{"id":107,"date":"2026-05-27T12:19:25","date_gmt":"2026-05-27T12:19:25","guid":{"rendered":"http:\/\/4.190.161.227\/?p=107"},"modified":"2026-05-27T12:19:27","modified_gmt":"2026-05-27T12:19:27","slug":"what-medical-device-companies-should-be-focusing-on-now","status":"publish","type":"post","link":"https:\/\/www.kolabtree.jp\/blog\/?p=107","title":{"rendered":"2026\u5e74\u306eEU MDR\u5bfe\u5fdc\uff1a\u533b\u7642\u6a5f\u5668\u4f01\u696d\u304c\u4eca\u53d6\u308a\u7d44\u3080\u3079\u304d\u3053\u3068"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">\u6b27\u5dde\u9023\u5408\u306e\u533b\u7642\u6a5f\u5668\u898f\u5247\u3001\u3044\u308f\u3086\u308bEU MDR(Medical Device Regulation)\u306f\u3001\u3059\u3067\u306b\u521d\u671f\u306e\u79fb\u884c\u671f\u9593\u3092\u904e\u304e\u3001\u672c\u683c\u7684\u306a\u904b\u7528\u30d5\u30a7\u30fc\u30ba\u306b\u5165\u3063\u3066\u3044\u307e\u3059\u30022021\u5e745\u6708\u306b\u9069\u7528\u304c\u958b\u59cb\u3055\u308c\u3066\u4ee5\u964d\u3001\u73fe\u5834\u3067\u660e\u3089\u304b\u306b\u306a\u3063\u305f\u8ab2\u984c\u3084\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4e0a\u306e\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u3001\u898f\u5236\u74b0\u5883\u306f\u7d99\u7d9a\u7684\u306b\u5909\u5316\u3057\u3066\u304d\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3001\u85ac\u4e8b\u62c5\u5f53\u8005\u3001\u81e8\u5e8a\u958b\u767a\u30c1\u30fc\u30e0\u306b\u3068\u3063\u3066\u30012026\u5e74\u306eEU MDR\u5bfe\u5fdc\u306f\u3001\u3082\u306f\u3084\u300cMDR\u3068\u306f\u4f55\u304b\u300d\u3092\u7406\u89e3\u3059\u308b\u6bb5\u968e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u91cd\u8981\u306a\u306e\u306f\u3001\u8907\u96d1\u306a\u8981\u4ef6\u3092\u5b9f\u52d9\u306e\u4e2d\u3067\u3069\u306e\u3088\u3046\u306b\u904b\u7528\u3057\u3001\u88fd\u54c1\u306e\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3092\u78ba\u4fdd\u3057\u3066\u3044\u304f\u304b\u3067\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>\u79fb\u884c\u671f\u9593\u304b\u3089\u5b9f\u904b\u7528\u3078\uff1a\u4f55\u304c\u5909\u308f\u3063\u305f\u306e\u304b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MDR\u5c0e\u5165\u521d\u671f\u306b\u306f\u3001\u4e3b\u306b\u79fb\u884c\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3084\u6e96\u5099\u72b6\u6cc1\u304c\u8b70\u8ad6\u306e\u4e2d\u5fc3\u3067\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u5b9f\u969b\u306b\u904b\u7528\u304c\u9032\u3080\u306b\u3064\u308c\u3066\u3001\u5236\u5ea6\u4e0a\u306e\u5927\u304d\u306a\u5236\u7d04\u304c\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u7279\u306b\u6df1\u523b\u3060\u3063\u305f\u306e\u304c\u3001\u8a8d\u8a3c\u6a5f\u95a2\u3067\u3042\u308bNotified Body\u306e\u5be9\u67fb\u30ad\u30e3\u30d1\u30b7\u30c6\u30a3\u4e0d\u8db3\u3068\u3001\u65e2\u5b58\u88fd\u54c1\u306e\u518d\u8a8d\u8a3c\u306b\u5fc5\u8981\u306a\u4f5c\u696d\u91cf\u306e\u5927\u304d\u3055\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b27\u5dde\u5e02\u5834\u3067\u533b\u7642\u6a5f\u5668\u4e0d\u8db3\u304c\u767a\u751f\u3059\u308b\u30ea\u30b9\u30af\u3092\u56de\u907f\u3059\u308b\u305f\u3081\u3001EU\u306f2023\u5e74\u306e\u6cd5\u6539\u6b63\u306b\u3088\u308a\u3001\u79fb\u884c\u671f\u9593\u306e\u5ef6\u9577\u3092\u5c0e\u5165\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u65e7\u6307\u4ee4\u306e\u3082\u3068\u3067\u8a8d\u8a3c\u3055\u308c\u305f\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u306f\u3001\u6a5f\u5668\u5206\u985e\u306b\u5fdc\u3058\u3066\u4ee5\u4e0b\u306e\u671f\u9593\u307e\u3067\u5e02\u5834\u306b\u6b8b\u308b\u3053\u3068\u304c\u53ef\u80fd\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9ad8\u30ea\u30b9\u30af\u6a5f\u5668\u3001\u3064\u307e\u308aClass III\u304a\u3088\u3073Class IIb\u306e\u57cb\u3081\u8fbc\u307f\u578b\u6a5f\u5668\u306b\u3064\u3044\u3066\u306f2027\u5e74\u307e\u3067\u3002<\/li>\n\n\n\n<li>\u4f4e\u30ea\u30b9\u30af\u6a5f\u5668\u3001\u3064\u307e\u308aClass IIa\u304a\u3088\u3073\u4e00\u90e8\u306eClass I\u6a5f\u5668\u306b\u3064\u3044\u3066\u306f2028\u5e74\u307e\u3067\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">\u3053\u306e\u5ef6\u9577\u63aa\u7f6e\u306f\u4f01\u696d\u306b\u4e00\u5b9a\u306e\u7336\u4e88\u3092\u4e0e\u3048\u308b\u3082\u306e\u3067\u3059\u304c\u3001\u898f\u5236\u5bfe\u5fdc\u306e\u8ca0\u62c5\u304c\u8efd\u304f\u306a\u3063\u305f\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u3001MDR\u9069\u5408\u306b\u5411\u3051\u305f\u5177\u4f53\u7684\u306a\u9032\u6357\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001\u6280\u8853\u6587\u66f8\u306e\u66f4\u65b0\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u4f53\u5236\u306e\u6574\u5099\u3001Notified Body\u3068\u306e\u7d99\u7d9a\u7684\u306a\u9023\u643a\u306a\u3069\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>\u3088\u308a\u53b3\u683c\u5316\u3059\u308b\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u8981\u4ef6<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MDR\u306b\u304a\u3051\u308b\u6700\u3082\u5927\u304d\u306a\u5909\u5316\u306e\u4e00\u3064\u304c\u3001\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u306b\u5bfe\u3059\u308b\u8981\u6c42\u6c34\u6e96\u306e\u5f15\u304d\u4e0a\u3052\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u65e7\u533b\u7642\u6a5f\u5668\u6307\u4ee4\u3067\u3042\u308bMDD(Medical Devices Directive)\u306e\u3082\u3068\u3067\u306f\u3001\u591a\u304f\u306e\u30e1\u30fc\u30ab\u30fc\u304c\u540c\u7b49\u6027\u30c7\u30fc\u30bf\u3092\u7528\u3044\u3066\u81e8\u5e8a\u8a55\u4fa1\u3092\u88dc\u5b8c\u3057\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001MDR\u3067\u306f\u305d\u306e\u57fa\u6e96\u304c\u5927\u5e45\u306b\u53b3\u683c\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5177\u4f53\u7684\u306b\u306f\u3001\u500b\u5225\u6a5f\u5668\u306b\u7d10\u3065\u304f\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u3088\u308a\u91cd\u8996\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u308a\u3001\u540c\u7b49\u6027\u3092\u4e3b\u5f35\u3059\u308b\u969b\u306e\u6761\u4ef6\u3082\u53b3\u3057\u304f\u306a\u308a\u307e\u3057\u305f\u3002\u307e\u305f\u3001\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u3001\u3044\u308f\u3086\u308bCER(Clinical Evaluation Report)\u306e\u5be9\u67fb\u306b\u304a\u3044\u3066\u3001Notified Body\u306b\u3088\u308b\u78ba\u8a8d\u3082\u3088\u308a\u8a73\u7d30\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">\u305d\u306e\u7d50\u679c\u3001\u81e8\u5e8a\u6226\u7565\u306f\u85ac\u4e8b\u6210\u529f\u306e\u4e2d\u5fc3\u7684\u306a\u8981\u7d20\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u30e1\u30fc\u30ab\u30fc\u306b\u306f\u3001\u7533\u8acb\u6642\u70b9\u3060\u3051\u3067\u306a\u304f\u3001\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u3066\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u3069\u306e\u3088\u3046\u306b\u751f\u6210\u30fb\u66f4\u65b0\u3057\u3066\u3044\u304f\u304b\u3092\u8a08\u753b\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>\u5e02\u8ca9\u5f8c\u76e3\u8996\uff1a\u5f62\u5f0f\u7684\u306a\u5bfe\u5fdc\u304b\u3089\u7d99\u7d9a\u7684\u306a\u8cac\u4efb\u3078<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MDR\u306f\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u3001\u3064\u307e\u308aPMS(Post Marketing Surveillance)\u306e\u4f4d\u7f6e\u3065\u3051\u3082\u5927\u304d\u304f\u5909\u3048\u307e\u3057\u305f\u3002\u5f93\u6765\u306e\u3088\u3046\u306a\u5b9a\u671f\u7684\u30fb\u5f62\u5f0f\u7684\u306a\u5bfe\u5fdc\u3067\u306f\u306a\u304f\u3001\u7d99\u7d9a\u7684\u304b\u3064\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u304f\u30d7\u30ed\u30bb\u30b9\u3068\u3057\u3066\u518d\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u73fe\u5728\u3001PMS\u306b\u306f\u4e3b\u306b\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u8981\u7d20\u304c\u542b\u307e\u308c\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Class IIa\u4ee5\u4e0a\u306e\u6a5f\u5668\u306b\u6c42\u3081\u3089\u308c\u308b\u5b9a\u671f\u5b89\u5168\u6027\u6700\u65b0\u5831\u544a\u3001\u3064\u307e\u308aPSUR(Periodic Safety Update Report)\u3002<\/li>\n\n\n\n<li>\u7d99\u7d9a\u7684\u306a\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u751f\u6210\u3059\u308b\u305f\u3081\u306e\u5e02\u8ca9\u5f8c\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u3001\u3064\u307e\u308aPMCF(Post-Market Clinical Follow-up)\u3002<\/li>\n\n\n\n<li>\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u304f\u7d99\u7d9a\u7684\u306a\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u8a55\u4fa1\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u306f\u3001\u533b\u7642\u6a5f\u5668\u898f\u5236\u304c\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u76e3\u8996\u3059\u308b\u65b9\u5411\u3078\u9032\u3093\u3067\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u6a5f\u5668\u306f\u4e0a\u5e02\u6642\u306b\u4e00\u5ea6\u8a55\u4fa1\u3055\u308c\u308b\u3060\u3051\u3067\u306f\u306a\u304f\u3001\u5e02\u5834\u3067\u5b9f\u969b\u306b\u4f7f\u7528\u3055\u308c\u305f\u5f8c\u306e\u6027\u80fd\u3084\u5b89\u5168\u6027\u306b\u57fa\u3065\u304d\u3001\u7d99\u7d9a\u7684\u306b\u8a55\u4fa1\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">\u591a\u304f\u306e\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u5805\u7262\u306aPMS\u4f53\u5236\u3092\u69cb\u7bc9\u3057\u3001\u305d\u308c\u3092\u81e8\u5e8a\u30fb\u85ac\u4e8b\u30fb\u54c1\u8cea\u7ba1\u7406\u306e\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3068\u7d71\u5408\u3059\u308b\u3053\u3068\u306f\u3001MDR\u5bfe\u5fdc\u306e\u4e2d\u3067\u3082\u7279\u306b\u30ea\u30bd\u30fc\u30b9\u3092\u8981\u3059\u308b\u8ab2\u984c\u306e\u4e00\u3064\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>Notified Body<\/strong><strong>\u306e\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u3068\u8a8d\u8a3c\u9045\u5ef6<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e00\u5b9a\u306e\u9032\u5c55\u306f\u3042\u308b\u3082\u306e\u306e\u3001Notified Body\u306e\u5be9\u67fb\u30ad\u30e3\u30d1\u30b7\u30c6\u30a3\u4e0d\u8db3\u306f\u3001MDR\u904b\u7528\u306b\u304a\u3051\u308b\u6700\u5927\u7d1a\u306e\u8ab2\u984c\u3068\u3057\u3066\u6b8b\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2021\u5e74\u4ee5\u964d\u3001\u6307\u5b9a\u3055\u308c\u305fNotified Body\u306e\u6570\u306f\u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u8a8d\u8a3c\u3092\u5fc5\u8981\u3068\u3059\u308b\u88fd\u54c1\u6570\u3084\u518d\u8a8d\u8a3c\u306e\u9700\u8981\u306f\u4f9d\u7136\u3068\u3057\u3066\u5927\u304d\u304f\u3001\u4f9b\u7d66\u304c\u8ffd\u3044\u3064\u3044\u3066\u3044\u306a\u3044\u306e\u304c\u5b9f\u60c5\u3067\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u554f\u984c\u304c\u8d77\u304d\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8a8d\u8a3c\u307e\u3067\u306e\u671f\u9593\u304c\u60f3\u5b9a\u3088\u308a\u9577\u671f\u5316\u3057\u3066\u3044\u308b\u3002<\/li>\n\n\n\n<li>\u65e9\u671f\u306bNotified Body\u3068\u63a5\u89e6\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u306b\u306a\u3063\u3066\u3044\u308b\u3002<\/li>\n\n\n\n<li>\u6280\u8853\u6587\u66f8\u3084\u81e8\u5e8a\u8a55\u4fa1\u306e\u6e96\u5099\u304c\u9045\u308c\u308b\u3068\u3001\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u306b\u5927\u304d\u306a\u5f71\u97ff\u304c\u51fa\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">\u79fb\u884c\u671f\u9593\u304c\u5ef6\u9577\u3055\u308c\u305f\u3068\u306f\u3044\u3048\u3001\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u306e\u958b\u59cb\u304c\u9045\u308c\u308c\u3070\u3001\u671f\u9650\u306b\u9593\u306b\u5408\u308f\u306a\u3044\u30ea\u30b9\u30af\u304c\u3042\u308a\u307e\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u4f59\u88d5\u3092\u6301\u3063\u305f\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3067\u6e96\u5099\u3092\u9032\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>EUDAMED<\/strong><strong>\u3068\u900f\u660e\u6027\u306e\u5411\u4e0a<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MDR\u306e\u3082\u3046\u4e00\u3064\u306e\u91cd\u8981\u306a\u67f1\u304c\u3001\u900f\u660e\u6027\u306e\u5411\u4e0a\u3067\u3059\u3002\u305d\u306e\u4e2d\u5fc3\u3068\u306a\u308b\u306e\u304c\u3001\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3067\u3042\u308bEUDAMED\u306e\u6bb5\u968e\u7684\u306a\u5c0e\u5165\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3059\u3079\u3066\u306e\u30e2\u30b8\u30e5\u30fc\u30eb\u304c\u5b8c\u5168\u306b\u7a3c\u50cd\u3057\u3066\u3044\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001EUDAMED\u306f\u4ee5\u4e0b\u306e\u60c5\u5831\u3092\u4e00\u5143\u7ba1\u7406\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u533b\u7642\u6a5f\u5668\u306e\u767b\u9332\u60c5\u5831\u3002<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a66\u9a13\u30fb\u81e8\u5e8a\u8abf\u67fb\u306b\u95a2\u3059\u308b\u60c5\u5831\u3002<\/li>\n\n\n\n<li>\u30d3\u30b8\u30e9\u30f3\u30b9\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u30c7\u30fc\u30bf\u3002<\/li>\n\n\n\n<li>\u88fd\u9020\u696d\u8005\u3001\u8f38\u5165\u696d\u8005\u3001\u4ee3\u7406\u4eba\u306a\u3069\u306e\u7d4c\u6e08\u4e8b\u696d\u8005\u60c5\u5831\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u306b\u3088\u308a\u3001\u898f\u5236\u5f53\u5c40\u3001\u533b\u7642\u5f93\u4e8b\u8005\u3001\u3055\u3089\u306b\u306f\u4e00\u822c\u306e\u4eba\u3005\u3082\u3001\u533b\u7642\u6a5f\u5668\u306e\u6027\u80fd\u3084\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u60c5\u5831\u3078\u30a2\u30af\u30bb\u30b9\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u306f\u3001\u30c7\u30fc\u30bf\u306e\u6b63\u78ba\u6027\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u9069\u6642\u5831\u544a\u306b\u5bfe\u3059\u308b\u671f\u5f85\u304c\u3053\u308c\u307e\u3067\u4ee5\u4e0a\u306b\u9ad8\u307e\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>MDCG<\/strong><strong>\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u91cd\u8981\u6027<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MDR\u305d\u306e\u3082\u306e\u306b\u52a0\u3048\u3001Medical Device Coordination Group\u3001\u3064\u307e\u308aMDCG\u304c\u767a\u884c\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3082\u3001MDR\u8981\u4ef6\u3092\u5b9f\u52d9\u3067\u89e3\u91c8\u3059\u308b\u3046\u3048\u3067\u6b20\u304b\u305b\u306a\u3044\u5b58\u5728\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u3089\u306e\u6587\u66f8\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u30c6\u30fc\u30de\u306b\u3064\u3044\u3066\u5b9f\u8df5\u7684\u306a\u65b9\u5411\u6027\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u81e8\u5e8a\u8a55\u4fa1\u3002<\/li>\n\n\n\n<li>PMS\u304a\u3088\u3073PSUR\u306e\u8981\u4ef6\u3002<\/li>\n\n\n\n<li>\u5206\u985e\u30eb\u30fc\u30eb\u3002<\/li>\n\n\n\n<li>\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3001\u3044\u308f\u3086\u308bSaMD\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u6cd5\u7684\u62d8\u675f\u529b\u3092\u6301\u3064\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001\u76e3\u67fb\u3084Notified Body\u306b\u3088\u308b\u5be9\u67fb\u3067\u306f\u3001\u5b9f\u8cea\u7684\u306a\u5224\u65ad\u57fa\u6e96\u3068\u3057\u3066\u6271\u308f\u308c\u308b\u3053\u3068\u304c\u591a\u304f\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u6700\u65b0\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u7d99\u7d9a\u7684\u306b\u628a\u63e1\u3057\u3001\u793e\u5185\u30d7\u30ed\u30bb\u30b9\u306b\u53cd\u6620\u3057\u3066\u3044\u304f\u3053\u3068\u304c\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u7dad\u6301\u306b\u306f\u4e0d\u53ef\u6b20\u3067\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>\u73fe\u5728\u3001\u591a\u304f\u306e\u4f01\u696d\u304c\u76f4\u9762\u3057\u3066\u3044\u308b\u8ab2\u984c<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MDR\u304c\u6210\u719f\u3059\u308b\u306b\u3064\u308c\u3001\u3044\u304f\u3064\u304b\u306e\u7d99\u7d9a\u7684\u306a\u8ab2\u984c\u304c\u660e\u78ba\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u307e\u305a\u3001\u30ea\u30bd\u30fc\u30b9\u3068\u30b3\u30b9\u30c8\u306e\u5727\u529b\u3067\u3059\u3002MDR\u5bfe\u5fdc\u306b\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u3001\u85ac\u4e8b\u5c02\u9580\u4eba\u6750\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3078\u306e\u5927\u304d\u306a\u6295\u8cc7\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b21\u306b\u3001\u30c7\u30fc\u30bf\u30ae\u30e3\u30c3\u30d7\u306e\u554f\u984c\u304c\u3042\u308a\u307e\u3059\u3002\u591a\u304f\u306e\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u3067\u306f\u3001MDR\u304c\u6c42\u3081\u308b\u6c34\u6e96\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u4e0d\u8db3\u3057\u3066\u304a\u308a\u3001\u65b0\u305f\u306a\u81e8\u5e8a\u8a66\u9a13\u3084PMCF\u6d3b\u52d5\u304c\u5fc5\u8981\u306b\u306a\u308b\u30b1\u30fc\u30b9\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3055\u3089\u306b\u3001\u696d\u52d9\u306e\u8907\u96d1\u5316\u3082\u5927\u304d\u306a\u8ab2\u984c\u3067\u3059\u3002\u85ac\u4e8b\u3001\u81e8\u5e8a\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u3001\u54c1\u8cea\u4fdd\u8a3c\u3092\u4e00\u3064\u306e\u6574\u5408\u6027\u3042\u308b\u30b7\u30b9\u30c6\u30e0\u3068\u3057\u3066\u7d71\u5408\u3059\u308b\u3053\u3068\u306f\u3001\u7279\u306b\u4e2d\u5c0f\u898f\u6a21\u306e\u4f01\u696d\u306b\u3068\u3063\u3066\u5bb9\u6613\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u52a0\u3048\u3066\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u304c\u7d99\u7d9a\u7684\u306b\u66f4\u65b0\u3055\u308c\u308b\u3053\u3068\u3067\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30fc\u30e0\u306f\u5e38\u306b\u5909\u5316\u3059\u308b\u8981\u4ef6\u306b\u5bfe\u5fdc\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">\u3053\u3046\u3057\u305f\u8ab2\u984c\u306b\u3088\u308a\u3001\u591a\u304f\u306e\u4f01\u696d\u304c\u85ac\u4e8b\u6226\u7565\u305d\u306e\u3082\u306e\u3092\u898b\u76f4\u3059\u5fc5\u8981\u306b\u8feb\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>\u533b\u7642\u6a5f\u5668\u4f01\u696d\u304c\u4eca\u53d6\u308a\u7d44\u3080\u3079\u304d\u3053\u3068<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">2026\u5e74\u4ee5\u964d\u3082MDR\u306b\u9069\u5207\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u304f\u305f\u3081\u306b\u306f\u3001\u4f01\u696d\u306f\u4ee5\u4e0b\u306e\u512a\u5148\u4e8b\u9805\u306b\u53d6\u308a\u7d44\u3080\u3079\u304d\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u307e\u305a\u3001\u81ea\u793e\u306e\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u3092\u76e3\u67fb\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u3069\u306e\u88fd\u54c1\u304c\u65e7\u6307\u4ee4\u306e\u8a8d\u8a3c\u4e0b\u306b\u3042\u308b\u306e\u304b\u3092\u78ba\u8a8d\u3057\u3001MDR\u79fb\u884c\u306b\u5411\u3051\u305f\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3092\u88fd\u54c1\u3054\u3068\u306b\u6574\u7406\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b21\u306b\u3001Notified Body\u3068\u306e\u65e9\u671f\u9023\u643a\u304c\u91cd\u8981\u3067\u3059\u3002\u5be9\u67fb\u67a0\u3092\u65e9\u3081\u306b\u78ba\u4fdd\u3057\u3001\u7d99\u7d9a\u7684\u304b\u3064\u80fd\u52d5\u7684\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u884c\u3046\u3053\u3068\u3067\u3001\u8a8d\u8a3c\u9045\u5ef6\u306e\u30ea\u30b9\u30af\u3092\u6291\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p 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wp-block-paragraph\">\u6700\u5f8c\u306b\u3001EUDAMED\u3078\u306e\u5bfe\u5fdc\u6e96\u5099\u3082\u9032\u3081\u308b\u3079\u304d\u3067\u3059\u3002\u4eca\u5f8c\u6c42\u3081\u3089\u308c\u308b\u30c7\u30fc\u30bf\u63d0\u51fa\u8981\u4ef6\u3092\u898b\u636e\u3048\u3001\u793e\u5185\u30b7\u30b9\u30c6\u30e0\u3084\u30c7\u30fc\u30bf\u7ba1\u7406\u4f53\u5236\u3092\u6574\u5099\u3057\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>\u591a\u304f\u306e\u4f01\u696d\u304c\u5916\u90e8\u306eMDR\u5c02\u9580\u5bb6\u3092\u6d3b\u7528\u3059\u308b\u7406\u7531<\/strong><\/h2>\n\n\n\n<p 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class=\"wp-block-list\">\n<li>\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u3001CER\u306e\u4f5c\u6210\u3002<\/li>\n\n\n\n<li>PMCF\u306e\u8a08\u753b\u7acb\u6848\u3068\u5b9f\u884c\u3002<\/li>\n\n\n\n<li>\u85ac\u4e8b\u6226\u7565\u304a\u3088\u3073\u7533\u8acb\u6587\u66f8\u306e\u4f5c\u6210\u3002<\/li>\n\n\n\n<li>\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3068\u306e\u6574\u5408\u6027\u78ba\u8a8d\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">Kolabtree\u306e\u3088\u3046\u306a\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u6d3b\u7528\u3059\u308c\u3070\u3001\u4f01\u696d\u306f\u7d4c\u9a13\u8c4a\u5bcc\u306a\u5c02\u9580\u5bb6\u3068\u3064\u306a\u304c\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u7279\u306b\u3001\u793e\u5185\u30ea\u30bd\u30fc\u30b9\u304c\u9650\u3089\u308c\u3066\u3044\u308b\u74b0\u5883\u3067\u306f\u3001\u5fc5\u8981\u306a\u5c02\u9580\u6027\u3092\u5fc5\u8981\u306a\u671f\u9593\u3060\u3051\u6d3b\u7528\u3067\u304d\u308b\u67d4\u8edf\u6027\u304c\u5927\u304d\u306a\u4fa1\u5024\u3092\u6301\u3061\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>\u307e\u3068\u3081<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MDR\u306f\u3001\u3082\u306f\u3084\u5c06\u6765\u306e\u8ab2\u984c\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3080\u3057\u308d\u73fe\u5728\u9032\u884c\u5f62\u3067\u898f\u5236\u5f53\u5c40\u306e\u76e3\u8996\u306f\u5f37\u307e\u308a\u3001\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u3001\u900f\u660e\u6027\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3067\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u304c\u3088\u308a\u91cd\u8996\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u65e9\u3044\u6bb5\u968e\u3067\u9069\u5207\u306a\u5c02\u9580\u77e5\u8b58\u3001\u30b7\u30b9\u30c6\u30e0\u3001\u6226\u7565\u306b\u6295\u8cc7\u3067\u304d\u308b\u4f01\u696d\u306b\u3068\u3063\u3066\u3001MDR\u5bfe\u5fdc\u306f\u5358\u306a\u308b\u898f\u5236\u4e0a\u306e\u30cf\u30fc\u30c9\u30eb\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u88fd\u54c1\u54c1\u8cea\u306e\u5411\u4e0a\u3001\u60a3\u8005\u5b89\u5168\u306e\u78ba\u4fdd\u3001\u305d\u3057\u3066\u9577\u671f\u7684\u306a\u5e02\u5834\u6210\u529f\u3092\u652f\u3048\u308b\u57fa\u76e4\u306b\u3082\u306a\u308a\u5f97\u307e\u3059\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u6b27\u5dde\u9023\u5408\u306e\u533b\u7642\u6a5f\u5668\u898f\u5247\u3001\u3044\u308f\u3086\u308bEU MDR(Medical Device Regulation)\u306f\u3001\u3059\u3067\u306b\u521d\u671f\u306e\u79fb\u884c\u671f\u9593\u3092\u904e\u304e\u3001\u672c\u683c\u7684\u306a\u904b\u7528\u30d5\u30a7\u30fc\u30ba\u306b\u5165\u3063\u3066\u3044\u307e\u3059\u30022021\u5e745\u6708\u306b\u9069\u7528\u304c\u958b\u59cb\u3055\u308c\u3066\u4ee5\u964d\u3001\u73fe\u5834\u3067\u660e\u3089\u304b\u306b\u306a\u3063\u305f\u8ab2\u984c\u3084\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4e0a\u306e\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u3001\u898f\u5236\u74b0\u5883\u306f\u7d99\u7d9a\u7684\u306b\u5909\u5316\u3057\u3066\u304d\u307e\u3057\u305f\u3002 \u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3001\u85ac\u4e8b\u62c5\u5f53\u8005\u3001\u81e8\u5e8a\u958b\u767a\u30c1\u30fc\u30e0\u306b\u3068\u3063\u3066\u30012026\u5e74\u306eEU MDR\u5bfe\u5fdc\u306f\u3001\u3082\u306f\u3084\u300cMDR\u3068\u306f\u4f55\u304b\u300d\u3092\u7406\u89e3\u3059\u308b\u6bb5\u968e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u91cd\u8981\u306a\u306e\u306f\u3001\u8907\u96d1\u306a\u8981\u4ef6\u3092\u5b9f\u52d9\u306e\u4e2d\u3067\u3069\u306e\u3088\u3046\u306b\u904b\u7528\u3057\u3001\u88fd\u54c1\u306e\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3092\u78ba\u4fdd\u3057\u3066\u3044\u304f\u304b\u3067\u3059\u3002 \u79fb\u884c\u671f\u9593\u304b\u3089\u5b9f\u904b\u7528\u3078\uff1a\u4f55\u304c\u5909\u308f\u3063\u305f\u306e\u304b MDR\u5c0e\u5165\u521d\u671f\u306b\u306f\u3001\u4e3b\u306b\u79fb\u884c\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3084\u6e96\u5099\u72b6\u6cc1\u304c\u8b70\u8ad6\u306e\u4e2d\u5fc3\u3067\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u5b9f\u969b\u306b\u904b\u7528\u304c\u9032\u3080\u306b\u3064\u308c\u3066\u3001\u5236\u5ea6\u4e0a\u306e\u5927\u304d\u306a\u5236\u7d04\u304c\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u7279\u306b\u6df1\u523b\u3060\u3063\u305f\u306e\u304c\u3001\u8a8d\u8a3c\u6a5f\u95a2\u3067\u3042\u308bNotified Body\u306e\u5be9\u67fb\u30ad\u30e3\u30d1\u30b7\u30c6\u30a3\u4e0d\u8db3\u3068\u3001\u65e2\u5b58\u88fd\u54c1\u306e\u518d\u8a8d\u8a3c\u306b\u5fc5\u8981\u306a\u4f5c\u696d\u91cf\u306e\u5927\u304d\u3055\u3067\u3059\u3002 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\u3053\u306e\u5ef6\u9577\u63aa\u7f6e\u306f\u4f01\u696d\u306b\u4e00\u5b9a\u306e\u7336\u4e88\u3092\u4e0e\u3048\u308b\u3082\u306e\u3067\u3059\u304c\u3001\u898f\u5236\u5bfe\u5fdc\u306e\u8ca0\u62c5\u304c\u8efd\u304f\u306a\u3063\u305f\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u3001MDR\u9069\u5408\u306b\u5411\u3051\u305f\u5177\u4f53\u7684\u306a\u9032\u6357\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001\u6280\u8853\u6587\u66f8\u306e\u66f4\u65b0\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u4f53\u5236\u306e\u6574\u5099\u3001Notified Body\u3068\u306e\u7d99\u7d9a\u7684\u306a\u9023\u643a\u306a\u3069\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002 \u3088\u308a\u53b3\u683c\u5316\u3059\u308b\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u8981\u4ef6 MDR\u306b\u304a\u3051\u308b\u6700\u3082\u5927\u304d\u306a\u5909\u5316\u306e\u4e00\u3064\u304c\u3001\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u306b\u5bfe\u3059\u308b\u8981\u6c42\u6c34\u6e96\u306e\u5f15\u304d\u4e0a\u3052\u3067\u3059\u3002 \u65e7\u533b\u7642\u6a5f\u5668\u6307\u4ee4\u3067\u3042\u308bMDD(Medical Devices Directive)\u306e\u3082\u3068\u3067\u306f\u3001\u591a\u304f\u306e\u30e1\u30fc\u30ab\u30fc\u304c\u540c\u7b49\u6027\u30c7\u30fc\u30bf\u3092\u7528\u3044\u3066\u81e8\u5e8a\u8a55\u4fa1\u3092\u88dc\u5b8c\u3057\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001MDR\u3067\u306f\u305d\u306e\u57fa\u6e96\u304c\u5927\u5e45\u306b\u53b3\u683c\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002 \u5177\u4f53\u7684\u306b\u306f\u3001\u500b\u5225\u6a5f\u5668\u306b\u7d10\u3065\u304f\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u3088\u308a\u91cd\u8996\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u308a\u3001\u540c\u7b49\u6027\u3092\u4e3b\u5f35\u3059\u308b\u969b\u306e\u6761\u4ef6\u3082\u53b3\u3057\u304f\u306a\u308a\u307e\u3057\u305f\u3002\u307e\u305f\u3001\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u3001\u3044\u308f\u3086\u308bCER(Clinical Evaluation Report)\u306e\u5be9\u67fb\u306b\u304a\u3044\u3066\u3001Notified Body\u306b\u3088\u308b\u78ba\u8a8d\u3082\u3088\u308a\u8a73\u7d30\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 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Surveillance)\u306e\u4f4d\u7f6e\u3065\u3051\u3082\u5927\u304d\u304f\u5909\u3048\u307e\u3057\u305f\u3002\u5f93\u6765\u306e\u3088\u3046\u306a\u5b9a\u671f\u7684\u30fb\u5f62\u5f0f\u7684\u306a\u5bfe\u5fdc\u3067\u306f\u306a\u304f\u3001\u7d99\u7d9a\u7684\u304b\u3064\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u304f\u30d7\u30ed\u30bb\u30b9\u3068\u3057\u3066\u518d\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002 \u73fe\u5728\u3001PMS\u306b\u306f\u4e3b\u306b\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u8981\u7d20\u304c\u542b\u307e\u308c\u307e\u3059\uff1a 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\u591a\u304f\u306e\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u5805\u7262\u306aPMS\u4f53\u5236\u3092\u69cb\u7bc9\u3057\u3001\u305d\u308c\u3092\u81e8\u5e8a\u30fb\u85ac\u4e8b\u30fb\u54c1\u8cea\u7ba1\u7406\u306e\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3068\u7d71\u5408\u3059\u308b\u3053\u3068\u306f\u3001MDR\u5bfe\u5fdc\u306e\u4e2d\u3067\u3082\u7279\u306b\u30ea\u30bd\u30fc\u30b9\u3092\u8981\u3059\u308b\u8ab2\u984c\u306e\u4e00\u3064\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 Notified Body\u306e\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u3068\u8a8d\u8a3c\u9045\u5ef6 \u4e00\u5b9a\u306e\u9032\u5c55\u306f\u3042\u308b\u3082\u306e\u306e\u3001Notified Body\u306e\u5be9\u67fb\u30ad\u30e3\u30d1\u30b7\u30c6\u30a3\u4e0d\u8db3\u306f\u3001MDR\u904b\u7528\u306b\u304a\u3051\u308b\u6700\u5927\u7d1a\u306e\u8ab2\u984c\u3068\u3057\u3066\u6b8b\u3063\u3066\u3044\u307e\u3059\u3002 2021\u5e74\u4ee5\u964d\u3001\u6307\u5b9a\u3055\u308c\u305fNotified Body\u306e\u6570\u306f\u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u8a8d\u8a3c\u3092\u5fc5\u8981\u3068\u3059\u308b\u88fd\u54c1\u6570\u3084\u518d\u8a8d\u8a3c\u306e\u9700\u8981\u306f\u4f9d\u7136\u3068\u3057\u3066\u5927\u304d\u304f\u3001\u4f9b\u7d66\u304c\u8ffd\u3044\u3064\u3044\u3066\u3044\u306a\u3044\u306e\u304c\u5b9f\u60c5\u3067\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u554f\u984c\u304c\u8d77\u304d\u3066\u3044\u307e\u3059\u3002 \u79fb\u884c\u671f\u9593\u304c\u5ef6\u9577\u3055\u308c\u305f\u3068\u306f\u3044\u3048\u3001\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u306e\u958b\u59cb\u304c\u9045\u308c\u308c\u3070\u3001\u671f\u9650\u306b\u9593\u306b\u5408\u308f\u306a\u3044\u30ea\u30b9\u30af\u304c\u3042\u308a\u307e\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u4f59\u88d5\u3092\u6301\u3063\u305f\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3067\u6e96\u5099\u3092\u9032\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 EUDAMED\u3068\u900f\u660e\u6027\u306e\u5411\u4e0a MDR\u306e\u3082\u3046\u4e00\u3064\u306e\u91cd\u8981\u306a\u67f1\u304c\u3001\u900f\u660e\u6027\u306e\u5411\u4e0a\u3067\u3059\u3002\u305d\u306e\u4e2d\u5fc3\u3068\u306a\u308b\u306e\u304c\u3001\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3067\u3042\u308bEUDAMED\u306e\u6bb5\u968e\u7684\u306a\u5c0e\u5165\u3067\u3059\u3002 \u3059\u3079\u3066\u306e\u30e2\u30b8\u30e5\u30fc\u30eb\u304c\u5b8c\u5168\u306b\u7a3c\u50cd\u3057\u3066\u3044\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001EUDAMED\u306f\u4ee5\u4e0b\u306e\u60c5\u5831\u3092\u4e00\u5143\u7ba1\u7406\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002 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Group\u3001\u3064\u307e\u308aMDCG\u304c\u767a\u884c\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3082\u3001MDR\u8981\u4ef6\u3092\u5b9f\u52d9\u3067\u89e3\u91c8\u3059\u308b\u3046\u3048\u3067\u6b20\u304b\u305b\u306a\u3044\u5b58\u5728\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u3053\u308c\u3089\u306e\u6587\u66f8\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u30c6\u30fc\u30de\u306b\u3064\u3044\u3066\u5b9f\u8df5\u7684\u306a\u65b9\u5411\u6027\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002 MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u6cd5\u7684\u62d8\u675f\u529b\u3092\u6301\u3064\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001\u76e3\u67fb\u3084Notified Body\u306b\u3088\u308b\u5be9\u67fb\u3067\u306f\u3001\u5b9f\u8cea\u7684\u306a\u5224\u65ad\u57fa\u6e96\u3068\u3057\u3066\u6271\u308f\u308c\u308b\u3053\u3068\u304c\u591a\u304f\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u6700\u65b0\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u7d99\u7d9a\u7684\u306b\u628a\u63e1\u3057\u3001\u793e\u5185\u30d7\u30ed\u30bb\u30b9\u306b\u53cd\u6620\u3057\u3066\u3044\u304f\u3053\u3068\u304c\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u7dad\u6301\u306b\u306f\u4e0d\u53ef\u6b20\u3067\u3059\u3002 \u73fe\u5728\u3001\u591a\u304f\u306e\u4f01\u696d\u304c\u76f4\u9762\u3057\u3066\u3044\u308b\u8ab2\u984c MDR\u304c\u6210\u719f\u3059\u308b\u306b\u3064\u308c\u3001\u3044\u304f\u3064\u304b\u306e\u7d99\u7d9a\u7684\u306a\u8ab2\u984c\u304c\u660e\u78ba\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 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[&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":108,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"swell_btn_cv_data":"","footnotes":""},"categories":[9],"tags":[],"class_list":["post-107","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-client"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>2026\u5e74\u306eEU MDR\u5bfe\u5fdc\uff1a\u533b\u7642\u6a5f\u5668\u4f01\u696d\u304c\u4eca\u53d6\u308a\u7d44\u3080\u3079\u304d\u3053\u3068 - Kolabtree Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/4.190.161.227\/?p=107\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"2026\u5e74\u306eEU MDR\u5bfe\u5fdc\uff1a\u533b\u7642\u6a5f\u5668\u4f01\u696d\u304c\u4eca\u53d6\u308a\u7d44\u3080\u3079\u304d\u3053\u3068 - Kolabtree Blog\" \/>\n<meta property=\"og:description\" content=\"\u6b27\u5dde\u9023\u5408\u306e\u533b\u7642\u6a5f\u5668\u898f\u5247\u3001\u3044\u308f\u3086\u308bEU MDR(Medical Device Regulation)\u306f\u3001\u3059\u3067\u306b\u521d\u671f\u306e\u79fb\u884c\u671f\u9593\u3092\u904e\u304e\u3001\u672c\u683c\u7684\u306a\u904b\u7528\u30d5\u30a7\u30fc\u30ba\u306b\u5165\u3063\u3066\u3044\u307e\u3059\u30022021\u5e745\u6708\u306b\u9069\u7528\u304c\u958b\u59cb\u3055\u308c\u3066\u4ee5\u964d\u3001\u73fe\u5834\u3067\u660e\u3089\u304b\u306b\u306a\u3063\u305f\u8ab2\u984c\u3084\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4e0a\u306e\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u3001\u898f\u5236\u74b0\u5883\u306f\u7d99\u7d9a\u7684\u306b\u5909\u5316\u3057\u3066\u304d\u307e\u3057\u305f\u3002 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MDR\u5c0e\u5165\u521d\u671f\u306b\u306f\u3001\u4e3b\u306b\u79fb\u884c\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3084\u6e96\u5099\u72b6\u6cc1\u304c\u8b70\u8ad6\u306e\u4e2d\u5fc3\u3067\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u5b9f\u969b\u306b\u904b\u7528\u304c\u9032\u3080\u306b\u3064\u308c\u3066\u3001\u5236\u5ea6\u4e0a\u306e\u5927\u304d\u306a\u5236\u7d04\u304c\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u7279\u306b\u6df1\u523b\u3060\u3063\u305f\u306e\u304c\u3001\u8a8d\u8a3c\u6a5f\u95a2\u3067\u3042\u308bNotified Body\u306e\u5be9\u67fb\u30ad\u30e3\u30d1\u30b7\u30c6\u30a3\u4e0d\u8db3\u3068\u3001\u65e2\u5b58\u88fd\u54c1\u306e\u518d\u8a8d\u8a3c\u306b\u5fc5\u8981\u306a\u4f5c\u696d\u91cf\u306e\u5927\u304d\u3055\u3067\u3059\u3002 \u6b27\u5dde\u5e02\u5834\u3067\u533b\u7642\u6a5f\u5668\u4e0d\u8db3\u304c\u767a\u751f\u3059\u308b\u30ea\u30b9\u30af\u3092\u56de\u907f\u3059\u308b\u305f\u3081\u3001EU\u306f2023\u5e74\u306e\u6cd5\u6539\u6b63\u306b\u3088\u308a\u3001\u79fb\u884c\u671f\u9593\u306e\u5ef6\u9577\u3092\u5c0e\u5165\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u65e7\u6307\u4ee4\u306e\u3082\u3068\u3067\u8a8d\u8a3c\u3055\u308c\u305f\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u306f\u3001\u6a5f\u5668\u5206\u985e\u306b\u5fdc\u3058\u3066\u4ee5\u4e0b\u306e\u671f\u9593\u307e\u3067\u5e02\u5834\u306b\u6b8b\u308b\u3053\u3068\u304c\u53ef\u80fd\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u3053\u306e\u5ef6\u9577\u63aa\u7f6e\u306f\u4f01\u696d\u306b\u4e00\u5b9a\u306e\u7336\u4e88\u3092\u4e0e\u3048\u308b\u3082\u306e\u3067\u3059\u304c\u3001\u898f\u5236\u5bfe\u5fdc\u306e\u8ca0\u62c5\u304c\u8efd\u304f\u306a\u3063\u305f\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u3001MDR\u9069\u5408\u306b\u5411\u3051\u305f\u5177\u4f53\u7684\u306a\u9032\u6357\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001\u6280\u8853\u6587\u66f8\u306e\u66f4\u65b0\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u4f53\u5236\u306e\u6574\u5099\u3001Notified Body\u3068\u306e\u7d99\u7d9a\u7684\u306a\u9023\u643a\u306a\u3069\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002 \u3088\u308a\u53b3\u683c\u5316\u3059\u308b\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u8981\u4ef6 MDR\u306b\u304a\u3051\u308b\u6700\u3082\u5927\u304d\u306a\u5909\u5316\u306e\u4e00\u3064\u304c\u3001\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u306b\u5bfe\u3059\u308b\u8981\u6c42\u6c34\u6e96\u306e\u5f15\u304d\u4e0a\u3052\u3067\u3059\u3002 \u65e7\u533b\u7642\u6a5f\u5668\u6307\u4ee4\u3067\u3042\u308bMDD(Medical Devices Directive)\u306e\u3082\u3068\u3067\u306f\u3001\u591a\u304f\u306e\u30e1\u30fc\u30ab\u30fc\u304c\u540c\u7b49\u6027\u30c7\u30fc\u30bf\u3092\u7528\u3044\u3066\u81e8\u5e8a\u8a55\u4fa1\u3092\u88dc\u5b8c\u3057\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001MDR\u3067\u306f\u305d\u306e\u57fa\u6e96\u304c\u5927\u5e45\u306b\u53b3\u683c\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002 \u5177\u4f53\u7684\u306b\u306f\u3001\u500b\u5225\u6a5f\u5668\u306b\u7d10\u3065\u304f\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u3088\u308a\u91cd\u8996\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u308a\u3001\u540c\u7b49\u6027\u3092\u4e3b\u5f35\u3059\u308b\u969b\u306e\u6761\u4ef6\u3082\u53b3\u3057\u304f\u306a\u308a\u307e\u3057\u305f\u3002\u307e\u305f\u3001\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u3001\u3044\u308f\u3086\u308bCER(Clinical Evaluation Report)\u306e\u5be9\u67fb\u306b\u304a\u3044\u3066\u3001Notified Body\u306b\u3088\u308b\u78ba\u8a8d\u3082\u3088\u308a\u8a73\u7d30\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u305d\u306e\u7d50\u679c\u3001\u81e8\u5e8a\u6226\u7565\u306f\u85ac\u4e8b\u6210\u529f\u306e\u4e2d\u5fc3\u7684\u306a\u8981\u7d20\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u30e1\u30fc\u30ab\u30fc\u306b\u306f\u3001\u7533\u8acb\u6642\u70b9\u3060\u3051\u3067\u306a\u304f\u3001\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u3066\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u3069\u306e\u3088\u3046\u306b\u751f\u6210\u30fb\u66f4\u65b0\u3057\u3066\u3044\u304f\u304b\u3092\u8a08\u753b\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002 \u5e02\u8ca9\u5f8c\u76e3\u8996\uff1a\u5f62\u5f0f\u7684\u306a\u5bfe\u5fdc\u304b\u3089\u7d99\u7d9a\u7684\u306a\u8cac\u4efb\u3078 MDR\u306f\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u3001\u3064\u307e\u308aPMS(Post Marketing Surveillance)\u306e\u4f4d\u7f6e\u3065\u3051\u3082\u5927\u304d\u304f\u5909\u3048\u307e\u3057\u305f\u3002\u5f93\u6765\u306e\u3088\u3046\u306a\u5b9a\u671f\u7684\u30fb\u5f62\u5f0f\u7684\u306a\u5bfe\u5fdc\u3067\u306f\u306a\u304f\u3001\u7d99\u7d9a\u7684\u304b\u3064\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u304f\u30d7\u30ed\u30bb\u30b9\u3068\u3057\u3066\u518d\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002 \u73fe\u5728\u3001PMS\u306b\u306f\u4e3b\u306b\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u8981\u7d20\u304c\u542b\u307e\u308c\u307e\u3059\uff1a \u3053\u308c\u306f\u3001\u533b\u7642\u6a5f\u5668\u898f\u5236\u304c\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u76e3\u8996\u3059\u308b\u65b9\u5411\u3078\u9032\u3093\u3067\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u6a5f\u5668\u306f\u4e0a\u5e02\u6642\u306b\u4e00\u5ea6\u8a55\u4fa1\u3055\u308c\u308b\u3060\u3051\u3067\u306f\u306a\u304f\u3001\u5e02\u5834\u3067\u5b9f\u969b\u306b\u4f7f\u7528\u3055\u308c\u305f\u5f8c\u306e\u6027\u80fd\u3084\u5b89\u5168\u6027\u306b\u57fa\u3065\u304d\u3001\u7d99\u7d9a\u7684\u306b\u8a55\u4fa1\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u591a\u304f\u306e\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u5805\u7262\u306aPMS\u4f53\u5236\u3092\u69cb\u7bc9\u3057\u3001\u305d\u308c\u3092\u81e8\u5e8a\u30fb\u85ac\u4e8b\u30fb\u54c1\u8cea\u7ba1\u7406\u306e\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3068\u7d71\u5408\u3059\u308b\u3053\u3068\u306f\u3001MDR\u5bfe\u5fdc\u306e\u4e2d\u3067\u3082\u7279\u306b\u30ea\u30bd\u30fc\u30b9\u3092\u8981\u3059\u308b\u8ab2\u984c\u306e\u4e00\u3064\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 Notified Body\u306e\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u3068\u8a8d\u8a3c\u9045\u5ef6 \u4e00\u5b9a\u306e\u9032\u5c55\u306f\u3042\u308b\u3082\u306e\u306e\u3001Notified Body\u306e\u5be9\u67fb\u30ad\u30e3\u30d1\u30b7\u30c6\u30a3\u4e0d\u8db3\u306f\u3001MDR\u904b\u7528\u306b\u304a\u3051\u308b\u6700\u5927\u7d1a\u306e\u8ab2\u984c\u3068\u3057\u3066\u6b8b\u3063\u3066\u3044\u307e\u3059\u3002 2021\u5e74\u4ee5\u964d\u3001\u6307\u5b9a\u3055\u308c\u305fNotified Body\u306e\u6570\u306f\u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u8a8d\u8a3c\u3092\u5fc5\u8981\u3068\u3059\u308b\u88fd\u54c1\u6570\u3084\u518d\u8a8d\u8a3c\u306e\u9700\u8981\u306f\u4f9d\u7136\u3068\u3057\u3066\u5927\u304d\u304f\u3001\u4f9b\u7d66\u304c\u8ffd\u3044\u3064\u3044\u3066\u3044\u306a\u3044\u306e\u304c\u5b9f\u60c5\u3067\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u554f\u984c\u304c\u8d77\u304d\u3066\u3044\u307e\u3059\u3002 \u79fb\u884c\u671f\u9593\u304c\u5ef6\u9577\u3055\u308c\u305f\u3068\u306f\u3044\u3048\u3001\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u306e\u958b\u59cb\u304c\u9045\u308c\u308c\u3070\u3001\u671f\u9650\u306b\u9593\u306b\u5408\u308f\u306a\u3044\u30ea\u30b9\u30af\u304c\u3042\u308a\u307e\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u4f59\u88d5\u3092\u6301\u3063\u305f\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3067\u6e96\u5099\u3092\u9032\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 EUDAMED\u3068\u900f\u660e\u6027\u306e\u5411\u4e0a MDR\u306e\u3082\u3046\u4e00\u3064\u306e\u91cd\u8981\u306a\u67f1\u304c\u3001\u900f\u660e\u6027\u306e\u5411\u4e0a\u3067\u3059\u3002\u305d\u306e\u4e2d\u5fc3\u3068\u306a\u308b\u306e\u304c\u3001\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3067\u3042\u308bEUDAMED\u306e\u6bb5\u968e\u7684\u306a\u5c0e\u5165\u3067\u3059\u3002 \u3059\u3079\u3066\u306e\u30e2\u30b8\u30e5\u30fc\u30eb\u304c\u5b8c\u5168\u306b\u7a3c\u50cd\u3057\u3066\u3044\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001EUDAMED\u306f\u4ee5\u4e0b\u306e\u60c5\u5831\u3092\u4e00\u5143\u7ba1\u7406\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002 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Group\u3001\u3064\u307e\u308aMDCG\u304c\u767a\u884c\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3082\u3001MDR\u8981\u4ef6\u3092\u5b9f\u52d9\u3067\u89e3\u91c8\u3059\u308b\u3046\u3048\u3067\u6b20\u304b\u305b\u306a\u3044\u5b58\u5728\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u3053\u308c\u3089\u306e\u6587\u66f8\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u30c6\u30fc\u30de\u306b\u3064\u3044\u3066\u5b9f\u8df5\u7684\u306a\u65b9\u5411\u6027\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002 MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u6cd5\u7684\u62d8\u675f\u529b\u3092\u6301\u3064\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001\u76e3\u67fb\u3084Notified 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property=\"article:published_time\" content=\"2026-05-27T12:19:25+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-27T12:19:27+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/4.190.161.227\/wp-content\/uploads\/2026\/05\/no4og.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Vipul Manchala\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Vipul Manchala\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" 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\u3053\u306e\u5ef6\u9577\u63aa\u7f6e\u306f\u4f01\u696d\u306b\u4e00\u5b9a\u306e\u7336\u4e88\u3092\u4e0e\u3048\u308b\u3082\u306e\u3067\u3059\u304c\u3001\u898f\u5236\u5bfe\u5fdc\u306e\u8ca0\u62c5\u304c\u8efd\u304f\u306a\u3063\u305f\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u3001MDR\u9069\u5408\u306b\u5411\u3051\u305f\u5177\u4f53\u7684\u306a\u9032\u6357\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001\u6280\u8853\u6587\u66f8\u306e\u66f4\u65b0\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u4f53\u5236\u306e\u6574\u5099\u3001Notified Body\u3068\u306e\u7d99\u7d9a\u7684\u306a\u9023\u643a\u306a\u3069\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002 \u3088\u308a\u53b3\u683c\u5316\u3059\u308b\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u8981\u4ef6 MDR\u306b\u304a\u3051\u308b\u6700\u3082\u5927\u304d\u306a\u5909\u5316\u306e\u4e00\u3064\u304c\u3001\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u306b\u5bfe\u3059\u308b\u8981\u6c42\u6c34\u6e96\u306e\u5f15\u304d\u4e0a\u3052\u3067\u3059\u3002 \u65e7\u533b\u7642\u6a5f\u5668\u6307\u4ee4\u3067\u3042\u308bMDD(Medical Devices Directive)\u306e\u3082\u3068\u3067\u306f\u3001\u591a\u304f\u306e\u30e1\u30fc\u30ab\u30fc\u304c\u540c\u7b49\u6027\u30c7\u30fc\u30bf\u3092\u7528\u3044\u3066\u81e8\u5e8a\u8a55\u4fa1\u3092\u88dc\u5b8c\u3057\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001MDR\u3067\u306f\u305d\u306e\u57fa\u6e96\u304c\u5927\u5e45\u306b\u53b3\u683c\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002 \u5177\u4f53\u7684\u306b\u306f\u3001\u500b\u5225\u6a5f\u5668\u306b\u7d10\u3065\u304f\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u3088\u308a\u91cd\u8996\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u308a\u3001\u540c\u7b49\u6027\u3092\u4e3b\u5f35\u3059\u308b\u969b\u306e\u6761\u4ef6\u3082\u53b3\u3057\u304f\u306a\u308a\u307e\u3057\u305f\u3002\u307e\u305f\u3001\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u3001\u3044\u308f\u3086\u308bCER(Clinical Evaluation Report)\u306e\u5be9\u67fb\u306b\u304a\u3044\u3066\u3001Notified Body\u306b\u3088\u308b\u78ba\u8a8d\u3082\u3088\u308a\u8a73\u7d30\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u305d\u306e\u7d50\u679c\u3001\u81e8\u5e8a\u6226\u7565\u306f\u85ac\u4e8b\u6210\u529f\u306e\u4e2d\u5fc3\u7684\u306a\u8981\u7d20\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u30e1\u30fc\u30ab\u30fc\u306b\u306f\u3001\u7533\u8acb\u6642\u70b9\u3060\u3051\u3067\u306a\u304f\u3001\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u3066\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u3069\u306e\u3088\u3046\u306b\u751f\u6210\u30fb\u66f4\u65b0\u3057\u3066\u3044\u304f\u304b\u3092\u8a08\u753b\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002 \u5e02\u8ca9\u5f8c\u76e3\u8996\uff1a\u5f62\u5f0f\u7684\u306a\u5bfe\u5fdc\u304b\u3089\u7d99\u7d9a\u7684\u306a\u8cac\u4efb\u3078 MDR\u306f\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u3001\u3064\u307e\u308aPMS(Post Marketing Surveillance)\u306e\u4f4d\u7f6e\u3065\u3051\u3082\u5927\u304d\u304f\u5909\u3048\u307e\u3057\u305f\u3002\u5f93\u6765\u306e\u3088\u3046\u306a\u5b9a\u671f\u7684\u30fb\u5f62\u5f0f\u7684\u306a\u5bfe\u5fdc\u3067\u306f\u306a\u304f\u3001\u7d99\u7d9a\u7684\u304b\u3064\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u304f\u30d7\u30ed\u30bb\u30b9\u3068\u3057\u3066\u518d\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002 \u73fe\u5728\u3001PMS\u306b\u306f\u4e3b\u306b\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u8981\u7d20\u304c\u542b\u307e\u308c\u307e\u3059\uff1a \u3053\u308c\u306f\u3001\u533b\u7642\u6a5f\u5668\u898f\u5236\u304c\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u76e3\u8996\u3059\u308b\u65b9\u5411\u3078\u9032\u3093\u3067\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u6a5f\u5668\u306f\u4e0a\u5e02\u6642\u306b\u4e00\u5ea6\u8a55\u4fa1\u3055\u308c\u308b\u3060\u3051\u3067\u306f\u306a\u304f\u3001\u5e02\u5834\u3067\u5b9f\u969b\u306b\u4f7f\u7528\u3055\u308c\u305f\u5f8c\u306e\u6027\u80fd\u3084\u5b89\u5168\u6027\u306b\u57fa\u3065\u304d\u3001\u7d99\u7d9a\u7684\u306b\u8a55\u4fa1\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u591a\u304f\u306e\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u5805\u7262\u306aPMS\u4f53\u5236\u3092\u69cb\u7bc9\u3057\u3001\u305d\u308c\u3092\u81e8\u5e8a\u30fb\u85ac\u4e8b\u30fb\u54c1\u8cea\u7ba1\u7406\u306e\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3068\u7d71\u5408\u3059\u308b\u3053\u3068\u306f\u3001MDR\u5bfe\u5fdc\u306e\u4e2d\u3067\u3082\u7279\u306b\u30ea\u30bd\u30fc\u30b9\u3092\u8981\u3059\u308b\u8ab2\u984c\u306e\u4e00\u3064\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 Notified Body\u306e\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u3068\u8a8d\u8a3c\u9045\u5ef6 \u4e00\u5b9a\u306e\u9032\u5c55\u306f\u3042\u308b\u3082\u306e\u306e\u3001Notified Body\u306e\u5be9\u67fb\u30ad\u30e3\u30d1\u30b7\u30c6\u30a3\u4e0d\u8db3\u306f\u3001MDR\u904b\u7528\u306b\u304a\u3051\u308b\u6700\u5927\u7d1a\u306e\u8ab2\u984c\u3068\u3057\u3066\u6b8b\u3063\u3066\u3044\u307e\u3059\u3002 2021\u5e74\u4ee5\u964d\u3001\u6307\u5b9a\u3055\u308c\u305fNotified Body\u306e\u6570\u306f\u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u8a8d\u8a3c\u3092\u5fc5\u8981\u3068\u3059\u308b\u88fd\u54c1\u6570\u3084\u518d\u8a8d\u8a3c\u306e\u9700\u8981\u306f\u4f9d\u7136\u3068\u3057\u3066\u5927\u304d\u304f\u3001\u4f9b\u7d66\u304c\u8ffd\u3044\u3064\u3044\u3066\u3044\u306a\u3044\u306e\u304c\u5b9f\u60c5\u3067\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u554f\u984c\u304c\u8d77\u304d\u3066\u3044\u307e\u3059\u3002 \u79fb\u884c\u671f\u9593\u304c\u5ef6\u9577\u3055\u308c\u305f\u3068\u306f\u3044\u3048\u3001\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u306e\u958b\u59cb\u304c\u9045\u308c\u308c\u3070\u3001\u671f\u9650\u306b\u9593\u306b\u5408\u308f\u306a\u3044\u30ea\u30b9\u30af\u304c\u3042\u308a\u307e\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u4f59\u88d5\u3092\u6301\u3063\u305f\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3067\u6e96\u5099\u3092\u9032\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 EUDAMED\u3068\u900f\u660e\u6027\u306e\u5411\u4e0a MDR\u306e\u3082\u3046\u4e00\u3064\u306e\u91cd\u8981\u306a\u67f1\u304c\u3001\u900f\u660e\u6027\u306e\u5411\u4e0a\u3067\u3059\u3002\u305d\u306e\u4e2d\u5fc3\u3068\u306a\u308b\u306e\u304c\u3001\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3067\u3042\u308bEUDAMED\u306e\u6bb5\u968e\u7684\u306a\u5c0e\u5165\u3067\u3059\u3002 \u3059\u3079\u3066\u306e\u30e2\u30b8\u30e5\u30fc\u30eb\u304c\u5b8c\u5168\u306b\u7a3c\u50cd\u3057\u3066\u3044\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001EUDAMED\u306f\u4ee5\u4e0b\u306e\u60c5\u5831\u3092\u4e00\u5143\u7ba1\u7406\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002 \u3053\u308c\u306b\u3088\u308a\u3001\u898f\u5236\u5f53\u5c40\u3001\u533b\u7642\u5f93\u4e8b\u8005\u3001\u3055\u3089\u306b\u306f\u4e00\u822c\u306e\u4eba\u3005\u3082\u3001\u533b\u7642\u6a5f\u5668\u306e\u6027\u80fd\u3084\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u60c5\u5831\u3078\u30a2\u30af\u30bb\u30b9\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002 \u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u306f\u3001\u30c7\u30fc\u30bf\u306e\u6b63\u78ba\u6027\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u9069\u6642\u5831\u544a\u306b\u5bfe\u3059\u308b\u671f\u5f85\u304c\u3053\u308c\u307e\u3067\u4ee5\u4e0a\u306b\u9ad8\u307e\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002 MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u91cd\u8981\u6027 MDR\u305d\u306e\u3082\u306e\u306b\u52a0\u3048\u3001Medical Device Coordination Group\u3001\u3064\u307e\u308aMDCG\u304c\u767a\u884c\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3082\u3001MDR\u8981\u4ef6\u3092\u5b9f\u52d9\u3067\u89e3\u91c8\u3059\u308b\u3046\u3048\u3067\u6b20\u304b\u305b\u306a\u3044\u5b58\u5728\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u3053\u308c\u3089\u306e\u6587\u66f8\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u30c6\u30fc\u30de\u306b\u3064\u3044\u3066\u5b9f\u8df5\u7684\u306a\u65b9\u5411\u6027\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002 MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u6cd5\u7684\u62d8\u675f\u529b\u3092\u6301\u3064\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001\u76e3\u67fb\u3084Notified 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