{"id":6859,"date":"2020-02-07T11:52:11","date_gmt":"2020-02-07T11:52:11","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6859"},"modified":"2020-11-10T11:05:35","modified_gmt":"2020-11-10T11:05:35","slug":"medical-device-eu-mdr-compliance-challenges-and-resource-crunch","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-eu-mdr-compliance-challenges-and-resource-crunch\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306eEU MDR\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3002\u8ab2\u984c\u3068\u30ea\u30bd\u30fc\u30b9\u306e\u903c\u8feb"},"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-69f2f2c5f3093\" 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-69f2f2c5f3093\"><\/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-eu-mdr-compliance-challenges-and-resource-crunch\/#EU_MDR_Resource_Crunch\" title=\"EU MDR\uff1a\u30ea\u30bd\u30fc\u30b9\u30fb\u30af\u30e9\u30f3\u30c1\">EU MDR\uff1a\u30ea\u30bd\u30fc\u30b9\u30fb\u30af\u30e9\u30f3\u30c1<\/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-eu-mdr-compliance-challenges-and-resource-crunch\/#Barriers_to_EU_MDR_compliance\" title=\"EU MDR\u9075\u5b88\u306e\u969c\u58c1\">EU MDR\u9075\u5b88\u306e\u969c\u58c1<\/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-eu-mdr-compliance-challenges-and-resource-crunch\/#Working_with_MDR_consultants\" title=\"MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u306e\u9023\u643a\u00a0\">MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u306e\u9023\u643a\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n<p><span style=\"font-weight: 400;\"><em>\u672c\u8a18\u4e8b\u3067\u306f\u3001\u305d\u306e\u8ab2\u984c\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">\u533b\u7642\u6a5f\u5668<\/a> \u30e1\u30fc\u30ab\u30fc\u304c\u76f4\u9762\u3057\u3066\u3044\u308b\u306e\u306f <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-compliance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">EU MDR\u5bfe\u5fdc<\/a> \u3092\u5229\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3057\u305f\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\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=MDRResourceCrunch\">MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u3092\u89e3\u6c7a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3057\u305f\u3002\u00a0<\/em><\/span><\/p>\n<blockquote><p><strong>Update 13 May 2020: The EU MDR Is now postponed to 26 May 2021 in light of COVID-19. This gives <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u533b\u7642\u6a5f\u5668<\/a> companies more time to prepare for it. This article will be updated as we have more data.\u00a0<\/strong><\/p><\/blockquote>\n<p>EU MDR\u306f\u3001\u6b27\u5dde\u5e02\u5834\u306b\u6295\u5165\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u898f\u5236\u3067\u3059\u3002\u65e2\u5b58\u306e\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08MDD\uff09\u306b\u4ee3\u308f\u308b\u3082\u306e\u3068\u3057\u3066\u30012017\u5e74\u306b\u5c0e\u5165\u3055\u308c\u307e\u3057\u305f\u3002\u5e02\u5834\u3067\u88fd\u54c1\u3092\u8ca9\u58f2\u3057\u3088\u3046\u3068\u3059\u308b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u73fe\u5728\u3001CE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306bMDR 2017\/745\u306b\u6e96\u62e0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3059\u3067\u306b\u5e02\u5834\u306b\u9032\u51fa\u3057\u3066\u3044\u308b\u65e2\u5b58\u306e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u65b0\u898f\u5236\u306b\u5408\u308f\u305b\u3066\u6280\u8853\u6587\u66f8\u3084\u30d7\u30ed\u30bb\u30b9\u3092\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u305d\u306e\u671f\u9650\u306f2020\u5e745\u670826\u65e5\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><span style=\"font-weight: 400;\">EU\u57df\u5185\u3067\u8ca9\u58f2\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u306b\u306f\u3001CE\u30de\u30fc\u30af\u306e\u8cbc\u4ed8\u304c\u5fc5\u8981\u3067\u3059\u3002EU\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3092\u8a8d\u8a3c\u3059\u308b\u6a29\u9650\u3092\u6301\u3064Notified Bodies\u3092\u6307\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002\u4eca\u56de\u306e\u898f\u5236\u3067\u306f\u3001\u5b89\u5168\u6027\u3068\u6027\u80fd\u306e\u5411\u4e0a\u3092\u76ee\u7684\u3068\u3057\u3066\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306e\u6587\u66f8\u5316\u3001\u540c\u7b49\u6027\u306e\u4e3b\u5f35\u3001\u81e8\u5e8a\u8a55\u4fa1\u3001\u6a5f\u5668\u306e\u5206\u985e\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306a\u3069\u304c\u5909\u66f4\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"EU_MDR_Resource_Crunch\"><\/span>EU MDR\uff1a\u30ea\u30bd\u30fc\u30b9\u30fb\u30af\u30e9\u30f3\u30c1<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u671f\u9650\u307e\u3067\u3042\u3068\u6570\u30f6\u6708\u3057\u304b\u306a\u3044\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u898f\u5236\u5f53\u5c40\u306e\u5c02\u9580\u5bb6\u3084\u533b\u7642\u6a5f\u5668\u4f01\u696d\u306e\u9593\u3067\u306f\u3001\u305d\u308c\u304c\u5b9f\u969b\u306b\u4f55\u3092\u610f\u5473\u3059\u308b\u306e\u304b\u304c\u4e0d\u900f\u660e\u3067\u3059\u3002\u696d\u754c\u3067\u306f\u3001MDR\u898f\u5236\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7406\u89e3\u3057\u3001\u5b9f\u884c\u3067\u304d\u308b\u5c02\u9580\u5bb6\u306e\u30ea\u30bd\u30fc\u30b9\u304c\u8457\u3057\u304f\u4e0d\u8db3\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<blockquote><p>\u7269\u4e8b\u3092\u6574\u7406\u3059\u308b\u3068\u00a0<span style=\"font-weight: 400;\">\u6b27\u5dde\u306b\u306f\u7d0427,000\u793e\u306e\u533b\u7642\u6280\u8853\u95a2\u9023\u4f01\u696d\u304c\u3042\u308a\u307e\u3059\u3002 <\/span><a href=\"https:\/\/mapmedtech.com\/2019\/06\/medtech-europe-publish-the-european-medical-technology-industry-in-figures-2019\/\"><span style=\"font-weight: 400;\">\u305d\u306e\u3046\u3061\u300195%<\/span><\/a><span style=\"font-weight: 400;\"> \u306f\u4e2d\u5c0f\u4f01\u696d\u3067\u3042\u308b\u3002\u3053\u306e\u3088\u3046\u306a\u4f01\u696d\u306e\u591a\u304f\u306f\u3001MDR\u306e\u8981\u6c42\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u793e\u5185\u30ea\u30bd\u30fc\u30b9\u3092\u6301\u3063\u3066\u3044\u306a\u3044\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u9075\u5b88\u3057\u306a\u3051\u308c\u3070\u3001\u88fd\u54c1\u304cEU\u5e02\u5834\u304b\u3089\u5b8c\u5168\u306b\u6392\u9664\u3055\u308c\u308b\u30ea\u30b9\u30af\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u696d\u754c\u3067\u4e2d\u5c0f\u4f01\u696d\u304c\u6025\u6210\u9577\u3057\u3066\u3044\u308b\u7406\u7531\u306e\u4e00\u3064\u306f\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u901f\u5ea6\u306b\u3082\u3042\u308a\u307e\u3059\u30022007\u5e74\u304b\u30892017\u5e74\u306e\u9593\u306b\u3001\u533b\u7642\u6280\u8853\u306b\u95a2\u3059\u308b\u6b27\u5dde\u306e\u7279\u8a31\u51fa\u9858\u6570\u306f\u7d0450%\u5897\u52a0\u3057\u307e\u3057\u305f\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Barriers_to_EU_MDR_compliance\"><\/span>EU MDR\u9075\u5b88\u306e\u969c\u58c1<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>EU MDR\u306f\u3001\u3053\u306e20\u5e74\u4ee5\u4e0a\u306e\u9593\u306b\u884c\u308f\u308c\u305f\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u6700\u5927\u306e\u5909\u66f4\u70b9\u306e\u4e00\u3064\u3067\u3059\u3002\u3044\u304f\u3064\u304b\u306e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u65b0\u3057\u3044\u8981\u6c42\u4e8b\u9805\u3092\u6e80\u305f\u3059\u305f\u3081\u306e\u30ea\u30bd\u30fc\u30b9\u3084\u5c02\u9580\u77e5\u8b58\u304c\u4e0d\u8db3\u3057\u3066\u3044\u308b\u3068\u611f\u3058\u3066\u3044\u307e\u3059\u3002\u4f01\u696d\u304c\u76f4\u9762\u3057\u3066\u3044\u308b\u8ab2\u984c\u306b\u306f\u6b21\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><strong>\u30ec\u30ae\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u660e\u78ba\u6027\u306e\u6b20\u5982<\/strong><br \/>\n<span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">RAPS\/KPMG\u304c\u6700\u8fd1\u5b9f\u65bd\u3057\u305f\u8abf\u67fb\u306b\u3088\u308b\u3068\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e78%\u4ee5\u4e0a\u304cEU MDR\u3092\u5341\u5206\u306b\u7406\u89e3\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u304c\u308f\u304b\u308a\u307e\u3057\u305f\u3002EU MDR\u306e\u5909\u66f4\u70b9\u306f\u591a\u5c90\u306b\u308f\u305f\u308b\u305f\u3081\u3001\u4f01\u696d\u306fMDR\u306e\u5b8c\u5168\u5b9f\u65bd\u306b\u5411\u3051\u3066\u5305\u62ec\u7684\u306a\u8a08\u753b\u3092\u7acb\u3066\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5909\u66f4\u70b9\u306e\u591a\u304f\u306f\u3001\u7d44\u7e54\u5185\u3060\u3051\u3067\u306a\u304f\u3001\u30d3\u30b8\u30cd\u30b9\u30d1\u30fc\u30c8\u30ca\u30fc\u3084\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u3068\u306e\u9593\u306e\u8907\u6570\u306e\u6a5f\u80fd\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3057\u307e\u3059\u3002 <\/span><\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u30e9\u30a4\u30bf\u30fc<\/a> \u30d0\u30b5\u30c3\u30af\u30fb\u30a8\u30eb\u30dd\u30e9\u30fc\u30c8\u306f\u8a00\u3046\u3002<\/span><\/span><br \/>\n\"M<span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001MDR\u306e\u8981\u4ef6\u3068\u305d\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306e\u91cd\u5927\u6027\u3092\u307e\u3060\u7406\u89e3\u3057\u3066\u3044\u307e\u305b\u3093\u3002\u7686\u304c\u982d\u3092\u60a9\u307e\u305b\u3066\u3044\u308b\u306e\u306f\u3001CER\u3068 \"\u5341\u5206\u306a\u81e8\u5e8a\u7684\u8a3c\u62e0 \"\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805\u306e\u3088\u3046\u3067\u3059\u300d\u3002\u307e\u305f\u3001Erpolat\u6c0f\u306f\u3001\u533b\u7642\u6a5f\u5668\u304c\u540c\u7b49\u6027\u3092\u4e3b\u5f35\u3059\u308b\u3053\u3068\u304c\u975e\u5e38\u306b\u96e3\u3057\u304f\u306a\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u4f4e\u30ea\u30b9\u30af\u306e\u6a5f\u5668\u306b\u3064\u3044\u3066\u5341\u5206\u306a\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u6301\u305f\u306a\u3044\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u306f\u5371\u6a5f\u7684\u306a\u72b6\u6cc1\u3067\u3059\u3002<\/span><\/p><\/blockquote>\n<p><strong>\u719f\u7df4\u3057\u305f\u30d7\u30ed\u30d5\u30a7\u30c3\u30b7\u30e7\u30ca\u30eb\u3078\u306e\u30a2\u30af\u30bb\u30b9\u306e\u6b20\u5982\u00a0<\/strong><br \/>\nMDR\u306e\u5c0e\u5165\u3092\u652f\u63f4\u3067\u304d\u308b\u5c02\u9580\u5bb6\u306e\u30d7\u30fc\u30eb\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u304b\u306a\u308a\u5c11\u306a\u3044\u3002<br \/>\n\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u5fc5\u8981\u3068\u3059\u308b\u4eba\u6750\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3002\u719f\u7df4\u3057\u305f\u5c02\u9580\u5bb6\u306e\u78ba\u4fdd\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u4e2d\u5c0f\u4f01\u696d\u304c\u76f4\u9762\u3059\u308b\u6700\u5927\u306e\u8ab2\u984c\u306e\u4e00\u3064\u3067\u3059\u3002Kolabtree\u793e\u3067\u306f\u3001\u9ad8\u30ea\u30b9\u30af\u306e\u533b\u7642\u6a5f\u5668\u3092\u542b\u3080\u3055\u307e\u3056\u307e\u306a\u30af\u30e9\u30b9\u306e\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\u30e9\u30a4\u30bf\u30fc\u3092\u6c42\u3081\u308b\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u304c\u5897\u3048\u3066\u3044\u308b\u3068\u3044\u3046\u3002\u65e2\u5b58\u306e\u4f01\u696d\u306f\u793e\u5185\u306b\u5c02\u9580\u5bb6\u30c1\u30fc\u30e0\u3092\u7f6e\u304f\u4f59\u88d5\u304c\u3042\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u304c\u3001\u4e2d\u5c0f\u4f01\u696d\u306f\u30aa\u30f3\u30c7\u30de\u30f3\u30c9\u3067\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u4ed5\u4e8b\u3092\u3057\u305f\u3044\u3068\u8003\u3048\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><strong>\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u306e\u6307\u5b9a\u306e\u9045\u308c\u00a0<\/strong><br \/>\n\u591a\u304f\u306e\u65e2\u5b58\u306e <a href=\"https:\/\/www.medtechdive.com\/news\/disruption-eu-mdr-notified-bodies-shortage-dive-awards\/564884\/\">\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u306f\u904e\u8ca0\u8377<\/a> \u3067\u3001\u305d\u306e\u4f5c\u696d\u91cf\u306b\u8ffd\u3044\u3064\u304f\u306e\u306b\u82e6\u52b4\u3057\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u6307\u5b9aNB\u306e\u9045\u308c\u3082\u3042\u308a\u3001\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u306f\u5f85\u3061\u6642\u9593\u304c\u3055\u3089\u306b\u9577\u304f\u306a\u3063\u3066\u3044\u308b\u3002 <span style=\"font-weight: 400;\">2020\u5e741\u6708\u73fe\u5728\u3001MDR\u8a8d\u8a3c\u304c\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u306f55\u793e\u4e2d9\u793e\u306e\u307f\u3002\u00a0<\/span><span style=\"font-weight: 400;\">\u307e\u305f\u3001RAPS\/KPMG\u306e\u8abf\u67fb\u3067\u306f\u300135%\u306e\u4f01\u696d\u304c\u3001\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u306e\u4e0d\u8db3\u304c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u969c\u5bb3\u306b\u306a\u3063\u3066\u3044\u308b\u3068\u611f\u3058\u3066\u3044\u308b\u3053\u3068\u304c\u5831\u544a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">MDR\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u306f\u6642\u9593\u3068\u30b3\u30b9\u30c8\u304c\u304b\u304b\u308b\u305f\u3081\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u7c21\u5358\u304b\u3064\u8fc5\u901f\u306b\u88fd\u54c1\u3092\u767a\u58f2\u3067\u304d\u308b\u4e2d\u56fd\u3084\u97d3\u56fd\u306a\u3069\u306e\u4ee3\u66ff\u5e02\u5834\u306b\u3082\u76ee\u3092\u5411\u3051\u59cb\u3081\u3066\u3044\u307e\u3059\u3002 <\/span><span style=\"font-weight: 400;\">RAPS\/KPMG\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u3046\u306143%\u304cEU\u5e02\u5834\u304b\u3089\u306e\u64a4\u9000\u3092\u8a08\u753b\u3057\u3066\u3044\u308b\u3068\u5831\u544a\u3057\u3066\u3044\u307e\u3059\u3002\u00a0\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Working_with_MDR_consultants\"><\/span><b>MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u306e\u9023\u643a\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">MDR\u306e\u5c02\u9580\u5bb6\u306b\u7c21\u5358\u306b\u30a2\u30af\u30bb\u30b9\u3067\u304d\u306a\u3044\u3053\u3068\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u4e2d\u5c0f\u4f01\u696d\u306b\u3068\u3063\u3066\u6df1\u523b\u306a\u969c\u5bb3\u3068\u306a\u3063\u3066\u304a\u308a\u3001\u4e88\u7b97\u3084\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306e\u5236\u7d04\u304c\u52a0\u308f\u308b\u3053\u3068\u3067\u3001EU\u5e02\u5834\u3067\u751f\u304d\u6b8b\u308b\u3053\u3068\u304c\u3067\u304d\u306a\u304f\u306a\u3063\u3066\u3057\u307e\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u30aa\u30f3\u30c7\u30de\u30f3\u30c9\u306e\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u5229\u7528\u3057\u3001\u5c02\u9580\u5bb6\u306b\u76f4\u63a5\u30bf\u30b9\u30af\u3092\u59d4\u8a17\u3059\u308b\u3053\u3068\u306f\u3001\u30b9\u30ad\u30eb\u30ae\u30e3\u30c3\u30d7\u3092\u89e3\u6c7a\u3059\u308b\u4e00\u3064\u306e\u65b9\u6cd5\u3067\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30a8\u30eb\u30dd\u30e9\u30c3\u30c8\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u7a2e\u985e\u306b\u304b\u304b\u308f\u3089\u305a\u3001\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u4f5c\u6210\u8005\u306e\u9700\u8981\u304c\u6025\u5897\u3057\u3066\u3044\u308b\u3053\u3068\u306b\u6c17\u3065\u3044\u305f\u3068\u8aac\u660e\u3057\u307e\u3059\u3002\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u306b\u306fCER\u6587\u66f8\u304c\u5fc5\u8981\u3067\u3059\u3002CER\u6587\u66f8\u306b\u306f\u3001\u3059\u3079\u3066\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u8a55\u4fa1\u60c5\u5831\u3001\u5b89\u5168\u6027\u3068\u6027\u80fd\u306b\u95a2\u3059\u308b\u6307\u793a\u3001\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u3053\u306e\u4f5c\u696d\u3092\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30b9\u30da\u30b7\u30e3\u30ea\u30b9\u30c8\u306b\u4f9d\u983c\u3059\u308b\u3053\u3068\u3067\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u8cb4\u91cd\u306a\u6642\u9593\u3068\u30b3\u30b9\u30c8\u3092\u524a\u6e1b\u3057\u3001\u5e02\u5834\u304b\u3089\u6392\u9664\u3055\u308c\u308b\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u307e\u305f\u3001\u591a\u304f\u306e\u4e2d\u5c0f\u4f01\u696d\u306f\u3001\u4eca\u5f8c\u306e\u65b9\u5411\u6027\u304c\u5b9a\u307e\u3063\u3066\u3044\u307e\u305b\u3093\u3002\u6cd5\u898f\u5236\u9075\u5b88\u306e\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u308b\u65e2\u5b58\u306e\u7d44\u7e54\u3082\u3042\u308a\u307e\u3059\u304c\u3001\u305d\u308c\u3089\u306f\u3088\u308a\u8907\u96d1\u306a\u30d7\u30ed\u30bb\u30b9\u3084\u5951\u7d04\u3092\u4f34\u3044\u307e\u3059\u3002Kolabtree\u306eMDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306f\u3001\u6cd5\u898f\u5236\u6226\u7565\u3001EU MDR\u30ae\u30e3\u30c3\u30d7\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3001\u7279\u5b9a\u306e\u8cea\u554f\u306b\u76f4\u63a5\u30a2\u30c9\u30d0\u30a4\u30b9\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u30d7\u30ed\u30bb\u30b9\u3092\u3088\u308a\u7c21\u5358\u306b\u3001\u3088\u308a\u65e9\u304f\u3001\u3088\u308a\u82e6\u75db\u306a\u304f\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n<p><strong>\u533b\u7642\u6a5f\u5668\u306e\u6cd5\u898f\u5236\u5bfe\u5fdc\u3067\u304a\u56f0\u308a\u3067\u3059\u304b\uff1f\u533b\u7642\u6a5f\u5668\u62c5\u5f53\u8005\u3068\u8a71\u3059 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations-mdr\">EU MDR\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a> \u306eKolabtree\u3067\u3001\u307e\u305f\u306f\u3001\u76f4\u63a5\u4ed5\u4e8b\u3092\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u30e9\u30a4\u30bf\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>\u95a2\u9023\u3059\u308b\u5c02\u9580\u5bb6<\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\u30e9\u30a4\u30bf\u30fc<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">EU MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">FDA\u63d0\u51fa\u66f8\u985e<\/a> | <a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">\u6587\u732e\u691c\u7d22\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-compliance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">\u898f\u5236\u9075\u5b88\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">\u30af\u30ea\u30cb\u30ab\u30eb\u30fb\u30c8\u30e9\u30a4\u30a2\u30eb\u30fb\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30e9\u30a4\u30bf\u30fc<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/post-market-surveillance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">PMS\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c4<\/a> | <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=MDRResourceCrunch\">PMCF\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c4<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">\u751f\u7269\u7d71\u8a08\u5b66\u306e\u5c02\u9580\u5bb6<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>This article outlines the challenges medical device manufacturers are facing with EU MDR compliance and the availability of freelance CER writers and MDR consultants as a solution.\u00a0 Update 13 May 2020: The EU MDR Is now postponed to 26 May 2021 in light of COVID-19. This gives medical device companies more time to prepare for it. This article will be updated as we have more data.\u00a0 The EU MDR is a new medical device regulation that affects all medical devices placed in the European market. It was introduced in 2017 to replace the existing Medical Device Directive (MDD). Any medical device company that wants to sell their products in the<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-eu-mdr-compliance-challenges-and-resource-crunch\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":6874,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,540],"tags":[499,535,474],"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 EU MDR Compliance: Challenges and Resource Crunch<\/title>\n<meta name=\"description\" content=\"An outline of challenges and barriers medical device manufacturers are facing with EU MDR Compliance and how to overcome them.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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