland-changes-eudamed-transition-and-annual-fees\/","title":{"rendered":"La MHRA del Reino Unido actualiza las directrices de registro de dispositivos m\u00e9dicos..."},"content":{"rendered":"<p>En <strong>20 de febrero de 2026, <\/strong>el<strong> Agencia Reguladora de Medicamentos y Productos Sanitarios<\/strong> public\u00f3 una actualizaci\u00f3n de su gu\u00eda sobre el registro de dispositivos m\u00e9dicos para su comercializaci\u00f3n en Gran Breta\u00f1a e Irlanda del Norte seg\u00fan el Reglamento de Dispositivos M\u00e9dicos del Reino Unido de 2002. La actualizaci\u00f3n afecta a los fabricantes y representantes autorizados que colocan dispositivos m\u00e9dicos y dispositivos de diagn\u00f3stico in vitro en el Reino Unido y <strong>Mercados de Irlanda del Norte, con implicaciones para las v\u00edas de registro de Irlanda del Norte, las tasas de registro anuales, <\/strong>y<strong> Transparencia del registro p\u00fablico. <\/strong><\/p>\n<div class=\"row\"  id=\"row-1057284623\">\n\n\t<div id=\"col-796925131\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-526523947\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-526523947 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Detalles de la actualizaci\u00f3n<\/h2>\n\t<div id=\"gap-349281164\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-349281164 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda actualizada aclara las modificaciones revisadas <strong>Requisitos de registro en Irlanda del Norte <\/strong>antes de<strong> 28 de mayo de 2026.<\/strong> A partir de esa fecha, la mayor\u00eda de los dispositivos m\u00e9dicos no hechos a medida deben registrarse en el <strong>Base de datos europea sobre productos sanitarios<\/strong> antes de comercializarse en los mercados de la UE o de Irlanda del Norte, y ya no se requerir\u00e1 el registro MHRA para dichos dispositivos en el mercado de Irlanda del Norte. <strong>Dispositivos hechos a medida<\/strong> permanecen fuera del \u00e1mbito de aplicaci\u00f3n de EUDAMED y deben seguir registrados en la MHRA para Irlanda del Norte.<\/p>\n<p>La gu\u00eda introduce un marco detallado para el informe anual <strong>R\u00e9gimen de tarifas de registro de la MHRA <\/strong>teniendo efecto <strong>a partir del 1 de abril de 2026.<\/strong> Las tarifas se calcular\u00e1n en funci\u00f3n de <strong>Nomenclatura global de dispositivos m\u00e9dicos de nivel 2 (GMDN)<\/strong> <strong>Categor\u00edas<\/strong> registrado en la MHRA, lo que requiere que los fabricantes revisen c\u00f3mo est\u00e1n estructuradas sus carteras de dispositivos para fines de registro.<\/p>\n<p>Se proporciona m\u00e1s aclaraci\u00f3n sobre <strong>dispositivos de diagn\u00f3stico in vitro (IVD)<\/strong> someti\u00e9ndose <strong>estudios de evaluaci\u00f3n del desempe\u00f1o,<\/strong> Confirmando que el registro debe completarse antes de comenzar los estudios en el Reino Unido. La actualizaci\u00f3n tambi\u00e9n reitera que <strong>Ant\u00edgeno de COVID-19<\/strong> <strong>y dispositivos de prueba molecular (PCR)<\/strong> debe obtener <strong>Aprobaci\u00f3n de dispositivos de prueba para el coronavirus (CTDA)<\/strong> validaci\u00f3n, o estar incluido en el protocolo pertinente, antes de que se acepte una solicitud de registro MHRA.<\/p>\n<p>Adem\u00e1s, la gu\u00eda confirma mejoras en la<strong> Base de datos de registro de acceso p\u00fablico (PARD).<\/strong> De <strong>23 de febrero de 2026, marca o nombre comercial de dispositivos m\u00e9dicos<\/strong> Se mostrar\u00e1n p\u00fablicamente, aumentando la transparencia en torno a los productos registrados.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-796925131 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-824355272\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Cronograma de implementaci\u00f3n regulatoria<\/h2>\n\t<div id=\"gap-1645041100\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1645041100 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<ul>\n<li><strong>23 de febrero de 2026:<\/strong> Dispositivo m\u00e9dico <strong>marcas y nombres comerciales<\/strong> comenzar\u00e1n a mostrarse en el <strong>Base de datos de registro de acceso p\u00fablico (PARD),<\/strong> Aumentar la visibilidad p\u00fablica de los productos registrados.<\/li>\n<li><strong>1 de abril de 2026: Cuotas de inscripci\u00f3n anuales <\/strong>para dispositivos m\u00e9dicos registrados en la<strong> Agencia Reguladora de Medicamentos y Productos Sanitarios<\/strong> entrar\u00e1 en vigor, con tarifas calculadas por <strong>Categor\u00eda de Nomenclatura global de dispositivos m\u00e9dicos (GMDN) de nivel 2.\u00a0<\/strong><\/li>\n<li><strong>28 de mayo de 2026: Registro en EUDAMED<\/strong> ser\u00e1 obligatorio para la mayor\u00eda <strong>dispositivos m\u00e9dicos no hechos a medida<\/strong> comercializados en los mercados de la UE o Irlanda del Norte. A partir de esta fecha, <strong>Ya no ser\u00e1 necesario el registro en la MHRA<\/strong> para aquellos dispositivos destinados al mercado de Irlanda del Norte.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-824355272 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-747757403\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Por qu\u00e9 es importante<\/h2>\n\t<div id=\"gap-2080783007\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2080783007 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n proporciona mayor <strong>claridad regulatoria<\/strong> sobre los acuerdos posteriores a la transici\u00f3n para Irlanda del Norte, alinea los procesos del Reino Unido con <strong>Infraestructura digital de la UE<\/strong> a trav\u00e9s de EUDAMED, y establece un marco estructurado <strong>marco de tarifas<\/strong> Para apoyar la supervisi\u00f3n regulatoria. Los cambios buscan mejorar la eficiencia y la transparencia, a la vez que concentran la carga administrativa adicional en actividades definidas de registro y mantenimiento de datos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-747757403 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-776452540\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Para qui\u00e9n es relevante<\/h2>\n\t<div id=\"gap-21868782\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-21868782 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La orientaci\u00f3n es relevante para <strong>fabricantes de dispositivos m\u00e9dicos y de diagn\u00f3stico in vitro, representantes autorizados, <\/strong>y<strong> equipos regulatorios, de calidad y de cumplimiento<\/strong> responsable del acceso al mercado del Reino Unido e Irlanda del Norte, as\u00ed como <strong>Equipos de TI y datos<\/strong> Gesti\u00f3n de presentaciones reglamentarias e informaci\u00f3n p\u00fablica de productos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-776452540 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1628065872\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Pr\u00f3ximos pasos<\/h2>\n\t<div id=\"gap-1279329564\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1279329564 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las partes interesadas deben revisar sus registros MHRA actuales para identificar los dispositivos que requerir\u00e1n <strong>Registro EUDAMED<\/strong> A finales de mayo de 2026, evaluar el impacto de <strong>cuotas anuales<\/strong> antes de abril de 2026 y actualizar los procesos internos en consecuencia. Los fabricantes que comercializan dispositivos en Irlanda del Norte tambi\u00e9n deben confirmar <strong>acuerdos de representante autorizado,<\/strong> asegurar <strong>Validaci\u00f3n CTDA<\/strong> cuando corresponda, y prepararse para una mayor visibilidad p\u00fablica de los detalles del producto en PARD.<\/p>\n<p>A medida que las organizaciones se adaptan a estos requisitos de registro en constante evoluci\u00f3n en el Reino Unido e Irlanda del Norte, <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> Apoya a los equipos regulatorios y de cumplimiento al monitorear los cronogramas de implementaci\u00f3n, hacer el seguimiento de las obligaciones espec\u00edficas de la jurisdicci\u00f3n y agilizar los flujos de trabajo de registro y gesti\u00f3n de datos. <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujo de trabajo con inteligencia artificial (IA) que permite a las organizaciones globales en sectores altamente regulados, incluidos productos de consumo y ciencias biol\u00f3gicas, navegar de manera proactiva en panoramas regulatorios complejos. <strong>Al combinar la IA avanzada de Agentic con expertos en el sector, <a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a><\/strong> Proporciona informaci\u00f3n predictiva y procesable oportuna y automatizaci\u00f3n de extremo a extremo, agilizando los procesos de cumplimiento, mitigando riesgos y acelerando el acceso al mercado en m\u00e1s de 160 pa\u00edses. <a href=\"http:\/\/regask.com\/es\/\"><strong>M\u00e1s informaci\u00f3n <\/strong><\/a>o<a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\"><strong> Reserve una demostraci\u00f3n ahora.\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1628065872 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1738046446\">\n\n\t<div id=\"col-2090186468\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-944893916\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-944893916 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfQu\u00e9 cambios introdujo la MHRA para el registro de dispositivos m\u00e9dicos en Irlanda del Norte?<\/h4>\n\t<div id=\"gap-393831565\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-393831565 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>A partir del 28 de mayo de 2026, la mayor\u00eda de los dispositivos no hechos a medida deber\u00e1n registrarse en EUDAMED para los mercados de la UE e Irlanda del Norte, y ya no ser\u00e1 necesario el registro en la MHRA para dichos dispositivos en Irlanda del Norte.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2090186468 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-765060921\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfCu\u00e1ndo entran en vigencia las tarifas anuales de registro de dispositivos m\u00e9dicos de la MHRA?<\/h4>\n\t<div id=\"gap-1588063972\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1588063972 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las tarifas de registro anuales entran en vigencia a partir del 1 de abril de 2026 y se calculan seg\u00fan la categor\u00eda GMDN de nivel 2 registrada en MHRA.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-765060921 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1873941427\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfEs necesario registrar en EUDAMED los productos sanitarios fabricados a medida?<\/h4>\n\t<div id=\"gap-874341705\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-874341705 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>No. Los dispositivos hechos a medida no requieren registro en EUDAMED y deben seguir estando registrados en la MHRA para el mercado de Irlanda del Norte.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1873941427 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-160701364\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfC\u00f3mo puede RegASK ayudar a los equipos a gestionar estos cambios de registro de MHRA?<\/h4>\n\t<div id=\"gap-1927843262\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1927843262 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> ayuda a los equipos regulatorios y de cumplimiento a rastrear los pr\u00f3ximos plazos, evaluar el impacto de las nuevas estructuras de tarifas y administrar las obligaciones de registro en el Reino Unido, Irlanda del Norte y la UE a trav\u00e9s de inteligencia regulatoria centralizada y flujos de trabajo automatizados.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-160701364 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 20 February 2026, the Medicines &amp; Healthcare products Regulatory Agency published an update to its guidance on registering medical devices for placement on the market in Great Britain and Northern Ireland under the UK Medical Devices Regulations 2002. The update affects manufacturers and authorised representatives placing medical devices and in vitro diagnostic devices on&#8230;<\/p>","protected":false},"author":41,"featured_media":9543,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,39],"tags":[],"class_list":["post-9540","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-medical-devices-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK MHRA Updates Medical Device Registration Guidance<\/title>\n<meta name=\"description\" content=\"Explore UK MHRA updates on medical device registration guidance and how Northern Ireland changes affect manufacturers.\" \/>\n<meta name=\"robots\" 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