{"id":9490,"date":"2026-02-16T17:21:56","date_gmt":"2026-02-16T09:21:56","guid":{"rendered":"https:\/\/regask.com\/?p=9490"},"modified":"2026-03-03T12:57:36","modified_gmt":"2026-03-03T04:57:36","slug":"eu%e5%a7%94%e5%93%a1%e4%bc%9a%e3%81%af%e3%80%812026%e5%b9%b45%e6%9c%88%e3%81%ab%e7%99%ba%e5%8a%b9%e3%81%99%e3%82%8b%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e7%99%bb%e9%8c%b2%e3%81%ae%e7%be%a9%e5%8b%99","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/eu-commission-releases-eudamed-version-2-22-0-with-mandatory-medical-device-registration-updates-effective-may-2026\/","title":{"rendered":"EU\u59d4\u54e1\u4f1a\u3001EUDAMED\u30d0\u30fc\u30b8\u30e7\u30f32.22.0\u3092\u30ea\u30ea\u30fc\u30b9\uff08\u7fa9\u52d9\u5316\u3092\u542b\u3080\uff09"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2026\u5e741\u67085\u65e5<\/strong>\u3001<strong> \u6b27\u5dde\u59d4\u54e1\u4f1a<\/strong> \u306e\u751f\u7523\u958b\u59cb\u3092\u767a\u8868\u3057\u305f <strong>EUDAMED \u30d0\u30fc\u30b8\u30e7\u30f3 2.22.0\u3001,<\/strong> \u5f37\u5316\u3059\u308b\u5fc5\u9808\u306e\u30b7\u30b9\u30c6\u30e0\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3092\u5c0e\u5165 <strong>\u533b\u7642\u6a5f\u5668\u306e\u767b\u9332\u3068\u30c7\u30fc\u30bf\u7ba1\u7406<\/strong> \u6b27\u5dde\u9023\u5408\u5168\u57df\u3002\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f <strong>\u88fd\u9020\u696d\u8005\u3001\u8a8d\u8a3c\u6a5f\u95a2\u3001\u305d\u306e\u4ed6\u306e\u533b\u7642\u6a5f\u5668\u95a2\u4fc2\u8005\u3001,<\/strong> 4\u3064\u306e\u30b3\u30a2EUDAMED\u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u4f7f\u7528\u304c\u7fa9\u52d9\u5316\u3055\u308c\u3001 <strong>2026\u5e745\u670828\u65e5\u3002. <\/strong><\/p>\n<div class=\"row\"  id=\"row-1596425006\">\n\n\t<div id=\"col-60515853\" 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-678032688\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-678032688 {\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-630598967\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-630598967 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u306e\u30ea\u30ea\u30fc\u30b9 <strong>EUDAMED<\/strong> <strong>\u30d0\u30fc\u30b8\u30e7\u30f3 2.22.0<\/strong> \u4e3b\u8981\u30e2\u30b8\u30e5\u30fc\u30eb\u5168\u4f53\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u30c7\u30fc\u30bf\u306e\u6b63\u78ba\u6027\u3001\u304a\u3088\u3073\u4f7f\u3044\u3084\u3059\u3055\u3092\u5f37\u5316\u3057\u307e\u3059\u3002 <strong>\u30a2\u30af\u30bf\u30fc\u767b\u9332\u3001\u30c7\u30d0\u30a4\u30b9\u8b58\u5225\uff08UDI\uff09\u3001\u8a3c\u660e\u66f8\u3001,<\/strong> \u305d\u3057\u3066 <strong>\u516c\u7684\u60c5\u5831\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3002.\u00a0<\/strong><\/p>\n<p>\u4ff3\u512a\u767b\u9332\u306b\u3064\u3044\u3066\u306f\u3001, <strong>\u201c\u300c\u6700\u7d42\u30c7\u30fc\u30bf\u78ba\u8a8d\u300d\u65e5<\/strong> \u30d0\u30fc\u30b8\u30e7\u30f3\u5225\u306b\u8868\u793a\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u308a\u3001\u767b\u9332\u3055\u308c\u3066\u3044\u308b\u3059\u3079\u3066\u306e\u30a2\u30af\u30bf\u30fc\u306e\u30c7\u30fc\u30bf\u691c\u8a3c\u30b9\u30c6\u30fc\u30bf\u30b9\u306e\u900f\u660e\u6027\u304c\u5411\u4e0a\u3057\u307e\u3057\u305f\u3002.<\/p>\n<p>\u30c7\u30d0\u30a4\u30b9\u306e\u767b\u9332\u306b\u3064\u3044\u3066\u306f\u3001, <strong>EMDN\u30b3\u30fc\u30c9\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u7ba1\u7406<\/strong> \u5b9f\u88c5\u3055\u308c\u3066\u304a\u308a\u3001 <strong>\u5ec3\u6b62\u3055\u308c\u305fEMDN\u30b3\u30fc\u30c9<\/strong> \u9078\u629e\u30ea\u30b9\u30c8\u304b\u3089\u524a\u9664\u3055\u308c\u3001\u73fe\u5728\u306e\u547d\u540d\u6cd5\u306e\u307f\u304c\u4f7f\u7528\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3057\u305f\u3002.<\/p>\n<p>\u8a3c\u660e\u66f8\u30e2\u30b8\u30e5\u30fc\u30eb\u5185\u3067\u306f\u3001, <strong>\u8a8d\u5b9a\u6a5f\u95a2<\/strong> \u53c2\u7167\u304c\u8a31\u53ef\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3057\u305f <strong>\u767b\u9332\u3055\u308c\u3066\u3044\u306a\u3044EU\u306e\u88fd\u9020\u696d\u8005\u307e\u305f\u306f\u751f\u7523\u8005<\/strong> \u62d2\u5426\u3055\u308c\u305f\u8a3c\u660e\u66f8\u3092\u767a\u884c\u3059\u308b\u5834\u5408\u3084\u3001\u95a2\u9023\u3059\u308b\u7533\u8acb\u3092\u51e6\u7406\u3059\u308b\u5834\u5408\u306a\u3069\u3001 <strong>\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u3002.\u00a0<\/strong><\/p>\n<p>\u6280\u8853\u7684\u306a\u89b3\u70b9\u304b\u3089\u8a00\u3048\u3070\u3001, <strong>XSD\u30b9\u30ad\u30fc\u30de\u30d0\u30fc\u30b8\u30e7\u30f33.0.25<\/strong> \u5168\u3066\u306e\u4eba\u306b\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b <strong>DTX\u30b5\u30fc\u30d3\u30b9\u30ea\u30af\u30a8\u30b9\u30c8\u3001,<\/strong> \u66f4\u65b0\u3055\u308c\u305f\u6280\u8853\u6587\u66f8\u306e\u8981\u4ef6\u3092\u53cd\u6620\u3057\u307e\u3059\u3002.<\/p>\n<p>\u4e00\u62ec\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u6a5f\u80fd\u304c\u5f37\u5316\u3055\u308c\u3001 <strong>\u90e8\u5206\u7684\u306a\u6210\u529f\u30b9\u30c6\u30fc\u30bf\u30b9\u3001,<\/strong> \u65b0\u3057\u3044<strong> XML\u30ec\u30b9\u30dd\u30f3\u30b9\u69cb\u9020<\/strong> \u30aa\u30d6\u30b8\u30a7\u30af\u30c8\u30ec\u30d9\u30eb\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002.<\/p>\n<p>\u516c\u958b\u30b5\u30a4\u30c8\u3067\u306f\u3001\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u306e\u6539\u5584\u3068\u3057\u3066\u3001 <strong>\u62e1\u5927\u3055\u308c\u305f\u56fd\u30aa\u30d7\u30b7\u30e7\u30f3<\/strong> \u305d\u3057\u3066 <strong>\u5f37\u5316\u3055\u308c\u305f\u6982\u8981\u30ec\u30dd\u30fc\u30c8\u30d5\u30a3\u30eb\u30bf\u30fc\u3001,<\/strong> \u533b\u7642\u6a5f\u5668\u60c5\u5831\u3078\u306e\u4e00\u822c\u306e\u30a2\u30af\u30bb\u30b9\u3092\u6539\u5584\u3059\u308b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-60515853 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1767097506\" 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>\u65bd\u884c\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3<\/h2>\n\t<div id=\"gap-1317536475\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1317536475 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u306e\u5fc5\u9808\u4f7f\u7528 <strong>4\u3064\u306e\u30b3\u30a2EUDAMED\u30e2\u30b8\u30e5\u30fc\u30eb<\/strong>, \u3001\u30a2\u30af\u30bf\u30fc\u767b\u9332\u3001\u30c7\u30d0\u30a4\u30b9\u8b58\u5225\uff08UDI\uff09\u3001\u8a3c\u660e\u66f8\u3001\u516c\u958b\u60c5\u5831\u3078\u306e\u30a2\u30af\u30bb\u30b9\u306a\u3069, <strong>2026\u5e745\u670828\u65e5\u306b\u767a\u52b9\u3057\u307e\u3059\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1767097506 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-85709375\" 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-1876953190\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1876953190 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u306e\u5fc5\u9808\u4f7f\u7528 <strong>4\u3064\u306e\u30b3\u30a2EUDAMED\u30e2\u30b8\u30e5\u30fc\u30eb\u3001,<\/strong> \u542b\u3080 <strong>\u30a2\u30af\u30bf\u30fc\u767b\u9332\u3001\u30c7\u30d0\u30a4\u30b9\u8b58\u5225\uff08UDI\uff09\u3001\u8a3c\u660e\u66f8\u3001\u516c\u958b\u60c5\u5831\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3001,<\/strong> \u767a\u52b9\u65e5 <strong>2026\u5e745\u670828\u65e5\u3002.<\/strong> \u3053\u306e\u65e5\u304b\u3089\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3001\u8a8d\u8a3c\u6a5f\u95a2\u3001\u305d\u306e\u4ed6\u306e\u95a2\u4fc2\u3059\u308b\u5229\u5bb3\u95a2\u4fc2\u8005\u306f\u3001\u4ee5\u4e0b\u306e\u66f4\u65b0\u3055\u308c\u305f\u8981\u4ef6\u3092\u9075\u5b88\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <strong>EUDAMED \u30d0\u30fc\u30b8\u30e7\u30f3 2.22.0\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-85709375 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1880312182\" 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>\u306a\u305c\u305d\u308c\u304c\u91cd\u8981\u306a\u306e\u304b<\/h2>\n\t<div id=\"gap-1377988141\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1377988141 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u308c\u3089\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306b\u3088\u308a\u3001<strong> \u898f\u5236\u306e\u660e\u78ba\u3055\u3001,<\/strong> EUDAMED\u3092\u3088\u308a\u5bc6\u63a5\u306b\u9023\u643a\u3055\u305b\u308b <strong>\u30c7\u30b8\u30bf\u30eb\u30c7\u30fc\u30bf\u30ac\u30d0\u30ca\u30f3\u30b9\u306e\u671f\u5f85\u3001,<\/strong> \u6539\u5584\u3059\u308b <strong>\u904b\u7528\u52b9\u7387<\/strong> \u5f37\u5316\u3055\u308c\u305f\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3068\u69cb\u9020\u5316\u3055\u308c\u305f\u30c7\u30fc\u30bf\u4ea4\u63db\u3092\u901a\u3058\u3066\u3001\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3068\u6280\u8853\u6a19\u6e96\u3092\u6d17\u7df4\u3055\u305b\u308b\u3053\u3068\u3067\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u3068\u3068\u3082\u306b\u3001\u898f\u5236\u5bfe\u8c61\u306e\u5229\u5bb3\u95a2\u4fc2\u8005\u306e\u4e0d\u5fc5\u8981\u306a\u7ba1\u7406\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-1880312182 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1196084269\" 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-1563022076\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1563022076 {\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\u3001IT\u304a\u3088\u3073\u30c7\u30fc\u30bf\u7ba1\u7406\u30c1\u30fc\u30e0\u3001,<\/strong> \u305d\u3057\u3066 <strong>\u8a8d\u5b9a\u6a5f\u95a2\u306e\u696d\u52d9<\/strong> EU\u533b\u7642\u6a5f\u5668\u306e\u767b\u9332\u3001\u8a8d\u8a3c\u3001\u7d99\u7d9a\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\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-1196084269 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-72698951\" 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-1716575948\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1716575948 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5229\u5bb3\u95a2\u4fc2\u8005\u306f\u65e2\u5b58\u306e <strong>\u30c7\u30fc\u30bf\u5165\u529b\u3068\u30c7\u30d0\u30a4\u30b9\u767b\u9332\u30d7\u30ed\u30bb\u30b9<\/strong> EUDAMED\u30d0\u30fc\u30b8\u30e7\u30f32.22.0\u3068\u306e\u6574\u5408\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u30b7\u30b9\u30c6\u30e0\u306e\u4e92\u63db\u6027\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002 <strong>XSD\u30b9\u30ad\u30fc\u30de\u30d0\u30fc\u30b8\u30e7\u30f33.0.25\u3001,<\/strong> \u305d\u3057\u3066\u5909\u5316\u306b\u5099\u3048\u308b <strong>EMDN\u30b3\u30fc\u30c9\u306e\u9078\u629e\u3001\u78ba\u8a8d\u65e5\u306e\u8ffd\u8de1\u3001, <\/strong>\u305d\u3057\u3066<strong> \u4e00\u62ec\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u306e\u56de\u7b54<\/strong> 2026\u5e745\u6708\u306e\u65bd\u884c\u65e5\u3092\u524d\u306b\u3057\u3066\u3002.<\/p>\n<p>\u7d44\u7e54\u304c\u5fc5\u9808\u306e EUDAMED \u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u4f7f\u7528\u3068\u9032\u5316\u3059\u308b\u30c7\u30fc\u30bf\u8981\u4ef6\u3078\u306e\u6e96\u5099\u72b6\u6cc1\u3092\u8a55\u4fa1\u3059\u308b\u969b\u3001\u898f\u5236\u30b7\u30b9\u30c6\u30e0\u306e\u5909\u66f4\u3092\u65e9\u671f\u306b\u628a\u63e1\u3059\u308b\u3053\u3068\u3067\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30ea\u30b9\u30af\u3092\u5927\u5e45\u306b\u8efd\u6e1b\u3067\u304d\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 EUDAMED \u306e\u66f4\u65b0\u3092\u8ffd\u8de1\u3057\u3001\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3001160 \u304b\u56fd\u4ee5\u4e0a\u3067\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u6e96\u5099\u3092\u52b9\u7387\u5316\u3067\u304d\u308b\u3088\u3046\u652f\u63f4\u3057\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\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-72698951 > .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-632519903\">\n\n\t<div id=\"col-1958791209\" 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-1127336914\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1127336914 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>EUDAMED \u30d0\u30fc\u30b8\u30e7\u30f3 2.22.0 \u3068\u306f\u4f55\u3067\u3059\u304b?<\/h4>\n\t<div id=\"gap-1100028907\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1100028907 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>EUDAMED \u30d0\u30fc\u30b8\u30e7\u30f3 2.22.0 \u306f\u3001EU \u5185\u306e\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u7ba1\u7406\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u304a\u3088\u3073\u6280\u8853\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306e\u5fc5\u9808\u66f4\u65b0\u3092\u5c0e\u5165\u3057\u305f\u88fd\u54c1\u30ea\u30ea\u30fc\u30b9\u3067\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1958791209 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1602001744\" 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>EUDAMED \u30b3\u30a2 \u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u5fc5\u9808\u4f7f\u7528\u306f\u3044\u3064\u958b\u59cb\u3055\u308c\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-1326586778\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1326586778 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>4\u3064\u306e\u30b3\u30a2EUDAMED\u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u5f37\u5236\u4f7f\u7528\u306f\u3001 <strong>2026\u5e745\u670828\u65e5\u3002.<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1602001744 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1638629348\" 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>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3067 EMDN \u30b3\u30fc\u30c9\u306b\u3069\u306e\u3088\u3046\u306a\u5909\u66f4\u304c\u52a0\u3048\u3089\u308c\u307e\u3057\u305f\u304b?<\/h4>\n\t<div id=\"gap-1970861226\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1970861226 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3067\u306f <strong>EMDN\u30b3\u30fc\u30c9\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u7ba1\u7406<\/strong> \u305d\u3057\u3066\u524a\u9664 <strong>\u5ec3\u6b62\u3055\u308c\u305f\u30b3\u30fc\u30c9<\/strong> \u30c7\u30d0\u30a4\u30b9\u767b\u9332\u306e\u9078\u629e\u304b\u3089\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1638629348 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-720544733\" 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\u3001AI \u306b\u3088\u308b\u898f\u5236\u5909\u66f4\u306b\u5bfe\u5fdc\u3059\u308b\u4f01\u696d\u3092\u3069\u306e\u3088\u3046\u306b\u30b5\u30dd\u30fc\u30c8\u3067\u304d\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-438323681\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-438323681 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> AI \u3092\u6d3b\u7528\u3057\u305f\u898f\u5236\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u3068\u5c02\u9580\u5bb6\u306b\u3088\u308b\u30ac\u30a4\u30c9\u4ed8\u304d\u81ea\u52d5\u5316\u3092\u901a\u3058\u3066\u3001\u7d44\u7e54\u304c\u898f\u5236\u5f53\u5c40\u306e\u66f4\u65b0\u3092\u76e3\u8996\u3057\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3001\u5185\u90e8\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u9069\u5fdc\u3055\u305b\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-720544733 > .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 5 January 2026, the European Commission announced the production release of EUDAMED version 2.22.0, introducing mandatory system updates that enhance medical device registration and data management across the European Union. The update affects manufacturers, Notified Bodies, and other medical device stakeholders, with mandatory use of the four core EUDAMED modules beginning on 28 May 2026.<\/p>","protected":false},"author":41,"featured_media":9491,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,39,538],"tags":[],"class_list":["post-9490","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-european-union"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU Commission Releases EUDAMED Version 2.22.0 Changes<\/title>\n<meta name=\"description\" content=\"Learn about the EU Commission&#039;s release of EUDAMED version 2.22.0, with updates for mandatory medical device registration effective May 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\/eu\u59d4\u54e1\u4f1a\u306f\u30012026\u5e745\u6708\u306b\u767a\u52b9\u3059\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u306e\u7fa9\u52d9\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU Commission Releases EUDAMED Version 2.22.0 With Mandatory Medical Device Registration Updates Effective May 2026\" \/>\n<meta property=\"og:description\" content=\"Learn about the EU Commission&#039;s release of EUDAMED version 2.22.0, with updates for mandatory medical device registration effective May 2026.\" \/>\n<meta property=\"og:url\" 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