{"id":9483,"date":"2026-02-16T16:04:40","date_gmt":"2026-02-16T08:04:40","guid":{"rendered":"https:\/\/regask.com\/?p=9483"},"modified":"2026-02-16T17:59:00","modified_gmt":"2026-02-16T09:59:00","slug":"la-fimea-de-finlandia-publica-una-guia-sobre-los-requisitos-de-la-ley-de-ia-de-la-ue-para-dispositivos-medicos-con-ia-vigente-a-partir-del-19-de-enero-de-2026","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/","title":{"rendered":"La FIMEA de Finlandia publica una gu\u00eda sobre los requisitos de la Ley de IA de la UE\u2026"},"content":{"rendered":"<p>En <strong>19 de enero de 2026, Agencia Finlandesa de Medicamentos (FIMEA)<\/strong> Orientaci\u00f3n publicada sobre el uso de <strong>inteligencia artificial en dispositivos m\u00e9dicos,<\/strong> marcando el <strong>fecha de vigencia<\/strong> de expectativas regulatorias aclaradas bajo la <strong>Reglamento de Inteligencia Artificial de la UE,<\/strong> junto con los existentes <strong>Reglamento de Dispositivos M\u00e9dicos (MDR)<\/strong> y <strong>Regulaci\u00f3n del diagn\u00f3stico in vitro (IVDR)<\/strong> Requisitos. La gu\u00eda se aplica a los fabricantes y distribuidores de dispositivos m\u00e9dicos con IA y se implementar\u00e1 <strong>en fases<\/strong> a medida que se ultiman los requisitos nacionales y de la UE.<\/p>\n<div class=\"row\"  id=\"row-48881004\">\n\n\t<div id=\"col-1829195253\" 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-1351726291\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1351726291 {\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-185086650\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-185086650 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda explica que <strong>dispositivos m\u00e9dicos que incorporan inteligencia artificial (MDAI)<\/strong> ahora est\u00e1n regulados bajo un marco combinado de <strong>MDR, IVDR,<\/strong> y el <strong>Reglamento de IA de la UE<\/strong>, en lugar de solo bajo la legislaci\u00f3n sobre dispositivos m\u00e9dicos. Hace hincapi\u00e9 en la necesidad de garantizar <strong>seguridad, sostenibilidad \u00e9tica y transparencia<\/strong> a lo largo de todo el ciclo de vida de los dispositivos m\u00e9dicos habilitados para IA.<\/p>\n<p>Las empresas que comercializan dispositivos con inteligencia artificial en la UE deben abordar <strong>obligaciones ampliadas de gesti\u00f3n de la calidad,<\/strong> incluyendo reforzado<strong> evaluaci\u00f3n de riesgos del ciclo de vida,<\/strong> m\u00e1s robusto <strong>documentaci\u00f3n t\u00e9cnica<\/strong>, y m\u00e1s claro <strong>medidas de transparencia<\/strong> relacionadas con la funcionalidad de la IA. La gu\u00eda tambi\u00e9n destaca la importancia de <strong>pr\u00e1cticas de manejo y gobernanza de datos<\/strong>, lo que refleja los riesgos espec\u00edficos de la IA, como la calidad de los datos, el sesgo y el rendimiento del sistema a lo largo del tiempo.<\/p>\n<p>Para <strong>sistemas de IA de alto riesgo<\/strong>, la orientaci\u00f3n se\u00f1ala la aplicaci\u00f3n de <strong>controles regulatorios m\u00e1s estrictos<\/strong>, en particular en materia de seguridad, transparencia y supervisi\u00f3n. La implementaci\u00f3n de estos requisitos se llevar\u00e1 a cabo <strong>en fases,<\/strong> Se espera mayor aclaraci\u00f3n a medida que contin\u00faen las conversaciones a nivel de la UE y se finalice la legislaci\u00f3n nacional. Por consiguiente, los plazos espec\u00edficos podr\u00edan cambiar.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1829195253 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-466952223\" 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-2072010129\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2072010129 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta gu\u00eda proporciona claridad regulatoria sobre c\u00f3mo <strong>Reglamento de IA de la UE<\/strong> Interact\u00faa con los marcos de dispositivos m\u00e9dicos existentes, lo que facilita una interpretaci\u00f3n m\u00e1s consistente en las funciones de cumplimiento. Refuerza la alineaci\u00f3n digital al integrar la gesti\u00f3n de riesgos espec\u00edfica de IA y la gobernanza de datos en los procesos establecidos de dispositivos m\u00e9dicos, a la vez que busca mejorar la eficiencia mediante expectativas m\u00e1s claras. Al mismo tiempo, el enfoque por fases busca minimizar la carga regulatoria innecesaria a medida que se definen progresivamente los requisitos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-466952223 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-587248508\" 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 esto es relevante para<\/h2>\n\t<div id=\"gap-618439387\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-618439387 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es particularmente relevante para <strong>Asuntos Regulatorios, Garant\u00eda de Calidad, I+D, TI<\/strong>, y <strong>Equipos de desarrollo de IA<\/strong> involucrado en el dise\u00f1o, cumplimiento y gesti\u00f3n del ciclo de vida de dispositivos m\u00e9dicos habilitados para IA destinados al mercado de la UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-587248508 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-430424745\" 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-2030684341\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2030684341 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Este desarrollo es relevante para <strong>Asuntos regulatorios, garant\u00eda de calidad, asuntos legales y cumplimiento, I+D, grupos de seguridad del paciente,<\/strong> y <strong>equipos comerciales o de marketing<\/strong> involucrado en la supervisi\u00f3n de productos alimenticios, investigaci\u00f3n nutricional y monitoreo de seguridad alimentaria en todo el mercado de EE. UU.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-430424745 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2008604690\" 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-2058332994\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2058332994 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las organizaciones deber\u00edan <strong>evaluar las carteras de productos actuales<\/strong> para identificar los componentes de la IA y evaluar la alineaci\u00f3n con ambos <strong>MDR IVDR<\/strong> y <strong>Requisitos espec\u00edficos de IA.<\/strong> Procesos internos para <strong>gesti\u00f3n de riesgos del ciclo de vida, manejo de datos,<\/strong> y <strong>documentaci\u00f3n t\u00e9cnica<\/strong> debe revisarse y actualizarse cuando sea necesario. Las partes interesadas tambi\u00e9n deben <strong>Monitorear el sitio web de Fimea<\/strong> para obtener m\u00e1s instrucciones sobre la implementaci\u00f3n por fases y estar preparado para adaptar los sistemas de calidad a medida que se publiquen directrices adicionales.<\/p>\n<p>A medida que las regulaciones de IA se cruzan cada vez m\u00e1s con el cumplimiento de los dispositivos m\u00e9dicos, mantenerse a la vanguardia de los requisitos en constante evoluci\u00f3n se vuelve fundamental. <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 actualizaciones regulatorias relacionadas con IA, evaluar el impacto y agilizar el cumplimiento en m\u00e1s de 140 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<\/strong>.\u00a0<\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2008604690 > .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-1651341095\">\n\n\t<div id=\"col-1544520011\" 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-421045435\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-421045435 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfEn qu\u00e9 se centra la orientaci\u00f3n de FIMEA?<\/h4>\n\t<div id=\"gap-194795567\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-194795567 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Aclara c\u00f3mo se regulan los dispositivos m\u00e9dicos habilitados para IA seg\u00fan el Reglamento de IA de la UE en combinaci\u00f3n con los requisitos del MDR y el IVDR.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1544520011 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1918182774\" 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 regulaciones se aplican a los dispositivos m\u00e9dicos habilitados para IA en la UE?<\/h4>\n\t<div id=\"gap-984899568\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-984899568 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los dispositivos m\u00e9dicos habilitados para IA deben cumplir con<strong> MDR o IVDR<\/strong> as\u00ed como el <strong>Reglamento de la UE sobre inteligencia artificial. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1918182774 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1030254623\" 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 entra en vigor la gu\u00eda?<\/h4>\n\t<div id=\"gap-685906820\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-685906820 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda se public\u00f3 el <strong>19 de enero de 2026,<\/strong> con <strong>implementaci\u00f3n por fases<\/strong> Se prev\u00e9 que se concreten a medida que se finalicen los requisitos nacionales y de la UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1030254623 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1082779681\" 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 brindar soporte a los equipos afectados por esta actualizaci\u00f3n?<\/h4>\n\t<div id=\"gap-1566564182\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1566564182 {\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 monitorear los cambios regulatorios relacionados con la IA, evaluar su impacto en las carteras de dispositivos m\u00e9dicos y poner en funcionamiento acciones de cumplimiento de manera eficiente a trav\u00e9s de conocimientos impulsados por IA y flujos de trabajo validados por expertos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1082779681 > .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 January 19, 2026, Finnish Medicines Agency (FIMEA) published guidance on the use of artificial intelligence in medical devices, marking the effective date of clarified regulatory expectations under the EU Artificial Intelligence Regulation, alongside existing Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements. The guidance applies to manufacturers and distributors of AI-enabled&#8230;<\/p>","protected":false},"author":41,"featured_media":9484,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,39,550],"tags":[],"class_list":["post-9483","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-finland-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Finland\u2019s FIMEA Issues Guidance on EU AI Act Regulations<\/title>\n<meta name=\"description\" content=\"Discover Finland\u2019s FIMEA guidance on EU AI Act requirements for AI enabled medical devices effective January 19, 2026.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/la-fimea-de-finlandia-publica-una-guia-sobre-los-requisitos-de-la-ley-de-ia-de-la-ue-para-dispositivos-medicos-con-ia-vigente-a-partir-del-19-de-enero-de-2026\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Finland\u2019s FIMEA Issues Guidance on EU AI Act Requirements for AI Enabled Medical Devices Effective January 19, 2026\" \/>\n<meta property=\"og:description\" content=\"Discover Finland\u2019s FIMEA guidance on EU AI Act requirements for AI enabled medical devices effective January 19, 2026.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/la-fimea-de-finlandia-publica-una-guia-sobre-los-requisitos-de-la-ley-de-ia-de-la-ue-para-dispositivos-medicos-con-ia-vigente-a-partir-del-19-de-enero-de-2026\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-16T08:04:40+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-16T09:59:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/finlands-fimea-issues-guidance-eu-ai-act-requirements-ai-enabled-medical-devices-effective-january-19-2026.png\" \/>\n\t<meta property=\"og:image:width\" content=\"904\" \/>\n\t<meta property=\"og:image:height\" content=\"622\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Shaffa Renaningtyas\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Shaffa Renaningtyas\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\\\/\"},\"author\":{\"name\":\"Shaffa Renaningtyas\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/b0e1938ef6f244f9f052a21f21cba1b6\"},\"headline\":\"Finland\u2019s FIMEA Issues Guidance on EU AI Act Requirem&hellip;\",\"datePublished\":\"2026-02-16T08:04:40+00:00\",\"dateModified\":\"2026-02-16T09:59:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\\\/\"},\"wordCount\":847,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/finlands-fimea-issues-guidance-eu-ai-act-requirements-ai-enabled-medical-devices-effective-january-19-2026.png\",\"articleSection\":[\"Regulatory News\",\"Medical Devices\",\"Finland\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\\\/\",\"name\":\"Finland\u2019s FIMEA Issues Guidance on EU AI Act Regulations\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/finlands-fimea-issues-guidance-eu-ai-act-requirements-ai-enabled-medical-devices-effective-january-19-2026.png\",\"datePublished\":\"2026-02-16T08:04:40+00:00\",\"dateModified\":\"2026-02-16T09:59:00+00:00\",\"description\":\"Discover Finland\u2019s FIMEA guidance on EU AI Act requirements for AI enabled medical devices effective January 19, 2026.\",\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/finlands-fimea-issues-guidance-eu-ai-act-requirements-ai-enabled-medical-devices-effective-january-19-2026.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/finlands-fimea-issues-guidance-eu-ai-act-requirements-ai-enabled-medical-devices-effective-january-19-2026.png\",\"width\":904,\"height\":622,\"caption\":\"Finlands Fimea Issues Guidance Eu Ai Act Requirements Ai Enabled Medical Devices Effective January 19 2026\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/b0e1938ef6f244f9f052a21f21cba1b6\",\"name\":\"Shaffa Renaningtyas\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"La FIMEA de Finlandia publica una gu\u00eda sobre la normativa de la Ley de IA de la UE","description":"Descubra la gu\u00eda FIMEA de Finlandia sobre los requisitos de la Ley de IA de la UE para dispositivos m\u00e9dicos habilitados para IA, vigente a partir del 19 de enero de 2026.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/es\/la-fimea-de-finlandia-publica-una-guia-sobre-los-requisitos-de-la-ley-de-ia-de-la-ue-para-dispositivos-medicos-con-ia-vigente-a-partir-del-19-de-enero-de-2026\/","og_locale":"es_ES","og_type":"article","og_title":"Finland\u2019s FIMEA Issues Guidance on EU AI Act Requirements for AI Enabled Medical Devices Effective January 19, 2026","og_description":"Discover Finland\u2019s FIMEA guidance on EU AI Act requirements for AI enabled medical devices effective January 19, 2026.","og_url":"https:\/\/regask.com\/es\/la-fimea-de-finlandia-publica-una-guia-sobre-los-requisitos-de-la-ley-de-ia-de-la-ue-para-dispositivos-medicos-con-ia-vigente-a-partir-del-19-de-enero-de-2026\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2026-02-16T08:04:40+00:00","article_modified_time":"2026-02-16T09:59:00+00:00","og_image":[{"width":904,"height":622,"url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/finlands-fimea-issues-guidance-eu-ai-act-requirements-ai-enabled-medical-devices-effective-january-19-2026.png","type":"image\/png"}],"author":"Shaffa Renaningtyas","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Shaffa Renaningtyas","Est. reading time":"4 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/#article","isPartOf":{"@id":"https:\/\/regask.com\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/"},"author":{"name":"Shaffa Renaningtyas","@id":"https:\/\/regask.com\/#\/schema\/person\/b0e1938ef6f244f9f052a21f21cba1b6"},"headline":"Finland\u2019s FIMEA Issues Guidance on EU AI Act Requirem&hellip;","datePublished":"2026-02-16T08:04:40+00:00","dateModified":"2026-02-16T09:59:00+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/"},"wordCount":847,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/finlands-fimea-issues-guidance-eu-ai-act-requirements-ai-enabled-medical-devices-effective-january-19-2026.png","articleSection":["Regulatory News","Medical Devices","Finland"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/regask.com\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/","url":"https:\/\/regask.com\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/","name":"La FIMEA de Finlandia publica una gu\u00eda sobre la normativa de la Ley de IA de la UE","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/finlands-fimea-issues-guidance-eu-ai-act-requirements-ai-enabled-medical-devices-effective-january-19-2026.png","datePublished":"2026-02-16T08:04:40+00:00","dateModified":"2026-02-16T09:59:00+00:00","description":"Descubra la gu\u00eda FIMEA de Finlandia sobre los requisitos de la Ley de IA de la UE para dispositivos m\u00e9dicos habilitados para IA, vigente a partir del 19 de enero de 2026.","inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/finlands-fimea-issues-guidance-eu-ai-act-requirements-ai-enabled-medical-devices-effective-january-19-2026.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/finlands-fimea-issues-guidance-eu-ai-act-requirements-ai-enabled-medical-devices-effective-january-19-2026.png","width":904,"height":622,"caption":"Finlands Fimea Issues Guidance Eu Ai Act Requirements Ai Enabled Medical Devices Effective January 19 2026"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Habilitando decisiones regulatorias m\u00e1s inteligentes","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/b0e1938ef6f244f9f052a21f21cba1b6","name":"Shaffa Renaningtyas"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/9483","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/users\/41"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/comments?post=9483"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/9483\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media\/9484"}],"wp:attachment":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media?parent=9483"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/categories?post=9483"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/tags?post=9483"}],"curies":[{"name":"Gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}