{"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":"%e8%8a%ac%e5%85%b0%e8%81%94%e9%82%a6%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e7%ae%a1%e7%90%86%e5%b1%80-fimea-%e5%8f%91%e5%b8%83%e5%85%b3%e4%ba%8e%e6%ac%a7%e7%9b%9f%e4%ba%ba%e5%b7%a5%e6%99%ba%e8%83%bd","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/finlands-fimea-issues-guidance-on-eu-ai-act-requirements-for-ai-enabled-medical-devices-effective-january-19-2026\/","title":{"rendered":"\u82ac\u5170FIMEA\u53d1\u5e03\u5173\u4e8e\u6b27\u76df\u4eba\u5de5\u667a\u80fd\u6cd5\u6848\u8981\u6c42\u7684\u6307\u5bfc\u610f\u89c1\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2026 \u5e74 1 \u6708 19 \u65e5\uff0c\u82ac\u5170\u836f\u54c1\u7ba1\u7406\u5c40 (FIMEA)<\/strong> \u5df2\u53d1\u5e03\u7684\u5173\u4e8e\u4f7f\u7528\u6307\u5357 <strong>\u4eba\u5de5\u667a\u80fd\u5728\u533b\u7597\u5668\u68b0\u4e2d\u7684\u5e94\u7528,<\/strong> \u6807\u8bb0 <strong>\u751f\u6548\u65e5\u671f<\/strong> \u5728\u660e\u786e\u7684\u76d1\u7ba1\u9884\u671f\u4e0b <strong>\u6b27\u76df\u4eba\u5de5\u667a\u80fd\u6cd5\u89c4,<\/strong> \u4e0e\u73b0\u6709\u8bbe\u65bd\u4e00\u8d77 <strong>\u533b\u7597\u5668\u68b0\u6cd5\u89c4 (MDR)<\/strong> \u548c <strong>\u4f53\u5916\u8bca\u65ad\u6cd5\u89c4\uff08IVDR\uff09<\/strong> \u8981\u6c42\u3002\u8be5\u6307\u5357\u9002\u7528\u4e8e\u4eba\u5de5\u667a\u80fd\u533b\u7597\u8bbe\u5907\u7684\u5236\u9020\u5546\u548c\u5206\u9500\u5546\uff0c\u5e76\u5c06\u4e88\u4ee5\u5b9e\u65bd\u3002 <strong>\u5206\u9636\u6bb5\u8fdb\u884c<\/strong> \u5f85\u6b27\u76df\u548c\u56fd\u5bb6\u8981\u6c42\u6700\u7ec8\u786e\u5b9a\u540e\u3002.<\/p>\n<div class=\"row\"  id=\"row-1711041677\">\n\n\t<div id=\"col-1275269444\" 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-319418382\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-319418382 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-385510702\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-385510702 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8be5\u6307\u5357\u89e3\u91ca\u8bf4\uff1a <strong>\u96c6\u6210\u4eba\u5de5\u667a\u80fd\u7684\u533b\u7597\u5668\u68b0\uff08MDAI\uff09<\/strong> \u73b0\u5728\u5747\u5728\u4ee5\u4e0b\u7efc\u5408\u6846\u67b6\u4e0b\u8fdb\u884c\u76d1\u7ba1\uff1a <strong>MDR\u3001IVDR\u3001,<\/strong> \u548c <strong>\u6b27\u76df\u4eba\u5de5\u667a\u80fd\u6cd5\u89c4<\/strong>, \u800c\u4e0d\u4ec5\u4ec5\u662f\u4f9d\u636e\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u3002\u5b83\u5f3a\u8c03\u4e86\u786e\u4fdd\u4ee5\u4e0b\u65b9\u9762\u7684\u5fc5\u8981\u6027\uff1a <strong>\u5b89\u5168\u3001\u7b26\u5408\u4f26\u7406\u7684\u53ef\u6301\u7eed\u6027\u548c\u900f\u660e\u5ea6<\/strong> \u8d2f\u7a7f\u4eba\u5de5\u667a\u80fd\u533b\u7597\u8bbe\u5907\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u3002.<\/p>\n<p>\u5728\u6b27\u76df\u5e02\u573a\u6295\u653e\u4eba\u5de5\u667a\u80fd\u8bbe\u5907\u7684\u516c\u53f8\u5fc5\u987b\u6ee1\u8db3\u4ee5\u4e0b\u8981\u6c42 <strong>\u6269\u5927\u8d28\u91cf\u7ba1\u7406\u4e49\u52a1,<\/strong> \u5305\u62ec\u52a0\u5f3a<strong> \u751f\u547d\u5468\u671f\u98ce\u9669\u8bc4\u4f30,<\/strong> \u66f4\u5f3a\u52b2 <strong>\u6280\u672f\u6587\u6863<\/strong>, \u66f4\u6e05\u6670 <strong>\u900f\u660e\u5ea6\u63aa\u65bd<\/strong> \u4e0e\u4eba\u5de5\u667a\u80fd\u529f\u80fd\u76f8\u5173\u3002\u8be5\u6307\u5357\u8fd8\u5f3a\u8c03\u4e86\u4ee5\u4e0b\u65b9\u9762\u7684\u91cd\u8981\u6027\uff1a <strong>\u6570\u636e\u5904\u7406\u548c\u6570\u636e\u6cbb\u7406\u5b9e\u8df5<\/strong>, \u8fd9\u53cd\u6620\u4e86\u4eba\u5de5\u667a\u80fd\u7279\u6709\u7684\u98ce\u9669\uff0c\u4f8b\u5982\u6570\u636e\u8d28\u91cf\u3001\u504f\u5dee\u548c\u7cfb\u7edf\u6027\u80fd\u968f\u65f6\u95f4\u7684\u53d8\u5316\u3002.<\/p>\n<p>\u4e3a\u4e86 <strong>\u9ad8\u98ce\u9669\u4eba\u5de5\u667a\u80fd\u7cfb\u7edf<\/strong>, \u8be5\u6307\u5357\u8868\u660e\u4e86\u4ee5\u4e0b\u5e94\u7528\uff1a <strong>\u66f4\u4e25\u683c\u7684\u76d1\u7ba1\u63a7\u5236<\/strong>, \u5c24\u5176\u662f\u5728\u5b89\u5168\u3001\u900f\u660e\u5ea6\u548c\u76d1\u7763\u65b9\u9762\u3002\u8fd9\u4e9b\u8981\u6c42\u7684\u5b9e\u65bd\u5c06\u5305\u62ec\uff1a <strong>\u5206\u9636\u6bb5\u8fdb\u884c,<\/strong> \u968f\u7740\u6b27\u76df\u5c42\u9762\u8ba8\u8bba\u7684\u7ee7\u7eed\u4ee5\u53ca\u5404\u56fd\u7acb\u6cd5\u7684\u6700\u7ec8\u786e\u5b9a\uff0c\u9884\u8ba1\u4f1a\u6709\u8fdb\u4e00\u6b65\u7684\u6f84\u6e05\u3002\u56e0\u6b64\uff0c\u5177\u4f53\u65f6\u95f4\u8868\u53ef\u80fd\u4f1a\u6709\u6240\u8c03\u6574\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1275269444 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-960398696\" 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>\u751f\u6548\u65e5\u671f<\/h2>\n\t<div id=\"gap-1624245840\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1624245840 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u672c\u6307\u5357\u5c31\u5982\u4f55\u8fdb\u884c\u76d1\u7ba1\u63d0\u4f9b\u4e86\u660e\u786e\u7684\u6307\u5bfc\u3002 <strong>\u6b27\u76df\u4eba\u5de5\u667a\u80fd\u6cd5\u89c4<\/strong> \u5b83\u4e0e\u73b0\u6709\u7684\u533b\u7597\u5668\u68b0\u6846\u67b6\u8fdb\u884c\u4ea4\u4e92\uff0c\u652f\u6301\u5408\u89c4\u804c\u80fd\u90e8\u95e8\u4e4b\u95f4\u66f4\u4e00\u81f4\u7684\u89e3\u8bfb\u3002\u5b83\u901a\u8fc7\u5c06\u4eba\u5de5\u667a\u80fd\u4e13\u5c5e\u7684\u98ce\u9669\u7ba1\u7406\u548c\u6570\u636e\u6cbb\u7406\u6574\u5408\u5230\u65e2\u5b9a\u7684\u533b\u7597\u5668\u68b0\u6d41\u7a0b\u4e2d\uff0c\u5f3a\u5316\u4e86\u6570\u5b57\u5316\u8f6c\u578b\uff0c\u540c\u65f6\u65e8\u5728\u901a\u8fc7\u66f4\u6e05\u6670\u7684\u9884\u671f\u6765\u63d0\u9ad8\u6548\u7387\u3002\u6b64\u5916\uff0c\u5206\u9636\u6bb5\u5b9e\u65bd\u7684\u65b9\u6cd5\u65e8\u5728\u968f\u7740\u8981\u6c42\u7684\u9010\u6b65\u660e\u786e\uff0c\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u4e0d\u5fc5\u8981\u7684\u76d1\u7ba1\u8d1f\u62c5\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-960398696 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-568676791\" 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>\u4e3a\u4ec0\u4e48\u8fd9\u4e0e\u2026\u2026\u76f8\u5173<\/h2>\n\t<div id=\"gap-2061509514\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2061509514 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6b64\u66f4\u65b0\u5c24\u5176\u9002\u7528\u4e8e <strong>\u6cd5\u89c4\u4e8b\u52a1\u3001\u8d28\u91cf\u4fdd\u8bc1\u3001\u7814\u53d1\u3001\u4fe1\u606f\u6280\u672f<\/strong>\uff0c \u548c <strong>\u4eba\u5de5\u667a\u80fd\u5f00\u53d1\u56e2\u961f<\/strong> \u53c2\u4e0e\u9762\u5411\u6b27\u76df\u5e02\u573a\u7684\u4eba\u5de5\u667a\u80fd\u533b\u7597\u8bbe\u5907\u7684\u8bbe\u8ba1\u3001\u5408\u89c4\u6027\u548c\u751f\u547d\u5468\u671f\u7ba1\u7406\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-568676791 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-283367442\" 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>\u8fd9\u9002\u7528\u4e8e\u54ea\u4e9b\u4eba\u7fa4<\/h2>\n\t<div id=\"gap-29900755\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-29900755 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8fd9\u4e00\u8fdb\u5c55\u4e0e\u4ee5\u4e0b\u65b9\u9762\u76f8\u5173\uff1a <strong>\u6cd5\u89c4\u4e8b\u52a1\u3001\u8d28\u91cf\u4fdd\u8bc1\u3001\u6cd5\u5f8b\u4e0e\u5408\u89c4\u3001\u7814\u53d1\u3001\u60a3\u8005\u5b89\u5168\u5c0f\u7ec4,<\/strong> \u548c <strong>\u5546\u4e1a\u6216\u8425\u9500\u56e2\u961f<\/strong> \u53c2\u4e0e\u7f8e\u56fd\u5e02\u573a\u7684\u98df\u54c1\u76d1\u7ba1\u3001\u8425\u517b\u7814\u7a76\u548c\u98df\u54c1\u5b89\u5168\u76d1\u6d4b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-283367442 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-603948133\" 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>\u4e0b\u4e00\u6b65<\/h2>\n\t<div id=\"gap-1490178567\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1490178567 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u7ec4\u7ec7\u5e94\u8be5 <strong>\u8bc4\u4f30\u73b0\u6709\u4ea7\u54c1\u7ec4\u5408<\/strong> \u8bc6\u522b\u4eba\u5de5\u667a\u80fd\u7ec4\u4ef6\u5e76\u8bc4\u4f30\u5176\u4e0e\u4e24\u8005\u7684\u4e00\u81f4\u6027 <strong>MDR IVDR<\/strong> \u548c <strong>\u4eba\u5de5\u667a\u80fd\u7279\u6709\u7684\u9700\u6c42\u3002.<\/strong> \u5185\u90e8\u6d41\u7a0b <strong>\u751f\u547d\u5468\u671f\u98ce\u9669\u7ba1\u7406\u3001\u6570\u636e\u5904\u7406,<\/strong> \u548c <strong>\u6280\u672f\u6587\u6863<\/strong> \u5e94\u8fdb\u884c\u5ba1\u67e5\uff0c\u5e76\u5728\u5fc5\u8981\u65f6\u8fdb\u884c\u66f4\u65b0\u3002\u5229\u76ca\u76f8\u5173\u8005\u4e5f\u5e94\u5982\u6b64\u3002 <strong>\u76d1\u63a7Fimea\u7684\u7f51\u7ad9<\/strong> \u6709\u5173\u5206\u9636\u6bb5\u5b9e\u65bd\u7684\u66f4\u591a\u8bf4\u660e\uff0c\u8bf7\u505a\u597d\u51c6\u5907\uff0c\u968f\u7740\u66f4\u591a\u6307\u5bfc\u7684\u53d1\u5e03\uff0c\u8c03\u6574\u8d28\u91cf\u4f53\u7cfb\u3002.<\/p>\n<p>\u968f\u7740\u4eba\u5de5\u667a\u80fd\u6cd5\u89c4\u4e0e\u533b\u7597\u5668\u68b0\u5408\u89c4\u6027\u4e4b\u95f4\u7684\u4ea4\u96c6\u65e5\u76ca\u589e\u591a\uff0c\u638c\u63e1\u4e0d\u65ad\u53d8\u5316\u7684\u8981\u6c42\u53d8\u5f97\u81f3\u5173\u91cd\u8981\u3002. <strong><a href=\"https:\/\/regask.com\/zh\/\">RegASK<\/a> \u662f\u4e00\u4e2a\u9886\u5148\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u76d1\u7ba1\u60c5\u62a5\u548c\u5de5\u4f5c\u6d41\u7f16\u6392\u5e73\u53f0<\/strong> \u5b83\u8d4b\u80fd\u5168\u7403\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u7ec4\u7ec7\uff0c\u5305\u62ec\u751f\u547d\u79d1\u5b66\u9886\u57df\uff0c\u4f7f\u5176\u80fd\u591f\u4e3b\u52a8\u5e94\u5bf9\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002\u901a\u8fc7\u5c06\u5148\u8fdb\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u4e0e\u4e13\u5bb6\u56e2\u961f\u76f8\u7ed3\u5408\uff0c, <a href=\"https:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u63d0\u4f9b\u53ca\u65f6\u3001\u53ef\u9884\u6d4b\u3001\u53ef\u64cd\u4f5c\u7684\u89c1\u89e3\u548c\u7aef\u5230\u7aef\u7684\u81ea\u52a8\u5316\uff0c\u5e2e\u52a9\u56e2\u961f\u8ddf\u8e2a\u4e0e\u4eba\u5de5\u667a\u80fd\u76f8\u5173\u7684\u76d1\u7ba1\u66f4\u65b0\u3001\u8bc4\u4f30\u5f71\u54cd\uff0c\u5e76\u7b80\u5316 140 \u591a\u4e2a\u56fd\u5bb6\u7684\u5408\u89c4\u6d41\u7a0b\u3002. <a href=\"https:\/\/regask.com\/zh\/\"><strong>\u4e86\u89e3\u66f4\u591a<\/strong><\/a> \u6216\u8005 <a href=\"https:\/\/regask.com\/zh\/%e9%a2%84%e8%ae%a2%e6%bc%94%e7%a4%ba\/\"><strong>\u7acb\u5373\u9884\u7ea6\u6f14\u793a<\/strong>.\u00a0<\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-603948133 > .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-1919200718\">\n\n\t<div id=\"col-2133963306\" 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>\u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/h3>\n\t<div id=\"gap-1358584895\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1358584895 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>FIMEA \u7684\u6307\u5bfc\u65b9\u9488\u4fa7\u91cd\u4e8e\u54ea\u4e9b\u65b9\u9762\uff1f<\/h4>\n\t<div id=\"gap-1804601966\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1804601966 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5b83\u9610\u660e\u4e86\u6b27\u76df\u4eba\u5de5\u667a\u80fd\u6cd5\u89c4\u5982\u4f55\u7ed3\u5408\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u548c\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u7684\u8981\u6c42\u6765\u76d1\u7ba1\u4eba\u5de5\u667a\u80fd\u533b\u7597\u5668\u68b0\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2133963306 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-40688547\" 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>\u6b27\u76df\u5bf9\u4eba\u5de5\u667a\u80fd\u533b\u7597\u5668\u68b0\u6709\u54ea\u4e9b\u76d1\u7ba1\u89c4\u5b9a\uff1f<\/h4>\n\t<div id=\"gap-1763743491\" class=\"gap-element clearfix\" style=\"display:block; 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height:auto;\">\n\t\t\n<style>\n#gap-609823242 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u5e2e\u52a9\u76d1\u7ba1\u548c\u5408\u89c4\u56e2\u961f\u76d1\u63a7\u4e0e\u4eba\u5de5\u667a\u80fd\u76f8\u5173\u7684\u76d1\u7ba1\u53d8\u5316\uff0c\u8bc4\u4f30\u5176\u5bf9\u533b\u7597\u5668\u68b0\u7ec4\u5408\u7684\u5f71\u54cd\uff0c\u5e76\u901a\u8fc7\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u6d1e\u5bdf\u548c\u4e13\u5bb6\u9a8c\u8bc1\u7684\u5de5\u4f5c\u6d41\u7a0b\uff0c\u9ad8\u6548\u5730\u5b9e\u65bd\u5408\u89c4\u884c\u52a8\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-987083539 > .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 v27.4) - 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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