{"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":"lagence-finlandaise-fimea-publie-des-lignes-directrices-sur-les-exigences-de-la-loi-europeenne-sur-lia-pour-les-dispositifs-medicaux-utilisant-lia-applicables-a-compter-du-19-janvie","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/","title":{"rendered":"L&#039;agence finlandaise FIMEA publie des lignes directrices sur les exigences de la loi europ\u00e9enne sur l&#039;IA\u2026"},"content":{"rendered":"<p>Sur <strong>19 janvier 2026, Agence finlandaise des m\u00e9dicaments (FIMEA)<\/strong> des directives publi\u00e9es sur l&#039;utilisation de <strong>intelligence artificielle dans les dispositifs m\u00e9dicaux,<\/strong> marquer le <strong>date d&#039;entr\u00e9e en vigueur<\/strong> des attentes r\u00e9glementaires clarifi\u00e9es en vertu de <strong>R\u00e8glement de l&#039;UE sur l&#039;intelligence artificielle,<\/strong> parall\u00e8lement \u00e0 l&#039;existant <strong>R\u00e8glement relatif aux dispositifs m\u00e9dicaux (RDM)<\/strong> et <strong>R\u00e8glement sur les dispositifs m\u00e9dicaux de diagnostic in vitro (IVDR)<\/strong> exigences. Ces lignes directrices s&#039;appliquent aux fabricants et distributeurs de dispositifs m\u00e9dicaux dot\u00e9s d&#039;intelligence artificielle et seront mises en \u0153uvre. <strong>par phases<\/strong> \u00e0 mesure que les exigences de l&#039;UE et les exigences nationales sont finalis\u00e9es.<\/p>\n<div class=\"row\"  id=\"row-697807433\">\n\n\t<div id=\"col-1441412621\" 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-874576297\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-874576297 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>D\u00e9tails de la mise \u00e0 jour<\/h2>\n\t<div id=\"gap-1920566008\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1920566008 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les directives expliquent que <strong>dispositifs m\u00e9dicaux int\u00e9grant l&#039;intelligence artificielle (MDAI)<\/strong> sont d\u00e9sormais r\u00e9glement\u00e9es dans le cadre d&#039;un syst\u00e8me combin\u00e9 de <strong>MDR, IVDR,<\/strong> et le <strong>R\u00e8glement de l&#039;UE sur l&#039;IA<\/strong>, et non pas uniquement en vertu de la l\u00e9gislation relative aux dispositifs m\u00e9dicaux. Elle souligne la n\u00e9cessit\u00e9 de garantir <strong>s\u00e9curit\u00e9, durabilit\u00e9 \u00e9thique et transparence<\/strong> tout au long du cycle de vie des dispositifs m\u00e9dicaux dot\u00e9s d&#039;IA.<\/p>\n<p>Les entreprises commercialisant des appareils dot\u00e9s d&#039;intelligence artificielle sur le march\u00e9 de l&#039;UE sont tenues de prendre en compte <strong>obligations \u00e9largies en mati\u00e8re de gestion de la qualit\u00e9,<\/strong> y compris renforc\u00e9<strong> \u00e9valuation des risques li\u00e9s au cycle de vie,<\/strong> plus robuste <strong>documentation technique<\/strong>, et plus clair <strong>mesures de transparence<\/strong> li\u00e9 aux fonctionnalit\u00e9s de l&#039;IA. Le guide souligne \u00e9galement l&#039;importance de <strong>pratiques de gestion et de gouvernance des donn\u00e9es<\/strong>, refl\u00e9tant les risques sp\u00e9cifiques \u00e0 l&#039;IA tels que la qualit\u00e9 des donn\u00e9es, les biais et les performances du syst\u00e8me au fil du temps.<\/p>\n<p>Pour <strong>syst\u00e8mes d&#039;IA \u00e0 haut risque<\/strong>, les directives signalent l&#039;application de <strong>des contr\u00f4les r\u00e9glementaires plus stricts<\/strong>, notamment en mati\u00e8re de s\u00e9curit\u00e9, de transparence et de contr\u00f4le. La mise en \u0153uvre de ces exigences aura lieu <strong>par phases,<\/strong> Des pr\u00e9cisions suppl\u00e9mentaires sont attendues \u00e0 mesure que les discussions au niveau de l&#039;UE se poursuivent et que la l\u00e9gislation nationale est finalis\u00e9e. Par cons\u00e9quent, les \u00e9ch\u00e9anciers pr\u00e9cis pourraient \u00e9voluer.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1441412621 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2101176192\" 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>Date d&#039;entr\u00e9e en vigueur<\/h2>\n\t<div id=\"gap-621402358\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-621402358 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ces lignes directrices apportent des \u00e9claircissements r\u00e9glementaires sur la mani\u00e8re dont <strong>R\u00e8glement de l&#039;UE sur l&#039;IA<\/strong> Ce syst\u00e8me interagit avec les cadres r\u00e9glementaires existants pour les dispositifs m\u00e9dicaux, favorisant une interpr\u00e9tation plus coh\u00e9rente entre les diff\u00e9rentes fonctions de conformit\u00e9. Il renforce l&#039;alignement num\u00e9rique en int\u00e9grant la gestion des risques et la gouvernance des donn\u00e9es sp\u00e9cifiques \u00e0 l&#039;IA dans les processus \u00e9tablis pour les dispositifs m\u00e9dicaux, tout en visant \u00e0 am\u00e9liorer l&#039;efficacit\u00e9 gr\u00e2ce \u00e0 des attentes plus claires. Parall\u00e8lement, cette approche progressive a pour objectif de minimiser les contraintes r\u00e9glementaires inutiles \u00e0 mesure que les exigences sont d\u00e9finies graduellement.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2101176192 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-95367000\" 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>Pourquoi cela est pertinent pour<\/h2>\n\t<div id=\"gap-1475970849\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1475970849 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour est particuli\u00e8rement pertinente pour <strong>Affaires r\u00e9glementaires, assurance qualit\u00e9, recherche et d\u00e9veloppement, informatique<\/strong>, et <strong>\u00e9quipes de d\u00e9veloppement de l&#039;IA<\/strong> impliqu\u00e9s dans la conception, la conformit\u00e9 et la gestion du cycle de vie des dispositifs m\u00e9dicaux dot\u00e9s d&#039;IA destin\u00e9s au march\u00e9 de l&#039;UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-95367000 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-796840353\" 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>\u00c0 qui cela s&#039;adresse-t-il ?<\/h2>\n\t<div id=\"gap-414881141\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-414881141 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette \u00e9volution est pertinente pour <strong>Affaires r\u00e9glementaires, assurance qualit\u00e9, affaires juridiques et conformit\u00e9, recherche et d\u00e9veloppement, groupes de s\u00e9curit\u00e9 des patients,<\/strong> et <strong>\u00e9quipes commerciales ou marketing<\/strong> Ils participent \u00e0 la surveillance des produits alimentaires, \u00e0 la recherche en nutrition et au contr\u00f4le de la s\u00e9curit\u00e9 alimentaire sur le march\u00e9 am\u00e9ricain.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-796840353 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1794030712\" 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>Prochaines \u00e9tapes<\/h2>\n\t<div id=\"gap-1853917537\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1853917537 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les organisations devraient <strong>\u00e9valuer les portefeuilles de produits actuels<\/strong> identifier les composants de l&#039;IA et \u00e9valuer leur alignement avec les deux <strong>MDR IVDR<\/strong> et <strong>Exigences sp\u00e9cifiques \u00e0 l&#039;IA.<\/strong> Processus internes pour <strong>gestion des risques li\u00e9s au cycle de vie, traitement des donn\u00e9es,<\/strong> et <strong>documentation technique<\/strong> Il convient de les revoir et de les mettre \u00e0 jour si n\u00e9cessaire. Les parties prenantes devraient \u00e9galement <strong>surveiller le site web de Fimea<\/strong> pour plus d&#039;instructions sur la mise en \u0153uvre progressive et soyez pr\u00eat \u00e0 adapter les syst\u00e8mes de qualit\u00e9 \u00e0 mesure que des directives suppl\u00e9mentaires seront publi\u00e9es.<\/p>\n<p>\u00c0 mesure que la r\u00e9glementation en mati\u00e8re d&#039;IA s&#039;entrem\u00eale de plus en plus avec la conformit\u00e9 des dispositifs m\u00e9dicaux, il devient essentiel d&#039;anticiper l&#039;\u00e9volution des exigences. <strong><a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> est une plateforme de pointe d&#039;intelligence r\u00e9glementaire et d&#039;orchestration des flux de travail bas\u00e9e sur l&#039;IA agentielle<\/strong> qui permet aux organisations internationales op\u00e9rant dans des secteurs fortement r\u00e9glement\u00e9s, notamment les sciences de la vie, d&#039;anticiper et de g\u00e9rer des environnements r\u00e9glementaires complexes. En combinant une IA agentique avanc\u00e9e et l&#039;expertise de sp\u00e9cialistes, <a href=\"https:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> Fournit des informations pr\u00e9dictives exploitables en temps opportun et une automatisation de bout en bout, aidant les \u00e9quipes \u00e0 suivre les mises \u00e0 jour r\u00e9glementaires li\u00e9es \u00e0 l&#039;IA, \u00e0 \u00e9valuer leur impact et \u00e0 rationaliser la conformit\u00e9 dans plus de 140 pays. <a href=\"https:\/\/regask.com\/fr\/\"><strong>En savoir plus<\/strong><\/a> ou <a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\"><strong>R\u00e9servez une d\u00e9mo d\u00e8s maintenant<\/strong>.\u00a0<\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1794030712 > .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-915431662\">\n\n\t<div id=\"col-925280580\" 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>FAQ<\/h3>\n\t<div id=\"gap-6112801\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-6112801 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Sur quoi portent les recommandations de la FIMEA\u00a0?<\/h4>\n\t<div id=\"gap-329716253\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-329716253 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Il pr\u00e9cise comment les dispositifs m\u00e9dicaux utilisant l&#039;IA sont r\u00e9glement\u00e9s par le r\u00e8glement europ\u00e9en sur l&#039;IA, en combinaison avec les exigences des r\u00e8glements MDR et IVDR.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-925280580 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-319445480\" 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>Quelles r\u00e9glementations s&#039;appliquent aux dispositifs m\u00e9dicaux dot\u00e9s d&#039;intelligence artificielle dans l&#039;UE\u00a0?<\/h4>\n\t<div id=\"gap-1406125275\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1406125275 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les dispositifs m\u00e9dicaux dot\u00e9s d&#039;IA doivent se conformer \u00e0<strong> MDR ou IVDR<\/strong> ainsi que le <strong>R\u00e8glement de l&#039;UE sur l&#039;intelligence artificielle. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-319445480 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-251989180\" 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>Quand ces directives entreront-elles en vigueur\u00a0?<\/h4>\n\t<div id=\"gap-857783797\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-857783797 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les directives ont \u00e9t\u00e9 publi\u00e9es le <strong>19 janvier 2026,<\/strong> avec <strong>mise en \u0153uvre progressive<\/strong> pr\u00e9vu d\u00e8s que les exigences de l&#039;UE et les exigences nationales seront finalis\u00e9es.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-251989180 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-828201097\" 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>Comment RegASK peut-il aider les \u00e9quipes concern\u00e9es par cette mise \u00e0 jour\u00a0?<\/h4>\n\t<div id=\"gap-1083499464\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1083499464 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> aide les \u00e9quipes de r\u00e9glementation et de conformit\u00e9 \u00e0 surveiller les changements r\u00e9glementaires li\u00e9s \u00e0 l&#039;IA, \u00e0 \u00e9valuer leur impact sur les portefeuilles de dispositifs m\u00e9dicaux et \u00e0 mettre en \u0153uvre efficacement des actions de conformit\u00e9 gr\u00e2ce \u00e0 des informations bas\u00e9es sur l&#039;IA et des flux de travail valid\u00e9s par des experts.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-828201097 > .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 v27.3 (Yoast SEO v27.5) - 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, 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