{"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-2069294526\">\n\n\t<div id=\"col-1464642318\" 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-1432135581\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1432135581 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306e\u8a73\u7d30<\/h2>\n\t<div id=\"gap-551823431\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-551823431 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u6b21\u306e\u3088\u3046\u306b\u8aac\u660e\u3055\u308c\u3066\u3044\u308b\u3002 <strong>\u4eba\u5de5\u77e5\u80fd\uff08MDAI\uff09\u3092\u7d44\u307f\u8fbc\u3093\u3060\u533b\u7642\u6a5f\u5668<\/strong> \u73fe\u5728\u306f\u3001\u4ee5\u4e0b\u306e\u67a0\u7d44\u307f\u306b\u57fa\u3065\u3044\u3066\u898f\u5236\u3055\u308c\u3066\u3044\u308b\u3002 <strong>MDR\u3001IVDR\u3001,<\/strong> \u305d\u3057\u3066 <strong>EU\u306eAI\u898f\u5236<\/strong>, \u533b\u7642\u6a5f\u5668\u6cd5\u306e\u307f\u3067\u306f\u306a\u304f\u3001\u4ee5\u4e0b\u306e\u70b9\u3092\u5f37\u8abf\u3059\u308b\u3002 <strong>\u5b89\u5168\u6027\u3001\u502b\u7406\u7684\u6301\u7d9a\u53ef\u80fd\u6027\u3001\u900f\u660e\u6027<\/strong> AI \u5bfe\u5fdc\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u308f\u305f\u308a\u307e\u3059\u3002.<\/p>\n<p>AI\u5bfe\u5fdc\u30c7\u30d0\u30a4\u30b9\u3092EU\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u4f01\u696d\u306f\u3001 <strong>\u54c1\u8cea\u7ba1\u7406\u7fa9\u52d9\u306e\u62e1\u5927\u3001,<\/strong> \u5f37\u5316\u3092\u542b\u3080<strong> \u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30ea\u30b9\u30af\u8a55\u4fa1\u3001,<\/strong> \u3088\u308a\u5805\u7262 <strong>\u6280\u8853\u6587\u66f8<\/strong>, \u3001\u305d\u3057\u3066\u3088\u308a\u660e\u78ba\u306b <strong>\u900f\u660e\u6027\u5bfe\u7b56<\/strong> AI\u6a5f\u80fd\u306b\u95a2\u9023\u3059\u308b\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001 <strong>\u30c7\u30fc\u30bf\u51e6\u7406\u3068\u30c7\u30fc\u30bf\u30ac\u30d0\u30ca\u30f3\u30b9\u306e\u5b9f\u8df5<\/strong>, \u30c7\u30fc\u30bf\u54c1\u8cea\u3001\u30d0\u30a4\u30a2\u30b9\u3001\u30b7\u30b9\u30c6\u30e0 \u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u306a\u3069\u306e AI \u7279\u6709\u306e\u30ea\u30b9\u30af\u3092\u6642\u9593\u306e\u7d4c\u904e\u3068\u3068\u3082\u306b\u53cd\u6620\u3057\u307e\u3059\u3002.<\/p>\n<p>\u306e\u305f\u3081\u306b <strong>\u9ad8\u30ea\u30b9\u30afAI\u30b7\u30b9\u30c6\u30e0<\/strong>, \u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001 <strong>\u3088\u308a\u53b3\u3057\u3044\u898f\u5236\u7ba1\u7406<\/strong>, \u7279\u306b\u5b89\u5168\u6027\u3001\u900f\u660e\u6027\u3001\u76e3\u7763\u306b\u95a2\u3059\u308b\u8981\u4ef6\u306e\u5b9f\u65bd\u306f\u3001 <strong>\u6bb5\u968e\u7684\u306b\u3001,<\/strong> EU\u30ec\u30d9\u30eb\u3067\u306e\u8b70\u8ad6\u304c\u7d99\u7d9a\u3055\u308c\u3001\u5404\u56fd\u306e\u6cd5\u5f8b\u304c\u6700\u7d42\u6c7a\u5b9a\u3055\u308c\u308b\u306b\u3064\u308c\u3066\u3001\u3055\u3089\u306a\u308b\u660e\u78ba\u5316\u304c\u671f\u5f85\u3055\u308c\u307e\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u5177\u4f53\u7684\u306a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306f\u5909\u66f4\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1464642318 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1470027246\" 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>\u767a\u52b9\u65e5<\/h2>\n\t<div id=\"gap-116311806\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-116311806 {\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-1470027246 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-71533407\" 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-311680822\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-311680822 {\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-71533407 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-318947300\" 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-1494533823\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1494533823 {\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-318947300 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2140476471\" 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-2000794932\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2000794932 {\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-2140476471 > .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-112482111\">\n\n\t<div id=\"col-444212318\" 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-169192293\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-169192293 {\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-927595618\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-927595618 {\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-444212318 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-527485334\" 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-264479058\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-264479058 {\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-527485334 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-879828390\" 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-717082699\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-717082699 {\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-879828390 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-150695923\" 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-920137977\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-920137977 {\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-150695923 > .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 v27.6 (Yoast SEO v27.6) - 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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