{"id":6631,"date":"2020-01-27T14:08:43","date_gmt":"2020-01-27T14:08:43","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6631"},"modified":"2021-10-04T07:46:46","modified_gmt":"2021-10-04T07:46:46","slug":"medical-device-regulatory-compliance-fda-vs-eu-mdr","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-regulatory-compliance-fda-vs-eu-mdr\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u6cd5\u898f\u5236\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9FDA\u3068EU MDR\u306e\u6bd4\u8f03"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">table of contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f28f0fd8114\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f28f0fd8114\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-regulatory-compliance-fda-vs-eu-mdr\/#1_Definitions\" title=\"1.\u5b9a\u7fa9\">1.\u5b9a\u7fa9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-regulatory-compliance-fda-vs-eu-mdr\/#2_Device_Classifications\" title=\"2.\u30c7\u30d0\u30a4\u30b9\u306e\u5206\u985e\">2.\u30c7\u30d0\u30a4\u30b9\u306e\u5206\u985e<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-regulatory-compliance-fda-vs-eu-mdr\/#3_Clinical_Testing_Processes\" title=\"3.\u81e8\u5e8a\u8a66\u9a13\u306e\u30d7\u30ed\u30bb\u30b9\">3.\u81e8\u5e8a\u8a66\u9a13\u306e\u30d7\u30ed\u30bb\u30b9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-regulatory-compliance-fda-vs-eu-mdr\/#A_note_on_MDR_Documentation_and_CERs\" title=\"MDR\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u3068CER\u306b\u95a2\u3059\u308b\u30e1\u30e2\">MDR\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u3068CER\u306b\u95a2\u3059\u308b\u30e1\u30e2<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-regulatory-compliance-fda-vs-eu-mdr\/#Future_implications_for_EU_MDR\" title=\"EU MDR\u3078\u306e\u4eca\u5f8c\u306e\u5f71\u97ff\">EU MDR\u3078\u306e\u4eca\u5f8c\u306e\u5f71\u97ff<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Kolabtree\u306e\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u3067\u3042\u308bMahasweta Pal\u6c0f\u306f\u3001\u4ee5\u4e0b\u306e\u5305\u62ec\u7684\u306a\u6bd4\u8f03\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations-mdr?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">\u533b\u7642\u6a5f\u5668\u898f\u5236\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/a> \u7c73\u56fd(FDA)\u3068\u6b27\u5dde(EU MDR)\u306e\u6bd4\u8f03\u3002\u00a0<\/em><\/p>\n<p>\u3092\u8907\u7d20\u5316\u3059\u308b\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations-mdr?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">EU MDR<\/a> \u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u6700\u5927\u306e\u95a2\u5fc3\u4e8b\u3067\u3042\u308a\u3001\u3088\u308a\u9ad8\u3044\u8b66\u6212\u5fc3\u3068\u30ea\u30b9\u30af\u3092\u4f34\u3046\u3082\u306e\u3067\u3057\u305f\u3002 <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u306f\u3001\u6226\u7565\u7684\u5f79\u5272\u3092\u62c5\u3063\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001EU MDR\u6307\u4ee4\u306e\u5b9f\u65bd\u306b\u5411\u3051\u3066\u6570\u30f6\u6708\u5f8c\u306b\u63a7\u3048\u3066\u304a\u308a\u3001EU MDR\u304c\u3082\u305f\u3089\u3059\u5909\u5316\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u975e\u5e38\u306b\u91cd\u8981\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u4e00\u65b9\u3001FDA\u306f\u3001\u5973\u6027\u306e\u751f\u547d\u3092\u8105\u304b\u3059\u5408\u4f75\u75c7\u3092\u4f34\u3046\u5973\u6027\u7528\u907f\u598a\u5177\u3067\u3042\u308bEssure\u306b\u3064\u3044\u3066\u3001\u5f15\u304d\u7d9a\u304d\u76e3\u8996\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002\u5f53\u7136\u306e\u3053\u3068\u306a\u304c\u3089\u3001\u898f\u5236\u5f53\u5c40\u306f\u591a\u304f\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u554f\u984c\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u307e\u3059\u3002\u4e00\u65b9\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u898f\u5236\u306e\u67a0\u7d44\u307f\u304c\u3088\u308a\u53b3\u3057\u304f\u306a\u308a\u3001\u5e02\u5834\u306e\u30ea\u30b9\u30af\u304c\u9ad8\u307e\u3063\u3066\u3044\u308b\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u88fd\u54c1\u306e\u5e02\u8ca9\u524d\u627f\u8a8d\u3092\u5f97\u308b\u30c1\u30e3\u30f3\u30b9\u3092\u8003\u3048\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u305d\u3053\u3067\u3001\u3053\u3053\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u85ac\u4e8b\u627f\u8a8d\u306e\u9055\u3044\u306b\u3064\u3044\u3066\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u8aac\u660e\u3057\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/FDA-Submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">FDA<\/a> \u3068\u306e\u3053\u3068\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations-mdr?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">EU MDR<\/a>.<\/p>\n<p>\u5dee\u7570\u304c\u3042\u308b\u3068\u601d\u308f\u308c\u308b\u70b9<\/p>\n<h3><span class=\"ez-toc-section\" id=\"1_Definitions\"><\/span>1.\u5b9a\u7fa9<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u7c73\u56fd <a href=\"https:\/\/www.fda.gov\/medical-devices\/device-advice-comprehensive-regulatory-assistance\/how-study-and-market-your-device\">\u898f\u5236\u7ba1\u7406<\/a> \u306f\u3001\u9023\u90a6\u98df\u54c1\u533b\u85ac\u54c1\u5316\u7ca7\u54c1\u6cd5\uff08Federal Food, Drug, and Cosmetic Act\uff09\u304a\u3088\u3073\u9023\u90a6\u898f\u5247\u96c6\u7b2c21\u5dfb\uff0821 CFR\uff09\u30d1\u30fc\u30c81\uff5e58\u3001800\uff5e1299\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u898f\u5236\u306b\u57fa\u3065\u3044\u3066\u6587\u66f8\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u9577\u304f\u3001\u5305\u62ec\u7684\u306a\u898f\u5236\u306e\u67a0\u7d44\u307f\u306f\u3001\u533b\u7642\u6a5f\u5668\u4f01\u696d\u304cFDA\u306e\u5e02\u5834\u8a8d\u53ef\u3092\u5f97\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u6a5f\u5668\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3054\u3068\u306b\u5b9a\u7fa9\u3055\u308c\u305f\u30bf\u30a4\u30c8\u30eb21-CFR\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u898f\u5247\u306b\u57fa\u3065\u3044\u3066\u3044\u307e\u3059\u3002FDA\u306e\u898f\u5236\u306b\u3088\u308b\u3068\u3001\u4f01\u696d\u306f\u3001\u5404\u6a5f\u5668\u306e\u5168\u4f53\u7684\u306a\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u8a55\u4fa1\u3057\u3001\u5408\u7406\u7684\u306a\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u4fdd\u8a3c\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u305d\u308c\u305e\u308c\u306e\u8ca9\u58f2\u7d4c\u8def\u3092\u9075\u5b88\u3057\u306a\u304c\u3089\u3001\u5fc5\u8981\u306a\u898f\u5236\u30b9\u30c6\u30c3\u30d7\u3092\u8e0f\u3080\u3002\u8ca9\u58f2\u7d4c\u8def\u306b\u306f\u3001\u5e02\u8ca9\u524d\u901a\u77e5\uff08510(k)\uff09\u3001\u30c7\u30ce\u30dc\u5206\u985e\u8981\u6c42\u3001\u514d\u9664\u3001\u5e02\u8ca9\u524d\u627f\u8a8d\uff08PMA\uff09\u3001\u88fd\u54c1\u958b\u767a\u30d7\u30ed\u30c8\u30b3\u30eb\uff08PDP\uff09\u3001\u4eba\u9053\u7684\u4f7f\u7528\u514d\u9664\uff08HDE\uff09\u3001\u751f\u7269\u88fd\u5264\u8a8d\u53ef\u7533\u8acb\uff08BLA\uff09\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u6b27\u5dde\u7248\u300cEU MDR\u300d\u306f\u300128\u30da\u30fc\u30b8\u306e\u524d\u6587\u300110\u7ae0\u300116\u306e\u4ed8\u5c5e\u66f8\u3067\u69cb\u6210\u3055\u308c\u3066\u304a\u308a\u3001\u4ed8\u5c5e\u66f8\u3054\u3068\u306b\u8907\u6570\u306e\u7ae0\u304c\u8a2d\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u7c21\u5358\u306b\u8aac\u660e\u3059\u308b\u3068\u3001\u5404\u7ae0\u3067\u306f\u3001\u7d4c\u6e08\u4e8b\u696d\u8005\u306e\u7fa9\u52d9\u3001\u6539\u8a02\u3055\u308c\u305fCE\u30de\u30fc\u30ad\u30f3\u30b0\u30d7\u30ed\u30bb\u30b9\u3001\u6a5f\u5668\u306e\u8b58\u5225\u3068\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u6a5f\u5668\u3068\u305d\u306e\u7d4c\u6e08\u4e8b\u696d\u8005\u306e\u767b\u9332\u3001\u5b89\u5168\u6027\u3068\u81e8\u5e8a\u6027\u80fd\u306e\u6982\u8981\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u6b27\u5dde\u30c7\u30fc\u30bf\u30d0\u30f3\u30af\u306e\u958b\u767a\u3068\u518d\u69cb\u7bc9\u306a\u3069\u306b\u3064\u3044\u3066\u8a73\u8ff0\u3057\u3066\u3044\u308b\u3002<\/p>\n<p>MDR\u3067\u306f\u3001\u6a5f\u5668\u306e\u4f7f\u7528\u76ee\u7684\u3092\u691c\u8a3c\u3059\u308b\u305f\u3081\u306e\u81e8\u5e8a\u60c5\u5831\u306e\u51e6\u7406\u3001\u9069\u5408\u6027\u8a55\u4fa1\u3001\u6a5f\u5668\u306b\u95a2\u3059\u308b\u81e8\u5e8a\u8abf\u67fb\u306a\u3069\u306e\u5f79\u5272\u306b\u3064\u3044\u3066\u3001\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306b\u5b9a\u3081\u3089\u308c\u305f\u4e3b\u306a\u8cac\u4efb\u3068\u6761\u4ef6\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u6700\u5f8c\u306b\u3001\u5927\u304d\u306a\u4e00\u6b69\u3068\u3057\u3066\u3001\u5e02\u8ca9\u3055\u308c\u305f\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3068\u8b66\u6212\u3092\u7d39\u4ecb\u3057\u3001\u5b88\u79d8\u7fa9\u52d9\u3084\u8cc7\u91d1\u63d0\u4f9b\u306e\u7fa9\u52d9\u3001\u7f70\u5247\u3001\u52a0\u76df\u56fd\u9593\u306e\u5354\u529b\u3001\u533b\u7642\u6a5f\u5668\u8abf\u6574\u30b0\u30eb\u30fc\u30d7\u3001\u30c7\u30fc\u30bf\u4fdd\u8b77\u3001\u6a5f\u5668\u767b\u9332\u306b\u3064\u3044\u3066\u3082\u89e6\u308c\u3066\u3044\u307e\u3059\u3002\u7b2cX\u7ae0\u306f\u3001\u3059\u3067\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u6a5f\u5668\u306e\u7de9\u548c\u306e\u305f\u3081\u306bEU\u304c\u5fc5\u8981\u3068\u8003\u3048\u308b\u6700\u7d42\u898f\u5b9a\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3059\u3002EU\u306eMDR\u3067\u306f\u3001MDD\u3068\u6bd4\u8f03\u3057\u3066\u5206\u985e\u30ab\u30c6\u30b4\u30ea\u30fc\u304c\u5909\u66f4\u3055\u308c\u3001\u5171\u901a\u4ed5\u69d8\u304c\u62e1\u5927\u3055\u308c\u305f\u305f\u3081\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u304c\u5909\u5316\u3057\u3066\u3044\u307e\u3059\u3002MDR\u306f\u3001\u305d\u308c\u307e\u3067\u306e\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08MDD\uff09\u3068\u80fd\u52d5\u7684\u690d\u8fbc\u307f\u578b\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08AIMDD\uff09\u306b\u4ee3\u308f\u308b\u3082\u306e\u3067\u3042\u308a\u3001MDR\u306f\u3001\u305d\u308c\u307e\u3067\u306e\u533b\u7642\u6a5f\u5668\u6307\u4ee4\u306b\u4ee3\u308f\u308b\u3082\u306e\u3067\u3059\u3002 <em>in vitro<\/em> IVDD\u306b\u4ee3\u308f\u308b\u3082\u306e\u3068\u3057\u3066\u3001\u8a3a\u65ad\u6a5f\u5668\u898f\u5236\uff08IVDR\uff09\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"2_Device_Classifications\"><\/span>2.\u30c7\u30d0\u30a4\u30b9\u306e\u5206\u985e<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u306b\u7740\u624b\u3059\u308b\u524d\u306e\u6700\u521d\u306e\u30b9\u30c6\u30c3\u30d7\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/510-k-submissions\">510(k)\u7533\u8acb<\/a> \u3092\u4f7f\u3063\u3066\u30c7\u30d0\u30a4\u30b9\u306b\u9069\u3057\u305f\u30af\u30e9\u30b9\u3092\u7279\u5b9a\u3059\u308b\u3053\u3068\u3067\u3059\u3002 <a href=\"https:\/\/www.fda.gov\/medical-devices\/device-advice-comprehensive-regulatory-assistance\/medical-device-databases\">\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9<\/a>.\u30ea\u30b9\u30af\u304c\u4f4e\u3044\u30af\u30e9\u30b9I\u304a\u3088\u3073\u4e2d\u7a0b\u5ea6\u306e\u30af\u30e9\u30b9II\u306e\u6a5f\u5668\u306f\u3001510(k)\u30d1\u30b9\u30a6\u30a7\u30a4\u306b\u3088\u3063\u3066\u898f\u5236\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u7d4c\u8def\u3067\u306f\u3001\u88fd\u54c1\u958b\u767a\u8005\u306f\u3001\u300c\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u300d\u3068\u547c\u3070\u308c\u308b\u4ee5\u524d\u306b\u627f\u8a8d\u3055\u308c\u305f\u6a5f\u5668\u3068\u306e\u6a5f\u80fd\u7684\u540c\u7b49\u6027\u3092\u8a3c\u660e\u3059\u308b\u30c7\u30fc\u30bf\u3092\u63d0\u793a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u300221CFR 880.9\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5236\u9650\u3092\u8d85\u3048\u306a\u3044\u533b\u7642\u88fd\u54c1\u306f\u3001\u3053\u306e\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u306e\u539f\u5247\u306b\u5f93\u3046\u3053\u3068\u3092\u514d\u9664\u3055\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u57cb\u3081\u8fbc\u307f\u578b\u306e\u6a5f\u5668\u306a\u3069\u3001\u305d\u306e\u7528\u9014\u306b\u3088\u3063\u3066\u75c5\u6c17\u3084\u602a\u6211\u306e\u30ea\u30b9\u30af\u304c\u9ad8\u304f\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3082\u306e\u306f\u3001\u30af\u30e9\u30b9III\u306b\u8a72\u5f53\u3057\u3001\u3088\u308a\u53b3\u683c\u306a\u30d1\u30b9\u30a6\u30a7\u30a4\u3067\u3042\u308b\u5e02\u8ca9\u627f\u8a8d\u3092\u53d7\u3051\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>\u5e02\u8ca9\u627f\u8a8d\uff08PMA\uff09\u3067\u306f\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u306f\u3001\u5229\u76ca\u5bfe\u30ea\u30b9\u30af\u306e\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306e\u53b3\u3057\u3044\u8a55\u4fa1\u306b\u5408\u81f4\u3059\u308b\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u5b9f\u8a3c\u3057\u3001\u691c\u8a3c\u3057\u305f\u30c7\u30fc\u30bf\u3092\u63d0\u793a\u3059\u308b\u3002\u6700\u3082\u91cd\u8981\u306a\u3053\u3068\u306f\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u306b\u306f\u3001\u74b0\u5883\u30ea\u30b9\u30af\u304c\u6700\u3082\u5c11\u306a\u304f\u3001\u751f\u547d\u7dad\u6301\u306e\u53ef\u80fd\u6027\u304c\u76f8\u5bfe\u7684\u306b\u9ad8\u3044\u3068\u3044\u3046\u8a3c\u62e0\u3092\u793a\u3059\u7fa9\u52d9\u304c\u3042\u308b\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u8fd1\u5e74\u3001FDA\u306f\u30af\u30e9\u30b9III\u306e\u6a5f\u5668\u3092\u300c\u4eba\u306e\u751f\u547d\u3092\u7dad\u6301\u3059\u308b\u3082\u306e\u3001\u4eba\u306e\u5065\u5eb7\u306e\u969c\u5bb3\u3092\u9632\u3050\u4e0a\u3067\u5b9f\u8cea\u7684\u306b\u91cd\u8981\u306a\u3082\u306e\u3001\u307e\u305f\u306f\u75c5\u6c17\u3084\u602a\u6211\u306e\u6f5c\u5728\u7684\u306a\u4e0d\u5408\u7406\u306a\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3059\u3082\u306e\u300d\u3068\u5206\u985e\u3057\u3066\u3044\u308b\u3002<\/p>\n<p>\u5b9f\u969b\u3001FDA\u306f\u3001\u30af\u30e9\u30b9III\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u4e00\u822c\u7ba1\u7406\u3068\u7279\u5225\u7ba1\u7406\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3042\u308b\u3068\u5224\u65ad\u3057\u3066\u3044\u308b\u3002\u305d\u306e\u305f\u3081\u3001\u3053\u308c\u3089\u306e\u6a5f\u5668\u306e\u8ca9\u58f2\u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306b\u306f\u3001Food, Drugs, &amp;Cosmetics Act\u306e515\u6761\u306b\u57fa\u3065\u304fPMA\u7533\u8acb\u304c\u5fc5\u8981\u3068\u306a\u308b\u3002\u3064\u307e\u308a\u3001\u6a5f\u5668\u306e\u5206\u985e\u304c\u6b63\u78ba\u3067\u3042\u308c\u3070\u3001\u533b\u7642\u6a5f\u5668\u30b9\u30dd\u30f3\u30b5\u30fc\u306f\u30d7\u30ed\u30bb\u30b9\u306e\u534a\u5206\u3092\u8d8a\u3048\u305f\u3053\u3068\u306b\u306a\u308b\u3002<\/p>\n<p>\u4e00\u65b9\u3001EU\u306eMDR\u306b\u57fa\u3065\u304f\u6a5f\u5668\u306e\u5206\u985e\u306f\u3001\u975e\u4fb5\u8972\u6027\u6a5f\u5668\u3001\u4fb5\u8972\u6027\u533b\u7642\u6a5f\u5668\u3001\u80fd\u52d5\u6027\u533b\u7642\u6a5f\u5668\u3001\u4f8b\u5916\u306e\u3042\u308b\u7279\u5225\u306a\u30ab\u30c6\u30b4\u30ea\u30fc\uff08\u907f\u598a\u5177\u3001\u6d88\u6bd2\u5264\u3001\u653e\u5c04\u7dda\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u3092\u542b\u3080\uff09\u306e4\u3064\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u5206\u304b\u308c\u3066\u3044\u307e\u3059\u3002MDR\u3067\u306f\u3001\u30ca\u30ce\u30de\u30c6\u30ea\u30a2\u30eb\u3092\u4f7f\u7528\u3057\u305f\u6cbb\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u8ffd\u52a0\u30eb\u30fc\u30eb\u304c\u3042\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u30c7\u30d0\u30a4\u30b9\u306f\u30ea\u30b9\u30af\u306b\u57fa\u3065\u3044\u3066\u5206\u985e\u3055\u308c\u3066\u304a\u308a\u3001\u3053\u308c\u306b\u3088\u308a\u3001\u5c06\u6765\u306e\u88fd\u54c1\u306b\u5fc5\u8981\u306a\u30c7\u30fc\u30bf\u306e\u898f\u6a21\u3084\u8a55\u4fa1\u306e\u6df1\u3055\u304c\u6c7a\u5b9a\u3055\u308c\u307e\u3059\u3002<\/p>\n<p>\u306e\u72ec\u7acb\u3057\u305f\u6307\u4ee4\u306f\u3055\u3066\u304a\u304d <em>in vitro<\/em> \u8a3a\u65ad\u30c7\u30d0\u30a4\u30b9\u3001\u3053\u3053\u3067\u306f\u30c7\u30d0\u30a4\u30b9\u30af\u30e9\u30b9\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u30af\u30e9\u30b9I - \u975e\u6ec5\u83cc\u3067\u63d0\u4f9b\u3055\u308c\u308b\u3001\u307e\u305f\u306f\u6e2c\u5b9a\u6a5f\u80fd\u3092\u6301\u305f\u306a\u3044\uff08\u4f4e\u30ea\u30b9\u30af<\/li>\n<li>\u30af\u30e9\u30b9I - \u7121\u83cc\u3067\u3042\u308b\u3053\u3068\u3001\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u6e2c\u5b9a\u6a5f\u80fd\u3092\u6709\u3059\u308b\u3053\u3068\uff08\u4f4e\uff0f\u4e2d\u30ea\u30b9\u30af\uff09\u3002MDR\u3067\u306f\u3001\u518d\u4f7f\u7528\u53ef\u80fd\u306a\u624b\u8853\u5668\u5177\u3092\u30af\u30e9\u30b9I\u306e\u518d\u4f7f\u7528\u53ef\u80fd\u306a\u624b\u8853\u5668\u5177\u3068\u3057\u3066\u3053\u306e\u30b0\u30eb\u30fc\u30d7\u306b\u8ffd\u52a0\u3057\u3066\u3044\u308b\u3002<\/li>\n<li>\u30af\u30e9\u30b9IIa\uff08\u4e2d\u7a0b\u5ea6\u306e\u30ea\u30b9\u30af<\/li>\n<li>\u30af\u30e9\u30b9IIb\uff08\u4e2d\/\u9ad8\u30ea\u30b9\u30af<\/li>\n<li>\u30af\u30e9\u30b9III\uff08\u30cf\u30a4\u30ea\u30b9\u30af<\/li>\n<\/ul>\n<p>EU MDR\u306e\u5404\u7ae0\u3084\u4ed8\u5c5e\u66f8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001\u5404\u6a5f\u5668\u30af\u30e9\u30b9\u306b\u306f\u500b\u5225\u306e\u8a66\u9a13\u8981\u4ef6\u304c\u3042\u308a\u307e\u3059\u3002\u30e6\u30fc\u30b6\u30fc\u304c\u64cd\u4f5c\u3059\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304c\u30d7\u30ea\u30a4\u30f3\u30b9\u30c8\u30fc\u30eb\u3055\u308c\u305f\u6a5f\u5668\u3082\u3001MDR\u306e\u7b2c6.11\u6761\u3001\u7b2c11\u898f\u5247\u306b\u57fa\u3065\u3044\u3066\u76e3\u67fb\u304a\u3088\u3073\u691c\u8a3c\u3055\u308c\u307e\u3059\u3002\u3053\u308c\u3089\u306b\u306f\u3001\u76e3\u8996\u88c5\u7f6e\u3001\u901a\u4fe1\u3001\u8a3a\u65ad\u3001\u6cbb\u7642\u306b\u4f7f\u7528\u3055\u308c\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304c\u542b\u307e\u308c\u308b\u3002\u307b\u3068\u3093\u3069\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001\u305d\u306e\u4f7f\u7528\u306b\u3088\u308a\u60a3\u8005\u306e\u72b6\u614b\u304c\u6df1\u523b\u306b\u60aa\u5316\u3057\u305f\u5834\u5408\u3001\u30af\u30e9\u30b9I\u307e\u305f\u306fIIb\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u751f\u7406\u7684\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306b\u4f7f\u7528\u3055\u308c\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3067\u3001\u305d\u306e\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u5909\u52d5\u306e\u6027\u8cea\u304c\u60a3\u8005\u306b\u76f4\u63a5\u7684\u306a\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3059\u5834\u5408\u306f\u3001IIb\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u4e00\u65b9\u3001\u8a3a\u65ad\u307e\u305f\u306f\u6cbb\u7642\u306b\u4f7f\u7528\u3055\u308c\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3067\u3001\u6b7b\u4ea1\u307e\u305f\u306f\u60a3\u8005\u306e\u72b6\u614b\u306e\u4e0d\u53ef\u9006\u7684\u306a\u60aa\u5316\u306e\u5371\u967a\u6027\u3092\u4f34\u3046\u3082\u306e\u306f\u30af\u30e9\u30b9III\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_Clinical_Testing_Processes\"><\/span>3.\u81e8\u5e8a\u8a66\u9a13\u306e\u30d7\u30ed\u30bb\u30b9<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u307b\u3068\u3093\u3069\u306e\u533b\u7642\u6a5f\u5668\u304c510(k)\u30d7\u30ed\u30bb\u30b9\u306b\u8a72\u5f53\u3059\u308b\u3053\u3068\u3092\u8003\u616e\u3059\u308b\u3068\u3001\u81e8\u5e8a\u8a66\u9a13\u306b\u306f\u3001\u6a5f\u5668\u306e\u7a2e\u985e\u3068\u8a66\u9a13\u671f\u9593\u4e2d\u306b\u542b\u307e\u308c\u308b\u7d50\u679c\u6307\u6a19\u306b\u57fa\u3065\u3044\u3066\u3001\u7d046\uff5e15\u30f6\u6708\u304b\u304b\u308b\u3053\u3068\u304c\u5206\u304b\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u6a5f\u5668\u306e\u5206\u985e\u3092\u6b63\u78ba\u306b\u6c7a\u5b9a\u3057\u305f\u5f8c\u3001\u591a\u6b21\u5143\u7684\u3067\u5fb9\u5e95\u7684\u306a\u5be9\u67fb\u3092\u53d7\u3051\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert?search=510(k)&amp;utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">510(k)\u7533\u8acb<\/a>\u3053\u308c\u3089\u306e\u8a55\u4fa1\u3092\u542b\u3081\u3066\u3001510(k)\u7533\u8acb\u3092\u6e96\u5099\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u5b89\u5168\u6027\u306e\u4e88\u5099\u30c6\u30b9\u30c8<\/li>\n<li>\u30ea\u30b9\u30af\u8a55\u4fa1<\/li>\n<li>\u5371\u967a\u6027\u306e\u8b58\u5225<\/li>\n<li>\u30cf\u30b6\u30fc\u30c9\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u8a08\u753b<\/li>\n<li>\u30ea\u30b9\u30af\u8efd\u6e1b\u306e\u305f\u3081\u306e\u6226\u7565\u7acb\u6848<\/li>\n<li>\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u5206\u6790<\/li>\n<li>\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u6709\u52b9\u6027\u691c\u8a3c<\/li>\n<li>\u5168\u4f53\u7684\u306a\u6b8b\u7559\u30ea\u30b9\u30af\u5206\u6790<\/li>\n<li>\u30ea\u30b9\u30af\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u5206\u6790<\/li>\n<li>\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u6700\u7d42\u5be9\u67fb<\/li>\n<\/ul>\n<p>\u30c7\u30d0\u30a4\u30b9\u30af\u30e9\u30b9\u304c\u7d76\u5bfe\u7684\u306b\u78ba\u5b9a\u3057\u3066\u3044\u306a\u3044\u5834\u5408\u3001FDA\u3078\u306e\u7533\u8acb\u306f <a href=\"https:\/\/www.emergobyul.com\/resources\/usa-process-chart\">510(g)\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u3088\u308b<\/a>.\u6700\u521d\u306e4\u3064\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u5c0f\u898f\u6a21\u306a\u8a66\u9a13\u304c\u884c\u308f\u308c\u30015\u756a\u76ee\u306e\u30b9\u30c6\u30c3\u30d7\u304b\u3089\u306f\u3001\u3055\u307e\u3056\u307e\u306a\u898f\u6a21\u306e\u81e8\u5e8a\u8a66\u9a13\u304c\u884c\u308f\u308c\u307e\u3059\u3002\u3057\u305f\u304c\u3063\u3066\u3001\u6a5f\u5668\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306e\u5168\u4f53\u7684\u306a\u5e73\u5747\u671f\u9593\u306f\u30017\u30f6\u6708\uff08\u81e8\u5e8a\u8a66\u9a13\u306e\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u671f\u9593\u304c1\u5e74\u672a\u6e80\u306e\u4f4e\u4fb5\u8972\u6027\u6a5f\u5668\uff09\u304b\u308914\u30f6\u6708\uff08\u81e8\u5e8a\u8a66\u9a13\u306e\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u671f\u9593\u304c1\u5e74\u4ee5\u4e0a\u306e\u8907\u96d1\u306a\u75be\u60a3\u3092\u5bfe\u8c61\u3068\u3057\u305f\u6a5f\u5668\uff09\u306e\u9593\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>\u4e00\u65b9\u3067\u3001\u30a2\u30f3\u30c0\u30fc <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations-mdr?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">EU MDR<\/a>\u30af\u30e9\u30b9I\u6a5f\u5668\u306f\u3001EU MDR\u306e\u9644\u5c5e\u66f8IV\u304a\u3088\u3073V\u306b\u57fa\u3065\u3044\u3066\u8a55\u4fa1\u3055\u308c\u3001CE\u30de\u30fc\u30ad\u30f3\u30b0\u306e\u305f\u3081\u306eNB\u306b\u3088\u308b\u9069\u5408\u6027\u8a55\u4fa1\u304c\u514d\u9664\u3055\u308c\u307e\u3059\u3002\u4e00\u65b9\u3001\u4e2d\u7a0b\u5ea6\u306e\u30ea\u30b9\u30af\u3092\u6301\u3064\u4e00\u90e8\u306e\u30af\u30e9\u30b9I\u6a5f\u5668\u3068\u30af\u30e9\u30b9IIa\u6a5f\u5668\u306f\u3001MDR\u306e\u9644\u5c5e\u66f8XI\uff08\u30d1\u30fc\u30c8A\uff09\u306b\u57fa\u3065\u3044\u3066\u9069\u5408\u6027\u8a55\u4fa1\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30af\u30e9\u30b9IIb\u304a\u3088\u3073\u30af\u30e9\u30b9III\u6a5f\u5668\u306f\u3001\u9644\u5c5e\u66f8II\u3001X\u3001XI\uff08\u30d1\u30fc\u30c8A\u304a\u3088\u3073B\uff09\u306e\u6761\u9805\u306b\u57fa\u3065\u304d\u3001\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306b\u3088\u308b\u9069\u5408\u6027\u8a55\u4fa1\u306e\u969b\u306b\u3001\u6a5f\u5668\u306e\u578b\u5f0f\u8a66\u9a13\u3001\u9069\u5408\u6027\u691c\u8a3c\u3001\u88fd\u54c1\u691c\u8a3c\u3001\u304a\u3088\u3073\u5e83\u7bc4\u306a\u30ea\u30b9\u30af\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u5f37\u529b\u306a\u6280\u8853\u6587\u66f8\u304c\u5fc5\u8981\u3067\u3059\u3002\u30af\u30e9\u30b9IIb\u304a\u3088\u3073III\u306e\u6a5f\u5668\u304c\u79fb\u690d\u53ef\u80fd\u306a\u6a5f\u5668\u3067\u3042\u308b\u5834\u5408\u3001MDR\u306f\u305d\u308c\u3089\u306e\u6a5f\u5668\u3092\u7279\u5225\u898f\u5b9a\u306e\u4e0b\u3067\u3055\u3089\u306b\u8a66\u9a13\u3059\u308b\u3088\u3046\u6307\u5b9a\u3057\u307e\u3059\u3002\u751f\u4f53\u5438\u53ce\u6027\u306e\u30d0\u30a4\u30aa\u30de\u30c6\u30ea\u30a2\u30eb\u3092\u542b\u3080\u6a5f\u5668\u306f\u3001NB\u304c\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3057\u305f\u5f8c\u3001\u5c02\u9580\u5bb6\u30d1\u30cd\u30eb\u306b\u3088\u308b\u7279\u5b9a\u306e\u8a55\u4fa1\u3092\u53d7\u3051\u308b\u3002<\/p>\n<p>MDR\u3067\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u6587\u66f8\u5316\u306b\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u5831\u544a\u304c\u542b\u307e\u308c\u307e\u3059\u3002<strong>\u5171\u901a\u4ed5\u69d8<\/strong>\"\u3068 \"\u30cf\u30fc\u30e2\u30ca\u30a4\u30ba\u30c9\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9 \"\u306e2\u3064\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.johner-institute.com\/articles\/regulatory-affairs\/common-specifications\/\">\u306f<\/a> \u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u8a31\u5bb9\u53ef\u80fd\u306a\u30ea\u30b9\u30af\u30fb\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u6bd4\u3092\u78ba\u4fdd\u3059\u308b\u30ea\u30b9\u30af\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3001\u96fb\u6c17\u7684\u5b89\u5168\u6027\u3001\u6a5f\u68b0\u7684\u5b89\u5168\u6027\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30d7\u30ed\u30bb\u30b9\uff08\u691c\u8a3c\u30fb\u59a5\u5f53\u6027\u78ba\u8a8d\uff09\u3001\u4f7f\u7528\u53ef\u80fd\u306a\u533b\u7642\u6a5f\u5668\u306a\u3069\u3001\u57fa\u672c\u7684\u306a\u5b89\u5168\u6027\u3068\u6027\u80fd\u306e\u8981\u4ef6\u306b\u6a5f\u5668\u304c\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u307e\u305f\u3001\u6280\u8853\u6587\u66f8\u4f5c\u6210\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u306f\u3001\u80fd\u52d5\u7684\u79fb\u690d\u6a5f\u5668\u306e\u5c06\u6765\u7684\u306a\u6539\u826f\u306e\u5fc5\u8981\u6027\u3092\u5831\u544a\u3059\u308b\u3053\u3068\u3082\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"A_note_on_MDR_Documentation_and_CERs\"><\/span>MDR\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u3068CER\u306b\u95a2\u3059\u308b\u30e1\u30e2<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>MDR\u3067\u306f\u3001\u524d\u81e8\u5e8a\u8a66\u9a13\u3084\u4e00\u822c\u7684\u306a\u5b89\u5168\u6027\u8a66\u9a13\u306e\u6280\u8853\u6587\u66f8\u3001\u6027\u80fd\u8a55\u4fa1\u3001\u9069\u5408\u6027\u8a55\u4fa1\u6587\u66f8\u306a\u3069\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u304c\u5fc5\u8981\u3068\u3059\u308b\u3055\u307e\u3056\u307e\u306a\u6587\u66f8\u306b\u3064\u3044\u3066\u8a73\u7d30\u306b\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/\">CE\u30de\u30fc\u30ad\u30f3\u30b0<\/a> \u9069\u5408\u5ba3\u8a00\u66f8\u3001EU\u9069\u5408\u5ba3\u8a00\u66f8\u3001\u533b\u7642\u6a5f\u5668\u3068\u305d\u306e\u7d4c\u6e08\u7684\u4e8b\u696d\u8005\u306b\u95a2\u3059\u308b\u63d0\u51fa\u3059\u3079\u304d\u60c5\u5831\u3001\u767b\u9332\u6587\u66f8\u3001\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u3001\u53ca\u3073\u63d0\u793a\u306b\u5fc5\u8981\u306a\u66f8\u985e <a href=\"https:\/\/www.kolabtree.com\/blog\/what-is-a-clinical-evaluation-report\/\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER<\/a>.EU\u306eMDR\u3067\u306f\u3001\u4e88\u5099\u7684\u306a\u5206\u985e\u57fa\u6e96\u3001\u578b\u5f0f\u8a66\u9a13\u306e\u9069\u5408\u6027\u8a55\u4fa1\u3001\u30ab\u30b9\u30bf\u30e0\u30e1\u30a4\u30c9\u6a5f\u5668\u306e\u624b\u9806\u3001\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3059\u308b\u6280\u8853\u6587\u66f8\u3001\u76f8\u95a2\u8868\u306a\u3069\u306e\u5831\u544a\u66f8\u3092\u63d0\u793a\u3059\u308b\u3053\u3068\u304c\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\uff08Notified Bodies\uff09\u306b\u5bfe\u3057\u3066\u306f\u3001\u3055\u307e\u3056\u307e\u306a\u6bb5\u968e\u3067\u3069\u306e\u3088\u3046\u306b\u81e8\u5e8a\u60c5\u5831\u3092\u53d7\u3051\u53d6\u308b\u304b\u306b\u3064\u3044\u3066\u3001\u7dbf\u5bc6\u306a\u8981\u4ef6\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002MDR\u3067\u306f\u3001\u3053\u308c\u307e\u3067\u533b\u7642\u76ee\u7684\u3067\u4f7f\u7528\u3055\u308c\u3066\u3044\u306a\u304b\u3063\u305f\u304c\u3001MDR\u306b\u533b\u7642\u76ee\u7684\u3067\u3042\u308b\u3068\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30fc\u30bf\u304c\u542b\u307e\u308c\u308b\u3053\u3068\u304c\u671f\u5f85\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u6700\u5f8c\u306b\u3001MDR\u3067\u306f\u9644\u5c5e\u66f8IX\u306b\u57fa\u3065\u3044\u3066\u6280\u8853\u6587\u66f8\u306e\u6700\u7d42\u76e3\u67fb\u3092\u53d7\u3051\u308b\u3053\u3068\u3092\u30e1\u30fc\u30ab\u30fc\u306b\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002NB\u306e\u5f79\u5272\u304c\u62e1\u5927\u3055\u308c\u305f\u305f\u3081\u3001\u3053\u306e2\u5e74\u9593\u306f\u3001\u65b0\u3057\u3044\u898f\u5236\u306b\u57fa\u3065\u3044\u3066\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u3092\u518d\u6307\u5b9a\u307e\u305f\u306f\u518d\u8a8d\u5b9a\u3059\u308b\u305f\u3081\u306e\u671f\u9593\u3068\u306a\u308a\u307e\u3057\u305f\u3002<\/p>\n<p><strong>\u3082\u8aad\u3093\u3067\u304f\u3060\u3055\u3044\u3002\u3092\u63a1\u7528\u3059\u308b\u306b\u306f\uff1f <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">CER\u30e9\u30a4\u30bf\u30fc<\/a> \u3042\u306a\u305f\u306e\u533b\u7642\u6a5f\u5668\u306e\u305f\u3081\u306b\u00a0<\/strong><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Future_implications_for_EU_MDR\"><\/span>EU MDR\u3078\u306e\u4eca\u5f8c\u306e\u5f71\u97ff<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u6ce8\u76ee\u3057\u3066\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/www.epmmagazine.com\/opinion\/brexit-and-healthcare-product-regulation-navigating-the-grey\/\">EU\u306eMDR\u306e\u5287\u7684\u306a\u5909\u5316\u306e\u4e2d\u3067<\/a>\u3057\u304b\u3057\u3001MDD\u306f\u6307\u4ee4\u3067\u3042\u308a\u3001\u5404\u56fd\u304c\u81ea\u56fd\u306e\u7acb\u6cd5\u653f\u7b56\u306b\u7d71\u5408\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u304b\u3063\u305f\u3053\u3068\u3092\u5fd8\u308c\u3066\u306f\u306a\u308a\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001MDR\u306f\u3001\u52a0\u76df\u56fd\u304c\u81ea\u56fd\u306e\u6cd5\u5f8b\u306b\u7d71\u5408\u3059\u308b\u3053\u3068\u306a\u304f\u3001\u76f4\u63a5\u9069\u7528\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u898f\u5247\u3067\u3059\u3002\u4ee5\u524d\u306eMDD\u3068\u540c\u69d8\u306b\u3001\u9069\u5408\u6027\u8a55\u4fa1\u306f\u30e1\u30fc\u30ab\u30fc\u304c\u6e96\u5099\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u898f\u5236\u4e0a\u306e\u4e3b\u8981\u306a\u30cf\u30fc\u30c9\u30eb\u3067\u3059\u3002\u9069\u5408\u6027\u8a55\u4fa1\u306f\u3001\u5f93\u6765\u306eMDD\u3068\u540c\u69d8\u306b\u3001EU\u52a0\u76df\u56fd\u304c\u6307\u5b9a\u3059\u308b\u6a5f\u95a2\u3067\u3042\u308bNotified Bodies\u306b\u3088\u3063\u3066\u8a55\u4fa1\u3055\u308c\u307e\u3059\u3002MDR\u3067\u306f\u3001\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306e\u6a5f\u80fd\u7684\u610f\u7fa9\u304c\u5927\u5e45\u306b\u898b\u76f4\u3055\u308c\u3001\u5c06\u6765\u7684\u306b\u306f\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306e\u6570\u304c\u6e1b\u308a\u3001\u6b8b\u308a\u306e\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306f\u30e9\u30a4\u30bb\u30f3\u30b9\u3092\u5931\u3046\u53ef\u80fd\u6027\u304c\u3042\u308b\u3068\u4e88\u6e2c\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u306e\u3088\u3046\u306a\u6a5f\u95a2\u3082\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2019\/1\/eu-lists-first-notified-body-under-mdr\">BSI UK\u304c\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u306b\u6307\u5b9a\u3055\u308c\u307e\u3057\u305f\u3002<\/a> \u306e\u4e0b\u3067\u3001\u6700\u8fd1\u3001MDR\u306e\u4e0b\u3067\u884c\u308f\u308c\u307e\u3057\u305f\u3002\u4eca\u5f8c\u3001BSI UK\u306e\u65b0\u3057\u3044MDR\u6307\u5b9a\u306e\u7bc4\u56f2\u306f\u3001\u533b\u85ac\u54c1\u3084\u30ca\u30ce\u30de\u30c6\u30ea\u30a2\u30eb\u3092\u7d44\u307f\u8fbc\u3093\u3060\u533b\u7642\u6a5f\u5668\u304b\u3089\u30af\u30e9\u30b9III\u306e\u30ab\u30b9\u30bf\u30e0\u30e1\u30a4\u30c9\u306e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u6a5f\u5668\u307e\u3067\u3068\u306a\u308b\u3002\u3057\u304b\u3057\u3001NB\u306e\u6307\u5b9a\u3084\u8cc7\u683c\u304c\u5c06\u6765\u7684\u306b\u3069\u306e\u3088\u3046\u306a\u610f\u5473\u3092\u6301\u3064\u304b\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u6ce8\u610f\u6df1\u304f\u898b\u5b88\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.epmmagazine.com\/opinion\/brexit-and-healthcare-product-regulation-navigating-the-grey\/\">\u30dd\u30b9\u30c8BREXIT<\/a> \u82f1\u56fd\u3067\u6307\u5b9a\u3055\u308c\u305fNB\u306f\u3001EU\u5185\u306e\u5168NB\u306e\u30ea\u30b9\u30c8\u306b\u542b\u307e\u308c\u306a\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>Overall, the EU MDR is a leap over the previously inadequate MDD. Moreover, since, active implantable devices\u2013which were associated with quality and safety breaches in the past few years\u2013will be undergoing higher levels of evaluation, the implementation of the MDR is anticipated to be binding. Effectively, the European Union may reach the par with the FDA in terms of 360\u00b0 surveillance of clinical information of CE marked products immediately, as well as those of the past. However, the differences that may still come about will be understood more clearly in the future, when <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> pertaining to the gap analysis is undertaken by regulatory bodies.<\/p>\n<p>\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u9075\u5b88\u306f\u3001\u5e38\u306b\u76e3\u8996\u3068\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u3092\u5fc5\u8981\u3068\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3092\u4f34\u3046\u8907\u96d1\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002EU MDR\u306b\u3088\u3063\u3066\u3001\u88fd\u54c1\u3092\u6b27\u5dde\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u3053\u3068\u306f\u3055\u3089\u306b\u96e3\u3057\u304f\u306a\u308a\u307e\u3057\u305f\u3002\u5c02\u9580\u5bb6\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u5354\u529b\u3059\u308b\u3053\u3068\u3067\u3001\u6642\u9593\u3068\u30a8\u30cd\u30eb\u30ae\u30fc\u3092\u7bc0\u7d04\u3057\u3001\u533b\u7642\u6a5f\u5668\u306e\u5e02\u5834\u6295\u5165\uff08\u304a\u3088\u3073\u5e02\u5834\u7dad\u6301\uff09\u3092\u6210\u529f\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>&#8212;<br \/>\n<strong>\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u65b9\u3078 <a href=\"https:\/\/kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u307e\u305f\u306f <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">\u533b\u7642\u6a5f\u5668CER\u30e9\u30a4\u30bf\u30fc<\/a>?Kolabtree\u306b\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3059\u308b\u3068\u3001\u4fe1\u983c\u3067\u304d\u308b\u5c02\u9580\u5bb6\u304b\u3089\u7121\u6599\u3067\u898b\u7a4d\u3082\u308a\u304c\u3082\u3089\u3048\u307e\u3059\u3002\u00a0<\/strong><\/p>\n<p>\u95a2\u9023\u3059\u308b\u5c02\u9580\u5bb6<\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\u30e9\u30a4\u30bf\u30fc<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">EU MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions\">FDA\u63d0\u51fa\u66f8\u985e<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">\u6587\u732e\u691c\u7d22\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-compliance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">\u898f\u5236\u9075\u5b88\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">\u30af\u30ea\u30cb\u30ab\u30eb\u30fb\u30c8\u30e9\u30a4\u30a2\u30eb\u30fb\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30e9\u30a4\u30bf\u30fc<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/post-market-surveillance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">PMS\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c4<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/country\/india\/subject\/post-market-clinical-followup?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">PMCF\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c4<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAvsMDR\">\u751f\u7269\u7d71\u8a08\u5b66\u306e\u5c02\u9580\u5bb6<\/a><\/strong><\/p>\n<div id=\"text-7\" class=\"awac-wrapper\">\n<div class=\"awac widget text-7\"><\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Mahasweta Pal, freelance medical writer on Kolabtree, provides a comprehensive comparison of medical device regulatory compliance in the US (FDA) vs that in Europe (EU MDR).\u00a0 Decomplicating the EU MDR has been a prime concern for medical device makers and, with higher vigilance and risks associated, medical device consultants have strategic roles to play. As medical device manufacturers brace towards the implementation of the EU MDR directives in the forthcoming months, it becomes extremely imperative to understand what changes the EU MDR brings with it. Meanwhile, the FDA continues its vigilance, the latest being on Essure\u2014a female sterilization device associated with life-threatening complications for women. Not surprisingly, regulatory offices are<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-regulatory-compliance-fda-vs-eu-mdr\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":32,"featured_media":6816,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[317,247,443,540],"tags":[529,295,528,523,474,524],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Device Regulatory Compliance: FDA vs EU MDR<\/title>\n<meta name=\"description\" content=\"Medical device regulatory compliance is significantly different in the US and Europe. 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