{"id":9490,"date":"2026-02-16T17:21:56","date_gmt":"2026-02-16T09:21:56","guid":{"rendered":"https:\/\/regask.com\/?p=9490"},"modified":"2026-03-03T12:57:36","modified_gmt":"2026-03-03T04:57:36","slug":"la-comision-europea-publica-la-version-2-22-0-de-eudamed-con-actualizaciones-obligatorias-para-el-registro-de-dispositivos-medicos-a-partir-de-mayo-de-2026","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/eu-commission-releases-eudamed-version-2-22-0-with-mandatory-medical-device-registration-updates-effective-may-2026\/","title":{"rendered":"La Comisi\u00f3n Europea publica la versi\u00f3n 2.22.0 de EUDAMED con\u2026"},"content":{"rendered":"<p>En <strong>5 de enero de 2026<\/strong>, el<strong> Comisi\u00f3n Europea<\/strong> anunci\u00f3 el lanzamiento de producci\u00f3n de <strong>EUDAMED versi\u00f3n 2.22.0,<\/strong> Introduciendo actualizaciones obligatorias del sistema que mejoran <strong>registro de dispositivos m\u00e9dicos y gesti\u00f3n de datos<\/strong> en toda la Uni\u00f3n Europea. La actualizaci\u00f3n afecta <strong>fabricantes, organismos notificados y otras partes interesadas en los dispositivos m\u00e9dicos,<\/strong> con el uso obligatorio de los cuatro m\u00f3dulos principales de EUDAMED a partir de <strong>28 de mayo de 2026. <\/strong><\/p>\n<div class=\"row\"  id=\"row-106795447\">\n\n\t<div id=\"col-544762441\" 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-147992570\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-147992570 {\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-1113442953\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1113442953 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La liberaci\u00f3n de <strong>EUDAMED<\/strong> <strong>versi\u00f3n 2.22.0<\/strong> fortalece la trazabilidad, la precisi\u00f3n de los datos y la facilidad de uso en m\u00f3dulos clave, incluidos <strong>registro de actores, identificaci\u00f3n de dispositivos (UDI), certificados,<\/strong> y <strong>acceso a la informaci\u00f3n p\u00fablica.\u00a0<\/strong><\/p>\n<p>Para el registro de actores, <strong>\u201cFechas de \u201d\u00daltima confirmaci\u00f3n de datos\u201d<\/strong> Ahora se muestran por versi\u00f3n, lo que mejora la transparencia en torno al estado de validaci\u00f3n de datos para todos los actores registrados.<\/p>\n<p>Para el registro del dispositivo, <strong>Control de versiones del c\u00f3digo EMDN<\/strong> se ha implementado y <strong>c\u00f3digos EMDN obsoletos<\/strong> Se han eliminado de las listas de selecci\u00f3n, garantizando as\u00ed que solo se utilice la nomenclatura actual.<\/p>\n<p>Dentro del m\u00f3dulo de certificados, <strong>Organismos notificados<\/strong> Ahora se permite hacer referencia <strong>fabricantes o productores de la UE no registrados<\/strong> al expedir certificados rechazados o gestionar solicitudes relacionadas, incluyendo <strong>dispositivos heredados.\u00a0<\/strong><\/p>\n<p>Desde un punto de vista t\u00e9cnico, <strong>Versi\u00f3n 3.0.25 del esquema XSD<\/strong> Ahora es obligatorio para todos <strong>Solicitudes de servicio DTX,<\/strong> reflejando los requisitos de documentaci\u00f3n t\u00e9cnica actualizados.<\/p>\n<p>Se ha mejorado la funcionalidad de carga masiva para permitir <strong>estados de \u00e9xito parcial,<\/strong> apoyado por nuevos<strong> Estructuras de respuesta XML<\/strong> que proporcionan retroalimentaci\u00f3n a nivel de objeto.<\/p>\n<p>En el sitio p\u00fablico, las mejoras de usabilidad incluyen <strong>opciones de pa\u00eds ampliadas<\/strong> y <strong>filtros de informes de resumen mejorados,<\/strong> Mejorar el acceso p\u00fablico a la informaci\u00f3n sobre dispositivos m\u00e9dicos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-544762441 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1474546260\" 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 cumplimiento<\/h2>\n\t<div id=\"gap-251042976\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-251042976 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Uso obligatorio del <strong>cuatro m\u00f3dulos principales de EUDAMED<\/strong>, registro de actores, identificaci\u00f3n de dispositivos (UDI), certificados y acceso a informaci\u00f3n p\u00fablica, <strong>Entrar\u00e1 en vigor el 28 de mayo de 2026. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1474546260 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1564219434\" 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>Fecha de entrada en vigor<\/h2>\n\t<div id=\"gap-601112716\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-601112716 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Uso obligatorio del <strong>cuatro m\u00f3dulos centrales de EUDAMED,<\/strong> incluido <strong>registro de actores, identificaci\u00f3n de dispositivos (UDI), certificados y acceso a informaci\u00f3n p\u00fablica,<\/strong> entra en vigor el <strong>28 de mayo de 2026.<\/strong> A partir de esta fecha, los fabricantes de dispositivos m\u00e9dicos, los organismos notificados y otras partes interesadas relevantes deben cumplir con los requisitos actualizados introducidos en <strong>EUDAMED versi\u00f3n 2.22.0. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1564219434 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1827656209\" 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-70902925\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-70902925 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Estas actualizaciones proporcionan mayor<strong> claridad regulatoria,<\/strong> alinear m\u00e1s estrechamente EUDAMED con <strong>Expectativas de gobernanza de datos digitales,<\/strong> y mejorar <strong>eficiencia operativa<\/strong> Mediante una trazabilidad mejorada y un intercambio de datos estructurado. Al perfeccionar los flujos de trabajo y los est\u00e1ndares t\u00e9cnicos, la actualizaci\u00f3n facilita el cumplimiento normativo y, al mismo tiempo, minimiza la carga administrativa innecesaria para las partes interesadas reguladas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1827656209 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2102001029\" 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-556997288\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-556997288 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es particularmente relevante para<strong> Equipos de Asuntos Regulatorios, Garant\u00eda de Calidad, TI y gesti\u00f3n de datos,<\/strong> y <strong>Operaciones del organismo notificado<\/strong> Participa en el registro, certificaci\u00f3n y supervisi\u00f3n continua del cumplimiento de los dispositivos m\u00e9dicos de la UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2102001029 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-155492476\" 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-1529915459\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1529915459 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las partes interesadas deben revisar las pol\u00edticas existentes <strong>Procesos de entrada de datos y registro de dispositivos<\/strong> Para garantizar la alineaci\u00f3n con la versi\u00f3n 2.22.0 de EUDAMED, evaluar la compatibilidad del sistema con <strong>Versi\u00f3n 3.0.25 del esquema XSD,<\/strong> y prepararse para los cambios <strong>Selecci\u00f3n de c\u00f3digo EMDN, seguimiento de fecha de confirmaci\u00f3n, <\/strong>y<strong> respuestas de carga masiva<\/strong> antes de la fecha de entrada en vigor de mayo de 2026.<\/p>\n<p>A medida que las organizaciones eval\u00faan su preparaci\u00f3n para el uso obligatorio del m\u00f3dulo EUDAMED y la evoluci\u00f3n de los requisitos de datos, tener una visibilidad temprana de los cambios en el sistema regulatorio puede reducir significativamente el riesgo de incumplimiento. <strong><a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con inteligencia artificial de agencia.<\/strong> que permite a las organizaciones globales en sectores altamente regulados, incluidas las ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Al combinar la IA Agentic avanzada con expertos en el sector, <a href=\"https:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> Proporciona informaci\u00f3n predictiva y procesable oportuna y automatizaci\u00f3n de extremo a extremo, lo que ayuda a los equipos a rastrear las actualizaciones de EUDAMED, evaluar el impacto y agilizar la preparaci\u00f3n para el cumplimiento en m\u00e1s de 160 pa\u00edses. <a href=\"https:\/\/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-155492476 > .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-1136001340\">\n\n\t<div id=\"col-204339625\" 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-1731603390\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1731603390 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfQu\u00e9 es la versi\u00f3n 2.22.0 de EUDAMED?<\/h4>\n\t<div id=\"gap-1369033446\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1369033446 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La versi\u00f3n 2.22.0 de EUDAMED es una versi\u00f3n de producci\u00f3n que introduce actualizaciones obligatorias para la gesti\u00f3n de datos de dispositivos m\u00e9dicos, la trazabilidad y las interfaces t\u00e9cnicas dentro de la UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-204339625 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1722195988\" 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 comienza el uso obligatorio de los m\u00f3dulos principales de EUDAMED?<\/h4>\n\t<div id=\"gap-91979980\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-91979980 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El uso obligatorio de los cuatro m\u00f3dulos principales de EUDAMED comienza el <strong>28 de mayo de 2026.<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1722195988 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1009543564\" 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>\u00bfQu\u00e9 cambios se realizaron a los c\u00f3digos EMDN en esta actualizaci\u00f3n?<\/h4>\n\t<div id=\"gap-249354661\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-249354661 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La actualizaci\u00f3n introduce <strong>Control de versiones del c\u00f3digo EMDN<\/strong> y elimina <strong>c\u00f3digos obsoletos<\/strong> de las selecciones de registro del dispositivo.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1009543564 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1876274982\" 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 las empresas a responder a los cambios regulatorios impulsados por la IA?<\/h4>\n\t<div id=\"gap-1029288634\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1029288634 {\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 las organizaciones a monitorear las actualizaciones de las autoridades regulatorias, evaluar el impacto en el cumplimiento y adaptar los flujos de trabajo internos a trav\u00e9s de inteligencia regulatoria impulsada por IA y automatizaci\u00f3n guiada por expertos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1876274982 > .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 5 January 2026, the European Commission announced the production release of EUDAMED version 2.22.0, introducing mandatory system updates that enhance medical device registration and data management across the European Union. The update affects manufacturers, Notified Bodies, and other medical device stakeholders, with mandatory use of the four core EUDAMED modules beginning on 28 May&#8230;<\/p>","protected":false},"author":41,"featured_media":9491,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,39,538],"tags":[],"class_list":["post-9490","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-european-union"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU Commission Releases EUDAMED Version 2.22.0 Changes<\/title>\n<meta name=\"description\" content=\"Learn about the EU Commission&#039;s release of EUDAMED version 2.22.0, with updates for mandatory medical device 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