{"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":"%e3%83%95%e3%82%a3%e3%83%b3%e3%83%a9%e3%83%b3%e3%83%89%e3%81%ae%e9%87%91%e8%9e%8d%e5%b8%82%e5%a0%b4%e7%9b%a3%e7%9d%a3%e5%ba%81%ef%bc%88fimea%ef%bc%89%e3%81%af%e3%80%812026%e5%b9%b41%e6%9c%8819","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/","title":{"rendered":"\u30d5\u30a3\u30f3\u30e9\u30f3\u30c9\u91d1\u878d\u60c5\u5831\u7701\u3001EU AI\u6cd5\u306e\u8981\u4ef6\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u884c\u2026"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2026 \u5e74 1 \u6708 19 \u65e5\u3001\u30d5\u30a3\u30f3\u30e9\u30f3\u30c9\u533b\u85ac\u54c1\u5e81 (FIMEA)<\/strong> \u306e\u4f7f\u7528\u306b\u95a2\u3059\u308b\u516c\u958b\u30ac\u30a4\u30c0\u30f3\u30b9 <strong>\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u4eba\u5de5\u77e5\u80fd\u3001,<\/strong> \u30de\u30fc\u30af <strong>\u767a\u52b9\u65e5<\/strong> \u660e\u78ba\u5316\u3055\u308c\u305f\u898f\u5236\u671f\u5f85\u306e <strong>EU\u4eba\u5de5\u77e5\u80fd\u898f\u5236,<\/strong> \u65e2\u5b58\u306e <strong>\u533b\u7642\u6a5f\u5668\u898f\u5236\uff08MDR\uff09<\/strong> \u305d\u3057\u3066 <strong>\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u898f\u5236\uff08IVDR\uff09<\/strong> \u8981\u4ef6\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306fAI\u5bfe\u5fdc\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u696d\u8005\u304a\u3088\u3073\u8ca9\u58f2\u696d\u8005\u306b\u9069\u7528\u3055\u308c\u3001 <strong>\u6bb5\u968e\u7684\u306b<\/strong> EU \u304a\u3088\u3073\u5404\u56fd\u306e\u8981\u4ef6\u304c\u78ba\u5b9a\u6b21\u7b2c\u304a\u77e5\u3089\u305b\u3057\u307e\u3059\u3002.<\/p>\n<div class=\"row\"  id=\"row-1076389742\">\n\n\t<div id=\"col-1275729531\" 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-139827372\" class=\"gap-element clearfix\" style=\"display:block; 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height:auto;\">\n\t\t\n<style>\n#gap-439565836 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001 <strong>EU\u306eAI\u898f\u5236<\/strong> \u65e2\u5b58\u306e\u533b\u7642\u6a5f\u5668\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3068\u9023\u643a\u3057\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u6a5f\u80fd\u5168\u4f53\u306b\u308f\u305f\u308b\u89e3\u91c8\u306e\u4e00\u8cab\u6027\u3092\u9ad8\u3081\u307e\u3059\u3002AI\u7279\u6709\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u3068\u30c7\u30fc\u30bf\u30ac\u30d0\u30ca\u30f3\u30b9\u3092\u65e2\u5b58\u306e\u533b\u7642\u6a5f\u5668\u30d7\u30ed\u30bb\u30b9\u306b\u7d71\u5408\u3059\u308b\u3053\u3068\u3067\u30c7\u30b8\u30bf\u30eb\u9023\u643a\u3092\u5f37\u5316\u3057\u3001\u3088\u308a\u660e\u78ba\u306a\u671f\u5f85\u5024\u306b\u57fa\u3065\u304f\u52b9\u7387\u6027\u306e\u5411\u4e0a\u3092\u76ee\u6307\u3057\u307e\u3059\u3002\u540c\u6642\u306b\u3001\u6bb5\u968e\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u306b\u3088\u308a\u3001\u8981\u4ef6\u304c\u6bb5\u968e\u7684\u306b\u5b9a\u7fa9\u3055\u308c\u308b\u306b\u3064\u308c\u3066\u3001\u4e0d\u5fc5\u8981\u306a\u898f\u5236\u8ca0\u62c5\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\u3092\u76ee\u6307\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1627108035 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1061851558\" 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>\u3053\u308c\u304c\u306a\u305c\u95a2\u9023\u3059\u308b\u306e\u304b<\/h2>\n\t<div id=\"gap-1147842392\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1147842392 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u7279\u306b\u3001 <strong>\u898f\u5236\u696d\u52d9\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001\u7814\u7a76\u958b\u767a\u3001IT<\/strong>\u3001 \u305d\u3057\u3066 <strong>AI\u958b\u767a\u30c1\u30fc\u30e0<\/strong> EU\u5e02\u5834\u5411\u3051\u306eAI\u5bfe\u5fdc\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u306b\u643a\u308f\u3063\u3066\u3044\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1061851558 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-307609999\" 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>\u8ab0\u306b\u95a2\u4fc2\u304c\u3042\u308b\u304b<\/h2>\n\t<div id=\"gap-1707878795\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1707878795 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u5c55\u958b\u306f\u3001 <strong>\u898f\u5236\u696d\u52d9\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001\u6cd5\u52d9\u30fb\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u7814\u7a76\u958b\u767a\u3001\u60a3\u8005\u5b89\u5168\u30b0\u30eb\u30fc\u30d7\u3001,<\/strong> \u305d\u3057\u3066 <strong>\u55b6\u696d\u307e\u305f\u306f\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u30c1\u30fc\u30e0<\/strong> \u7c73\u56fd\u5e02\u5834\u5168\u4f53\u3067\u98df\u54c1\u88fd\u54c1\u306e\u76e3\u7763\u3001\u6804\u990a\u7814\u7a76\u3001\u98df\u54c1\u5b89\u5168\u76e3\u8996\u306b\u643a\u308f\u3063\u3066\u3044\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-307609999 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-82891122\" 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>\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/h2>\n\t<div id=\"gap-1395819059\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1395819059 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u7d44\u7e54\u306f <strong>\u73fe\u5728\u306e\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u3092\u8a55\u4fa1\u3059\u308b<\/strong> AI\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3092\u7279\u5b9a\u3057\u3001\u4e21\u8005\u306e\u6574\u5408\u6027\u3092\u8a55\u4fa1\u3059\u308b <strong>MDR IVDR<\/strong> \u305d\u3057\u3066 <strong>AI \u56fa\u6709\u306e\u8981\u4ef6\u3002.<\/strong> \u5185\u90e8\u30d7\u30ed\u30bb\u30b9 <strong>\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30ea\u30b9\u30af\u7ba1\u7406\u3001\u30c7\u30fc\u30bf\u51e6\u7406\u3001,<\/strong> \u305d\u3057\u3066 <strong>\u6280\u8853\u6587\u66f8<\/strong> \u5fc5\u8981\u306b\u5fdc\u3058\u3066\u898b\u76f4\u3057\u3001\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u307e\u305f\u3001\u5229\u5bb3\u95a2\u4fc2\u8005\u306f <strong>Fimea\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3092\u76e3\u8996\u3059\u308b<\/strong> \u6bb5\u968e\u7684\u306a\u5c0e\u5165\u306b\u95a2\u3059\u308b\u8a73\u7d30\u306a\u6307\u793a\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u3061\u3089\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u307e\u305f\u3001\u8ffd\u52a0\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u304c\u516c\u958b\u3055\u308c\u305f\u3089\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3092\u9069\u5fdc\u3055\u305b\u308b\u6e96\u5099\u3092\u3057\u3066\u304a\u3044\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n<p>AI \u898f\u5236\u304c\u533b\u7642\u6a5f\u5668\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u307e\u3059\u307e\u3059\u91cd\u306a\u308b\u306b\u3064\u308c\u3066\u3001\u9032\u5316\u3059\u308b\u8981\u4ef6\u3092\u5148\u53d6\u308a\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u306b\u306a\u308a\u307e\u3059\u3002. <strong><a href=\"https:\/\/regask.com\/ja\/\">RegASK<\/a> \u306f\u3001\u4e3b\u8981\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8AI\u898f\u5236\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u304a\u3088\u3073\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u30aa\u30fc\u30b1\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002<\/strong> \u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u3092\u542b\u3080\u898f\u5236\u306e\u53b3\u3057\u3044\u5206\u91ce\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u7d44\u7e54\u304c\u3001\u8907\u96d1\u306a\u898f\u5236\u74b0\u5883\u3092\u7a4d\u6975\u7684\u306b\u4e57\u308a\u8d8a\u3048\u3089\u308c\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002\u9ad8\u5ea6\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u3068\u5c02\u9580\u5bb6\u306e\u77e5\u898b\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001, <a href=\"https:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u30bf\u30a4\u30e0\u30ea\u30fc\u306a\u4e88\u6e2c\u7684\u304b\u3064\u5b9f\u7528\u7684\u306a\u6d1e\u5bdf\u3068\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u81ea\u52d5\u5316\u3092\u63d0\u4f9b\u3057\u3001\u30c1\u30fc\u30e0\u304c AI \u95a2\u9023\u306e\u898f\u5236\u306e\u66f4\u65b0\u3092\u8ffd\u8de1\u3057\u3001\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3001140 \u304b\u56fd\u4ee5\u4e0a\u3067\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u5408\u7406\u5316\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002. <a href=\"https:\/\/regask.com\/ja\/\"><strong>\u3082\u3063\u3068\u8a73\u3057\u304f\u77e5\u308b<\/strong><\/a> \u307e\u305f\u306f <a href=\"https:\/\/regask.com\/ja\/%e3%83%87%e3%83%a2%e3%82%92%e4%ba%88%e7%b4%84%e3%81%99%e3%82%8b\/\"><strong>\u4eca\u3059\u3050\u30c7\u30e2\u3092\u4e88\u7d04\u3059\u308b<\/strong>.\u00a0<\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-82891122 > .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-1398240993\">\n\n\t<div id=\"col-1079295\" 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>\u3088\u304f\u3042\u308b\u8cea\u554f<\/h3>\n\t<div id=\"gap-1542487618\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1542487618 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>FIMEA \u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u4f55\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-674149320\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-674149320 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001AI \u5bfe\u5fdc\u533b\u7642\u6a5f\u5668\u304c MDR \u304a\u3088\u3073 IVDR \u8981\u4ef6\u3068\u7d44\u307f\u5408\u308f\u305b\u3066 EU AI \u898f\u5236\u306e\u4e0b\u3067\u3069\u306e\u3088\u3046\u306b\u898f\u5236\u3055\u308c\u308b\u304b\u3092\u660e\u78ba\u306b\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1079295 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-685231900\" 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>EU \u3067\u306f AI \u5bfe\u5fdc\u533b\u7642\u6a5f\u5668\u306b\u3069\u306e\u3088\u3046\u306a\u898f\u5236\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-265511442\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-265511442 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>AI\u5bfe\u5fdc\u533b\u7642\u6a5f\u5668\u306f\u3001<strong> MDR\u307e\u305f\u306fIVDR<\/strong> \u3060\u3051\u3067\u306a\u304f <strong>EU \u4eba\u5de5\u77e5\u80fd\u898f\u5236\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-685231900 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1936122545\" 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>\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3044\u3064\u767a\u52b9\u3057\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-1121145325\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1121145325 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001 <strong>2026\u5e741\u670819\u65e5,<\/strong> \u3068 <strong>\u6bb5\u968e\u7684\u306a\u5b9f\u65bd<\/strong> EU \u304a\u3088\u3073\u5404\u56fd\u306e\u8981\u4ef6\u304c\u6700\u7d42\u6c7a\u5b9a\u3055\u308c\u308b\u3068\u4e88\u60f3\u3055\u308c\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1936122545 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-835792576\" 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>RegASK \u306f\u3001\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306e\u5f71\u97ff\u3092\u53d7\u3051\u308b\u30c1\u30fc\u30e0\u3092\u3069\u306e\u3088\u3046\u306b\u30b5\u30dd\u30fc\u30c8\u3067\u304d\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-1090566252\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1090566252 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u898f\u5236\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30fc\u30e0\u304c AI \u95a2\u9023\u306e\u898f\u5236\u5909\u66f4\u3092\u76e3\u8996\u3057\u3001\u533b\u7642\u6a5f\u5668\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u3078\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3001AI \u4e3b\u5c0e\u306e\u6d1e\u5bdf\u3068\u5c02\u9580\u5bb6\u306b\u3088\u3063\u3066\u691c\u8a3c\u3055\u308c\u305f\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u901a\u3058\u3066\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30a2\u30af\u30b7\u30e7\u30f3\u3092\u52b9\u7387\u7684\u306b\u904b\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u652f\u63f4\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-835792576 > .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 medical devices and will be implemented in phases as EU and national requirements are finalized.<\/p>","protected":false},"author":43,"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 v28.0 (Yoast SEO v28.3) - 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\/ja\/\u30d5\u30a3\u30f3\u30e9\u30f3\u30c9\u306e\u91d1\u878d\u5e02\u5834\u76e3\u7763\u5e81\uff08fimea\uff09\u306f\u30012026\u5e741\u670819\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\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\/ja\/\u30d5\u30a3\u30f3\u30e9\u30f3\u30c9\u306e\u91d1\u878d\u5e02\u5834\u76e3\u7763\u5e81\uff08fimea\uff09\u306f\u30012026\u5e741\u670819\/\" \/>\n<meta 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