{"id":6459,"date":"2019-11-18T03:26:48","date_gmt":"2019-11-18T03:26:48","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6459"},"modified":"2020-10-30T17:27:47","modified_gmt":"2020-10-30T17:27:47","slug":"what-is-a-clinical-evaluation-report","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-clinical-evaluation-report\/","title":{"rendered":"\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u3068\u306f\uff1f"},"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-69f31ad91a205\" 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-69f31ad91a205\"><\/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\/what-is-a-clinical-evaluation-report\/#EU_MDR_and_CE_Marking\" title=\"EU MDR\u3068CE\u30de\u30fc\u30ad\u30f3\u30b0\">EU MDR\u3068CE\u30de\u30fc\u30ad\u30f3\u30b0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-clinical-evaluation-report\/#Clinical_Evaluation_Report\" title=\"\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\">\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-clinical-evaluation-report\/#Equivalence\" title=\"\u540c\u7b49\u6027\">\u540c\u7b49\u6027<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-clinical-evaluation-report\/#Literature_Review\" title=\"\u6587\u732e\u8abf\u67fb \">\u6587\u732e\u8abf\u67fb <\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-clinical-evaluation-report\/#How_long_does_it_take_to_write_a_CER\" title=\"CER\u306e\u4f5c\u6210\u306b\u306f\u3069\u306e\u304f\u3089\u3044\u306e\u6642\u9593\u304c\u304b\u304b\u308a\u307e\u3059\u304b\uff1f\u00a0\">CER\u306e\u4f5c\u6210\u306b\u306f\u3069\u306e\u304f\u3089\u3044\u306e\u6642\u9593\u304c\u304b\u304b\u308a\u307e\u3059\u304b\uff1f\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-clinical-evaluation-report\/#Clinical_Evaluation_Report_Writers\" title=\"\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u4f5c\u6210\u8005\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u4f5c\u6210\u8005<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-clinical-evaluation-report\/#How_to_hire_a_freelance_CER_writer\" title=\"\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\u30e9\u30a4\u30bf\u30fc\u3092\u96c7\u3046\u306b\u306f\u00a0\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\u30e9\u30a4\u30bf\u30fc\u3092\u96c7\u3046\u306b\u306f\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n<p>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=WhatisCER\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER<\/a> is a technical document required by <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 that want to sell or distribute products in Europe. The CER provides a comprehensive overview of the medical device design and composition, intended usage and applications, clinical trials analysis and outcomes, relevant literature reviews, protocols and instructions for use.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"EU_MDR_and_CE_Marking\"><\/span>EU MDR\u3068CE\u30de\u30fc\u30ad\u30f3\u30b0<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u6b27\u5dde\u306e\u533b\u7642\u6a5f\u5668\u306f\u3001EU\u306e\u898f\u5236\uff08MDD\u3001MDR\u3001IVDR\u306e\u3044\u305a\u308c\u304b\uff09\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u300cCE\u30de\u30fc\u30af\u300d\u306e\u53d6\u5f97\u304c\u5fc5\u8981\u3067\u3059\u3002\u6700\u8fd1\u306e\u6b27\u5dde\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u898f\u5236\u306f\u3001EU\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u30fb\u627f\u8a8d\u65b9\u6cd5\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u3066\u3044\u307e\u3059\u3002MDR\u306f\u300120\u5e74\u4ee5\u4e0a\u306b\u308f\u305f\u308b\u533b\u7642\u6a5f\u5668\u6cd5\u306e\u6700\u5927\u306e\u5909\u66f4\u70b9\u3067\u3059\u3002MDR\u306e\u4e3b\u306a\u5909\u66f4\u70b9\uff08MDD\u3068\u306e\u6bd4\u8f03\uff09\u306b\u306f\u3001\u6a5f\u5668\u306e\u5206\u985e\u3001\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306e\u6587\u66f8\u5316\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><strong>\u7d9a\u304d\u3092\u8aad\u3080 <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">\u533b\u7642\u6a5f\u5668\u306bCE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306e\u30d2\u30f3\u30c8<\/a><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Clinical_Evaluation_Report\"><\/span>\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>MDR\u3067\u306f\u3001CER\uff08Clinical Evaluation Report\uff09\u304c\u975e\u5e38\u306b\u91cd\u8996\u3055\u308c\u3066\u3044\u307e\u3059\u3002CER\u306f\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306e\u4e00\u90e8\u3092\u69cb\u6210\u3057\u307e\u3059\u3002\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3068\u306f\u3001\u898f\u5236\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u4e3b\u8981\u306a\u6587\u66f8\u3067\u3042\u308a\u3001\u6a5f\u5668\u306b\u95a2\u3059\u308b\u3059\u3079\u3066\u306e\u60c5\u5831\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001CER\u304c\u5341\u5206\u306b\u6e96\u5099\u3055\u308c\u3001\u3088\u304f\u7dad\u6301\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306b\u3001\u3044\u304f\u3064\u304b\u306e\u5bfe\u7b56\u3092\u8b1b\u3058\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002CER\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306f\u901a\u5e38\u30014\u3064\u306e\u30b9\u30c6\u30fc\u30b8\u3067\u69cb\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u6a5f\u5668\u306e\u7bc4\u56f2\u3001\u4f7f\u7528\u76ee\u7684\u3001\u6cbb\u7642\/\u8a3a\u65ad\u4e0a\u306e\u4e3b\u5f35\u306e\u5b9a\u7fa9<\/li>\n<li>\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u8b58\u5225\u3068\u59a5\u5f53\u6027\u306e\u78ba\u8a8d<\/li>\n<li>\u30c7\u30fc\u30bf\u3092\u5206\u6790\u3057\u3001\u8981\u4ef6\u3092\u3059\u3079\u3066\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u89e3\u91c8\u3059\u308b<\/li>\n<li>\u5e02\u8ca9\u5f8c\u8abf\u67fb\uff08PMS\uff09\u4e2d\u306b\u56de\u7b54\u304c\u5f97\u3089\u308c\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u30ea\u30b9\u30af\u3068\u4e0d\u78ba\u5b9f\u6027\u306e\u7279\u5b9a<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">CER\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u5b9a\u671f\u7684\u306b\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <\/span><span style=\"font-weight: 400;\">\u3053\u306e\u6587\u66f8\u306b\u306f\u3001MEDDEV 2.7\/1 Rev.4 Annex 1\uff08MDR \u306e\u5b89\u5168\u53ca\u3073\u6027\u80fd\u8981\u4ef6\uff09\u306e\u5fc5\u9808\u8981\u4ef6\uff08ER\uff09\u3078\u306e\u9069\u5408\u6027\u306e\u8a3c\u660e\u3092\u88cf\u4ed8\u3051\u308b\u81e8\u5e8a\u7684\u8a3c\u62e0\u304c\u542b\u307e\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u307e\u305f\u3001\u672c\u6587\u66f8\u306b\u306f\u3001\u6a5f\u5668\u306e\u7269\u7406\u7684\u30fb\u6280\u8853\u7684\u5074\u9762\u53ca\u3073\u69cb\u6210\u3092\u3001\u4f7f\u7528\u8aac\u660e\u66f8\u3068\u3068\u3082\u306b\u8a18\u8f09\u3059\u308b\u3002\u00a0<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-6464 size-full\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/11\/clinical-evaluation-report.jpg\" alt=\"\" width=\"904\" height=\"718\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/11\/clinical-evaluation-report.jpg 904w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/11\/clinical-evaluation-report-300x238.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/11\/clinical-evaluation-report-768x610.jpg 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/11\/clinical-evaluation-report-300x238@2x.jpg 600w\" sizes=\"(max-width: 904px) 100vw, 904px\" \/><\/p>\n<p><em>\u3067\u8aac\u660e\u3055\u308c\u3066\u3044\u308bCER\u306e4\u3064\u306e\u30b9\u30c6\u30fc\u30b8\u3002 <span style=\"font-weight: 400;\"><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/17522\/attachments\/1\/translations\/en\/renditions\/native\">MEDDEV 2.7\/ rev.4<\/a>.\u00a0<\/span><\/em><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Equivalence\"><\/span>\u540c\u7b49\u6027<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u81ea\u793e\u306e\u533b\u7642\u6a5f\u5668\u3084\u3001\u5b89\u5168\u6027\u3084\u81e8\u5e8a\u6027\u80fd\u304c\u5909\u308f\u3089\u306a\u3044\u540c\u7b49\u306e\u6a5f\u5668\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002MDR\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u88fd\u54c1\u304c\u540c\u7b49\u3067\u3042\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306b\u3001\u751f\u7269\u5b66\u7684\u3001\u6280\u8853\u7684\u3001\u81e8\u5e8a\u7684\u306e3\u3064\u306e\u8981\u7d20\u3092\u8003\u616e\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><strong>\u6280\u8853\u7684\u540c\u7b49\u6027<\/strong> \u3068\u306f\u3001\u6a5f\u5668\u306e\u8a2d\u8a08\u4ed5\u69d8\u3084\u69cb\u6210\u304c\u540c\u3058\u3067\u3042\u308a\u3001\u540c\u3058\u6761\u4ef6\u3067\u3001\u540c\u3058\u5c55\u958b\u65b9\u6cd5\u3084\u52d5\u4f5c\u539f\u7406\u3067\u4f7f\u7528\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002 <strong>\u81e8\u5e8a\u7684\u540c\u7b49\u6027<\/strong> \u3068\u306f\u3001\u8eab\u4f53\u306e\u540c\u3058\u5834\u6240\u3067\u3001\u540c\u3058\u96c6\u56e3\u306b\u5bfe\u3057\u3066\u3001\u540c\u3058\u75c7\u72b6\u3092\u6cbb\u7642\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u3001\u540c\u69d8\u306e\u6027\u80fd\u3092\u9054\u6210\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002<br \/>\n<strong>\u751f\u7269\u5b66\u7684\u540c\u7b49\u6027<\/strong> \u3068\u306f\u3001\u5f53\u8a72\u533b\u7642\u6a5f\u5668\u304c\u751f\u7269\u5b66\u7684\u30ea\u30b9\u30af\u3092\u5f15\u304d\u8d77\u3053\u3055\u306a\u3044\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002<\/p>\n<p>\u533b\u7642\u6a5f\u5668\u304c\u540c\u7b49\u6027\u3092\u8a3c\u660e\u3067\u304d\u306a\u3044\u5834\u5408\u3001\u3055\u3089\u306a\u308b\u81e8\u5e8a\u8abf\u67fb\u3092\u884c\u3046\u304b\u3001\u88fd\u54c1\u304b\u3089\u30af\u30ec\u30fc\u30e0\u3092\u524a\u9664\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Literature_Review\"><\/span>\u6587\u732e\u8abf\u67fb <b><\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u6587\u732e\u8abf\u67fb\u306e\u7d50\u679c\u306f\u3001\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u4e2d\u6838\u3092\u306a\u3059\u3082\u306e\u3067\u3059\u3002\u30c7\u30d0\u30a4\u30b9\u306b\u95a2\u9023\u3059\u308b\u3059\u3079\u3066\u306e\u51fa\u7248\u3055\u308c\u305f\u6587\u732e\u306b\u7c21\u5358\u306b\u30a2\u30af\u30bb\u30b9\u3067\u304d\u3001\u4e3b\u5f35\u3092\u88cf\u4ed8\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3088\u3046\u3001\u5f37\u529b\u306a\u6587\u732e\u8abf\u67fb\u30d7\u30ed\u30bb\u30b9\u3092\u78ba\u7acb\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u306b\u306f\u3001\u4e00\u822c\u7684\u306b\u3001\u6b63\u3057\u3044\u691c\u7d22\u7528\u8a9e\u3092\u7279\u5b9a\u3057\u3001PubMED\u3084MEDLine\u306a\u3069\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u4f7f\u7528\u3057\u3001\u95a2\u9023\u3059\u308b\u6587\u732e\u3092\u898b\u3064\u3051\u3001\u95a2\u9023\u3059\u308b\u53c2\u8003\u6587\u732e\u3092\u4f7f\u7528\u3059\u308b\u306a\u3069\u3057\u3066\u8a55\u4fa1\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u719f\u7df4\u3057\u305f\u7814\u7a76\u8005\u306e\u5c02\u9580\u77e5\u8b58\u304c\u5fc5\u8981\u3067\u3059\u3002\u307e\u305f\u3001\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u3067\u306f\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u3067\u306f\u7b54\u3048\u3089\u308c\u306a\u3044\u7591\u554f\u70b9\u3092\u89e3\u6c7a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_long_does_it_take_to_write_a_CER\"><\/span><b>CER\u306e\u4f5c\u6210\u306b\u306f\u3069\u306e\u304f\u3089\u3044\u306e\u6642\u9593\u304c\u304b\u304b\u308a\u307e\u3059\u304b\uff1f\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">CER\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u30c7\u30fc\u30bf\u3092\u7279\u5b9a\u30fb\u53ce\u96c6\u3057\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6cbf\u3063\u3066\u6587\u66f8\u3092\u4f5c\u6210\u3059\u308b\u306b\u306f\u3001\u6570\u9031\u9593\u304b\u3089\u6570\u30f6\u6708\u3092\u8981\u3057\u307e\u3059\u3002CE\u30de\u30fc\u30af\u53d6\u5f97\u5f8c\u3082\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\uff08PMS\uff09\u306f\u30d7\u30ed\u30bb\u30b9\u306e\u5927\u90e8\u5206\u3092\u5360\u3081\u3066\u304a\u308a\u3001PMS\u306f\u30e1\u30fc\u30ab\u30fc\u306e\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u4e2d\u6838\u3092\u6210\u3059\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u307e\u305f\u3001PMS\u306f\u30e1\u30fc\u30ab\u30fc\u306e\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u4e2d\u6838\u3092\u306a\u3059\u3082\u306e\u3067\u3059\u3002\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u3001\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u7a4d\u6975\u7684\u306b\u53ce\u96c6\u3057\u3001\u5b89\u5168\u6027\u3068\u6027\u80fd\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u304b\u3069\u3046\u304b\u3092\u8a55\u4fa1\u3059\u308bPMCF\uff08Post-Market Clinical Followup\uff09\u304c\u5fc5\u8981\u306b\u306a\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">CER\u306f\u9759\u7684\u306a\u6587\u66f8\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001EU\u3067\u306e\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3092\u7dad\u6301\u3057\u3001\u88fd\u54c1\u306e\u30ea\u30b3\u30fc\u30eb\u3092\u56de\u907f\u3057\u3001\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u7dad\u6301\u306b\u4f7f\u308f\u308c\u308b\u6642\u9593\u3068\u30ea\u30bd\u30fc\u30b9\u3092\u5408\u7406\u5316\u3059\u308b\u305f\u3081\u306b\u3001\u30b0\u30c3\u30c9\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3092\u53d6\u308a\u5165\u308c\u305f\u5f37\u56fa\u306a\u30d7\u30ed\u30bb\u30b9\u3068\u6226\u7565\u3092\u958b\u767a\u3059\u308b\u3053\u3068\u304c\u63a8\u5968\u3055\u308c\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p>CER\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\u3092\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u5c02\u9580\u5bb6\u306b\u59d4\u8a17\u3059\u308b\u3053\u3068\u3067\u3001\u8cb4\u91cd\u306a\u6642\u9593\u3068\u30a8\u30cd\u30eb\u30ae\u30fc\u3092\u7bc0\u7d04\u3059\u308b\u3053\u3068\u304c\u3067\u304d\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=CERTips\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u4f5c\u6210\u8005<\/a> \u306f\u3001Kolabtree\u30673,000\u7c73\u30c9\u30eb\u304b\u3089\u306eCER\u3092\u958b\u767a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Clinical_Evaluation_Report_Writers\"><\/span>\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u4f5c\u6210\u8005<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>CER\u3092\u4f5c\u6210\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u6642\u9593\u3068\u5c02\u9580\u77e5\u8b58\u306f\u3001\u793e\u5185\u306b\u5c02\u9580\u5bb6\u304c\u3044\u306a\u3044\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3084\u4e2d\u5c0f\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u30ea\u30bd\u30fc\u30b9\u306e\u8ca0\u62c5\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\u30e9\u30a4\u30bf\u30fc\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u30a2\u30ca\u30ea\u30b9\u30c8\u3001\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u306e\u5c02\u9580\u5bb6\u3001\u751f\u7269\u7d71\u8a08\u5b66\u8005\u3001\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306a\u3069\u3001\u5916\u90e8\u306e\u5c02\u9580\u5bb6\u3068\u5354\u529b\u3059\u308b\u3053\u3068\u3067\u3001\u4f01\u696d\u306fCER\u6226\u7565\u3092\u5f37\u56fa\u306a\u3082\u306e\u306b\u3057\u3001\u30c7\u30fc\u30bf\u304c\u3059\u3079\u3066\u691c\u8a3c\u3055\u308c\u3001\u6b63\u78ba\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_to_hire_a_freelance_CER_writer\"><\/span><b>\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\u30e9\u30a4\u30bf\u30fc\u3092\u96c7\u3046\u306b\u306f\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">CER\u30e9\u30a4\u30bf\u30fc\u306b\u6c42\u3081\u3089\u308c\u308b\u30b9\u30ad\u30eb\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u3084\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u3092\u6271\u3063\u305f\u7d4c\u9a13\u3001MEDDEV 2.7\/ rev.4\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068\u3001\u6cbb\u7642\u5206\u91ce\u306b\u95a2\u3059\u308b\u77e5\u8b58\u3001\u5f37\u3044\u5206\u6790\u80fd\u529b\u306a\u3069\u3067\u3059\u30024\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068\u3001\u6cbb\u7642\u9818\u57df\u306b\u95a2\u3059\u308b\u77e5\u8b58\u3001\u512a\u308c\u305f\u5206\u6790\u80fd\u529b\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002 <strong>Kolabtree\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u5c02\u9580\u5bb6\u96c6\u56e3\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u8cc7\u683c\u3092\u6301\u3064\u4eba\u304c\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/services\/clinical-evaluation-report-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u4f5c\u6210\u8005<\/a>\u306f\u3001\u3042\u306a\u305f\u304c\u5341\u5206\u306b\u8abf\u67fb\u3057\u305f\u4e0a\u3067CER\u3092\u307e\u3068\u3081\u308b\u304a\u624b\u4f1d\u3044\u3092\u3057\u307e\u3059\u3002\u3042\u306a\u305f\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3057\u3066\u3001\u5c02\u9580\u5bb6\u304b\u3089\u898b\u7a4d\u3082\u308a\u3092\u3082\u3089\u3046\u306e\u306f\u7121\u6599\u3067\u3059\u3002\u00a0 <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">\u30b9\u30bf\u30fc\u30c8<\/a><\/strong><\/span><\/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=WhatIsCER\">\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=WhatIsCER\">\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=WhatIsCER\">\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=WhatIsCER\">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=WhatIsCER\">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=WhatIsCER\">\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=WhatIsCER\">\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=WhatIsCER\">\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=WhatIsCER\">\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=WhatIsCER\">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=WhatIsCER\">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=WhatIsCER\">\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=WhatIsCER\">\u00a0\u88fd\u54c1\u958b\u767a\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u00a0<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>A clinical evaluation report (CER) is a technical document required by medical device companies that want to sell or distribute products in Europe. The CER provides a comprehensive overview of the medical device design and composition, intended usage and applications, clinical trials analysis and outcomes, relevant literature reviews, protocols and instructions for use. EU MDR and CE Marking Medical devices in Europe need to get a &#8220;CE Mark&#8221;, which indicates that the product complies with the EU regulations (MDD, MDR or IVDR, whichever is applicable). The recent Medical Device Regulations in Europe has significantly impacted the way medical devices are regulated and approved in the EU. The MDR is the<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-clinical-evaluation-report\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":6465,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,540,147],"tags":[498,499,500],"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>What is a Clinical Evaluation Report? - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"A clinical evaluation report (CER) is a document required by all medical devices that want to sell in Europe. Here&#039;s a quick guide.\" \/>\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\/what-is-a-clinical-evaluation-report\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What is a Clinical Evaluation Report?\" \/>\n<meta property=\"og:description\" content=\"A clinical evaluation report (CER) is a document required by all medical devices that want to sell in Europe. Here&#039;s a quick guide.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-clinical-evaluation-report\/\" \/>\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=\"2019-11-18T03:26:48+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-10-30T17:27:47+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/11\/what-is-clinical-evaluation-report.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1351\" \/>\n\t<meta property=\"og:image:height\" content=\"901\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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=\"5\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"What is a Clinical Evaluation Report? - The Kolabtree Blog","description":"A clinical evaluation report (CER) is a document required by all medical devices that want to sell in Europe. 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