{"id":9540,"date":"2026-02-25T10:57:53","date_gmt":"2026-02-25T02:57:53","guid":{"rendered":"https:\/\/regask.com\/?p=9540"},"modified":"2026-02-25T10:57:53","modified_gmt":"2026-02-25T02:57:53","slug":"%e8%8b%b1%e5%9b%bdmhra%e3%80%81%e5%8c%97%e3%82%a2%e3%82%a4%e3%83%ab%e3%83%a9%e3%83%b3%e3%83%89%e3%81%ae%e5%a4%89%e6%9b%b4%e3%80%81eudamd%e7%a7%bb%e8%a1%8c%e3%80%81%e5%b9%b4%e4%bc%9a%e8%b2%bb%e3%81%aa","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/uk-mhra-updates-medical-device-registration-guidance-with-northern-ireland-changes-eudamed-transition-and-annual-fees\/","title":{"rendered":"\u82f1\u56fd MHRA \u304c\u533b\u7642\u6a5f\u5668\u767b\u9332\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u66f4\u65b0\u2026"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2026\u5e742\u670820\u65e5, <\/strong>\u305d\u306e<strong> \u533b\u85ac\u54c1\u30fb\u533b\u7642\u88fd\u54c1\u898f\u5236\u5e81<\/strong> \u82f1\u56fd\u533b\u7642\u6a5f\u5668\u898f\u52362002\u306b\u57fa\u3065\u304d\u3001\u30b0\u30ec\u30fc\u30c8\u30d6\u30ea\u30c6\u30f3\u304a\u3088\u3073\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u3067\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u533b\u7642\u6a5f\u5668\u306e\u767b\u9332\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u6700\u65b0\u7248\u3092\u516c\u958b\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u66f4\u65b0\u306f\u3001\u82f1\u56fd\u304a\u3088\u3073\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u3067\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u6a5f\u5668\u3092\u8ca9\u58f2\u3059\u308b\u88fd\u9020\u696d\u8005\u304a\u3088\u3073\u8a8d\u5b9a\u4ee3\u7406\u5e97\u306b\u5f71\u97ff\u3057\u307e\u3059\u3002 <strong>\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u5e02\u5834\u3001\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u306e\u767b\u9332\u65b9\u6cd5\u3001\u5e74\u9593\u767b\u9332\u6599\u3078\u306e\u5f71\u97ff, <\/strong>\u305d\u3057\u3066<strong> \u516c\u7684\u767b\u9332\u7c3f\u306e\u900f\u660e\u6027\u3002. <\/strong><\/p>\n<div class=\"row\"  id=\"row-161970773\">\n\n\t<div id=\"col-371735845\" 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-617420636\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-617420636 {\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-169688455\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-169688455 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u6539\u8a02\u3055\u308c\u305f <strong>\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u306e\u767b\u9332\u8981\u4ef6 <\/strong>\u5148\u306b<strong> 2026\u5e745\u670828\u65e5\u3002.<\/strong> \u305d\u306e\u65e5\u304b\u3089\u3001\u307b\u3068\u3093\u3069\u306e\u975e\u30ab\u30b9\u30bf\u30e0\u30e1\u30a4\u30c9\u533b\u7642\u6a5f\u5668\u306f\u3001 <strong>\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9<\/strong> EU \u307e\u305f\u306f\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u5e02\u5834\u306b\u6295\u5165\u3055\u308c\u308b\u524d\u306b\u3001\u3053\u308c\u3089\u306e\u30c7\u30d0\u30a4\u30b9\u306b\u3064\u3044\u3066\u306f MHRA \u767b\u9332\u304c\u5fc5\u8981\u306a\u304f\u306a\u308a\u3001\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u5e02\u5834\u5411\u3051\u306e\u3053\u308c\u3089\u306e\u30c7\u30d0\u30a4\u30b9\u306b\u3064\u3044\u3066\u306f MHRA \u767b\u9332\u306f\u4e0d\u8981\u306b\u306a\u308a\u307e\u3059\u3002. <strong>\u30ab\u30b9\u30bf\u30e0\u30e1\u30a4\u30c9\u30c7\u30d0\u30a4\u30b9<\/strong> EUDAMED \u306e\u9069\u7528\u7bc4\u56f2\u5916\u306e\u307e\u307e\u3067\u3042\u308a\u3001\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u306e MHRA \u306b\u5f15\u304d\u7d9a\u304d\u767b\u9332\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u5e74\u9593\u306e\u8a73\u7d30\u306a\u67a0\u7d44\u307f\u3092\u7d39\u4ecb\u3057\u3066\u3044\u308b\u3002 <strong>MHRA\u767b\u9332\u6599\u5236\u5ea6 <\/strong>\u767a\u52b9 <strong>2026\u5e744\u67081\u65e5\u304b\u3089\u3002.<\/strong> \u6599\u91d1\u306f\u4ee5\u4e0b\u306b\u57fa\u3065\u3044\u3066\u8a08\u7b97\u3055\u308c\u307e\u3059 <strong>\u30ec\u30d9\u30eb2 \u30b0\u30ed\u30fc\u30d0\u30eb\u533b\u7642\u6a5f\u5668\u547d\u540d\u6cd5 (GMDN)<\/strong> <strong>\u30ab\u30c6\u30b4\u30ea\u30fc<\/strong> MHRA \u306b\u767b\u9332\u3055\u308c\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u767b\u9332\u76ee\u7684\u3067\u30c7\u30d0\u30a4\u30b9 \u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u306e\u69cb\u9020\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u307e\u3059\u3002.<\/p>\n<p>\u3055\u3089\u306b\u8a73\u3057\u304f\u8aac\u660e\u3059\u308b\u3068\u3001 <strong>\u4f53\u5916\u8a3a\u65ad\u7528\u6a5f\u5668\uff08IVD\uff09<\/strong> \u9032\u884c\u4e2d <strong>\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u8a55\u4fa1\u7814\u7a76\u3001,<\/strong> \u82f1\u56fd\u3067\u306e\u7814\u7a76\u958b\u59cb\u524d\u306b\u767b\u9332\u3092\u5b8c\u4e86\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u305f\u3002\u307e\u305f\u3001\u3053\u306e\u66f4\u65b0\u3067\u306f\u3001 <strong>COVID-19\u6297\u539f<\/strong> <strong>\u304a\u3088\u3073\u5206\u5b50\uff08PCR\uff09\u691c\u67fb\u88c5\u7f6e<\/strong> \u53d6\u5f97\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b <strong>\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u691c\u67fb\u6a5f\u5668\u627f\u8a8d\uff08CTDA\uff09<\/strong> MHRA \u767b\u9332\u7533\u8acb\u304c\u53d7\u7406\u3055\u308c\u308b\u306b\u306f\u3001\u305d\u306e\u524d\u306b\u3001\u691c\u8a3c\u3092\u53d7\u3051\u308b\u304b\u3001\u95a2\u9023\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u8a18\u8f09\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n<p>\u3055\u3089\u306b\u3001\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001<strong> \u30d1\u30d6\u30ea\u30c3\u30af \u30a2\u30af\u30bb\u30b9\u767b\u9332\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9 (PARD)\u3002.<\/strong> \u304b\u3089 <strong>2026\u5e742\u670823\u65e5\u3001\u533b\u7642\u6a5f\u5668\u306e\u30d6\u30e9\u30f3\u30c9\u540d\u307e\u305f\u306f\u5546\u6a19\u540d<\/strong> \u516c\u958b\u3055\u308c\u3001\u767b\u9332\u3055\u308c\u305f\u88fd\u54c1\u306e\u900f\u660e\u6027\u304c\u5411\u4e0a\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-371735845 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-333420720\" 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>\u898f\u5236\u5b9f\u65bd\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3<\/h2>\n\t<div id=\"gap-763381977\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-763381977 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<ul>\n<li><strong>2026\u5e742\u670823\u65e5:<\/strong> \u533b\u7642\u6a5f\u5668 <strong>\u30d6\u30e9\u30f3\u30c9\u540d\u3068\u5546\u6a19\u540d<\/strong> \u8868\u793a\u3055\u308c\u59cb\u3081\u307e\u3059 <strong>\u30d1\u30d6\u30ea\u30c3\u30af\u30a2\u30af\u30bb\u30b9\u767b\u9332\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\uff08PARD\uff09,<\/strong> \u767b\u9332\u3055\u308c\u305f\u88fd\u54c1\u306e\u77e5\u540d\u5ea6\u3092\u9ad8\u3081\u307e\u3059\u3002.<\/li>\n<li><strong>2026\u5e744\u67081\u65e5: \u5e74\u9593\u767b\u9332\u6599 <\/strong>\u767b\u9332\u533b\u7642\u6a5f\u5668\u306e\u5834\u5408<strong> \u533b\u85ac\u54c1\u30fb\u533b\u7642\u88fd\u54c1\u898f\u5236\u5e81<\/strong> \u6709\u52b9\u3068\u306a\u308a\u3001\u6599\u91d1\u306f <strong>\u30ec\u30d9\u30eb 2 \u306e Global Medical Device Nomenclature (GMDN) \u30ab\u30c6\u30b4\u30ea\u3002.\u00a0<\/strong><\/li>\n<li><strong>2026\u5e745\u670828\u65e5: EUDAMED\u767b\u9332<\/strong> \u307b\u3068\u3093\u3069\u306e\u4eba\u306b\u3068\u3063\u3066\u5fc5\u9808\u3068\u306a\u308b <strong>\u975e\u30ab\u30b9\u30bf\u30e0\u30e1\u30a4\u30c9\u306e\u533b\u7642\u6a5f\u5668<\/strong> EU\u307e\u305f\u306f\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u5e02\u5834\u306b\u4e0a\u5834\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u65e5\u304b\u3089\u3001, <strong>MHRA\u767b\u9332\u306f\u4e0d\u8981\u306b\u306a\u308a\u307e\u3059<\/strong> \u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u5e02\u5834\u5411\u3051\u306e\u30c7\u30d0\u30a4\u30b9\u5411\u3051\u3067\u3059\u3002.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-333420720 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1639059783\" 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-873970256\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-873970256 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3067\u306f\u3001 <strong>\u898f\u5236\u306e\u660e\u78ba\u3055<\/strong> \u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u306e\u79fb\u884c\u5f8c\u306e\u53d6\u308a\u6c7a\u3081\u306b\u95a2\u3059\u308b\u82f1\u56fd\u306e\u30d7\u30ed\u30bb\u30b9\u3092 <strong>EU\u30c7\u30b8\u30bf\u30eb\u30a4\u30f3\u30d5\u30e9<\/strong> EUDAMED\u3092\u901a\u3058\u3066\u3001\u69cb\u9020\u5316\u3055\u308c\u305f <strong>\u6599\u91d1\u4f53\u7cfb<\/strong> \u898f\u5236\u76e3\u7763\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u3002\u3053\u308c\u3089\u306e\u5909\u66f4\u306f\u3001\u8ffd\u52a0\u306e\u7ba1\u7406\u8ca0\u62c5\u3092\u7279\u5b9a\u306e\u767b\u9332\u304a\u3088\u3073\u30c7\u30fc\u30bf\u7dad\u6301\u6d3b\u52d5\u306b\u96c6\u4e2d\u3055\u305b\u3064\u3064\u3001\u52b9\u7387\u6027\u3068\u900f\u660e\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1639059783 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-216604971\" 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-1222722455\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1222722455 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001 <strong>\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3001\u8a8d\u5b9a\u4ee3\u7406\u5e97\u3001, <\/strong>\u305d\u3057\u3066<strong> \u898f\u5236\u3001\u54c1\u8cea\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30fc\u30e0<\/strong> \u82f1\u56fd\u304a\u3088\u3073\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u306e\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3092\u62c5\u5f53\u3057\u3001 <strong>IT\u304a\u3088\u3073\u30c7\u30fc\u30bf\u30c1\u30fc\u30e0<\/strong> \u898f\u5236\u7533\u8acb\u304a\u3088\u3073\u516c\u958b\u88fd\u54c1\u60c5\u5831\u306e\u7ba1\u7406\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-216604971 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-226210067\" 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-1377028022\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1377028022 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u95a2\u4fc2\u8005\u306f\u3001\u73fe\u5728\u306eMHRA\u767b\u9332\u3092\u78ba\u8a8d\u3057\u3001\u5fc5\u8981\u306a\u6a5f\u5668\u3092\u7279\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <strong>EUDAMED\u767b\u9332<\/strong> 2026\u5e745\u6708\u4e0b\u65ec\u307e\u3067\u306b\u3001 <strong>\u5e74\u4f1a\u8cbb<\/strong> 2026\u5e744\u6708\u307e\u3067\u306b\u3001\u793e\u5185\u30d7\u30ed\u30bb\u30b9\u3092\u66f4\u65b0\u3057\u3001\u305d\u308c\u306b\u5fdc\u3058\u3066\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u5e02\u5834\u306b\u30c7\u30d0\u30a4\u30b9\u3092\u6295\u5165\u3059\u308b\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u4ee5\u4e0b\u306e\u70b9\u3082\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <strong>\u59d4\u4efb\u4ee3\u7406\u4eba\u5951\u7d04,<\/strong> \u78ba\u4fdd\u3059\u308b <strong>CTDA\u691c\u8a3c<\/strong> \u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001PARD \u3067\u88fd\u54c1\u306e\u8a73\u7d30\u3092\u516c\u958b\u3057\u3084\u3059\u304f\u3059\u308b\u305f\u3081\u306e\u6e96\u5099\u3092\u884c\u3044\u307e\u3059\u3002.<\/p>\n<p>\u7d44\u7e54\u304c\u82f1\u56fd\u304a\u3088\u3073\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u306e\u767b\u9332\u8981\u4ef6\u306e\u5909\u5316\u306b\u9069\u5fdc\u3059\u308b\u306b\u3064\u308c\u3066\u3001, <a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u5b9f\u88c5\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3092\u76e3\u8996\u3057\u3001\u7ba1\u8f44\u533a\u57df\u56fa\u6709\u306e\u7fa9\u52d9\u3092\u8ffd\u8de1\u3057\u3001\u767b\u9332\u304a\u3088\u3073\u30c7\u30fc\u30bf\u7ba1\u7406\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u5408\u7406\u5316\u3059\u308b\u3053\u3068\u3067\u3001\u898f\u5236\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30c1\u30fc\u30e0\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002. <a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u306f\u3001\u6d88\u8cbb\u8ca1\u3084\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u306a\u3069\u306e\u898f\u5236\u306e\u53b3\u3057\u3044\u5206\u91ce\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u7d44\u7e54\u304c\u8907\u96d1\u306a\u898f\u5236\u74b0\u5883\u306b\u7a4d\u6975\u7684\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3001\u4e3b\u8981\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8 AI \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>\u9ad8\u5ea6\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8AI\u3068\u5c02\u9580\u5bb6\u306e\u5354\u529b\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001, <a href=\"http:\/\/regask.com\/ja\/\">RegASK<\/a><\/strong> \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\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30d7\u30ed\u30bb\u30b9\u3092\u5408\u7406\u5316\u3057\u3001\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u3001160 \u304b\u56fd\u4ee5\u4e0a\u3067\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3092\u52a0\u901f\u3057\u307e\u3059\u3002. <a href=\"http:\/\/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-226210067 > .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-1182478043\">\n\n\t<div id=\"col-1876535732\" 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-729240973\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-729240973 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>MHRA \u306f\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332\u306b\u3069\u306e\u3088\u3046\u306a\u5909\u66f4\u3092\u5c0e\u5165\u3057\u307e\u3057\u305f\u304b?<\/h4>\n\t<div id=\"gap-1086789877\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1086789877 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>2026 \u5e74 5 \u6708 28 \u65e5\u4ee5\u964d\u3001EU \u304a\u3088\u3073\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u5e02\u5834\u5411\u3051\u306e\u975e\u30ab\u30b9\u30bf\u30e0 \u30e1\u30a4\u30c9\u306e\u30c7\u30d0\u30a4\u30b9\u306e\u307b\u3068\u3093\u3069\u306f EUDAMED \u306b\u767b\u9332\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u3067\u306f\u3053\u308c\u3089\u306e\u30c7\u30d0\u30a4\u30b9\u306b\u5bfe\u3059\u308b MHRA \u767b\u9332\u306f\u4e0d\u8981\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1876535732 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1176397565\" 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>MHRA \u533b\u7642\u6a5f\u5668\u767b\u9332\u6599\u306f\u3044\u3064\u304b\u3089\u767a\u751f\u3057\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-663458888\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-663458888 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5e74\u9593\u767b\u9332\u6599\u306f 2026 \u5e74 4 \u6708 1 \u65e5\u304b\u3089\u6709\u52b9\u3068\u306a\u308a\u3001MHRA \u306b\u767b\u9332\u3055\u308c\u305f\u30ec\u30d9\u30eb 2 GMDN \u30ab\u30c6\u30b4\u30ea\u3054\u3068\u306b\u8a08\u7b97\u3055\u308c\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1176397565 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-646342001\" 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>\u30ab\u30b9\u30bf\u30e0\u30e1\u30a4\u30c9\u306e\u533b\u7642\u6a5f\u5668\u306f EUDAMED \u306b\u767b\u9332\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-1186715589\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1186715589 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3044\u3044\u3048\u3002\u30ab\u30b9\u30bf\u30e0\u30e1\u30a4\u30c9\u306e\u30c7\u30d0\u30a4\u30b9\u306b\u306f EUDAMED \u767b\u9332\u306f\u5fc5\u8981\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u5e02\u5834\u3067\u306f\u5f15\u304d\u7d9a\u304d MHRA \u306b\u767b\u9332\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-646342001 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2071960205\" 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\u30c1\u30fc\u30e0\u304c\u3053\u308c\u3089\u306e MHRA \u767b\u9332\u306e\u5909\u66f4\u3092\u7ba1\u7406\u3059\u308b\u306e\u306b\u3069\u306e\u3088\u3046\u306b\u5f79\u7acb\u3061\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-1725909474\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1725909474 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u96c6\u4e2d\u5316\u3055\u308c\u305f\u898f\u5236\u60c5\u5831\u3068\u81ea\u52d5\u5316\u3055\u308c\u305f\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u901a\u3058\u3066\u3001\u898f\u5236\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30fc\u30e0\u304c\u4eca\u5f8c\u306e\u671f\u9650\u3092\u8ffd\u8de1\u3057\u3001\u65b0\u3057\u3044\u6599\u91d1\u4f53\u7cfb\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3001\u82f1\u56fd\u3001\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u3001EU \u5168\u4f53\u306e\u767b\u9332\u7fa9\u52d9\u3092\u7ba1\u7406\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2071960205 > .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 20 February 2026, the Medicines &amp; Healthcare products Regulatory Agency published an update to its guidance on registering medical devices for placement on the market in Great Britain and Northern Ireland under the UK Medical Devices Regulations 2002. The update affects manufacturers and authorised representatives placing medical devices and in vitro diagnostic devices on the UK and Northern Ireland markets, with implications for Northern Ireland registration pathways, annual registration fees, and public register transparency.<\/p>","protected":false},"author":43,"featured_media":9543,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,39],"tags":[],"class_list":["post-9540","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-medical-devices-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.5 (Yoast SEO v28.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK MHRA Updates Medical Device Registration Guidance<\/title>\n<meta name=\"description\" content=\"Explore UK MHRA updates on medical device registration guidance and how Northern Ireland changes affect manufacturers.\" \/>\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\/\u82f1\u56fdmhra\u3001\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u306e\u5909\u66f4\u3001eudamd\u79fb\u884c\u3001\u5e74\u4f1a\u8cbb\u306a\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UK MHRA Updates Medical Device Registration Guidance with Northern Ireland Changes, EUDAMED Transition, and Annual Fees\" \/>\n<meta property=\"og:description\" content=\"Explore UK MHRA updates on medical device registration guidance and how Northern Ireland changes affect manufacturers.\" \/>\n<meta property=\"og:url\" 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