{"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-6a6a0c669697f\" 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-6a6a0c669697f\"><\/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><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/spotlight-kolabtrees-research-consultant-and-data-scientist-dr-cidila-d\/\">Literature search<\/a> results form a core part of the clinical evaluation report.A strong literature review process needs to be established so that all published literature relevant to the device is easily accessible and can support the claim being made. Literature reviews typically need the expertise of a skilled researcher who can identify the correct search term, use databases like PubMED or MEDLine, find relevant literature and appraise it, including using relevant references. The literature review should also address any questions that the clinical data is unable to answer.<\/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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