{"id":19839,"date":"2025-05-15T08:55:13","date_gmt":"2025-05-15T05:55:13","guid":{"rendered":"https:\/\/medfilesgroup.com\/?p=19839"},"modified":"2025-05-15T09:49:15","modified_gmt":"2025-05-15T06:49:15","slug":"%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%8a%e3%82%88%e3%81%b3ivd%e3%81%ae%e3%82%af%e3%83%a9%e3%82%b9%e5%a4%89%e6%9b%b4%e3%81%a8%e7%a7%bb%e8%a1%8c%e6%9c%9f%e9%96%93%e3%81%ab%e3%81%a4%e3%81%84","status":"publish","type":"post","link":"https:\/\/medfilesgroup.com\/ja\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%8a%e3%82%88%e3%81%b3ivd%e3%81%ae%e3%82%af%e3%83%a9%e3%82%b9%e5%a4%89%e6%9b%b4%e3%81%a8%e7%a7%bb%e8%a1%8c%e6%9c%9f%e9%96%93%e3%81%ab%e3%81%a4%e3%81%84\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073IVD\u306e\u30af\u30e9\u30b9\u5909\u66f4\u3068\u79fb\u884c\u671f\u9593\u306b\u3064\u3044\u3066\u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u3053\u3068"},"content":{"rendered":"\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<p>\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u306f\u3001\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08MDR\uff1aRegulation (EU) 2017\/745\uff09\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08IVDR\uff1aRegulation (EU) 2017\/746\uff09\u306e\u5c0e\u5165\u306b\u3088\u308a\u3001\u5927\u304d\u306a\u524d\u9032\u3092\u9042\u3052\u307e\u3057\u305f\u3002\u3053\u308c\u3089\u306e\u898f\u5247\u306f\u3001\u6a5f\u5668\u306e\u5206\u985e\u306b\u5909\u66f4\u3092\u3082\u305f\u3089\u3059\u3060\u3051\u3067\u306a\u304f\u3001\u88fd\u9020\u696d\u8005\u3001\u533b\u7642\u5f93\u4e8b\u8005\u3001\u898f\u5236\u5f53\u5c40\u304c\u5186\u6ed1\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u3001\u79fb\u884c\u671f\u9593\u3082\u8a2d\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u672c\u30d6\u30ed\u30b0\u8a18\u4e8b\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\uff08IVD\uff09\u306e\u5206\u985e\u306b\u304a\u3051\u308b\u5909\u66f4\u70b9\u3068\u3001MDR\u304a\u3088\u3073IVDR\u306b\u57fa\u3065\u304f\u79fb\u884c\u671f\u9593\u306b\u3064\u3044\u3066\u3001\u5305\u62ec\u7684\u306b\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:500px\">\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1200\" height=\"628\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/04\/md-and-ivd.jpg\" alt=\"Medical device and IVD class change\" class=\"wp-image-16869\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/04\/md-and-ivd.jpg 1200w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/04\/md-and-ivd-300x157.jpg 300w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/04\/md-and-ivd-1024x536.jpg 1024w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/04\/md-and-ivd-768x402.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/figure>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-dc03b434293162de1420828a33e00494\"><strong>\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073IVD\u306e\u30af\u30e9\u30b9\u5909\u66f4\u3068\u306f\u4f55\u3092\u610f\u5473\u3059\u308b\u306e\u304b\uff1f<\/strong><\/h2>\n\n\n\n<p>MDR\u304a\u3088\u3073IVDR\u306f\u3001\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u30b7\u30b9\u30c6\u30e0\u3092\u629c\u672c\u7684\u306b\u898b\u76f4\u3057\u3001\u898f\u5236\u8981\u4ef6\u3092\u6280\u8853\u306e\u9032\u6b69\u3084\u60a3\u8005\u306e\u5b89\u5168\u6027\u3078\u306e\u914d\u616e\u3068\u3088\u308a\u9069\u5408\u3055\u305b\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u306f\u3001\u5f93\u6765\u3068\u540c\u69d8\u306b\u30ea\u30b9\u30af\u306b\u57fa\u3065\u304f\u5206\u985e\uff08\u30af\u30e9\u30b9 I\u3014\u6700\u3082\u4f4e\u30ea\u30b9\u30af\u3015\u304b\u3089\u30af\u30e9\u30b9 III\u3014\u6700\u3082\u9ad8\u30ea\u30b9\u30af\u3015\uff09\u304c\u7dad\u6301\u3055\u308c\u3066\u3044\u308b\u4e00\u65b9\u3067\u3001IVDR\u3067\u306fIVD\u306b\u5bfe\u3057\u3066\u72ec\u81ea\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u5206\u985e\uff08\u30af\u30e9\u30b9 A\u3014\u6700\u3082\u4f4e\u30ea\u30b9\u30af\u3015\u304b\u3089\u30af\u30e9\u30b9 D\u3014\u6700\u3082\u9ad8\u30ea\u30b9\u30af\u3015\uff09\u304c\u5c0e\u5165\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u5206\u985e\u3067\u306f\u3001\u6a5f\u5668\u305d\u306e\u3082\u306e\u306e\u30ea\u30b9\u30af\u3060\u3051\u3067\u306a\u304f\u3001\u4f7f\u7528\u76ee\u7684\u3084\u8a3a\u65ad\u30fb\u6cbb\u7642\u306b\u304a\u3051\u308b\u5f79\u5272\u306a\u3069\u3082\u8003\u616e\u3055\u308c\u307e\u3059\u3002\u307e\u305f\u3001\u6a5f\u5668\u306e\u4f7f\u7528\u76ee\u7684\u3001\u81e8\u5e8a\u5224\u65ad\u306b\u304a\u3051\u308b\u60c5\u5831\u306e\u91cd\u8981\u6027\u3001\u516c\u8846\u885b\u751f\u3078\u306e\u5f71\u97ff\u306a\u3069\u3082\u3001MDR\u304a\u3088\u3073IVDR\u306e\u4e0b\u3067\u306f\u5206\u985e\u6c7a\u5b9a\u306b\u304a\u3044\u3066\u3088\u308a\u91cd\u8981\u306a\u8981\u7d20\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u88fd\u9020\u696d\u8005\u306b\u3068\u3063\u3066\u306f\u3001\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u5168\u4f53\u3092\u518d\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002\u4ee5\u524d\u306e\u6307\u4ee4\u4e0b\u3067\u4f4e\u30ea\u30b9\u30af\u306b\u5206\u985e\u3055\u308c\u3066\u3044\u305f\u6a5f\u5668\u304c\u3001MDR\u3084IVDR\u3067\u306f\u3088\u308a\u9ad8\u30ea\u30b9\u30af\u306b\u518d\u5206\u985e\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u5909\u5316\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u65b0\u305f\u306a\u898f\u5236\u74b0\u5883\u3092\u6b63\u3057\u304f\u7406\u89e3\u3057\u3001\u66f4\u65b0\u3055\u308c\u305f\u6574\u5408\u898f\u683c\u3078\u306e\u9069\u5408\u3092\u78ba\u5b9f\u306b\u884c\u3046\u59ff\u52e2\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group has-background\" style=\"background-color:#f3f3f3\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-5502e6bf54d185579990b743268e26ae\"><strong>\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073IVD\u306f\u3069\u306e\u3088\u3046\u306b\u5206\u985e\u3055\u308c\u308b\u306e\u304b\uff1f<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color has-medium-font-size wp-elements-50736872893cb8d05288a9082e27c67b\"><strong>MDR\u5206\u985e\uff08\u533b\u7642\u6a5f\u5668\uff09<\/strong><\/h3>\n\n\n\n<p>MDR\uff08\u533b\u7642\u6a5f\u5668\u898f\u5247\uff09\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u306f\u4e3b\u306b\u30ea\u30b9\u30af\u306b\u57fa\u3065\u3044\u3066\u304a\u308a\u3001\u30af\u30e9\u30b9 I\uff08\u6700\u3082\u4f4e\u30ea\u30b9\u30af\uff09\u304b\u3089\u30af\u30e9\u30b9 III\uff08\u6700\u3082\u9ad8\u30ea\u30b9\u30af\uff09\u307e\u3067\u5206\u304b\u308c\u3066\u3044\u307e\u3059\u3002\u30ea\u30b9\u30af\u306e\u7a0b\u5ea6\u306f\u3001\u6a5f\u5668\u306e\u4f7f\u7528\u76ee\u7684\u3084\u8eab\u4f53\u3068\u306e\u63a5\u89e6\u671f\u9593\u306a\u3069\u306b\u3088\u308a\u6c7a\u5b9a\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u30af\u30e9\u30b9<\/strong><strong> I<\/strong>\uff1a\u60a3\u8005\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u4f7f\u7528\u8005\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u304c\u4f4e\u3044\u6a5f\u5668\u3002<br>\u3000\u4f8b\uff1a\u975e\u4fb5\u8972\u6027\u306e\u6a5f\u5668\uff08\u5305\u5e2f\uff09\u3001\u518d\u4f7f\u7528\u53ef\u80fd\u306a\u5916\u79d1\u7528\u5668\u5177\u3001\u624b\u52d5\u8074\u8a3a\u5668\u3001\u77ef\u6b63\u7528\u773c\u93e1\u3001\u624b\u52d5\u8eca\u6905\u5b50\u3001\u4f53\u6e29\u8a08\u306a\u3069\u3002<\/li>\n\n\n\n<li><strong>\u30af\u30e9\u30b9 IIa<\/strong>\uff1a\u4f4e\u301c\u4e2d\u7a0b\u5ea6\u306e\u30ea\u30b9\u30af\u3092\u4f34\u3046\u6a5f\u5668\u3002<br>\u3000\u4f8b\uff1a\u88dc\u8074\u5668\u3001\u70b9\u9f3b\u85ac\u3001\u6b6f\u51a0\u3001\u8eab\u4f53\u691c\u67fb\u7528\u306e\u8d85\u97f3\u6ce2\u88c5\u7f6e\u306a\u3069\u3002<\/li>\n\n\n\n<li><strong>\u30af\u30e9\u30b9 IIb<\/strong>\uff1a\u4e2d\u301c\u9ad8\u30ea\u30b9\u30af\u3092\u4f34\u3046\u6a5f\u5668\u3002<br>\u3000\u4f8b\uff1a\u4eba\u5de5\u547c\u5438\u5668\u3001\u8f38\u6db2\u30dd\u30f3\u30d7\u3001\u624b\u8853\u7528\u30ec\u30fc\u30b6\u30fc\u3001\u81a3\u7528\u30af\u30ea\u30fc\u30e0\u30fb\u30b8\u30a7\u30eb\u30fb\u5ea7\u85ac\u306a\u3069\u3002<\/li>\n\n\n\n<li><strong>\u30af\u30e9\u30b9<\/strong><strong> III<\/strong>\uff1a\u6700\u3082\u9ad8\u3044\u30ea\u30b9\u30af\u3092\u6301\u3064\u6a5f\u5668\u3002\u591a\u304f\u306f\u4f53\u5185\u306b\u690d\u3048\u8fbc\u307e\u308c\u308b\u3082\u306e\u3084\u751f\u547d\u7dad\u6301\u306b\u95a2\u308f\u308b\u3082\u306e\u3002<br>\u3000\u4f8b\uff1a\u5fc3\u81d3\u5f01\u3001\u8c4a\u80f8\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u690d\u8fbc\u307f\u578b\u30da\u30fc\u30b9\u30e1\u30fc\u30ab\u30fc\u3001\u4eba\u5de5\u95a2\u7bc0\u306a\u3069\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color has-medium-font-size wp-elements-2f5e80ecbd37813b0747062ec0f0bc25\"><strong>IVDR\u5206\u985e\uff08\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\uff09<\/strong><\/h3>\n\n\n\n<p>IVDR\uff08\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u898f\u5247\uff09\u3082\u30ea\u30b9\u30af\u306b\u57fa\u3065\u304f\u5206\u985e\u30b7\u30b9\u30c6\u30e0\u3092\u63a1\u7528\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u4f53\u5916\u8a3a\u65ad\u6a5f\u5668\u306b\u95a2\u3057\u3066\u306f\u30af\u30e9\u30b9 A\uff08\u6700\u3082\u4f4e\u30ea\u30b9\u30af\uff09\u304b\u3089\u30af\u30e9\u30b9 D\uff08\u6700\u3082\u9ad8\u30ea\u30b9\u30af\uff09\u307e\u3067\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u5206\u985e\u306f\u3001\u516c\u8846\u885b\u751f\u30ea\u30b9\u30af\u3084\u500b\u4eba\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u306a\u3069\u3092\u8003\u616e\u3057\u3066\u884c\u308f\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u30af\u30e9\u30b9<\/strong><strong> A<\/strong>\uff1a\u6700\u3082\u4f4e\u30ea\u30b9\u30af\u306e\u6a5f\u5668\u3002<br>\u3000\u4f8b\uff1a\u4e00\u822c\u7684\u306a\u7814\u7a76\u5ba4\u7528\u8a66\u85ac\uff08\u4f53\u5916\u8a3a\u65ad\u306b\u4f7f\u7528\u3067\u304d\u308b\u3082\u306e\uff09\u3001\u4f53\u5916\u8a3a\u65ad\u7528\u306e\u6a5f\u5668\u306a\u3069\u3002<\/li>\n\n\n\n<li><strong>\u30af\u30e9\u30b9<\/strong><strong> B<\/strong>\uff1a\u4f4e\u301c\u4e2d\u7a0b\u5ea6\u306e\u30ea\u30b9\u30af\u3092\u6301\u3064\u6a5f\u5668\u3002<br>\u3000\u4f8b\uff1a\u598a\u5a20\u81ea\u5df1\u691c\u67fb\u85ac\u3001\u5bb6\u5ead\u7528\u8840\u7cd6\u5024\u6e2c\u5b9a\u5668\u3001CRP\u691c\u67fb\u306a\u3069\u3002<\/li>\n\n\n\n<li><strong>\u30af\u30e9\u30b9 C<\/strong>\uff1a\u4e2d\u301c\u9ad8\u30ea\u30b9\u30af\u306e\u6a5f\u5668\u3002<br>\u3000\u4f8b\uff1aHIV\u306e\u8840\u6db2\u691c\u67fb\u3001B\u578b\u30fbC\u578b\u809d\u708e\u30a6\u30a4\u30eb\u30b9\u691c\u67fb\u3001\u30c0\u30a6\u30f3\u75c7\u306e\u51fa\u751f\u524d\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u691c\u67fb\u3001\u6027\u611f\u67d3\u75c7\u306e\u75c5\u539f\u4f53\u691c\u51fa\u691c\u67fb\u306a\u3069\u3002<\/li>\n\n\n\n<li><strong>\u30af\u30e9\u30b9<\/strong><strong> D<\/strong>\uff1a\u516c\u8846\u885b\u751f\u304a\u3088\u3073\u500b\u4eba\u306b\u5bfe\u3057\u3066\u6700\u3082\u9ad8\u30ea\u30b9\u30af\u3068\u306a\u308b\u6a5f\u5668\u3002<br>\u3000\u4f8b\uff1a\u8840\u6db2\u30d0\u30f3\u30af\u3067\u306e\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3092\u76ee\u7684\u3068\u3057\u305f\u3001HIV\u3084C\u578b\u809d\u708e\u306a\u3069\u306e\u8840\u6db2\u5a92\u4ecb\u30a6\u30a4\u30eb\u30b9\u3084\u9ad8\u30ea\u30b9\u30af\u611f\u67d3\u75c7\u306e\u691c\u51fa\u691c\u67fb\u3001ABO\u5f0f\u304a\u3088\u3073Rh\u5f0f\u8840\u6db2\u578b\u5224\u5b9a\u691c\u67fb\u306a\u3069\u3002<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1920\" height=\"554\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/10\/medical-device-and-ivd-services.jpg\" alt=\"\" class=\"wp-image-14427\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/10\/medical-device-and-ivd-services.jpg 1920w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/10\/medical-device-and-ivd-services-300x87.jpg 300w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/10\/medical-device-and-ivd-services-1024x295.jpg 1024w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/10\/medical-device-and-ivd-services-768x222.jpg 768w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/10\/medical-device-and-ivd-services-1536x443.jpg 1536w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/><\/figure>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-835c8cffddbb3243bba17fc3525449b4\"><strong>\u5206\u985e\u5909\u66f4\u306e\u5b9f\u4f8b<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color has-medium-font-size wp-elements-671fac19140c58724024f75bf882ee95\"><strong>\u533b\u7642\u6a5f\u5668\u306e\u4f8b\uff1a\u7269\u8cea\u30d9\u30fc\u30b9\u306e\u533b\u7642\u6a5f\u5668<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>MDD\uff08\u65e7\u6307\u4ee4\uff09\u4e0b\u3067\u306e\u5206\u985e\uff1a<\/strong>\u3000\u591a\u304f\u306e\u7269\u8cea\u30d9\u30fc\u30b9\u306e\u533b\u7642\u6a5f\u5668\u306f\u30af\u30e9\u30b9 I \u306b\u5206\u985e\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u3053\u308c\u306b\u306f\u3001\u5275\u50b7\u6cbb\u7652\u3092\u52a9\u3051\u308b\u76ee\u7684\u3067\u7279\u5b9a\u306e\u7269\u8cea\u304c\u542b\u6d78\u3055\u308c\u305f\u5275\u50b7\u30b1\u30a2\u88fd\u54c1\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u30af\u30e9\u30b9 I \u6a5f\u5668\u306f\u3001\u88fd\u9020\u696d\u8005\u304c\u81ea\u5df1\u8a8d\u8a3c\u3067\u304d\u3001\u8a8d\u8a3c\u6a5f\u95a2\uff08Notified Body\uff09\u306e\u5be9\u67fb\u306f\u4e0d\u8981\u3067\u3057\u305f\u3002<\/li>\n\n\n\n<li><strong>MDR\uff08\u65b0\u898f\u5247\uff09\u4e0b\u3067\u306e\u5206\u985e\uff1a<\/strong>\u3000\u3053\u308c\u3089\u306e\u7269\u8cea\u30d9\u30fc\u30b9\u306e\u533b\u7642\u6a5f\u5668\u306f\u3001MDR\u4e0b\u3067\u306f\u30af\u30e9\u30b9 IIa \u4ee5\u4e0a\u306b\u518d\u5206\u985e\u3055\u308c\u308b\u3053\u3068\u304c\u4e00\u822c\u7684\u3067\u3059\u3002\u518d\u5206\u985e\u306e\u7406\u7531\u306f\u3001\u3053\u308c\u3089\u306e\u6a5f\u5668\u306b\u542b\u307e\u308c\u308b\u7269\u8cea\u306e\u85ac\u7406\u4f5c\u7528\u3001\u514d\u75ab\u4f5c\u7528\u3001\u307e\u305f\u306f\u4ee3\u8b1d\u4f5c\u7528\u306b\u95a2\u9023\u3059\u308b\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u8a55\u4fa1\u304c\u3088\u308a\u91cd\u8996\u3055\u308c\u3066\u3044\u308b\u305f\u3081\u3067\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u4ee5\u524d\u306f\u30af\u30e9\u30b9 I \u3060\u3063\u305f\u3053\u308c\u3089\u306e\u6a5f\u5668\u306e\u88fd\u9020\u696d\u8005\u3082\u3001\u8a8d\u8a3c\u6a5f\u95a2\u3092\u542b\u3080\u3088\u308a\u53b3\u683c\u306a\u9069\u5408\u6027\u8a55\u4fa1\u624b\u7d9a\u304d\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color has-medium-font-size wp-elements-33e1958d95f9641c085bcb7667127b45\"><strong>\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\uff08IVD\uff09\u306e\u4f8b\uff1aIVD\u30a2\u30c3\u30bb\u30a4\uff0f\u8a66\u85ac<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>IVDD\uff08\u65e7\u6307\u4ee4\uff09\u4e0b\u3067\u306e\u5206\u985e\uff1a<\/strong>\u3000HIV\u306a\u3069\u306e\u75be\u60a3\u306b\u5bfe\u3059\u308b\u8a66\u85ac\u3092\u542b\u3080\u591a\u304f\u306eIVD\u30a2\u30c3\u30bb\u30a4\u306f\u3001\u88fd\u9020\u696d\u8005\u306b\u3088\u308b\u81ea\u5df1\u8a8d\u8a3c\u304c\u53ef\u80fd\u3067\u3057\u305f\u3002IVDD\u3067\u306f\u3001\u9650\u5b9a\u7684\u306a\u9ad8\u30ea\u30b9\u30afIVD\u306e\u307f\u304c\u8a8d\u8a3c\u6a5f\u95a2\u306e\u95a2\u4e0e\u3092\u5fc5\u8981\u3068\u3057\u3066\u304a\u308a\u3001\u5927\u591a\u6570\u306eIVD\u306f\u8a8d\u8a3c\u6a5f\u95a2\u306e\u76f4\u63a5\u7684\u306a\u76e3\u7763\u306a\u3057\u306b\u5e02\u5834\u306b\u51fa\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3057\u305f\u3002<\/li>\n\n\n\n<li><strong>IVDR\uff08\u65b0\u898f\u5247\uff09\u4e0b\u3067\u306e\u5206\u985e<\/strong>\uff1a\u3000IVDR\u3067\u306f\u3001IVD\u306b\u5bfe\u3057\u3066\u65b0\u305f\u306a\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u5206\u985e\u30b7\u30b9\u30c6\u30e0\u304c\u5c0e\u5165\u3055\u308c\u3001\u8a8d\u8a3c\u6a5f\u95a2\u306e\u95a2\u4e0e\u304c\u5927\u5e45\u306b\u62e1\u5927\u3055\u308c\u307e\u3057\u305f\u3002\u3059\u3079\u3066\u306eIVD\u30a2\u30c3\u30bb\u30a4\u304a\u3088\u3073\u7279\u5b9a\u306e\u8a66\u85ac\u306f\u3001IVDR\u4e0b\u3067\u306f\u30af\u30e9\u30b9B\u4ee5\u4e0a\u306b\u518d\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001HIV\u306a\u3069\u611f\u67d3\u75c7\u306e\u691c\u51fa\u306b\u4f7f\u7528\u3055\u308c\u308bIVD\u30a2\u30c3\u30bb\u30a4\u3084\u8a66\u85ac\u306f\u3001IVDR\u3067\u306f\u30af\u30e9\u30b9C\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u30af\u30e9\u30b9B\u4ee5\u4e0a\u3078\u306e\u518d\u5206\u985e\u306b\u3088\u308a\u3001\u8a8d\u8a3c\u6a5f\u95a2\u306b\u3088\u308b\u9069\u5408\u6027\u8a55\u4fa1\u304c\u5fc5\u9808\u3068\u306a\u308a\u3001\u5e02\u8ca9\u524d\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u306e\u8981\u4ef6\u3082IVDD\u306b\u6bd4\u3079\u3066\u5927\u5e45\u306b\u53b3\u683c\u5316\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u5909\u66f4\u306f\u3001\u516c\u8846\u885b\u751f\u3078\u306e\u5f71\u97ff\u3084\u3001IVD\u30a2\u30c3\u30bb\u30a4\u306b\u3088\u3063\u3066\u63d0\u4f9b\u3055\u308c\u308b\u8a3a\u65ad\u60c5\u5831\u306e\u6b63\u78ba\u6027\u3078\u306e\u61f8\u5ff5\u304c\u9ad8\u307e\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u53cd\u6620\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group has-background\" style=\"background-color:#c0e3fabf\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-620ea5d306bc0941fc759f4fc6476068\" id=\"transition\"><strong>\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073IVD\u306e\u79fb\u884c\u671f\u9593<\/strong><\/h2>\n\n\n\n<p>\u65b0\u305f\u306a\u898f\u5247\u306e\u5c0e\u5165\u306b\u4f34\u3046\u8ab2\u984c\u3092\u8003\u616e\u3057\u3001MDR\u304a\u3088\u3073IVDR\u306e\u4e21\u65b9\u306b\u306f\u3001\u88fd\u9020\u696d\u8005\u3084\u305d\u306e\u4ed6\u306e\u95a2\u4fc2\u8005\u304c\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u79fb\u884c\u671f\u9593\u304c\u8a2d\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u79fb\u884c\u671f\u9593\u306f\u3001\u65e7\u6307\u4ee4\u306e\u3082\u3068\u3067\u8a8d\u8a3c\u3055\u308c\u305f\u6a5f\u5668\u304c\u5f15\u304d\u7d9a\u304d\u5e02\u5834\u306b\u4f9b\u7d66\u3055\u308c\u308b\u7336\u4e88\u671f\u9593\u3068\u3057\u3066\u6a5f\u80fd\u3057\u3001\u88fd\u9020\u696d\u8005\u304c\u81ea\u793e\u306e\u88fd\u54c1\u3092\u65b0\u3057\u3044\u898f\u5236\u57fa\u6e96\u306b\u9069\u5408\u3055\u305b\u308b\u305f\u3081\u306e\u8ffd\u52a0\u7684\u306a\u6642\u9593\u3092\u78ba\u4fdd\u3067\u304d\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color has-medium-font-size wp-elements-9113566c86a27dbb085eab5da0487445\"><strong>MDR\u79fb\u884c\u671f\u9593\u306e\u8a73\u7d30<\/strong><\/h3>\n\n\n\n<p>MDR\uff08\u533b\u7642\u6a5f\u5668\u898f\u5247\uff09\u306f\u30012021\u5e745\u670826\u65e5\u306b\u6b63\u5f0f\u306b\u65bd\u884c\u3055\u308c\u307e\u3057\u305f\u3002\u5f53\u521d\u306f\u3001\u88fd\u9020\u696d\u8005\u304c\u6280\u8853\u6587\u66f8\u3092\u66f4\u65b0\u3057\u3001\u65b0\u898f\u5247\u306b\u9069\u5408\u3059\u308b\u305f\u3081\u306e\u4e00\u822c\u7684\u306a\u79fb\u884c\u671f\u9593\u3068\u3057\u3066\u30012024\u5e745\u670826\u65e5\u307e\u3067\u306e3\u5e74\u9593\u304c\u8a2d\u5b9a\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u5f71\u97ff\u3092\u542b\u3080\u7d99\u7d9a\u7684\u306a\u8ab2\u984c\u3092\u8003\u616e\u3057\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306f\u7279\u5b9a\u306e\u88fd\u54c1\u30af\u30e9\u30b9\u306b\u5bfe\u3057\u3066\u671f\u9650\u3092\u5ef6\u9577\u3057\u307e\u3057\u305f\u3002\u4ee5\u4e0b\u306f\u6700\u65b0\u306e\u66f4\u65b0\u60c5\u5831\u306b\u57fa\u3065\u304f\u5185\u5bb9\u3067\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30af\u30e9\u30b9 I \u6a5f\u5668\uff08MDR\u4e0b\u3067\u518d\u5206\u985e\u3055\u308c\u3001\u8a8d\u8a3c\u6a5f\u95a2\u306e\u95a2\u4e0e\u304c\u5fc5\u8981\u3068\u306a\u308b\u3082\u306e\uff09\u306f\u30012021\u5e745\u670826\u65e5\u4ee5\u524d\u306b\u9069\u5408\u5ba3\u8a00\u304c\u4f5c\u6210\u3055\u308c\u3066\u3044\u305f\u5834\u5408\u306b\u9650\u308a\u30012028\u5e7412\u670831\u65e5\u307e\u3067\u306e\u9069\u5408\u7336\u4e88\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u9ad8\u30ea\u30b9\u30af\u6a5f\u5668\uff08\u30af\u30e9\u30b9 IIa\u3001IIb\u3001III\uff09\u3067\u3001MDD\u4e0b\u3067\u3059\u3067\u306b\u8a8d\u8a3c\u6a5f\u95a2\u306e\u8a8d\u8a3c\u3092\u5fc5\u8981\u3068\u3057\u3066\u3044\u305f\u3082\u306e\u306f\u3001\u4ee5\u4e0b\u306e\u3044\u305a\u308c\u304b\u306e\u6761\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u5834\u5408\u306b\u9650\u308a\u3001\u79fb\u884c\u671f\u9593\u306e\u9069\u7528\u304c\u53ef\u80fd\u3067\u3059\uff082021\u5e745\u670826\u65e5\u6642\u70b9\u3067\u6709\u52b9\u306a\u8a8d\u8a3c\u66f8\u3092\u4fdd\u6301\u3057\u3001\u304b\u30642023\u5e743\u670820\u65e5\u4ee5\u524d\u306b\u5931\u52b9\u3057\u305f\u5834\u5408\uff09\uff1a<ul><li>\u8a3c\u660e\u66f8\u306e\u6709\u52b9\u671f\u9650\u524d\u306b\u3001\u88fd\u9020\u696d\u8005\u3068\u8a8d\u5b9a\u6a5f\u95a2\u304c\u3001\u5931\u52b9\u3057\u305f\u8a3c\u660e\u66f8\u306e\u5bfe\u8c61\u3068\u306a\u308b\u6a5f\u5668\u307e\u305f\u306f\u305d\u306e\u4ee3\u66ff\u3092\u610f\u56f3\u3057\u305f\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u9069\u5408\u6027\u8a55\u4fa1\u306b\u3064\u3044\u3066\u66f8\u9762\u306b\u3088\u308b\u5408\u610f\u3092\u7de0\u7d50\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u307e\u305f\u306f<\/li><\/ul>\n<ul class=\"wp-block-list\">\n<li>\u52a0\u76df\u56fd\u306e\u4e3b\u7ba1\u5f53\u5c40\u304c\u3001\u8a72\u5f53\u3059\u308b\u9069\u5408\u6027\u8a55\u4fa1\u624b\u9806\u304b\u3089\u306e\u9069\u7528\u9664\u5916\u3092\u8a8d\u3081\u305f\u5834\u5408\u3001\u307e\u305f\u306f\u88fd\u9020\u696d\u8005\u306b\u5bfe\u3057\u3066\u8a72\u5f53\u3059\u308b\u9069\u5408\u6027\u8a55\u4fa1\u624b\u9806\u306e\u5b9f\u65bd\u3092\u6c42\u3081\u305f\u5834\u5408\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u4e0a\u8a18\u306e\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u79fb\u884c\u671f\u9593\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\uff1a<ul><li>2027\u5e7412\u670831\u65e5\u307e\u3067\uff1a\u3059\u3079\u3066\u306e\u30af\u30e9\u30b9III\u6a5f\u5668\u3001\u304a\u3088\u3073\u7e2b\u5408\u7cf8\u3001\u30b9\u30c6\u30fc\u30d7\u30eb\u3001\u6b6f\u79d1\u7528\u5145\u586b\u6750\u3001\u6b6f\u5217\u77ef\u6b63\u5668\u5177\u3001\u6b6f\u51a0\u3001\u306d\u3058\u3001\u304f\u3055\u3073\u3001\u30d7\u30ec\u30fc\u30c8\u3001\u30ef\u30a4\u30e4\u30fc\u3001\u30d4\u30f3\u3001\u30af\u30ea\u30c3\u30d7\u3001\u30b3\u30cd\u30af\u30bf\u3092\u9664\u304f\u30af\u30e9\u30b9IIb\u306e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u6a5f\u5668\u3002<\/li><\/ul>\n<ul class=\"wp-block-list\">\n<li>2028\u5e7412\u670831\u65e5\u307e\u3067\uff1a\u305d\u306e\u4ed6\u3059\u3079\u3066\u306e\u30af\u30e9\u30b9IIb\u6a5f\u5668\u3001\u30af\u30e9\u30b9IIa\u6a5f\u5668\u3001\u306a\u3089\u3073\u306b\u7121\u83cc\u72b6\u614b\u3067\u5e02\u5834\u306b\u51fa\u3055\u308c\u308b\u3001\u307e\u305f\u306f\u8a08\u6e2c\u6a5f\u80fd\u3092\u6709\u3059\u308b\u30af\u30e9\u30b9I\u6a5f\u5668\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u6a5f\u5668\u304c\u4e0a\u8a18\u306e\u65e5\u4ed8\u307e\u3067\u306b\u5e02\u5834\u306b\u51fa\u3055\u308c\u308b\u3001\u307e\u305f\u306f\u4f7f\u7528\u958b\u59cb\u3055\u308c\u308b\u305f\u3081\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u6761\u4ef6\u3092\u3059\u3079\u3066\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff1a<ul><li>\u8a72\u5f53\u3059\u308b\u9650\u308a\u3001\u6a5f\u5668\u304c\u5f15\u304d\u7d9a\u304dMDD\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3001<\/li><\/ul>\n<ul class=\"wp-block-list\">\n<li>\u6a5f\u5668\u306e\u8a2d\u8a08\u304a\u3088\u3073\u76ee\u7684\u3068\u3059\u308b\u4f7f\u7528\u306b\u91cd\u5927\u306a\u5909\u66f4\u304c\u306a\u3044\u3053\u3068\u3001<\/li>\n\n\n\n<li>\u6a5f\u5668\u304c\u60a3\u8005\u3001\u4f7f\u7528\u8005\u3001\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u8005\u306e\u5065\u5eb7\u3084\u5b89\u5168\u3001\u3042\u308b\u3044\u306f\u516c\u8846\u885b\u751f\u306e\u4fdd\u8b77\u306b\u5bfe\u3057\u3066\u5bb9\u8a8d\u3067\u304d\u306a\u3044\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3055\u306a\u3044\u3053\u3068\u3001<\/li>\n\n\n\n<li>2024\u5e745\u670826\u65e5\u307e\u3067\u306b\u3001\u88fd\u9020\u696d\u8005\u307e\u305f\u306f\u8a8d\u53ef\u4ee3\u7406\u4eba\u304c\u3001\u5f53\u8a72\u6a5f\u5668\u307e\u305f\u306f\u305d\u306e\u4ee3\u66ff\u3092\u610f\u56f3\u3059\u308b\u6a5f\u5668\u306b\u3064\u3044\u3066\u3001\u8a8d\u5b9a\u6a5f\u95a2\u306b\u5bfe\u3057\u3066\u9069\u5408\u6027\u8a55\u4fa1\u306e\u6b63\u5f0f\u306a\u7533\u8acb\u3092\u884c\u3063\u3066\u304a\u308a\u3001\u304b\u30642024\u5e749\u670826\u65e5\u307e\u3067\u306b\u88fd\u9020\u696d\u8005\u3068\u8a8d\u5b9a\u6a5f\u95a2\u304c\u66f8\u9762\u306b\u3088\u308b\u5408\u610f\u3092\u7de0\u7d50\u3057\u3066\u3044\u308b\u3053\u3068\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u79fb\u884c\u671f\u9593\u306e\u5bfe\u8c61\u3068\u306a\u308b\u6a5f\u5668\u306f\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u3001\u5e02\u5834\u76e3\u8996\u3001\u8b66\u6212\u3001\u304a\u3088\u3073\u7d4c\u6e08\u4e8b\u696d\u8005\u3084\u6a5f\u5668\u306e\u767b\u9332\u306b\u95a2\u3059\u308bMDR\u306e\u8981\u4ef6\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-text-color has-darker-blue-color has-alpha-channel-opacity has-darker-blue-background-color has-background is-style-wide\"\/>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color has-medium-font-size wp-elements-75f12bf0c52c6c021d8f707f540450e3\"><strong>IVDR\u79fb\u884c\u671f\u9593\u306e\u8abf\u6574<\/strong><\/h3>\n\n\n\n<p>IVDR\u306e\u79fb\u884c\u306f2017\u5e745\u670826\u65e5\u306b\u958b\u59cb\u3055\u308c\u3001\u5f53\u521d\u306e\u5168\u9762\u9069\u7528\u65e5\u306f2022\u5e745\u670826\u65e5\u306b\u8a2d\u5b9a\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u696d\u754c\u306e\u6e96\u5099\u72b6\u6cc1\u3084\u8a8d\u5b9a\u6a5f\u95a2\u306e\u78ba\u4fdd\u306b\u5bfe\u3059\u308b\u61f8\u5ff5\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306f\u6a5f\u5668\u306e\u30af\u30e9\u30b9\u306b\u57fa\u3065\u3044\u305f\u6bb5\u968e\u7684\u306a\u79fb\u884c\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3092\u5c0e\u5165\u3057\u307e\u3057\u305f\u3002\u6700\u65b0\u306eIVDR\u6539\u6b63\u306b\u3088\u308a\u3001\u79fb\u884c\u671f\u9593\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u304c\u66f4\u65b0\u3055\u308c\u30012024\u5e747\u67089\u65e5\u306b\u516c\u8868\u3055\u308c\u307e\u3057\u305f\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>2017\u5e745\u670825\u65e5\u4ee5\u964d\u306bIVDD\u306b\u57fa\u3065\u3044\u3066\u8a8d\u5b9a\u6a5f\u95a2\u304b\u3089\u767a\u884c\u3055\u308c\u30012022\u5e745\u670826\u65e5\u6642\u70b9\u3067\u6709\u52b9\u3067\u3042\u308a\u3001\u305d\u306e\u5f8c\u3082\u53d6\u308a\u6d88\u3055\u308c\u3066\u3044\u306a\u3044\u8a3c\u660e\u66f8\u306f\u3001\u4ee5\u4e0b\u306e\u3044\u305a\u308c\u304b\u306e\u6761\u4ef6\u3092\u6e80\u305f\u3059\u5834\u5408\u3001\u8a3c\u660e\u66f8\u306b\u8a18\u8f09\u3055\u308c\u305f\u6709\u52b9\u671f\u9593\u7d42\u4e86\u5f8c\u30822027\u5e7412\u670831\u65e5\u307e\u3067\u6709\u52b9\u3068\u3055\u308c\u307e\u3059\uff1a\n<ul class=\"wp-block-list\">\n<li>\u8a3c\u660e\u66f8\u306e\u6709\u52b9\u671f\u9650\u524d\u306b\u3001\u88fd\u9020\u696d\u8005\u3068\u8a8d\u5b9a\u6a5f\u95a2\u304c\u3001\u5931\u52b9\u3057\u305f\u8a3c\u660e\u66f8\u306e\u5bfe\u8c61\u6a5f\u5668\u307e\u305f\u306f\u305d\u306e\u4ee3\u66ff\u3092\u610f\u56f3\u3057\u305f\u6a5f\u5668\u306b\u95a2\u3059\u308b\u9069\u5408\u6027\u8a55\u4fa1\u306b\u3064\u3044\u3066\u66f8\u9762\u306b\u3088\u308b\u5408\u610f\u3092\u7de0\u7d50\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u307e\u305f\u306f<\/li>\n\n\n\n<li>\u672c\u898f\u5247\u7b2c54\u6761\u7b2c1\u9805\u306b\u57fa\u3065\u304d\u3001\u52a0\u76df\u56fd\u306e\u4e3b\u7ba1\u5f53\u5c40\u304c\u8a72\u5f53\u3059\u308b\u9069\u5408\u6027\u8a55\u4fa1\u624b\u9806\u304b\u3089\u306e\u9069\u7528\u9664\u5916\u3092\u8a8d\u3081\u305f\u5834\u5408\u3001\u307e\u305f\u306f\u7b2c92\u6761\u7b2c1\u9805\u306b\u57fa\u3065\u304d\u3001\u88fd\u9020\u696d\u8005\u306b\u5bfe\u3057\u3066\u8a72\u5f53\u3059\u308b\u9069\u5408\u6027\u8a55\u4fa1\u624b\u9806\u306e\u5b9f\u65bd\u3092\u6c42\u3081\u305f\u5834\u5408\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u4e0a\u8a18\u306e\u6709\u52b9\u306aIVDD\u8a3c\u660e\u66f8\u306e\u5bfe\u8c61\u3068\u306a\u308b\u6a5f\u5668\u306f\u30012027\u5e7412\u670831\u65e5\u307e\u3067\u5e02\u5834\u306b\u51fa\u3059\u3053\u3068\u3001\u307e\u305f\u306f\u4f7f\u7528\u958b\u59cb\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/li>\n\n\n\n<li>IVDR\u306e\u4e0b\u3067\u8a8d\u5b9a\u6a5f\u95a2\u306b\u3088\u308b\u8a55\u4fa1\u304c\u5fc5\u8981\u3068\u306a\u308b\u3088\u3046\u518d\u5206\u985e\u3055\u308c\u305f\u6a5f\u5668\u3067\u30012022\u5e745\u670826\u65e5\u4ee5\u524d\u306bIVDD\u306b\u57fa\u3065\u3044\u3066\u9069\u5408\u5ba3\u8a00\u304c\u4f5c\u6210\u3055\u308c\u3066\u3044\u308b\u3082\u306e\u306f\u3001\u4ee5\u4e0b\u306e\u65e5\u4ed8\u307e\u3067\u5e02\u5834\u306b\u51fa\u3059\u3053\u3068\u3001\u307e\u305f\u306f\u4f7f\u7528\u958b\u59cb\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\uff1a\n<ul class=\"wp-block-list\">\n<li>2027\u5e7412\u670831\u65e5\u307e\u3067\uff1a\u30af\u30e9\u30b9D\u6a5f\u5668\u3001<\/li>\n\n\n\n<li>2028\u5e7412\u670831\u65e5\u307e\u3067\uff1a\u30af\u30e9\u30b9C\u6a5f\u5668\u3001<\/li>\n\n\n\n<li>2029\u5e7412\u670831\u65e5\u307e\u3067\uff1a\u30af\u30e9\u30b9B\u6a5f\u5668\u304a\u3088\u3073\u7121\u83cc\u72b6\u614b\u3067\u5e02\u5834\u306b\u51fa\u3055\u308c\u308b\u30af\u30e9\u30b9A\u6a5f\u5668\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u6a5f\u5668\u304c\u4e0a\u8a18\u306e\u65e5\u4ed8\u307e\u3067\u306b\u5e02\u5834\u306b\u51fa\u3055\u308c\u308b\u3001\u307e\u305f\u306f\u4f7f\u7528\u958b\u59cb\u3055\u308c\u308b\u305f\u3081\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u6761\u4ef6\u3092\u3059\u3079\u3066\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff1a\n<ul class=\"wp-block-list\">\n<li>\u8a72\u5f53\u3059\u308b\u9650\u308a\u3001\u6a5f\u5668\u304c\u5f15\u304d\u7d9a\u304dIVDD\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3001<\/li>\n\n\n\n<li>\u6a5f\u5668\u306e\u8a2d\u8a08\u304a\u3088\u3073\u76ee\u7684\u3068\u3059\u308b\u4f7f\u7528\u306b\u91cd\u5927\u306a\u5909\u66f4\u304c\u306a\u3044\u3053\u3068\u3001<\/li>\n\n\n\n<li>\u6a5f\u5668\u304c\u60a3\u8005\u3001\u4f7f\u7528\u8005\u3001\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u8005\u306e\u5065\u5eb7\u3084\u5b89\u5168\u3001\u3042\u308b\u3044\u306f\u516c\u8846\u885b\u751f\u306e\u4fdd\u8b77\u306b\u5bfe\u3057\u3066\u5bb9\u8a8d\u3067\u304d\u306a\u3044\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3055\u306a\u3044\u3053\u3068\u3001<\/li>\n\n\n\n<li>2025\u5e745\u670826\u65e5\u307e\u3067\u306b\u3001\u88fd\u9020\u696d\u8005\u304cIVDR\u306b\u6e96\u62e0\u3057\u305f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3092\u5c0e\u5165\u3057\u3066\u3044\u308b\u3053\u3068\u3001<\/li>\n\n\n\n<li>\u88fd\u9020\u696d\u8005\u307e\u305f\u306f\u8a8d\u53ef\u4ee3\u7406\u4eba\u304c\u3001\u5f53\u8a72\u6a5f\u5668\u307e\u305f\u306f\u305d\u306e\u4ee3\u66ff\u3092\u610f\u56f3\u3059\u308b\u6a5f\u5668\u306b\u95a2\u3059\u308b\u9069\u5408\u6027\u8a55\u4fa1\u306b\u3064\u3044\u3066\u3001\u4ee5\u4e0b\u306e\u671f\u65e5\u307e\u3067\u306b\u8a8d\u5b9a\u6a5f\u95a2\u3078\u6b63\u5f0f\u306a\u7533\u8acb\u3092\u884c\u3063\u3066\u3044\u308b\u3053\u3068\uff1a\n<ul class=\"wp-block-list\">\n<li>2025\u5e745\u670826\u65e5\u307e\u3067\uff1a\u6709\u52b9\u306aIVDD\u8a3c\u660e\u66f8\u306e\u5bfe\u8c61\u6a5f\u5668\u304a\u3088\u3073\u30af\u30e9\u30b9D\u3078\u518d\u5206\u985e\u3055\u308c\u308b\u6a5f\u5668\u3001<\/li>\n\n\n\n<li>2026\u5e745\u670826\u65e5\u307e\u3067\uff1a\u30af\u30e9\u30b9C\u3078\u518d\u5206\u985e\u3055\u308c\u308b\u6a5f\u5668\u3001<\/li>\n\n\n\n<li>2027\u5e745\u670826\u65e5\u307e\u3067\uff1a\u30af\u30e9\u30b9B\u307e\u305f\u306f\u7121\u83cc\u72b6\u614b\u3067\u5e02\u5834\u306b\u51fa\u3055\u308c\u308b\u30af\u30e9\u30b9A\u3078\u518d\u5206\u985e\u3055\u308c\u308b\u6a5f\u5668\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u8a8d\u5b9a\u6a5f\u95a2\u3068\u88fd\u9020\u696d\u8005\u304c\u66f8\u9762\u306b\u3088\u308b\u5408\u610f\u3092\u7de0\u7d50\u3057\u3066\u3044\u308b\u3053\u3068\uff08\u7de0\u7d50\u671f\u9650\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\uff09\uff1a\n<ul class=\"wp-block-list\">\n<li>2025\u5e749\u670826\u65e5\u307e\u3067\uff1a\u6709\u52b9\u306aIVDD\u8a3c\u660e\u66f8\u306e\u5bfe\u8c61\u6a5f\u5668\u304a\u3088\u3073\u30af\u30e9\u30b9D\u3078\u518d\u5206\u985e\u3055\u308c\u308b\u6a5f\u5668\u3001<\/li>\n\n\n\n<li>2026\u5e749\u670826\u65e5\u307e\u3067\uff1a\u30af\u30e9\u30b9C\u3078\u518d\u5206\u985e\u3055\u308c\u308b\u6a5f\u5668\u3001<\/li>\n\n\n\n<li>2027\u5e749\u670826\u65e5\u307e\u3067\uff1a\u30af\u30e9\u30b9B\u307e\u305f\u306f\u7121\u83cc\u72b6\u614b\u3067\u5e02\u5834\u306b\u51fa\u3055\u308c\u308b\u30af\u30e9\u30b9A\u3078\u518d\u5206\u985e\u3055\u308c\u308b\u6a5f\u5668\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u79fb\u884c\u671f\u9593\u306e\u5bfe\u8c61\u3068\u306a\u308b\u6a5f\u5668\u306f\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u3001\u5e02\u5834\u76e3\u8996\u3001\u8b66\u6212\u3001\u304a\u3088\u3073\u7d4c\u6e08\u4e8b\u696d\u8005\u304a\u3088\u3073\u6a5f\u5668\u306e\u767b\u9332\u306b\u95a2\u3059\u308bIVDR\u306e\u8981\u4ef6\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-a1d9c60c8ad1015d6f62bafc8e2288d0\"><strong>\u898f\u5236\u306e\u5909\u66f4\u306f\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073IVD\u88fd\u9020\u696d\u8005\u306b\u8ab2\u984c\u3092\u3082\u305f\u3089\u3059<\/strong><\/h2>\n\n\n\n<p>\u610f\u56f3\u3055\u308c\u305f\u79fb\u884c\u671f\u9593\u304c\u8a2d\u3051\u3089\u308c\u3066\u3044\u308b\u3082\u306e\u306e\u3001\u88fd\u9020\u696d\u8005\u306b\u3068\u3063\u3066\u306f\u591a\u304f\u306e\u8ab2\u984c\u304c\u5b58\u5728\u3057\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u6280\u8853\u3084\u533b\u7642\u306e\u9032\u5c55\u304c\u7d9a\u304f\u4e2d\u3067\u3001\u79fb\u884c\u671f\u9593\u4e2d\u306b\u4e00\u90e8\u306e\u6a5f\u5668\u304c\u518d\u5206\u985e\u3055\u308c\u308b\u53ef\u80fd\u6027\u3082\u3042\u308a\u3001\u72b6\u6cc1\u306f\u3088\u308a\u8907\u96d1\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u88fd\u9020\u696d\u8005\u306f\u3001\u5909\u5316\u3059\u308b\u74b0\u5883\u306b\u3064\u3044\u3066\u5e38\u306b\u60c5\u5831\u3092\u628a\u63e1\u3057\u3001\u6a5f\u5668\u306e\u9078\u5b9a\u3084\u4f7f\u7528\u306b\u95a2\u3059\u308b\u7684\u78ba\u306a\u5224\u65ad\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u79fb\u884c\u671f\u9593\u306f\u3001\u8a8d\u5b9a\u6a5f\u95a2\u3068\u306e\u9023\u643a\u3092\u6df1\u3081\u3001\u6280\u8853\u6587\u66f8\u3092\u66f4\u65b0\u3057\u3001\u65b0\u305f\u306a\u898f\u5236\u3078\u306e\u5186\u6ed1\u306a\u79fb\u884c\u3092\u56f3\u308b\u305f\u3081\u306e\u91cd\u8981\u306a\u6642\u671f\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u5909\u66f4\u3068\u79fb\u884c\u671f\u9593\u306f\u3001\u88fd\u9020\u696d\u8005\u3001\u533b\u7642\u5c02\u9580\u5bb6\u3001\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u5354\u529b\u7684\u306a\u53d6\u308a\u7d44\u307f\u3092\u5fc5\u8981\u3068\u3057\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u898f\u5236\u5909\u66f4\u306b\u4f34\u3046\u8ab2\u984c\u3068\u6a5f\u4f1a\u3092\u7a4d\u6975\u7684\u306b\u53d7\u3051\u5165\u308c\u308b\u3053\u3068\u306f\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u3068\u3063\u3066\u3001\u3088\u308a\u5b89\u5168\u3067\u9769\u65b0\u7684\u3001\u304b\u3064\u60a3\u8005\u4e2d\u5fc3\u306e\u672a\u6765\u3092\u7bc9\u304f\u305f\u3081\u306e\u9053\u3068\u306a\u308b\u3067\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>\u73fe\u5728\u3001\u6307\u4ee4\uff08MDD\/IVDD\uff09\u306b\u9069\u5408\u3057\u305f\u6a5f\u5668\u3092\u304a\u6301\u3061\u306e\u7d4c\u6e08\u4e8b\u696d\u8005\u306e\u65b9\u3001\u307e\u305f\u306fMDR\/IVDR\u306b\u57fa\u3065\u304d\u65b0\u305f\u306a\u6a5f\u5668\u3092\u5c0e\u5165\u3057\u305f\u3044\u3068\u304a\u8003\u3048\u306e\u65b9\u306f\u3001\u4eca\u3053\u305d\u884c\u52d5\u306e\u6642\u3067\u3059\u3002Medfiles\u306e\u533b\u7642\u6a5f\u5668\u30c1\u30fc\u30e0\u306f\u3001MDR\u304a\u3088\u3073IVDR\u306e\u6539\u6b63\u3078\u306e\u5bfe\u5fdc\u3092\u3001\u7686\u69d8\u3068\u8cb4\u793e\u304c\u5186\u6ed1\u306b\u9032\u3081\u3089\u308c\u308b\u3088\u3046\u3001\u559c\u3093\u3067\u30b5\u30dd\u30fc\u30c8\u3044\u305f\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button has-custom-font-size\" style=\"font-size:15px\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/ja\/our-services\/medical-devices-and-ivds\/\">\u5f53\u793e\u306e\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073IVD\u30b5\u30fc\u30d3\u30b9\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u77e5\u308b<\/a><\/div>\n\n\n\n<div class=\"wp-block-button has-custom-font-size\" style=\"font-size:15px\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/ja\/contact-us\/contact-form\/\">\u8a73\u7d30\u306b\u3064\u3044\u3066\u306e\u304a\u554f\u3044\u5408\u308f\u305b\u306f\u3053\u3061\u3089<\/a><\/div>\n\n\n\n<div class=\"wp-block-button has-custom-font-size\" style=\"font-size:15px\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/contact-us\/subscribe-newsletter\/\">\u6700\u65b0\u60c5\u5831\u3092\u304a\u5c4a\u3051\u3059\u308b\u30cb\u30e5\u30fc\u30b9\u30ec\u30bf\u30fc\u306b\u3054\u767b\u9332\u304f\u3060\u3055\u3044<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-cover is-light has-parallax\"><span aria-hidden=\"true\" class=\"wp-block-cover__background has-white-background-color has-background-dim-30 has-background-dim\"><\/span><div class=\"wp-block-cover__image-background wp-image-19105 has-parallax\" style=\"background-position:50% 50%;background-image:url(https:\/\/medfilesgroup.com\/wp-content\/uploads\/2025\/04\/medfiles-graphic.jpg)\"><\/div><div class=\"wp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\"><strong>\u30d6\u30ed\u30b0\uff1a<\/strong>EU IVDR \u2015 \u6280\u8853\u6587\u66f8\u306e\u6574\u5099\u3001\u8a8d\u5b9a\u6a5f\u95a2\u306e\u30d7\u30ed\u30bb\u30b9\u3001\u79fb\u884c\u671f\u9593\u3078\u306e\u5bfe\u5fdc<\/h2>\n\n\n\n<p class=\"has-black-color has-text-color\" style=\"font-size:16px\">IVDR\u306b\u304a\u3051\u308b\u6280\u8853\u6587\u66f8\u306e\u8981\u4ef6\u3001\u8a8d\u5b9a\u6a5f\u95a2\u306b\u3088\u308b\u9069\u5408\u6027\u8a55\u4fa1\u306b\u304b\u304b\u308b\u671f\u9593\u3001\u5fc5\u8981\u306a\u79fb\u884c\u671f\u9593\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u3001EU\u3067\u306e\u9069\u5408\u3068\u5e02\u5834\u6210\u529f\u306e\u305f\u3081\u306b\u91cd\u8981\u3067\u3059\u3002\u3053\u306e\u30c6\u30fc\u30de\u306b\u95a2\u3059\u308b\u5305\u62ec\u7684\u306a\u30d6\u30ed\u30b0\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<div 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