{"id":6258,"date":"2019-11-11T17:47:10","date_gmt":"2019-11-11T17:47:10","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6258"},"modified":"2021-01-07T14:15:00","modified_gmt":"2021-01-07T14:15:00","slug":"how-to-get-a-ce-mark-for-your-medical-device-eu-mdr","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306eCE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3059\u308b\u306b\u306f\uff08EU MDR"},"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-69f166826bdf1\" 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-69f166826bdf1\"><\/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\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/#Introduction_to_CE_Marking_MDR\" title=\"CE\u30de\u30fc\u30ad\u30f3\u30b0\u3068MDR\u306e\u7d39\u4ecb\">CE\u30de\u30fc\u30ad\u30f3\u30b0\u3068MDR\u306e\u7d39\u4ecb<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/#Reclassification\" title=\"\u518d\u5206\u985e\">\u518d\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\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/#Technical_Documentation\" title=\"\u30c6\u30af\u30cb\u30ab\u30eb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\">\u30c6\u30af\u30cb\u30ab\u30eb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/#Clinical_Evaluation_Reports\" title=\"\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\">\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\n<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/#Post_Market_Surveillance_PMS_and_Vigilance\" title=\"\u30dd\u30b9\u30c8\u30fb\u30de\u30fc\u30b1\u30c3\u30c8\u30fb\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\uff08PMS\uff09\u3068\u30f4\u30a3\u30b8\u30e9\u30f3\u30b9\">\u30dd\u30b9\u30c8\u30fb\u30de\u30fc\u30b1\u30c3\u30c8\u30fb\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\uff08PMS\uff09\u3068\u30f4\u30a3\u30b8\u30e9\u30f3\u30b9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/#Traceability_and_Transparency\" title=\"\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u3068\u900f\u660e\u6027\">\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u3068\u900f\u660e\u6027<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/#Unique_Device_Identification_system_UDI_System\" title=\"UDI(Unique Device Identification)\u30b7\u30b9\u30c6\u30e0\">UDI(Unique Device Identification)\u30b7\u30b9\u30c6\u30e0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/#Labelling\" title=\"\u30e9\u30d9\u30ea\u30f3\u30b0\">\u30e9\u30d9\u30ea\u30f3\u30b0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/#Single_Use_Devices_and_their_Reprocessing\" title=\"\u30b7\u30f3\u30b0\u30eb\u30e6\u30fc\u30b9\u30c7\u30d0\u30a4\u30b9\u3068\u305d\u306e\u518d\u51e6\u7406\">\u30b7\u30f3\u30b0\u30eb\u30e6\u30fc\u30b9\u30c7\u30d0\u30a4\u30b9\u3068\u305d\u306e\u518d\u51e6\u7406<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/#Conclusions\" title=\"\u7d50\u8ad6\">\u7d50\u8ad6<\/a><\/li><\/ul><\/nav><\/div>\n<p><em><span style=\"font-weight: 400;\">EU\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u306f\u3001CE\u30de\u30fc\u30afMDR\u306e\u53d6\u5f97\u304c\u5fc5\u8981\u3067\u3059\u3002\u6700\u65b0\u306eEU\u533b\u7642\u6a5f\u5668\u898f\u5247\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30d7\u30ed\u30bb\u30b9\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306e\u30bd\u30d5\u30a3\u30fc\u30fb\u30ed\u30fc\u30ec\u30f3\u30bd\u30f3\u535a\u58eb\u304c\u3001EU MDR\u306e\u4e3b\u306a\u5909\u66f4\u70b9\u3068\u305d\u306e\u7d50\u679c\u306b\u3064\u3044\u3066\u6982\u8aac\u3057\u307e\u3059\u3002<br \/>\n\u5c02\u9580\u5bb6\u306b\u76f8\u8ac7\u3057\u305f\u3044\u5834\u5408\u76f8\u8ac7\u3059\u308b <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report--cer-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDR-CEMark\">CER\u30e9\u30a4\u30bf\u30fc<\/a> \u305d\u3057\u3066 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDR-CEMark\">MDR\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a> \u3092Kolabtree\u306b\u63b2\u8f09\u3057\u307e\u3057\u305f\u3002\u00a0\u00a0<\/span><\/em><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Introduction_to_CE_Marking_MDR\"><\/span><b>CE\u30de\u30fc\u30ad\u30f3\u30b0\u3068MDR\u306e\u7d39\u4ecb<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u8fd1\u5e74\u3001\u3044\u304f\u3064\u304b\u306e\u6709\u540d\u306a\u4e8b\u4ef6\u3067\u3001\u672c\u88fd\u54c1\u306e\u5f31\u70b9\u304c\u6d6e\u304d\u5f6b\u308a\u306b\u306a\u308a\u307e\u3057\u305f\u3002<\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:31993L0042\"> <span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u6307\u4ee4(MDD)<\/span><\/a><span style=\"font-weight: 400;\"> \u6b27\u5dde\u9023\u5408(EU)\u3067\u6d3b\u8e8d\u3059\u308b\u306e\u3067\u3059\u3002<\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32017R0745\"> <span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u898f\u5236\uff08MDR<\/span><\/a><span style=\"font-weight: 400;\"> \u306f\u3001\u3053\u308c\u3089\u306e\u5f31\u70b9\u306b\u5bfe\u51e6\u3057\u3001\u6b27\u5dde\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u6027\u80fd\u3068\u5b89\u5168\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u306b\u5c0e\u5165\u3055\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u65b0\u3057\u3044\u898f\u5236\uff08\u6b63\u5f0f\u540d\u79f0\uff1aREGULATION (EU) 2017\/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices\uff09\u306f\u30015\u65e5\u306b\u6b27\u5dde\u8b70\u4f1a\u3067\u627f\u8a8d\u3055\u308c\u307e\u3057\u305f\u3002<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> 2017\u5e744\u6708\u30015\u65e5\u306b\u6b27\u5dde\u9023\u5408\u306e\u5b98\u5831\u306b\u63b2\u8f09\u3055\u308c\u305f<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> 2017\u5e745\u6708\u306e\u3053\u3068\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">MDR\u306f\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u3092\u5f62\u6210\u3059\u308b\u79d1\u5b66\u7684\u30fb\u6280\u8853\u7684\u72b6\u6cc1\u306e\u5909\u5316\u306b\u5bfe\u5fdc\u3057\u3066\u3001\u533b\u7642\u6a5f\u5668\u3092\u898f\u5236\u3059\u308b\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u5927\u304d\u304f\u8ee2\u63db\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u306e\u898f\u5236\u306e\u65bd\u884c\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u8abf\u6574\u3067\u304d\u308b\u3088\u3046\u306b\u30013\u5e74\u9593\u306e\u79fb\u884c\u671f\u9593\u3092\u7d4c\u3066\u6bb5\u968e\u7684\u306b\u884c\u308f\u308c\u307e\u3059\u3002EU\u57df\u5185\u3067\u306e\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306f\u65b0\u898f\u52472017\/745\u306b\u57fa\u3065\u304dCE\u30de\u30fc\u30afMDR\u3092\u53d6\u5f97\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u7fa9\u52d9\u306f\u3001\u5e02\u8ca9\u3055\u308c\u3066\u3044\u308b\u65e2\u5b58\u306e\u88fd\u54c1\u3060\u3051\u3067\u306a\u304f\u3001\u73fe\u5728\u958b\u767a\u4e2d\u306e\u88fd\u54c1\u306b\u3082\u5f71\u97ff\u3057\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">MDR\u3067\u5c0e\u5165\u3055\u308c\u305f\u5909\u66f4\u306f\u3001\u6a5f\u5668\u306e\u5206\u985e\u3001\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306e\u6587\u66f8\u5316\u3001\u5e02\u8ca9\u5f8c\u306e\u6d3b\u52d5\u3001\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u30d3\u30b8\u30cd\u30b9\u30d1\u30fc\u30c8\u30ca\u30fc\u306a\u3069\u3001CE\u30de\u30fc\u30ad\u30f3\u30b0\u30d7\u30ed\u30bb\u30b9\u306e\u591a\u304f\u306e\u5074\u9762\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u3002\u65b0\u898f\u5236\u306e\u4e3b\u306a\u76ee\u7684\u306f\u3001\u4ee5\u4e0b\u3092\u53ef\u80fd\u306b\u3059\u308b\u3053\u3068\u3067\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\"\u9ad8\u6c34\u6e96\u306e\u5b89\u5168\u6027\u3068\u5065\u5eb7\u3092\u78ba\u4fdd\u3057\u3064\u3064\u3001\u6280\u8853\u9769\u65b0\u3092\u652f\u63f4\u3059\u308b\u533b\u7642\u6a5f\u5668\u306e\u5805\u7262\u3067\u900f\u660e\u6027\u306e\u9ad8\u3044\u3001\u4e88\u6e2c\u53ef\u80fd\u3067\u6301\u7d9a\u53ef\u80fd\u306a\u898f\u5236\u306e\u67a0\u7d44\u307f\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u3053\u308c\u3089\u306e\u6307\u4ee4\u306e\u629c\u672c\u7684\u306a\u898b\u76f4\u3057\u304c\u5fc5\u8981\u3067\u3042\u308b \"\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002<\/span><\/i><span style=\"font-weight: 400;\"> (MDR 2017\/745, 1)\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Reclassification\"><\/span><b>\u518d\u5206\u985e<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u306f\u3001\u88fd\u54c1\u3092\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u968e\u5c64\u5316\u3057\u3001CE\u30de\u30fc\u30ad\u30f3\u30b0\u306b\u5fc5\u8981\u306a\u9069\u5408\u6027\u8a55\u4fa1\u30eb\u30fc\u30c8\u3092\u898f\u5b9a\u3059\u308b\u3082\u306e\u3067\u3059\u3002MDR\u898f\u5247\u3067\u306f\u3001\u30af\u30e9\u30b9I\u304b\u3089\u30af\u30e9\u30b9III\u307e\u3067\u306e\u5168\u4f53\u7684\u306a\u5206\u985e\u30b9\u30ad\u30fc\u30e0\u306f\u7dad\u6301\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u4e00\u90e8\u306e\u88fd\u54c1\u306f\u518d\u5206\u985e\u3055\u308c\u3066\u3044\u307e\u3059\u3002MDR\u306e\u5206\u985e\u898f\u5247\u306f\u4ed8\u5c5e\u66f8VIII\u306b\u307e\u3068\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u7279\u306b\u3001\u4e00\u90e8\u306e\u30c7\u30b8\u30bf\u30eb\u88fd\u54c1\u304a\u3088\u3073\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u88fd\u54c1\u306b\u5bfe\u3059\u308b\u8981\u6c42\u4e8b\u9805\u306f\u3001\u5206\u985e\u898f\u524711\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u518d\u5229\u7528\u53ef\u80fd\u306a\u30af\u30e9\u30b91\u306e\u6a5f\u5668\u3001\u5316\u7ca7\u54c1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u610f\u56f3\u7684\u306a\u533b\u7642\u6a5f\u80fd\u3092\u6301\u305f\u306a\u3044\u88fd\u54c1\uff08MDR\u4ed8\u5c5e\u66f8XVI\u306b\u8a18\u8f09\uff09\u306b\u3082\u6539\u9769\u3055\u308c\u305f\u7fa9\u52d9\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u81ea\u793e\u88fd\u54c1\u3092\u6b63\u78ba\u306b\u5206\u985e\u3057\u3001\u65b0\u305f\u306a\u9069\u5408\u6027\u8a55\u4fa1\u30eb\u30fc\u30c8\u304c\u5fc5\u8981\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u6a5f\u5668\u304c\u3088\u308a\u9ad8\u3044\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306e\u30b0\u30eb\u30fc\u30d7\u306b\u518d\u5206\u985e\u3055\u308c\u308b\u5834\u5408\u306e\u8ab2\u984c\u3067\u3042\u308a\u3001\u5bb9\u6613\u306b\u5165\u624b\u3067\u304d\u306a\u3044\u53ef\u80fd\u6027\u306e\u3042\u308b\u81e8\u5e8a\u30c7\u30fc\u30bf\u3084\u6280\u8853\u30c7\u30fc\u30bf\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">MDR\u898f\u5236\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u3068\u305d\u306e\u30d3\u30b8\u30cd\u30b9\u30d1\u30fc\u30c8\u30ca\u30fc\uff08\u88fd\u54c1\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u5185\u306e\u7d4c\u6e08\u4e8b\u696d\u8005\u3092\u542b\u3080\uff09\u306e\u4e21\u65b9\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001MDR\u7b2c25\u6761\uff08\u7b2c13\u6761\u304a\u3088\u3073\u7b2c14\u6761\u306b\u52a0\u3048\u3066\uff09\u3067\u660e\u78ba\u306b\u898f\u5236\u3055\u308c\u3066\u3044\u308b\u88fd\u54c1\u306e\u8f38\u5165\u696d\u8005\u304a\u3088\u3073\u8ca9\u58f2\u696d\u8005\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u307e\u305f\u3001MDR\u7b2c11\u6761\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001EU\u516c\u8a8d\u4ee3\u7406\u5e97\uff08EUAR\uff09\u306b\u306f\u3001\u3088\u308a\u53b3\u683c\u306a\u8981\u4ef6\u304c\u8ab2\u305b\u3089\u308c\u3066\u3044\u307e\u3059\u3002EUAR\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u306f\u3001\u767b\u9332\u3055\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u305a\u3001\u9069\u5207\u306a\u898f\u5236\u30b7\u30b9\u30c6\u30e0\u3001\u4eba\u54e1\u3001\u8ce0\u511f\u8cac\u4efb\u4fdd\u967a\u3092\u5099\u3048\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002MDR\u7b2c15\u6761\u306b\u306f\u3001\u88fd\u9020\u696d\u8005\u304a\u3088\u3073EUAR\u7d44\u7e54\u306b\u4efb\u547d\u3055\u308c\u308b\u898f\u5236\u9075\u5b88\u8cac\u4efb\u8005\uff08PRRC\uff09\u306e\u8981\u4ef6\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u4eba\u7269\u306f\u3001\u95a2\u9023\u3059\u308b\u79d1\u5b66\u5206\u91ce\u3067\u306e\u9069\u5207\u306a\u5b66\u6b74\u30681\u5e74\u4ee5\u4e0a\u306e\u5b9f\u52d9\u7d4c\u9a13\u3001\u3042\u308b\u3044\u306f4\u5e74\u4ee5\u4e0a\u306e\u5b9f\u52d9\u7d4c\u9a13\u306e\u3044\u305a\u308c\u304b\u3092\u6709\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u96f6\u7d30\u4f01\u696d\u3084\u5c0f\u898f\u6a21\u4f01\u696d\u306f\u3001PRRC\u3092\u5e38\u8a2d\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u9069\u5207\u306a\u5019\u88dc\u8005\u3092\u7d99\u7d9a\u7684\u306b\u78ba\u4fdd\u3057\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Technical_Documentation\"><\/span><b>\u30c6\u30af\u30cb\u30ab\u30eb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>\u00a0<\/b><span style=\"font-weight: 400;\">\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\uff08\u307e\u305f\u306f\u30c7\u30b6\u30a4\u30f3\u30c9\u30b7\u30a8\uff09\u306f\u3001\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u91cd\u8981\u306a\u8981\u7d20\u3067\u3059\u3002\u3053\u306e\u66f8\u985e\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5305\u62ec\u7684\u306a\u8aac\u660e\u304c\u542b\u307e\u308c\u3001\u898f\u5236\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u6a5f\u80fd\u3001\u30c7\u30b6\u30a4\u30f3\u3001\u4f7f\u7528\u76ee\u7684\u3001\u81e8\u5e8a\u8a55\u4fa1\u3001\u30af\u30ec\u30fc\u30e0\u306a\u3069\u306e\u8a73\u7d30\u306a\u60c5\u5831\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002MDR\u3067\u306f\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306e\u4f5c\u6210\u306b\u95a2\u3059\u308b\u73fe\u884c\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u5927\u5e45\u306b\u5909\u66f4\u3059\u308b\u3053\u3068\u304c\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u4e16\u754c\u306e\u898f\u5236\u5f53\u5c40\u304c\u8981\u6c42\u3059\u308b\u6280\u8853\u6587\u66f8\u3092\u8abf\u548c\u3055\u305b\u308b\u305f\u3081\u306b\u3001\u8981\u4ef6\u306f\u73fe\u884c\u306eGHTF\uff08Global Harmonization Task Force\uff09\u306eSTED\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u57fa\u3065\u3044\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">MDD\u306e\u5fc5\u9808\u8981\u4ef6\uff08ER\uff09\u306f\u3001\u5b89\u5168\u304a\u3088\u3073\u6027\u80fd\u8981\u4ef6\uff08MDR Annex I\uff09\u306b\u7f6e\u304d\u63db\u3048\u3089\u308c\u307e\u3057\u305f\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u9069\u7528\u3055\u308c\u308b\u8981\u6c42\u4e8b\u9805\u3092\u7279\u5b9a\u3057\u3001\u6280\u8853\u30fb\u81e8\u5e8a\u30c7\u30fc\u30bf\u304a\u3088\u3073\u30ea\u30b9\u30af\u7ba1\u7406\u3092\u901a\u3058\u3066\u9069\u5408\u6027\u3092\u78ba\u4fdd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u95a2\u9023\u3059\u308b\u6574\u5408\u898f\u683c\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u6a5f\u5668\u306b\u3064\u3044\u3066\u306f\u3001\u9069\u5408\u306e\u63a8\u5b9a\u304c\u7d99\u7d9a\u3055\u308c\u307e\u3059\uff08MDR\u7b2c8\u6761\u306b\u6982\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\uff09\u3002\u3057\u304b\u3057\u3001\u6574\u5408\u898f\u683c\u304c\u5b58\u5728\u3057\u306a\u3044\u3001\u307e\u305f\u306f\u4e0d\u5341\u5206\u306a\u5834\u5408\u306b\u306f\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306f\u5171\u901a\u4ed5\u69d8\u3092\u5b9a\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Clinical_Evaluation_Reports\"><\/span><b>\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8<br \/>\n<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u6587\u66f8\u5316\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u6700\u8fd1\u306eMDD\u306e\u6539\u8a02\u3067\u306f\u3001CER\u306b\u304a\u3051\u308b\u81e8\u5e8a\u8a66\u9a13\u304c\u3088\u308a\u91cd\u8996\u3055\u308c\u3066\u3044\u307e\u3059\u3002MDR\u3067\u306f\u3001\u81e8\u5e8a\u7684\u8a3c\u62e0\u3068\u8a55\u4fa1\u306e\u5fc5\u8981\u6027\u304c\u3088\u308a\u660e\u78ba\u306b\u306a\u3063\u3066\u3044\u307e\u3059\uff08MDR Annex XIV, Part A\uff09\u3002\u307e\u305f\u3001\u540c\u7b49\u6027\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306e\u57fa\u6e96\u304c\u3088\u308a\u53b3\u3057\u304f\u306a\u308a\u3001\u81e8\u5e8a\u8a55\u4fa1\u306b\u304a\u3051\u308b\u79d1\u5b66\u6587\u732e\u306e\u4f7f\u7528\u304c\u53b3\u3057\u304f\u898f\u5236\u3055\u308c\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u30e1\u30fc\u30ab\u30fc\u306fCER\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u5909\u66f4\u3057\u305f\u308a\u3001\u81e8\u5e8a\u8a66\u9a13\u304b\u3089\u8ffd\u52a0\u306e\u30c7\u30fc\u30bf\u3092\u5165\u624b\u3057\u305f\u308a\u3059\u308b\u5fc5\u8981\u304c\u51fa\u3066\u304f\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u307e\u305f\u3001\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\uff08NB\uff09\u306b\u3088\u308bCER\u306e\u7cbe\u67fb\u304c\u5f37\u5316\u3055\u308c\u308b\u3053\u3068\u3082\u4e88\u60f3\u3055\u308c\u307e\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u81ea\u793e\u306e\u30ec\u30ac\u30b7\u30fc\u304a\u3088\u3073\u958b\u767a\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u306b\u542b\u307e\u308c\u308bCER\u3092\u898b\u76f4\u3057\u3001\u305d\u308c\u3089\u304c\u65b0\u3057\u3044\u4ed5\u69d8\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u6700\u521d\u306eCE\u30de\u30fc\u30ad\u30f3\u30b0\u304c\u9650\u3089\u308c\u305f\u81e8\u5e8a\u30c7\u30fc\u30bf\u3067\u30b5\u30dd\u30fc\u30c8\u3055\u308c\u3066\u304a\u308a\u3001\u5e02\u8ca9\u5f8c\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u6d3b\u52d5\u306b\u3088\u3063\u3066\u8ffd\u52a0\u30c7\u30fc\u30bf\u304c\u5f97\u3089\u308c\u305f\u5834\u5408\u306b\u306f\u7279\u306b\u91cd\u8981\u3067\u3059\u3002\u9ad8\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306e\u6a5f\u5668\uff08\u30af\u30e9\u30b9III\u307e\u305f\u306f\u79fb\u690d\u53ef\u80fd\u306a\u6a5f\u5668\u306a\u3069\uff09\u306b\u3064\u3044\u3066\u306f\u3001\u5b89\u5168\u6027\u3068\u81e8\u5e8a\u6027\u80fd\u306e\u6982\u8981\u3092\u307e\u3068\u3081\u3001EUDAMED\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\uff08\u4e0b\u8a18\u53c2\u7167\uff09\u306b\u5bc4\u8a17\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\uff08MDR\u7b2c32\u6761\uff09\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Post_Market_Surveillance_PMS_and_Vigilance\"><\/span><b>\u30dd\u30b9\u30c8\u30fb\u30de\u30fc\u30b1\u30c3\u30c8\u30fb\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\uff08PMS\uff09\u3068\u30f4\u30a3\u30b8\u30e9\u30f3\u30b9<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u65b0\u3057\u3044MDR\u3067\u306f\u3001PMS\u3068\u30d3\u30b8\u30e9\u30f3\u30b9\u6d3b\u52d5\u306e\u8981\u4ef6\u304c\u5927\u304d\u304f\u5909\u308f\u308b\u3053\u3068\u304c\u4e88\u60f3\u3055\u308c\u307e\u3059\u3002\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u6f5c\u5728\u7684\u306a\u5b89\u5168\u6027\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u3001\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08PMCF\uff09\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u7d99\u7d9a\u3055\u308c\u3001\u7d99\u7d9a\u7684\u306a\u81e8\u5e8a\u8a55\u4fa1\u306b\u8ca2\u732e\u3057\u307e\u3059\uff08MDR Annex XIV, Part B\uff09\u3002\u5b9a\u671f\u7684\u306a\u5b89\u5168\u6027\u66f4\u65b0\u5831\u544a\uff08PSUR\uff09\u304c\u5fc5\u8981\u3068\u306a\u308b\u304c\u3001\u305d\u306e\u983b\u5ea6\u306f\u6a5f\u5668\u306e\u7a2e\u985e\u306b\u3088\u3063\u3066\u7570\u306a\u308b\uff08MDR\u7b2c86\u6761\uff09\u3002  \u96fb\u5b50\u30d3\u30b8\u30e9\u30f3\u30b9\u5831\u544a\u304c\u5c0e\u5165\u3055\u308c\uff08MDR\u7b2c92\u6761\uff09\u3001\u91cd\u7be4\u306a\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u306e\u5831\u544a\u671f\u9593\u304c\u77ed\u7e2e\u3055\u308c\u308b\uff08MDR\u7b2c87\u6761\uff09\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Traceability_and_Transparency\"><\/span><b>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u3068\u900f\u660e\u6027<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u900f\u660e\u6027\u306f\u3001MDR\u304c\u6539\u5584\u3057\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u91cd\u8981\u306a\u5206\u91ce\u306e\u4e00\u3064\u3067\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u201ctransparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30d8\u30eb\u30b9\u30b1\u30a2<\/a> professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system\u2019\u2019. <\/span><\/i><span style=\"font-weight: 400;\">MDR\u7b2c33\u6761\u306b\u306f\u3001\u767b\u9332\u3055\u308c\u305f\u6a5f\u5668\u3084\u7d4c\u6e08\u4e8b\u696d\u8005\u3001\u81e8\u5e8a\u8a66\u9a13\u3084\u5e02\u8ca9\u5f8c\u306e\u6d3b\u52d5\u306b\u3064\u3044\u3066\u30e1\u30fc\u30ab\u30fc\u304b\u3089\u63d0\u4f9b\u3055\u308c\u305f\u30c7\u30fc\u30bf\u3092\u542b\u3080\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u6b27\u5dde\u30c7\u30fc\u30bf\u30d0\u30f3\u30af\uff08EUDAMED\uff09\u306e\u898f\u5b9a\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001NB\u306f\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u4e0a\u3067\u60c5\u5831\u3084\u8a3c\u660e\u66f8\u3092\u63d0\u4f9b\u3059\u308b\u3002\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u3001\u3053\u306e\u30c7\u30fc\u30bf\u304c\u4e00\u822c\u306b\u516c\u958b\u3055\u308c\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002EUDAMED\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306b\u3088\u3063\u3066\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u9032\u884c\u4e2d\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3067\u3042\u308a\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u3053\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u767a\u5c55\u3092\u6ce8\u610f\u6df1\u304f\u898b\u5b88\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Unique_Device_Identification_system_UDI_System\"><\/span><b><i>UDI(Unique Device Identification)\u30b7\u30b9\u30c6\u30e0<\/i><\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">MDR\u306f\u3001EU\u57df\u5185\u3067\u8ca9\u58f2\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u6a5f\u5668\u306b\u3064\u3044\u3066\u3001\u6a5f\u5668\u56fa\u6709\u306e\u8b58\u5225\u30b7\u30b9\u30c6\u30e0\uff08UDI\u30b7\u30b9\u30c6\u30e0\uff09\u306b\u3088\u308b\u8b58\u5225\u3068\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u7fa9\u52d9\u3065\u3051\u3066\u3044\u308b\uff08MDR\u7b2c27\u6761\uff5e\u7b2c29\u6761\u304a\u3088\u3073MDR\u4ed8\u5c5e\u66f8VI\uff09\u3002UDI\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u56fd\u969b\u7684\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u57fa\u3065\u3044\u3066\u63a8\u5968\u3055\u308c\u3066\u304a\u308a\u3001\u5e02\u8ca9\u5f8c\u306e\u5b89\u5168\u95a2\u9023\u6d3b\u52d5\u3092\u6539\u5584\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u898f\u5236\u306e\u4e0b\u3067\u306f\u3001\u5404\u6a5f\u5668\u306bUDI\u3092\u4ed8\u4e0e\u3057\u3001\u305d\u306e\u30c7\u30fc\u30bf\u3092EUDAMED\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306b\u4fdd\u5b58\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002UDI\u306f\u3001\u88fd\u54c1\u306e\u767a\u58f2\u524d\u306b\u3001\u627f\u8a8d\u3055\u308c\u305f\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304b\u3089\u63d0\u4f9b\u3055\u308c\u3001UDI\u30ad\u30e3\u30ea\u30a2\u306f\u3001\u6a5f\u5668\u307e\u305f\u306f\u305d\u306e\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u6307\u5b9a\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u63d0\u6848\u3055\u308c\u3066\u3044\u308bEU\u306eUDI\u30b7\u30b9\u30c6\u30e0\u306e\u6b63\u78ba\u306a\u4ed5\u69d8\u306f\u307e\u3060\u78ba\u8a8d\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u304c\u3001\u65b0\u3057\u304f\u8a2d\u7acb\u3055\u308c\u305f\u7c73\u56fd\u306e\u30b7\u30b9\u30c6\u30e0\u3092\u53cd\u6620\u3057\u305f\u3082\u306e\u306b\u306a\u308b\u3068\u601d\u308f\u308c\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u3053\u308c\u3089\u306e\u8981\u4ef6\u306f\u79fb\u884c\u671f\u9593\u306e\u7d42\u4e86\u6642\u306b\u306f\u7fa9\u52d9\u5316\u3055\u308c\u307e\u305b\u3093\u304c\u3001\u9ad8\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306e\u6a5f\u5668\u306b\u3064\u3044\u3066\u306f2021\u5e74\u521d\u982d\u306b\u767a\u52b9\u3057\u307e\u3059\u3002\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306e\u4f4e\u3044\u6a5f\u5668\u306b\u3064\u3044\u3066\u306f\u3001\u305d\u306e\u5f8c\u6570\u5e74\u304b\u3051\u3066\u6bb5\u968e\u7684\u306b\u5c0e\u5165\u3055\u308c\u308b\u4e88\u5b9a\u3067\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Labelling\"><\/span><b><i>\u30e9\u30d9\u30ea\u30f3\u30b0<\/i><\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u307e\u305f\u3001MDR\u898f\u5236\u3067\u306f\u3001\u88fd\u54c1\u306e\u8868\u793a\u3084\u88fd\u54c1\u306e\u4e88\u9632\u7684\u8a18\u8ff0\u306b\u95a2\u3059\u308b\u5909\u66f4\u3082\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u30c7\u30fc\u30bf\u306b\u52a0\u3048\u3066\u3001\u95a2\u9023\u60c5\u5831\u3092\u30e1\u30fc\u30ab\u30fc\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3067\u516c\u958b\u3057\u3001\u5b9a\u671f\u7684\u306b\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u8981\u4ef6\u306f\u3001\u30e9\u30d9\u30eb\u3084\u7121\u83cc\u5305\u88c5\uff08MDR\u4ed8\u5c5e\u66f8I\uff09\u306e\u5177\u4f53\u7684\u306a\u5185\u5bb9\u3001\u8106\u5f31\u306a\u60a3\u8005\u30b0\u30eb\u30fc\u30d7\u306e\u305f\u3081\u306e\u60c5\u5831\u306e\u8a18\u8f09\u3001\u4e88\u9632\u63aa\u7f6e\u3001\u5371\u967a\u7269\u8cea\u306b\u95a2\u3059\u308b\u60c5\u5831\u306a\u3069\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Single_Use_Devices_and_their_Reprocessing\"><\/span><b>\u30b7\u30f3\u30b0\u30eb\u30e6\u30fc\u30b9\u30c7\u30d0\u30a4\u30b9\u3068\u305d\u306e\u518d\u51e6\u7406<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u30b7\u30f3\u30b0\u30eb\u30e6\u30fc\u30b9\u6a5f\u5668\u306e\u518d\u51e6\u7406\u306f\u3001MDR\u7b2c17\u6761\u306b\u898f\u5b9a\u3055\u308c\u305f\u5305\u62ec\u7684\u306a\u8981\u6c42\u4e8b\u9805\u306b\u57fa\u3065\u304d\u3001\u56fd\u5185\u6cd5\u3067\u8a8d\u3081\u3089\u308c\u305f\u74b0\u5883\u3067\u306e\u307f\u8a31\u53ef\u3055\u308c\u307e\u3059\u3002MDR\u7b2c17\u6761\u306b\u898f\u5b9a\u3055\u308c\u305f\u5305\u62ec\u7684\u306a\u8981\u6c42\u4e8b\u9805\u306b\u57fa\u3065\u304d\u3001\u5358\u56de\u4f7f\u7528\u6a5f\u5668\u306e\u518d\u51e6\u7406\u3092\u884c\u3046\u4e8b\u696d\u8005\u306f\u88fd\u9020\u8005\u3068\u307f\u306a\u3055\u308c\u3001\u6700\u521d\u306e\u5358\u56de\u4f7f\u7528\u6a5f\u5668\u3068\u540c\u7b49\u306e\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u78ba\u4fdd\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u5f71\u97ff\u3092\u53d7\u3051\u308b\u7d44\u7e54\u306f\u3001\u56fd\u5185\u6cd5\u3067\u518d\u51e6\u7406\u304c\u8a8d\u3081\u3089\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3057\u3001\u305d\u306e\u7d50\u679c\u3068\u3057\u3066\u306e\u7fa9\u52d9\u3092\u78ba\u5b9f\u306b\u679c\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u30d7\u30ed\u30bb\u30b9\u306e\u5c0e\u5165\u3001\u4eba\u54e1\u306e\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3001\u4ee5\u524d\u306f\u4e0d\u8981\u3067\u3042\u3063\u305f\u30ea\u30bd\u30fc\u30b9\u306e\u52d5\u54e1\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Conclusions\"><\/span><b>\u7d50\u8ad6<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">MDR\u306f\u3001\u6b27\u5dde\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306eCE-marking\u30d7\u30ed\u30bb\u30b9\u306b\u5927\u304d\u306a\u5909\u5316\u3092\u3082\u305f\u3089\u3059\u3053\u3068\u304c\u4e88\u60f3\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u5909\u66f4\u306f\u5e83\u7bc4\u56f2\u306b\u308f\u305f\u308b\u305f\u3081\u3001\u7d44\u7e54\u306fMDR\u306e\u5b8c\u5168\u5b9f\u65bd\u306b\u5411\u3051\u3066\u5305\u62ec\u7684\u304b\u3064\u69cb\u9020\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u3068\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5909\u66f4\u70b9\u306e\u591a\u304f\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u7d44\u7e54\u5185\u306e\u8907\u6570\u306e\u90e8\u9580\u3001\u30d3\u30b8\u30cd\u30b9\u30d1\u30fc\u30c8\u30ca\u30fc\u3001NB\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u3002\u307e\u305f\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805\u306e\u8a73\u7d30\u5316\uff08MDR Annex IX\uff09\u3084\u3001\u6f5c\u5728\u7684\u306a\u8ce0\u511f\u8cac\u4efb\u3092\u5341\u5206\u306b\u30ab\u30d0\u30fc\u3059\u308b\u4fdd\u967a\u306e\u8981\u6c42\u306a\u3069\u3001\u7d44\u7e54\u306b\u5e83\u304f\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u5909\u66f4\u3082\u3042\u308a\u307e\u3059\u3002\u7d44\u7e54\u5185\u304a\u3088\u3073\u7d44\u7e54\u9593\u306e\u5229\u5bb3\u95a2\u4fc2\u8005\u304c\u9023\u643a\u3059\u308b\u3053\u3068\u3067\u3001\u898f\u5236\u30d5\u30a7\u30fc\u30ba\u9593\u306e\u79fb\u884c\u3092\u30b9\u30e0\u30fc\u30ba\u306b\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n<p><strong>\u533b\u7642\u6a5f\u5668\u306e\u5c02\u9580\u5bb6\u306b\u76f8\u8ac7\u3059\u308b\u5fc5\u8981\u304c\u3042\u3063\u305f\u308a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report--cer-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDR-CEMark\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u4f5c\u6210\u8005<\/a>?\u8cc7\u683c\u3092\u6301\u3063\u305fPhD\u30ec\u30d9\u30eb\u306e\u5c02\u9580\u5bb6\u3068\u5354\u529b\u3057\u3066 <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDR-CEMark\">\u30b3\u30e9\u30d6\u30c4\u30ea\u30fc<\/a>.\u3042\u306a\u305f\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3057\u3066\u3001\u898b\u7a4d\u3082\u308a\u3092\u3082\u3089\u3046\u306e\u306f\u7121\u6599\u3067\u3059\u3002<\/strong><\/p>\n<p>&nbsp;<\/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=MDR-CEMark\">\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=MDR-CEMark\">\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=MDR-CEMark\">\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=MDR-CEMark\">EU MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDR-CEMark\">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=MDR-CEMark\">\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=MDR-CEMark\">\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=MDR-CEMark\">\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=MDR-CEMark\">\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=MDR-CEMark\">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=MDR-CEMark\">PMCF\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c4<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDR-CEMark\">\u00a0\u751f\u7269\u7d71\u8a08\u5b66\u306e\u5c02\u9580\u5bb6<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-development?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDR-CEMark\">\u00a0\u88fd\u54c1\u958b\u767a\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u00a0<\/a><\/strong><\/p>\n<p><strong>\u00a0<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>All medical devices to be placed on the EU Market need to get a CE Mark MDR. The latest EU Medical Device Regulations have significantly impacted the compliance process. Medical device consultant Sophie Laurenson, Ph.D., outlines the major changes in the EU MDR and the consequence of these changes. Need to speak with an expert? Consult CER Writers and MDR experts on Kolabtree.\u00a0\u00a0 Introduction to CE Marking &amp; MDR In recent years, several high-profile incidents have highlighted the weaknesses in the Medical Device Directives (MDD) active in the European Union (EU). The Medical Device Regulation (MDR) was introduced to address these weaknesses and improve the performance and safety of medical<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":6280,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,317,443,540],"tags":[],"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>How to get a CE mark for your medical device (EU MDR)<\/title>\n<meta name=\"description\" content=\"The EU MDR has significantly impacted regulatory compliance for medical devices in the EU market. Read how you can get a CE Mark MDR.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to get a CE mark for your medical device (EU MDR)\" \/>\n<meta property=\"og:description\" content=\"The EU MDR has significantly impacted regulatory compliance for medical devices in the EU market. Read how you can get a CE Mark MDR.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2019-11-11T17:47:10+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-01-07T14:15:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/11\/CE-mark-EU-MDR.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=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"8\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"How to get a CE mark for your medical device (EU MDR)","description":"The EU MDR has significantly impacted regulatory compliance for medical devices in the EU market. 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