{"id":6961,"date":"2020-02-17T12:56:43","date_gmt":"2020-02-17T12:56:43","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6961"},"modified":"2020-10-28T11:30:13","modified_gmt":"2020-10-28T11:30:13","slug":"clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/","title":{"rendered":"EU MDR\u6e96\u62e0\u306e\u305f\u3081\u306e\u81e8\u5e8a\u8a55\u4fa1\u30025\u3064\u306e\u884c\u52d5\u6307\u91dd\u3068\u6ce8\u610f\u70b9"},"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-69f4c39a9a246\" 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-69f4c39a9a246\"><\/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\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/#1_DO_Be_proactive\" title=\"1.DO:\u7a4d\u6975\u7684\u306b\u884c\u52d5\u3059\u308b\">1.DO:\u7a4d\u6975\u7684\u306b\u884c\u52d5\u3059\u308b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/#2_DO_Understand_applicable_requirements\" title=\"2.DO:\u8a72\u5f53\u3059\u308b\u300d\u8981\u6c42\u4e8b\u9805\u306e\u7406\u89e3\">2.DO:\u8a72\u5f53\u3059\u308b\u300d\u8981\u6c42\u4e8b\u9805\u306e\u7406\u89e3<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/#3_DO_Be_systematic_and_structured\" title=\"3.DO:\u4f53\u7cfb\u7684\u3001\u69cb\u9020\u7684\u3067\u3042\u308b\u3053\u3068\">3.DO:\u4f53\u7cfb\u7684\u3001\u69cb\u9020\u7684\u3067\u3042\u308b\u3053\u3068<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/#4_DO_Make_your_clinical_evaluation_a_living_process\" title=\"4.DO:\u81e8\u5e8a\u8a55\u4fa1\u3092 &quot;\u751f\u304d\u305f\u30d7\u30ed\u30bb\u30b9 &quot;\u306b\u3059\u308b\">4.DO:\u81e8\u5e8a\u8a55\u4fa1\u3092 \"\u751f\u304d\u305f\u30d7\u30ed\u30bb\u30b9 \"\u306b\u3059\u308b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/#5_DO_Collaborate_with_experts\" title=\"5.DO:\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u3068\u306e\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\">5.DO:\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u3068\u306e\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/#6_DONT_Rely_on_Grandfathering\" title=\"6.DON&#039;T:\u30b0\u30e9\u30f3\u30c9\u30d5\u30a1\u30b6\u30ea\u30f3\u30b0\u306b\u983c\u308b\">6.DON'T:\u30b0\u30e9\u30f3\u30c9\u30d5\u30a1\u30b6\u30ea\u30f3\u30b0\u306b\u983c\u308b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/#7_DONT_Fall_for_the_simplicity_old_technology_or_low-risk_class_of_your_devices\" title=\"7.DON&#039;T\u30c7\u30d0\u30a4\u30b9\u306e\u300c\u30b7\u30f3\u30d7\u30eb\u3055\u3001\u53e4\u3044\u6280\u8853\u3001\u4f4e\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u300d\u306b\u9a19\u3055\u308c\u3066\u306f\u3044\u3051\u307e\u305b\u3093\u3002\">7.DON'T\u30c7\u30d0\u30a4\u30b9\u306e\u300c\u30b7\u30f3\u30d7\u30eb\u3055\u3001\u53e4\u3044\u6280\u8853\u3001\u4f4e\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u300d\u306b\u9a19\u3055\u308c\u3066\u306f\u3044\u3051\u307e\u305b\u3093\u3002<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/#8_DONT_Claim_equivalence_if_you_dont_have_a_certain_amount_of_data_belongs_to_your_competitor\" title=\"8.DON&#039;T:\u7af6\u5408\u4ed6\u793e\u306e\u300c\u3042\u308b\u4e00\u5b9a\u306e\u30c7\u30fc\u30bf\u300d\u3092\u6301\u3063\u3066\u3044\u306a\u3044\u5834\u5408\u3001\u540c\u7b49\u6027\u3092\u4e3b\u5f35\u3059\u308b\u3002\">8.DON'T:\u7af6\u5408\u4ed6\u793e\u306e\u300c\u3042\u308b\u4e00\u5b9a\u306e\u30c7\u30fc\u30bf\u300d\u3092\u6301\u3063\u3066\u3044\u306a\u3044\u5834\u5408\u3001\u540c\u7b49\u6027\u3092\u4e3b\u5f35\u3059\u308b\u3002<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/#9_DONT_Underestimate_the_power_of_post-market_clinical_follow-up\" title=\"9.DON&#039;T\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u306e\u529b\u3092\u904e\u5c0f\u8a55\u4fa1\u3059\u308b\u3053\u3068\">9.DON'T\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u306e\u529b\u3092\u904e\u5c0f\u8a55\u4fa1\u3059\u308b\u3053\u3068<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/#10_DONT_Forget_that_Medical_Device_Regulation_now_covers_more_than_Medical_Devices\" title=\"10.DON&#039;T\u533b\u7642\u6a5f\u5668\u898f\u5236\u300d\u306f\u4eca\u3084\u300c\u533b\u7642\u6a5f\u5668\u300d\u4ee5\u4e0a\u306e\u3082\u306e\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u5fd8\u308c\u3066\u306f\u306a\u3089\u306a\u3044\u3002\">10.DON'T\u533b\u7642\u6a5f\u5668\u898f\u5236\u300d\u306f\u4eca\u3084\u300c\u533b\u7642\u6a5f\u5668\u300d\u4ee5\u4e0a\u306e\u3082\u306e\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u5fd8\u308c\u3066\u306f\u306a\u3089\u306a\u3044\u3002<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>\u30d0\u30b5\u30c3\u30af\u30fb\u30a8\u30eb\u30dd\u30e9\u30fc\u30c8 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations-mdr?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CER-DosDonts\">MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u305d\u3057\u3066 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CER-DosDonts\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\u30e9\u30a4\u30bf\u30fc<\/a> \u306e\u305f\u3081\u306b\u5f93\u3046\u3079\u304d\u30d9\u30b9\u30c8\u30fb\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3092\u6319\u3052\u3066\u3044\u307e\u3059\u3002\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=CER-DosDonts\">\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a55\u4fa1<\/a> \u3092\u8a08\u753b\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CER-DosDonts\">EU MDR\u5bfe\u5fdc<\/a>. <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/basak-erpolat?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CER-DosDonts\">\u30d0\u30b5\u30c3\u30af<\/a> \u306f\u300180\u4ee5\u4e0a\u306eMDD\/MDR\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u643a\u308f\u3063\u3066\u304d\u307e\u3057\u305f\u3002<br \/>\n<\/em><\/p>\n<p><span style=\"font-weight: 400;\">\u65b0\u3057\u3044\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08MDR 2017\/745\uff09\u306f\u30012007\/47\/EC\u3067\u6539\u6b63\u3055\u308c\u305f\u73fe\u884c\u306e\u533b\u7642\u6a5f\u5668\u6307\u4ee4MDD 93\/42\/EEC\u306b\u307e\u3082\u306a\u304f\u53d6\u3063\u3066\u4ee3\u308f\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002\u3053\u306e\u65b0\u898f\u5247\u3067\u306f\u3001\u73fe\u5728MDD\u3067\u30ab\u30d0\u30fc\u3055\u308c\u3066\u3044\u308b\u898f\u5236\u4e8b\u9805\u304c\u5927\u5e45\u306b\u6539\u8a02\u3055\u308c\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u5168\u304f\u65b0\u3057\u3044\u8981\u4ef6\u304c\u5c0e\u5165\u3055\u308c\u307e\u3059\u3002 <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=CER-DosDonts\">CE\u30de\u30fc\u30af\u53d6\u5f97<\/a> \u3092\u3001\u81ea\u793e\u88fd\u54c1\u3068Competent Authority\/Notified Body\u306e\u30ec\u30d3\u30e5\u30a2\u30fc\u306b\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u30022017\u5e74\u306bMDR\u304c\u767a\u8868\u3055\u308c\u305f\u77ac\u9593\u304b\u3089\u3001\u533b\u7642\u6a5f\u5668\u30bb\u30af\u30bf\u30fc\u306f\u3001\u65b0\u3057\u3044\u8981\u6c42\u4e8b\u9805\u306e\u7bc4\u56f2\u3084\u81ea\u793e\u306e\u6a5f\u5668\u3078\u306e\u5f71\u97ff\u3092\u7406\u89e3\u3057\u3088\u3046\u3068\u52aa\u529b\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u30b0\u30ec\u30fc\u30be\u30fc\u30f3\u3084\u3001\u3059\u3079\u3066\u306e\u30ea\u30b9\u30af\u30af\u30e9\u30b9\uff08\u30af\u30e9\u30b9I\u3001IIa\u3001IIb\u3001III\uff09\u306e\u6a5f\u5668\u306b\u3059\u3079\u3066\u306e\u8981\u6c42\u4e8b\u9805\u304c\u9069\u7528\u3055\u308c\u308b\u304b\u3069\u3046\u304b\u306b\u3064\u3044\u3066\u3082\u8b70\u8ad6\u3055\u308c\u3066\u304d\u307e\u3057\u305f\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3068\u306f\u3044\u3048\u3001\u6700\u3082\u30db\u30c3\u30c8\u306a\u8a71\u984c\u306e\u4e00\u3064\u304c\u300c\u81e8\u5e8a\u8a55\u4fa1\u300d\u3067\u3042\u308b\u3053\u3068\u306f\u78ba\u304b\u3067\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u30015\u670826\u65e5\u306e\u671f\u9650\u307e\u3067\u306b\u3001MDR\u306b\u57fa\u3065\u304fCE\u30de\u30fc\u30af\u306e\u627f\u8a8d\u3092\u3067\u304d\u308b\u3060\u3051\u7c21\u5358\u306b\u5f97\u308b\u305f\u3081\u306b\u3001\u5b9f\u969b\u306e\u8981\u6c42\u4e8b\u9805\u3060\u3051\u3067\u306a\u304f\u3001\u300c\u96a0\u308c\u305f\u30c8\u30ea\u30c3\u30af\u300d\u3092\u51e6\u7406\u3057\u3088\u3046\u3068\u3057\u307e\u3057\u305f\u3002<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\">, 2020.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001MDR\u306e\u9075\u5b88\u3092\u5b9f\u73fe\u3059\u308b\u305f\u3081\u306b\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u81e8\u5e8a\u8a55\u4fa1\u3092\u884c\u3046\u969b\u306e5\u3064\u306eDO\u3068DON'T\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_DO_Be_proactive\"><\/span>1.DO:\u7a4d\u6975\u7684\u306b\u884c\u52d5\u3059\u308b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u7a4d\u6975\u7684\u306b\u884c\u52d5\u3059\u308b\u3053\u3068\u304cMDR\u5bfe\u5fdc\u306e\u6700\u3082\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8\u3067\u3042\u308b\u3053\u3068\u306f\u3001\u81ea\u660e\u306e\u7406\u3067\u306f\u306a\u3044\u3067\u3057\u3087\u3046\u304b\u3002\u3057\u304b\u3057\u3001\u307b\u3068\u3093\u3069\u306e\u30e1\u30fc\u30ab\u30fc\u306f\u30012019\u5e74\u672b\u307e\u3067\u3001MDR\u306e\u5ef6\u671f\u3092\u5f85\u3063\u3066\u3044\u307e\u3057\u305f\u3002\u6b27\u5dde\u59d4\u54e1\u4f1a\u304cMDR\u306e\u8981\u6c42\u4e8b\u9805\u306b\u5408\u308f\u305b\u308b\u305f\u3081\u306b\u596e\u95d8\u3057\u3066\u3044\u308b\u59ff\u3092\u898b\u3066\u307b\u3057\u3044\u3068\u9858\u3063\u3066\u3044\u305f\u306e\u3067\u3059\u3002\u3055\u3089\u306b\u7c73\u56fd\u306f\u3001EU\u5e02\u5834\u306b\u304a\u3051\u308b\u81ea\u793e\u306e\u73fe\u5728\u306e\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u3092\u5b88\u308b\u305f\u3081\u306b\u3001MDR\u3068IVDR\u306e\u4e21\u65b9\u30923\u5e74\u9045\u3089\u305b\u308b\u3088\u3046\u3001EU\u306b\u7279\u5225\u306b\u8981\u8acb\u3057\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u305d\u308c\u306f\u5b9f\u73fe\u3057\u307e\u305b\u3093\u3067\u3057\u305f\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4eca\u3084\u8ab0\u3082\u304c\u30012020\u5e745\u6708\u306bMDD\u306b\u4ee3\u308f\u3063\u3066MDR\u304c\u5c0e\u5165\u3055\u308c\u308b\u3053\u3068\u3092\u53d7\u3051\u5165\u308c\u3066\u304a\u308a\u3001\u81ea\u5206\u305f\u3061\u306e\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u304c\u3053\u308c\u307e\u3067\u306e\u3088\u3046\u306b\u89aa\u3057\u307f\u3084\u3059\u304f\u3001\u624b\u306e\u5c4a\u304f\u5b58\u5728\u3067\u306f\u306a\u304f\u306a\u308b\u3053\u3068\u3092\u77e5\u3063\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u306a\u305c\uff1f<br \/>\n<\/span><span style=\"font-weight: 400;\">\u4f5c\u696d\u91cf\u304c\u591a\u3044\u304b\u3089\u3067\u3059\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">2019\u5e74\u306b\u306f\u30012020\u5e74\u307e\u3067\u306b20\u306e\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u304cMDR\u306b\u6307\u5b9a\u3055\u308c\u308b\u3068\uff08\u697d\u89b3\u7684\u306b\uff09\u4e88\u6e2c\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u30012020\u5e742\u670815\u65e5\u6642\u70b9\u3067\u306f\u3001\u4ee5\u4e0b\u306e11\u306eNotified Bodies\u304c\u6307\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">BSI\u30a2\u30b7\u30e5\u30a2\u30e9\u30f3\u30b9\uff08\u82f1\u56fd<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">BSI\u30a2\u30b7\u30e5\u30a2\u30e9\u30f3\u30b9\uff08\u30aa\u30e9\u30f3\u30c0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">DARE!!!\u30b5\u30fc\u30d3\u30b9B.V.(\u30aa\u30e9\u30f3\u30c0)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Dekra Certification B.V\uff08\u30aa\u30e9\u30f3\u30c0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Dekra Certification GmbH\uff08\u30c9\u30a4\u30c4<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">DNV GL Presafe AS<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALIT\u00c0 S.P.A. (\u30a4\u30bf\u30ea\u30a2)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">MEDCERT ZERTIFIZIERUNGS- UND PR\u00dcFUNGSGESELLSCHAFT F\u00dcR DIE MEDIZIN GMBH\uff08\u30c9\u30a4\u30c4<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u56fd\u5bb6\u898f\u683c\u5c40\uff08NSAI<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">T\u00dcV Rheinland LGA Products GmbH\uff08\u30c9\u30a4\u30c4<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">T\u00dcV S\u00dcD Product Service GmbH Zertifizierstellen (\u30c9\u30a4\u30c4)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u4ee5\u4e0b\u306e\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u3082\u3001MDR\u306b\u57fa\u3065\u304f\u6307\u5b9a\u306e\u305f\u3081\u306e\u8a55\u4fa1\u671f\u9593\u4e2d\u3067\u3059\u3002<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30d9\u30eb\u30ea\u30f3\u30fb\u30b5\u30fc\u30c8\uff08\u30c9\u30a4\u30c4<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">DQS\uff08\u30c9\u30a4\u30c4<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">ECM\/ENTE\uff08\u30a4\u30bf\u30ea\u30a2<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">IMNB\uff08\u30a4\u30f3\u30bf\u30fc\u30c6\u30c3\u30af\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">PCBC\uff08\u30dd\u30fc\u30e9\u30f3\u30c9<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">SGS Belgium (\u30d9\u30eb\u30ae\u30fc)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">SGS Fimko\uff08\u30b9\u30a4\u30b9<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">SGS UK (\u82f1\u56fd)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">T\u00dcV NORD\uff08\u30c9\u30a4\u30c4<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u756a\u53f7\u306b\u3088\u308b\u5236\u9650\u306e\u4ed6\u306b\u3001\u6307\u5b9a\u306e\u7bc4\u56f2\u306b\u3082\u5236\u9650\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u307e\u3067\u306e\u3068\u3053\u308d\u3001\u30d5\u30eb\u30b9\u30b3\u30fc\u30d7\uff08\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u540d\u79f0\u3092\u30ab\u30d0\u30fc\u3059\u308b\uff09\u306e\u9069\u5408\u6027\u8a55\u4fa1\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u308b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306f\u4e00\u63e1\u308a\u3067\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u308c\u3089\u306e\u9650\u754c\u3092\u8a8d\u8b58\u3057\u3001\u6642\u9593\u3068\u30a8\u30cd\u30eb\u30ae\u30fc\u3092\u7bc0\u7d04\u3059\u308b\u305f\u3081\u306b\u6226\u7565\u3092\u5909\u66f4\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u307e\u305f\u3001\u81e8\u5e8a\u8a55\u4fa1\u3092\u542b\u3080\u66f8\u985e\u306e\u300c\u5be9\u67fb\u300d\u306b\u540c\u610f\u3057\u3066\u304f\u308c\u308b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u304c\u898b\u3064\u304b\u3063\u305f\u5834\u5408\u3067\u3082\u3001\u300c\u4f5c\u696d\u91cf\u300d\u3068\u3044\u3046\u7406\u7531\u304b\u3089\u3001MDD\u306b\u6bd4\u3079\u3066\u5927\u5e45\u306b\u6642\u9593\u304c\u304b\u304b\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u3082\u899a\u3048\u3066\u304a\u3044\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u7a4d\u6975\u7684\u306b\u884c\u52d5\u3057\u3001\u5354\u529b\u3057\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u306e\u5229\u7528\u53ef\u80fd\u6027\u3084\u9069\u7528\u6027\u306b\u5fdc\u3058\u3066\u3001\u7d4c\u8def\u3092\u6226\u7565\u7684\u306b\u6c7a\u5b9a\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u3068\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u304c\u3059\u3079\u3066\u306e\u672c\u8cea\u3067\u3042\u308a\u3001\u6574\u5408\u6027\u306e\u3042\u308b\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u63a1\u7528\u3059\u308c\u3070\u3001\u591a\u304f\u306e\u6642\u9593\u3001\u30b3\u30b9\u30c8\u3001\u52b4\u529b\u3092\u7bc0\u7d04\u3067\u304d\u308b\u3053\u3068\u3092\u899a\u3048\u3066\u304a\u3044\u3066\u304f\u3060\u3055\u3044\u3002\u3053\u308c\u306f\u7279\u306b\u81e8\u5e8a\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u306b\u5f53\u3066\u306f\u307e\u308a\u3001\u73fe\u5728\u3067\u306f\u300c\u81ea\u793e\u306e\u6a5f\u5668\u3067\u4f5c\u6210\u3055\u308c\u305f\u5341\u5206\u306a\u91cf\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u300d\u3092\u30ab\u30d0\u30fc\u3059\u308b\u3053\u3068\u304c\u671f\u5f85\u3055\u308c\u3066\u3044\u307e\u3059\uff08\u8a73\u7d30\u306f\u4ee5\u4e0b\u3092\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\uff09\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u6307\u5b9a\u3055\u308c\u305fNotified Bodies\u3068\u305d\u306e\u7bc4\u56f2\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <a href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/index.cfm?fuseaction=directive.notifiedbody&amp;dir_id=34\">\u3053\u308c<\/a>.<\/span><\/p>\n<p><strong>\u3082\u8aad\u3093\u3067\u304f\u3060\u3055\u3044\u3002<\/strong> <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CER-DosDonts\"><strong>\u3042\u306a\u305f\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306bCER\u30e9\u30a4\u30bf\u30fc\u3092\u63a1\u7528\u3059\u308b\u65b9\u6cd5<\/strong><\/a><\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_DO_Understand_applicable_requirements\"><\/span>2.DO:\u8a72\u5f53\u3059\u308b\u300d\u8981\u6c42\u4e8b\u9805\u306e\u7406\u89e3<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">MDR\u306b\u57fa\u3065\u304f\u81e8\u5e8a\u8a55\u4fa1\u306b\u3064\u3044\u3066\u307e\u305a\u7406\u89e3\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u306e\u306f\u3001\u81e8\u5e8a\u8a55\u4fa1\u306f\u3082\u306f\u3084\u5358\u306a\u308b\u5831\u544a\u66f8\u3067\u306f\u306a\u3044\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306f\u3001\u300c\u7d99\u7d9a\u7684\u306a\u81e8\u5e8a\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u300d\u306e\u6700\u7d42\u7684\u306a\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u3067\u3042\u308a\u3001\u9069\u7528\u3055\u308c\u308b\u4e00\u822c\u5b89\u5168\u6027\u80fd\u8981\u4ef6\uff08GSPR\uff09\u3078\u306e\u9069\u5408\u6027\u3092\u4e3b\u5f35\u3059\u308b\u305f\u3081\u306e\u300c\u81e8\u5e8a\u7684\u8a3c\u62e0\u300d\u3092\u307e\u3068\u3081\u305f\u3082\u306e\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">MDR\u306e\u81e8\u5e8a\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u30ab\u30d0\u30fc\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u4e00\u822c\u7684\u306a\u90e8\u5206\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u308c\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u81e8\u5e8a\u958b\u767a\u8a08\u753b<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a66\u9a13<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u5b89\u5168\u6027\u3068\u81e8\u5e8a\u6210\u7e3e\u306e\u6982\u8981<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u5171\u901a\u4ed5\u69d8<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/post-market-surveillance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CER-DosDonts\">\u5e02\u8ca9\u5f8c\u8abf\u67fb<\/a> (PMS)\/\u88fd\u54c1\u5b89\u5168\u6027\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u5831\u544a\u6d3b\u52d5<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08PMCF\uff09\u6d3b\u52d5<\/span><\/li>\n<\/ul>\n<p><b>\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b<\/b><span style=\"font-weight: 400;\"> \u305d\u3057\u3066 <\/span><b>\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8<\/b><span style=\"font-weight: 400;\"> \u306f\u3001\u81e8\u5e8a\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u306e\u69cb\u6210\u8981\u7d20\u3068\u3057\u3066\u3059\u3067\u306b\u77e5\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3051\u308c\u3069\u3082\u3002 <\/span><b>PMS<\/b><span style=\"font-weight: 400;\"> \u305d\u3057\u3066 <\/span><b>PMCF\u306e\u6d3b\u52d5<\/b><span style=\"font-weight: 400;\"> MDD\u3067\u306f\u3001\u3053\u308c\u307e\u3067\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u4e00\u90e8\u3068\u306a\u3063\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u3053\u308c\u3089\u306e\u6d3b\u52d5\u306b\u95a2\u3059\u308b\u8981\u6c42\u306f\u4efb\u610f\u3067\u306f\u306a\u304f\u306a\u308a\u307e\u3057\u305f\uff08PMS\u304a\u3088\u3073PMCF\u306e\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u3001\u5f15\u304d\u7d9a\u304d\u3054\u89a7\u304f\u3060\u3055\u3044\uff09\u3002PMS\u306f\u30af\u30e9\u30b9I\u88fd\u54c1\u306b\u306e\u307f\u4f7f\u7528\u3055\u308c\u3001PMCF\u306f\u30af\u30e9\u30b9II\u88fd\u54c1\u306b\u306e\u307f\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002 <\/span><b>\u88fd\u54c1\u5b89\u5168\u6027\u5831\u544a\u66f8\uff08PSUR<\/b><span style=\"font-weight: 400;\"> \u306f\u3001\u300c\u30af\u30e9\u30b9\u2161a\u4ee5\u4e0a\u306e\u88fd\u54c1\u300d\u306ePMS\u6d3b\u52d5\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u65b0\u3057\u3044\u306e\u306f <\/span><b>\u81e8\u5e8a\u958b\u767a\u8a08\u753b<\/b><span style=\"font-weight: 400;\">\u88fd\u85ac\u696d\u754c\u3067\u306f\u3001\u5e02\u8ca9\u524d\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u306e\u3059\u3079\u3066\u306e\u81e8\u5e8a\u8a66\u9a13\u304a\u3088\u3073\u975e\u81e8\u5e8a\u8a66\u9a13\u3092\u8a08\u753b\u3059\u308b\u969b\u306b\u5e83\u304f\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u533b\u7642\u6a5f\u5668\u3067\u306f\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u304c\u7fa9\u52d9\u3065\u3051\u3089\u308c\u305f\u3070\u304b\u308a\u3067\u3042\u308b\u305f\u3081\u3001\u300c\u81e8\u5e8a\u958b\u767a\u8a08\u753b\u300d\u306f\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u65b0\u898f\u306e\u8981\u7d20\u3067\u3059\u3002\u00a0<\/span><\/p>\n<p><b>\u5b89\u5168\u6027\u3068\u81e8\u5e8a\u7684\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u306e\u6982\u8981\uff08SSCP<\/b><span style=\"font-weight: 400;\"> \u304c\u5fc5\u8981\u3067\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u300c\u79fb\u690d\u53ef\u80fd\u306a\u30c7\u30d0\u30a4\u30b9\u3001\u304a\u3088\u3073\u30af\u30e9\u30b9III\u306e\u30c7\u30d0\u30a4\u30b9\u306e\u3046\u3061\u3001\u30ab\u30b9\u30bf\u30e0\u30e1\u30a4\u30c9\u307e\u305f\u306f\u6cbb\u9a13\u7528\u306e\u30c7\u30d0\u30a4\u30b9\u4ee5\u5916\u306e\u3082\u306e<\/span><\/i><span style=\"font-weight: 400;\">\u201d; this is compiled entirely from Technical File\/Design Dossier through design verification\/validation reports, the risk management report\/file, the clinical evaluation report, and post-market surveillance (PMS) and post-market clinical follow-up (PMCF) plans and reports. The critical part of SSCP is they will be publicly available for intended users \u2013both <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 if relevant for patients. The specifications on SSCP content was given in Article 32 of MDR.<\/span><\/p>\n<p><b>\u81e8\u5e8a\u8a66\u9a13\uff08\u30d7\u30ec\u30de\u30fc\u30b1\u30c3\u30c8<\/b><span style=\"font-weight: 400;\">)\u3082\u3001\u7279\u306b\u79fb\u690d\u53ef\u80fd\u306a\u6a5f\u5668\u3084\u30af\u30e9\u30b9III\u306e\u6a5f\u5668\u306b\u3064\u3044\u3066\u306f\u5b9f\u65bd\u3055\u308c\u308b\u3053\u3068\u304c\u671f\u5f85\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u7b2c61\u6761\u3067\u306f\u3001\u3053\u306e\u8981\u6c42\u3092\u514d\u9664\u3059\u308b\u305f\u3081\u306e\u300c\u67d4\u8edf\u6027\u300d\u304c\u4e0e\u3048\u3089\u308c\u3066\u3044\u308b\u3002<\/span><\/p>\n<p><i><span style=\"font-weight: 400;\">\"\u30fb\u540c\u4e00\u30e1\u30fc\u30ab\u30fc\u304c\u65e2\u306b\u8ca9\u58f2\u3057\u3066\u3044\u308b\u6a5f\u5668\u3092\u6539\u9020\u3057\u3066\u8a2d\u8a08\u3055\u308c\u3066\u3044\u308b\u3002<br \/>\n<\/span><\/i><i><span style=\"font-weight: 400;\">- \u5909\u66f4\u3055\u308c\u305f\u6a5f\u5668\u304c\u3001\u5e02\u8ca9\u3055\u308c\u3066\u3044\u308b\u6a5f\u5668\u3068\u540c\u7b49\u3067\u3042\u308b\u3053\u3068\u304c\u88fd\u9020\u8005\u306b\u3088\u3063\u3066\u8a3c\u660e\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3002<br \/>\n<\/span><\/i><i><span style=\"font-weight: 400;\">- \u5e02\u8ca9\u3055\u308c\u3066\u3044\u308b\u6a5f\u5668\u306e\u81e8\u5e8a\u8a55\u4fa1\u306f\u3001\u5909\u66f4\u3055\u308c\u305f\u6a5f\u5668\u304c\u95a2\u9023\u3059\u308b\u5b89\u5168\u6027\u3068\u6027\u80fd\u306e\u8981\u6c42\u4e8b\u9805\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u306e\u306b\u5341\u5206\u306a\u3082\u306e\u3067\u3042\u308b\u3053\u3068\u3002\"<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">\u3068\u3002<\/span><\/p>\n<p><i><span style=\"font-weight: 400;\">\u300c\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u3068\u3044\u3046\u8981\u6c42\u306f\u3001\u79fb\u690d\u53ef\u80fd\u306a\u6a5f\u5668\u304a\u3088\u3073\u30af\u30e9\u30b9III\u306e\u6a5f\u5668\u306b\u306f\u9069\u7528\u3055\u308c\u306a\u3044\u3002\u00a0<\/span><\/i><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><i><span style=\"font-weight: 400;\">\u6307\u4ee490\/385\/EEC\u307e\u305f\u306f\u6307\u4ee493\/42\/EEC\u306b\u5f93\u3063\u3066\u5408\u6cd5\u7684\u306b\u5e02\u8ca9\u307e\u305f\u306f\u4f7f\u7528\u3055\u308c\u3066\u304a\u308a\u3001\u81e8\u5e8a\u8a55\u4fa1\u304c\u884c\u308f\u308c\u3066\u3044\u308b\u3082\u306e\u3002\u00a0<\/span><\/i><\/li>\n<\/ul>\n<p><i><span style=\"font-weight: 400;\">- \u5341\u5206\u306a\u81e8\u5e8a\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u3044\u3066\u304a\u308a\u3001\u304b\u3064<br \/>\n<\/span><\/i><i><span style=\"font-weight: 400;\">- \u305d\u306e\u7a2e\u985e\u306e\u6a5f\u5668\u306e\u81e8\u5e8a\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u88fd\u54c1\u56fa\u6709\u306e\u5171\u901a\u4ed5\u69d8\u66f8\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u305d\u308c\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3002<\/span><\/i><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><i><span style=\"font-weight: 400;\">\u00a0\u7e2b\u5408\u7cf8\u3001\u30b9\u30c6\u30fc\u30d7\u30eb\u3001\u6b6f\u79d1\u7528\u8a70\u3081\u7269\u3001\u6b6f\u79d1\u7528\u77ef\u6b63\u5668\u5177\u3001\u6b6f\u51a0\u3001\u306d\u3058\u3001\u304f\u3055\u3073\u3001\u30d7\u30ec\u30fc\u30c8\u3001\u30ef\u30a4\u30e4\u30fc\u3001\u30d4\u30f3\u3001\u30af\u30ea\u30c3\u30d7\u3001\u307e\u305f\u306f\u30b3\u30cd\u30af\u30bf\u30fc\u3067\u3001\u81e8\u5e8a\u8a55\u4fa1\u304c\u5341\u5206\u306a\u81e8\u5e8a\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u3044\u3066\u304a\u308a\u3001\u95a2\u9023\u3059\u308b\u88fd\u54c1\u56fa\u6709\u306e\u5171\u901a\u4ed5\u69d8\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3082\u306e\uff08\u305d\u306e\u3088\u3046\u306a\u5171\u901a\u4ed5\u69d8\u304c\u5229\u7528\u53ef\u80fd\u306a\u5834\u5408\uff09\u3002\"<\/span><\/i><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u4ee5\u4e0a\u306e\u3088\u3046\u306b\u3001MDR\u306b\u3088\u3063\u3066\u5c0e\u5165\u3055\u308c\u305f\u3082\u3046\u4e00\u3064\u306e\u7528\u8a9e\u306f <\/span><b>\"Common Specifications \"\u306e\u7565\u3002<\/b><span style=\"font-weight: 400;\"> \u3053\u308c\u306f\u3001\u300c\u6a5f\u5668\u3001\u30d7\u30ed\u30bb\u30b9\u307e\u305f\u306f\u30b7\u30b9\u30c6\u30e0\u306b\u9069\u7528\u3055\u308c\u308b\u6cd5\u7684\u7fa9\u52d9\u3092\u9075\u5b88\u3059\u308b\u305f\u3081\u306e\u624b\u6bb5\u3092\u63d0\u4f9b\u3059\u308b\u3001\u898f\u683c\u4ee5\u5916\u306e\u4e00\u9023\u306e\u6280\u8853\u7684\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u81e8\u5e8a\u7684\u8981\u6c42\u4e8b\u9805\u300d\u3092\u610f\u5473\u3057\u307e\u3059\u3002\u3053\u308c\u307e\u3067\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u81ea\u793e\u306e\u6a5f\u5668\u304c\u300c\u6574\u5408\u898f\u683c\u300d\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3068\u4e3b\u5f35\u3057\u3066\u304d\u305f\u305f\u3081\u3001\u3053\u306e\u5171\u901a\u4ed5\u69d8\u66f8\u306f\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u7279\u306b\u9b45\u529b\u7684\u306a\u3082\u306e\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u5171\u901a\u4ed5\u69d8\u66f8\u306f\u3001\u3088\u308a\u53b3\u3057\u3044\u8981\u4ef6\u3092\u8981\u6c42\u3057\u3066\u304a\u308a\u3001\u3055\u3089\u306b\u60aa\u3044\u3053\u3068\u306b\u3001\u307e\u3060\u6e96\u5099\u304c\u3067\u304d\u3066\u3044\u307e\u305b\u3093\u3002EU\u306f\u3001\u300c\u4f7f\u3044\u6368\u3066\u533b\u7642\u6a5f\u5668\u306e\u518d\u51e6\u7406\u300d\u306b\u95a2\u3059\u308b\u5171\u901a\u4ed5\u69d8\u306e\u300c\u30c9\u30e9\u30d5\u30c8\u300d\u3092\u63d0\u6848\u3057\u307e\u3057\u305f\u3002<\/span><span style=\"font-weight: 400;\">\"\u30012019\u5e74\u306b\u306f\u3001\u307e\u3060\u627f\u8a8d\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u307e\u305f\u3001MEDDEVs\u306b\u4ee3\u308f\u3063\u3066\u3001MDCG\uff08Medical Device Coordination Group\uff09\u304c\u767a\u884c\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u304c\u671f\u5f85\u3055\u308c\u3066\u304a\u308a\u3001\u73fe\u5728\uff082020\u5e742\u670815\u65e5\u6642\u70b9\uff09\u3001\u81e8\u5e8a\u8a66\u9a13\u3068\u8a55\u4fa1\u306b\u7279\u5316\u3057\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\u306f1\u3064\u3057\u304b\u767a\u884c\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u304c\u3001\u3053\u308c\u3089\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306f\u3001\u6b63\u78ba\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306b\u3001\u7d99\u7d9a\u7684\u306b\u9075\u5b88\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">MDCG\u304c\u627f\u8a8d\u3057\u305f\u6587\u66f8\u306b\u5f93\u3046\u3053\u3068\u3067\u3001\u81e8\u5e8a\u8a55\u4fa1\u3084\u8abf\u67fb\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805\u306b\u5bfe\u3059\u308b\u6709\u7528\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u3084\u3088\u308a\u660e\u78ba\u306a\u7406\u89e3\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u30a2\u30af\u30bb\u30b9\u3067\u304d\u307e\u3059\u3002 <a href=\"https:\/\/ec.europa.eu\/growth\/sectors\/medical-devices\/new-regulations\/guidance_en\">\u3053\u308c<\/a>. <\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_DO_Be_systematic_and_structured\"><\/span>3.DO:\u4f53\u7cfb\u7684\u3001\u69cb\u9020\u7684\u3067\u3042\u308b\u3053\u3068<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u3053\u308c\u306f\u3001MEDDEV 2.7.1 Rev.\u306b\u3042\u308b\u3088\u3046\u306b\u3001\u81e8\u5e8a\u8a55\u4fa1\u90e8\u5206\u306e\u8981\u6c42\u4e8b\u9805\u3067\u3042\u308b\u3002\u81e8\u5e8a\u8a55\u4fa1\u306f\u3001\u9069\u5408\u6027\u306e\u4e3b\u5f35\u3092\u5bb9\u6613\u306b\u3059\u308b\u305f\u3081\u306b\u3001\u65b9\u6cd5\u8ad6\u7684\u306b\u5065\u5168\u3067\u3042\u308a\u3001\u3088\u304f\u69cb\u9020\u5316\u3055\u308c\u3066 \u3044\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u304c\u610f\u56f3\u3055\u308c\u305f\u901a\u308a\u306b\u4f7f\u7528\u3055\u308c\u305f\u5834\u5408\u306e\u81e8\u5e8a\u7684\u306a\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u5b9f\u8a3c\u3059\u308b\u305f\u3081\u306b\u3001\u9069\u5207\u306b\u69cb\u6210\u3055\u308c\u305f\u691c\u7d22\u306e\u7d44\u307f\u5408\u308f\u305b\u306b\u3088\u308a\u3001\u975e\u5e38\u306b\u7684\u78ba\u306a\u30c7\u30fc\u30bf\u304c\u691c\u7d22\u3055\u308c\u3001\u8981\u7d04\u3055\u308c\u308b\u30b7\u30b9\u30c6\u30de\u30c6\u30a3\u30c3\u30af\u306a\u3082\u306e\u3068\u306a\u308a\u307e\u3059\u3002\u4e00\u65b9\u3067\u3001\u5e83\u7bc4\u306a\u691c\u7d22\u30ad\u30fc\u30ef\u30fc\u30c9\u3092\u7528\u3044\u3066\u3001\u7121\u95a2\u4fc2\u306a\u30c7\u30fc\u30bf\u304c\u4f55\u5343\u4ef6\u3082\u30d2\u30c3\u30c8\u3059\u308b\u3068\u3044\u3046\u60aa\u5922\u306e\u3088\u3046\u306a\u72b6\u6cc1\u306b\u306a\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002\u6ce8\u5c04\u5668\u3084\u51a0\u52d5\u8108\u30b9\u30c6\u30f3\u30c8\u3092\u88fd\u9020\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u4ed6\u306e\u7d44\u307f\u5408\u308f\u305b\uff08\u6a5f\u5668\u306e\u7279\u6027\u3001\u30d6\u30fc\u30eb\u6f14\u7b97\u5b50\u3001\u5546\u6a19\u540d\u306a\u3069\uff09\u3092\u4f34\u308f\u306a\u3044\u4e00\u822c\u7684\u306a\u7528\u8a9e\u3092\u4f7f\u7528\u3059\u308b\u3068\u3001\u4f55\u5343\u3082\u306e\u8a18\u4e8b\u304c\u30d2\u30c3\u30c8\u3057\u307e\u3059\u304c\u3001\u4f7f\u3044\u9053\u304c\u306a\u304f\u3001MDR\u306e\u671f\u9650\u304c\u53b3\u3057\u3044\u73fe\u5728\u3067\u306f\u6642\u9593\u3082\u3042\u308a\u307e\u305b\u3093\u3002MEDDEV 2.7.1 Rev.4\u3067\u306f\u3001\u3053\u306e\u8ab2\u984c\u3092\u514b\u670d\u3059\u308b\u305f\u3081\u3001\u6700\u9069\u306a\u7d50\u679c\u3092\u5f97\u308b\u305f\u3081\u306e\u3044\u304f\u3064\u304b\u306e\u691c\u7d22\u6226\u7565\u3092\u63d0\u6848\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3055\u3089\u306b\u3001\u81e8\u5e8a\u8a55\u4fa1\u306f\u5341\u5206\u306b\u69cb\u6210\u3055\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3064\u307e\u308a\u3001\u691c\u7d22\u3055\u308c\u305f\u79d1\u5b66\u7684\u30c7\u30fc\u30bf\u3084\u542b\u307e\u308c\u3066\u3044\u308b\u79d1\u5b66\u7684\u30c7\u30fc\u30bf\u304c\u3001\u88fd\u54c1\u306e\u6587\u732e\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u6587\u66f8\u3001\u5e02\u8ca9\u5f8c\u306e\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u3001\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u3068\u3069\u306e\u3088\u3046\u306b\u6574\u5408\u3057\u3066\u3044\u308b\u304b\u304c\u660e\u78ba\u306b\u793a\u3055\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u3088\u3046\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001\u76e3\u67fb\u6cd5\u4eba\u306b\u9069\u3057\u305f\u6587\u66f8\u3092\u4f5c\u6210\u3059\u308b\u306e\u306b\u3082\u5f79\u7acb\u3061\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_DO_Make_your_clinical_evaluation_a_living_process\"><\/span>4.DO:\u81e8\u5e8a\u8a55\u4fa1\u3092 \"\u751f\u304d\u305f\u30d7\u30ed\u30bb\u30b9 \"\u306b\u3059\u308b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<blockquote><p><span style=\"font-weight: 400;\">\u524d\u8ff0\u306e\u901a\u308a\u3001\u81e8\u5e8a\u8a55\u4fa1\u306f\u3082\u306f\u3084\u5358\u306a\u308b\u300c\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\u66f8\u30fb\u5831\u544a\u66f8\u300d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305d\u308c\u306f\u3001\u300c\u300d\u3067\u3059\u3002<\/span><i><span style=\"font-weight: 400;\">\u66ae\u3089\u3057\u306e\u30d7\u30ed\u30bb\u30b9\u300d\u3002<\/span><\/i><span style=\"font-weight: 400;\"> \u7406\u60f3\u7684\u306b\u306f\uff09\u81e8\u5e8a\u958b\u767a\u8a08\u753b\u306b\u57fa\u3065\u304d\u3001\u3053\u306e\u8a08\u753b\u306b\u6cbf\u3063\u305f\u5e02\u8ca9\u5f8c\u8abf\u67fb\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u6d3b\u52d5\u306b\u3088\u3063\u3066\u7d99\u7d9a\u7684\u306b\u4f9b\u7d66\u3055\u308c\u308b\u3002\u00a0<\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3057\u3001\u66f4\u65b0\u671f\u9593\u30925\u5e74\u306b\u8a2d\u5b9a\u3059\u308b\u3053\u3068\u306f\u3001MDR\u3067\u306f\u73fe\u5b9f\u7684\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u5b9f\u969b\u3001\u7b2c61\u6761\u7b2c11\u9805\u304a\u3088\u3073\u7b2c12\u9805\u306b\u306f\u3001\u6b21\u306e\u3088\u3046\u306b\u660e\u793a\u3055\u308c\u3066\u3044\u308b\u3002 <\/span><i><span style=\"font-weight: 400;\">\u300c\u81e8\u5e8a\u8a55\u4fa1\u53ca\u3073\u305d\u306e\u6587\u66f8\u306f\u3001\u88fd\u9020\u8005\u306ePMCF\u8a08\u753b[...]\u53ca\u3073\u5e02\u8ca9\u5f8c\u8abf\u67fb\u8a08\u753b[...]\u306e\u5b9f\u65bd\u304b\u3089\u5f97\u3089\u308c\u305f\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u7528\u3044\u3066\u3001\u5f53\u8a72\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u66f4\u65b0\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/span><\/i><span style=\"font-weight: 400;\">. <\/span><i><span style=\"font-weight: 400;\">\u00a0\u30af\u30e9\u30b9\u2162\u306e\u6a5f\u5668\u304a\u3088\u3073\u690d\u8fbc\u307f\u578b\u6a5f\u5668\u306b\u3064\u3044\u3066\u306f\u3001PMCF\u8a55\u4fa1\u5831\u544a\u66f8\u3001\u304a\u3088\u3073\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u5b89\u5168\u6027\u3068\u81e8\u5e8a\u6027\u80fd\u306e\u8981\u7d04\uff08\u4e2d\u7565\uff09\u3092\u66f4\u65b0\u3059\u308b\u3053\u3068\u3002 <\/span><\/i><b><i>\u5c11\u306a\u304f\u3068\u3082\u6bce\u5e74<\/i><\/b><i><span style=\"font-weight: 400;\"> \u305d\u306e\u30c7\u30fc\u30bf\u3092\u4f7f\u3063\u3066\u300d\u3002<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">\u3064\u307e\u308a\u3001\u5341\u5206\u306a\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u4e3b\u5f35\u3057\u7d9a\u3051\u308b\u305f\u3081\u306b\u3001\u7d99\u7d9a\u7684\u306aPMCF\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u308b\u306e\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u5168\u4f53\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u6587\u66f8\u3001PMS\u53ca\u3073PMCF\u6d3b\u52d5\u3001\uff08\u5fc5\u8981\u306b\u5fdc\u3058\u3066\uff09\u88fd\u54c1\u8cc7\u6599\u3092\u542b\u3080\u69d8\u3005\u306a\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u9593\u3067\u7d99\u7d9a\u7684\u306b\u76f8\u4e92\u4f5c\u7528\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_DO_Collaborate_with_experts\"><\/span>5.DO:\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u3068\u306e\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306eEU MDR\u6e96\u62e0\u306e\u305f\u3081\u306e\u81e8\u5e8a\u8a55\u4fa1\u3092\u5916\u90e8\u306b\u59d4\u8a17\u3059\u308b\u5834\u5408\u3082\u3001\u4eba\u3092\u96c7\u3046\u5834\u5408\u3082\u3001\u8457\u8005\u3084\u30e1\u30c7\u30a3\u30ab\u30eb\u30fb\u30ec\u30d3\u30e5\u30a2\u30fc\u306e\u8cc7\u683c\u306b\u95a2\u3059\u308b\u8981\u4ef6\u304c\u9069\u7528\u3055\u308c\u308b\u3053\u3068\u306b\u6ce8\u610f\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4eca\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u8ab2\u984c\u306f\u3001\u81e8\u5e8a\u8a55\u4fa1\u306e\u8981\u4ef6\u304c\u53b3\u3057\u304f\u306a\u3063\u305f\u3053\u3068\u3067\u3001\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u306e\u5c02\u9580\u5bb6\u3067\u3042\u308b\u30e9\u30a4\u30bf\u30fc\u306e\u307b\u3068\u3093\u3069\u304c\u3001\u3059\u3067\u306b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306b\u8a55\u4fa1\u8005\u3068\u3057\u3066\u63a1\u7528\u3055\u308c\u3066\u3044\u305f\u3053\u3068\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u9700\u8981\u306e\u5897\u52a0\u306b\u4f34\u3044\u3001\u65b0\u305f\u306a\u4eba\u6750\u304c\u53c2\u5165\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u00a0<\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">\u3057\u305f\u304c\u3063\u3066\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u3001MDR\u306e\u8981\u6c42\u4e8b\u9805\u306b\u3064\u3044\u3066\u9069\u5207\u306a\u7d4c\u9a13\u3092\u6301\u3061\u3001\u7406\u89e3\u3057\u3066\u3044\u308b\u5c02\u9580\u5bb6\u306a\u3069\u306e\u5354\u529b\u3092\u5f97\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations-mdr?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CER-DosDonts\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u4f5c\u6210\u8005<\/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=CER-DosDonts\">EU MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>.\u00a0<\/span><\/p><\/blockquote>\n<p><strong>\u3082\u8aad\u3093\u3067\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-eu-mdr-compliance-challenges-and-resource-crunch\/\">\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<\/a><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"6_DONT_Rely_on_Grandfathering\"><\/span>6.DON'T:\u30b0\u30e9\u30f3\u30c9\u30d5\u30a1\u30b6\u30ea\u30f3\u30b0\u306b\u983c\u308b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">MDR\u304c\u767b\u5834\u3059\u308b\u3068\u3001\u300c\u79c1\u306e\u6a5f\u5668\u306f\u4f55\u5341\u5e74\u3082\u524d\u304b\u3089\u5b58\u5728\u3057\u3001MDD\u306b\u5b8c\u5168\u306b\u9069\u5408\u3057\u3066\u3044\u305f\u306e\u3067\u3001MDR\u3067\u3082CE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3057\u3066\u304f\u3060\u3055\u3044\u300d\u3068\u3044\u3046\u30e1\u30fc\u30ab\u30fc\u306e\u4e3b\u5f35\u306f\u7834\u305f\u3093\u3057\u3066\u3057\u307e\u3044\u307e\u3057\u305f\u3002\u306a\u305c\u306a\u3089\u3001MDR\u3067\u306f\u3001\u3088\u308a\u53b3\u683c\u3067\u771f\u65b0\u3057\u3044\u898f\u5247\u3084\u8981\u4ef6\u304c\u5c0e\u5165\u3055\u308c\u3001\u305d\u306e\u7d50\u679c\u3001MDD\u3067\u306f\u307b\u3068\u3093\u3069\u30ab\u30d0\u30fc\u3055\u308c\u3066\u3044\u306a\u3044\u65b0\u3057\u3044\u9069\u5408\u6027\u8a55\u4fa1\u30eb\u30fc\u30c8\u304c\u5c0e\u5165\u3055\u308c\u308b\u304b\u3089\u3067\u3059\u3002\u3057\u305f\u304c\u3063\u3066\u3001MDR\u306e\u4e0b\u3067CE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u3059\u3079\u3066\u306e\u6a5f\u5668\uff08\u304a\u3088\u3073MDR\u306e\u4ed8\u5c5e\u66f8XVI\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u533b\u7642\u76ee\u7684\u3092\u610f\u56f3\u3057\u3066\u3044\u306a\u3044\u88fd\u54c1\uff09\u306f\u3001\u65b0\u305f\u306a\u9069\u5408\u6027\u8a55\u4fa1\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\uff08Notified Bodies\uff09\u3084\u6240\u8f44\u5b98\u5e81\u306f\u3001\u3053\u308c\u307e\u3067\u306eMDD\u6e96\u62e0\u306e\u5c65\u6b74\u3092\u983c\u308a\u306b\u306f\u3057\u307e\u305b\u3093\u306e\u3067\u3001\u7279\u306b\u81e8\u5e8a\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u65b0\u3057\u3044\u8981\u6c42\u4e8b\u9805\u306b\u5099\u3048\u3066\u304f\u3060\u3055\u3044\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"7_DONT_Fall_for_the_simplicity_old_technology_or_low-risk_class_of_your_devices\"><\/span>7.DON'T\u30c7\u30d0\u30a4\u30b9\u306e\u300c\u30b7\u30f3\u30d7\u30eb\u3055\u3001\u53e4\u3044\u6280\u8853\u3001\u4f4e\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u300d\u306b\u9a19\u3055\u308c\u3066\u306f\u3044\u3051\u307e\u305b\u3093\u3002<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u3042\u306a\u305f\u306f\u3001\u30af\u30e9\u30b9I\u306e\u820c\u5727\u5b50\u3001\u6ce8\u5c04\u5668\u3001\u30d0\u30f3\u30c9\u30a8\u30a4\u30c9\u3001\u8f38\u6db2\u30c1\u30e5\u30fc\u30d6\u306a\u3069\u306e\u30e1\u30fc\u30ab\u30fc\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u304c\u3001\u3053\u308c\u3089\u306f\u4f55\u5341\u5e74\u3082\u524d\u304b\u3089\u4f7f\u7528\u3055\u308c\u3066\u304a\u308a\u3001\u4e16\u754c\u4e2d\u306e\u3042\u3089\u3086\u308b\u30af\u30ea\u30cb\u30c3\u30af\u3067\u7c21\u5358\u306b\u5165\u624b\u3067\u304d\u307e\u3059\u3002 <strong>\u3057\u304b\u3057\u3001\u3060\u304b\u3089\u3068\u3044\u3063\u3066\u3001EU\u57df\u5185\u3067\u306e\u8ca9\u58f2\u3092\u7d99\u7d9a\u3059\u308b\u305f\u3081\u306b\u3001\u300c\u81e8\u5e8a\u30c7\u30fc\u30bf\u300d\u306b\u57fa\u3065\u304f\u81e8\u5e8a\u8a55\u4fa1\u3092\u884c\u3046\u5fc5\u8981\u304c\u306a\u3044\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u00a0<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3057\u304b\u3057\u3001\u3053\u306e\u3088\u3046\u306a\u6a5f\u5668\u306b\u5bfe\u3057\u3066\u3001\u3069\u306e\u3088\u3046\u306a\u300c\u81e8\u5e8a\u30c7\u30fc\u30bf\u300d\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u3053\u306e\u8b70\u8ad6\u306f\u4e00\u90e8\u3001PMCF\u6226\u7565\uff08\u4e0b\u8a18\u53c2\u7167\uff09\u306b\u5c5e\u3057\u307e\u3059\u304c\u3001\u4e00\u3064\u7406\u89e3\u3057\u3066\u304a\u304b\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u306e\u306f\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u751f\u6210\u3059\u308b\u305f\u3081\u306b\u3001\u6a5f\u5668\u306e\u7279\u6027\u306b\u5fdc\u3058\u3066\u8abf\u6574\u3067\u304d\u308b\u69d8\u3005\u306a\u30aa\u30d7\u30b7\u30e7\u30f3\u304c\u3042\u308b\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u30ad\u30fc\u30ef\u30fc\u30c9\u306f\u300c\u30c6\u30fc\u30e9\u30fc\u30ea\u30f3\u30b0\u300d\u3067\u3059\u304c\u3001Dos\u306e\u6700\u521d\u306e\u9805\u76ee\u3067\u8ff0\u3079\u305f\u3088\u3046\u306b\u3001\u7a4d\u6975\u7684\u306b\u3001\u3069\u306e\u3088\u3046\u306a\u6226\u7565\u3092\u63a1\u7528\u3059\u308b\u304b\u3092\u8b70\u8ad6\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"8_DONT_Claim_equivalence_if_you_dont_have_a_certain_amount_of_data_belongs_to_your_competitor\"><\/span>8.DON'T:\u7af6\u5408\u4ed6\u793e\u306e\u300c\u3042\u308b\u4e00\u5b9a\u306e\u30c7\u30fc\u30bf\u300d\u3092\u6301\u3063\u3066\u3044\u306a\u3044\u5834\u5408\u3001\u540c\u7b49\u6027\u3092\u4e3b\u5f35\u3059\u308b\u3002<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u79c1\u306e\u88fd\u54c1\u306f\u3001\u3053\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u4f01\u696d\u304c\u88fd\u9020\u3057\u305f\u88fd\u54c1\u3068\u540c\u3058\u3067\u3059\u300d\u3068\u8ff0\u3079\u3001\u300c\u3042\u306a\u305f\u306e\u30c7\u30d0\u30a4\u30b9\u300d\u306e\u6027\u80fd\u3068\u5b89\u5168\u6027\u3092\u793a\u3059\u3059\u3079\u3066\u306e\u516c\u8868\u30c7\u30fc\u30bf\u3092\u307e\u3068\u3081\u305f\u6700\u65b0\u306e\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306f\u3001\u304a\u305d\u3089\u304f\u300c\u6700\u5f8c\u306e\u300d\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u3060\u3063\u305f\u3068\u601d\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u306a\u305c\uff1f\u00a0<\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">\u306a\u305c\u306a\u3089\u3001\u81e8\u5e8a\u8a55\u4fa1\u306b\u95a2\u3059\u308b\uff08\u975e\uff09\u516c\u5f0f\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u3042\u308bMEDDEV 2.7.1 Rev.4\uff082016\uff09\u304c\u767a\u8868\u3055\u308c\u308b\u307e\u3067\u306f\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u3084\u8a3c\u660e\u306e\u63d0\u793a\u306b\u95a2\u3059\u308b\u8981\u4ef6\u306f\u305d\u308c\u307b\u3069\u53b3\u3057\u304f\u306a\u304b\u3063\u305f\u304b\u3089\u3067\u3059\u30022016\u5e746\u6708\u307e\u3067\u306bMEDDEV 2.7.1 Rev.4\u3067\u306f\u3001\u540c\u7b49\u6027\u306e\u4e3b\u5f35\u306b\u95a2\u3059\u308b\u3088\u308a\u53b3\u683c\u306a\u30eb\u30fc\u30eb\u304c\u5c0e\u5165\u3055\u308c\u3001\u7af6\u5408\u6a5f\u5668\u3067\u4f5c\u6210\u3055\u308c\u305f\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u62e1\u5f35\u3059\u308b\u305f\u3081\u306b\u30013\u6b21\u5143\u7684\u306a\u7279\u6027\uff08\u81e8\u5e8a\u7684\u3001\u6280\u8853\u7684\u3001\u751f\u7269\u5b66\u7684\uff09\u3092\u6e80\u305f\u3059\u6761\u4ef6\u304c\u5b9a\u3081\u3089\u308c\u307e\u3057\u305f\u3002\u3055\u3089\u306b\u3001\u7af6\u5408\u88fd\u54c1\u3068\u306e\u540c\u7b49\u6027\u3092\u4e3b\u5f35\u3059\u308b\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u4e21\u88fd\u54c1\u306e\u985e\u4f3c\u6027\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306b\u3001\u5f53\u8a72\u88fd\u54c1\u306e\u6280\u8853\u8cc7\u6599\u307e\u305f\u306f\u8a2d\u8a08\u8cc7\u6599\u3092\u5165\u624b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u304c\u660e\u793a\u3055\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u65b0\u3057\u3044\u8981\u6c42\u306f\u3001\u307b\u3068\u3093\u3069\u306e\u30e1\u30fc\u30ab\u30fc\u306e\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u69cb\u9020\u3001\u9577\u3055\u3001\u5185\u5bb9\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3057\u305f\u3002 <\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">\u3057\u304b\u3057\u3001\u3053\u308c\u3089\u306e\u8981\u6c42\u4e8b\u9805\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u4e00\u90e8\u306e\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306f\u3001\u540c\u7b49\u6027\u306e\u4e3b\u5f35\u306e\u305f\u3081\u306b\u62bd\u51fa\u3055\u308c\u305f\u60c5\u5831\u306e\u300c\u30bd\u30fc\u30b9\u300d\u3068\u3057\u3066\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u57fa\u672c\u7684\u306bIFU\u3084\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3092\u63d0\u4f9b\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u540c\u7b49\u6027\u306e\u4e3b\u5f35\u3092\u53d7\u3051\u5165\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001MDR\u3067\u306f\u305d\u308c\u304c\u3067\u304d\u306a\u304f\u306a\u308a\u307e\u3057\u305f\u3002\u5177\u4f53\u7684\u306b\u306f\u3001MDR\u306e\u7b2c61\u6761\u7b2c5\u9805\u3067\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <\/span><b>(1)<\/b><span style=\"font-weight: 400;\"> 2\u793e\u306e\u30e1\u30fc\u30ab\u30fc\u306f\u30012\u53f0\u76ee\u306e\u30c7\u30d0\u30a4\u30b9\u306e\u30e1\u30fc\u30ab\u30fc\u304c\u7d99\u7d9a\u7684\u306b\u6280\u8853\u6587\u66f8\u306b\u5b8c\u5168\u306b\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u3053\u3068\u3092\u660e\u793a\u7684\u306b\u8a8d\u3081\u308b\u5951\u7d04\u3092\u7de0\u7d50\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002 <\/span><b>\u305d\u3057\u3066<\/b> <b>(2)<\/b><span style=\"font-weight: 400;\"> \u5f53\u521d\u306e\u81e8\u5e8a\u8a55\u4fa1\u304c\u672c\u898f\u5247\u306e\u8981\u4ef6\u306b\u6e96\u62e0\u3057\u3066\u884c\u308f\u308c\u3066\u3044\u308b\u3053\u3068\u3002 <\/span><b>\u305d\u3057\u3066<\/b> <b>(3)<\/b><span style=\"font-weight: 400;\"> \u7b2c2\u306e\u6a5f\u5668\u306e\u88fd\u9020\u8005\u304c\u3001\u305d\u306e\u660e\u78ba\u306a\u8a3c\u62e0\u3092\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306b\u63d0\u51fa\u3059\u308b\u3053\u3068\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30ac\u30a4\u30c0\u30f3\u30b9\u300d\u6587\u66f8\uff08MEDDEV 2.7.1 Rev.4\uff09\u3067\u8a00\u53ca\u3055\u308c\u3066\u3044\u305f\u3053\u306e\u8981\u4ef6\u306f\u3001\u73fe\u5728\u3001\u300cEU \u898f\u5247\u300d\u306e\u4e0b\u3067\u7fa9\u52d9\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3064\u307e\u308a\u3001\u7af6\u5408\u4ed6\u793e\u304c\u4f5c\u6210\u3057\u305f\u516c\u8868\u6e08\u307f\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u306b\u4f55\u5e74\u3082\u4f9d\u5b58\u3057\u3066\u3044\u305f\u30e1\u30fc\u30ab\u30fc\u306f\u3001PMCF\u6d3b\u52d5\u306b\u3088\u3063\u3066\u81ea\u793e\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u4f5c\u6210\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u304f\u306a\u3063\u305f\u306e\u3067\u3059\uff08PMCF\u306e\u8a73\u7d30\u306f\u4ee5\u4e0b\u3092\u53c2\u7167\uff09\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"9_DONT_Underestimate_the_power_of_post-market_clinical_follow-up\"><\/span>9.DON'T\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u306e\u529b\u3092\u904e\u5c0f\u8a55\u4fa1\u3059\u308b\u3053\u3068<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\"><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=CER-DosDonts\">\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7<\/a> \u307e\u305f\u306f\u300cPMCF\u300d\u306f\u3001MDR\u306e\u300c\u30e2\u30ce\u300d\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u304b\u3064\u3066\u306f\u3001\u533b\u7642\u6a5f\u5668\u5206\u91ce\u3067PMCF\u8abf\u67fb\u304c\u884c\u308f\u308c\u308b\u3053\u3068\u306f\u307b\u3068\u3093\u3069\u3042\u308a\u307e\u305b\u3093\u3067\u3057\u305f\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">MDR\u306b\u3088\u308a\u3001PMCF\u306f\u81e8\u5e8a\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u306e\u300c\u7d99\u7d9a\u7684\u306a\u90e8\u5206\u300d\u3068\u306a\u308a\u307e\u3057\u305f\u3002\u88fd\u9020\u696d\u8005\u306f\u3001\u7279\u306b\u305d\u306e\u6a5f\u5668\u304c\u79fb\u690d\u53ef\u80fd\u3067\u30af\u30e9\u30b9III\u3067\u3042\u308b\u5834\u5408\u3001\u7d99\u7d9a\u7684\u306aPMCF\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3067\u306f\u3001PMCF\u3068\u306f\u5358\u306b\u81e8\u5e8a\u8abf\u67fb\u3092\u610f\u5473\u3059\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u307e\u3042\u3001\u90e8\u5206\u7684\u306b\u306f\u306d\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">MDR\u3067\u306f\u3001\u9644\u5c5e\u66f8XIV\u30d1\u30fc\u30c8B\u3067PMCF\u3092\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u300cPMCF \u3068\u306f\u3001\u7b2c 61 \u6761\u53ca\u3073\u672c\u4ed8\u5c5e\u66f8\u306e\u30d1\u30fc\u30c8 A \u3067\u8a00\u53ca\u3055\u308c\u305f\u81e8\u5e8a\u8a55\u4fa1\u3092\u66f4\u65b0\u3059\u308b\u7d99\u7d9a\u7684\u306a \u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308a\u3001\u88fd\u9020\u8005\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u8a08\u753b\u306e\u4e2d\u3067\u53d6\u308a\u6271\u308f\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002PMCF\u3092\u5b9f\u65bd\u3059\u308b\u5834\u5408\u3001\u88fd\u9020\u8005\u306f\u3001CE\u30de\u30fc\u30ad\u30f3\u30b0\u304c\u4ed8\u3055\u308c\u3001\u95a2\u9023\u3059\u308b\u9069\u5408\u6027\u8a55\u4fa1\u624b\u9806\u3067\u8a00\u53ca\u3055\u308c\u305f\u610f\u56f3\u3055\u308c\u305f\u76ee\u7684\u306e\u7bc4\u56f2\u5185\u3067\u5e02\u5834\u306b\u51fa\u3055\u308c\u308b\u304b\u3001\u307e\u305f\u306f\u4f7f\u7528\u3055\u308c\u308b\u6a5f\u5668\u306e\u30d2\u30c8\u3067\u306e\u4f7f\u7528\u304b\u3089\u3001\u7a4d\u6975\u7684\u306b\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3057\u3001\u8a55\u4fa1\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\"\u305d\u306e\u76ee\u7684\u306f\u3001\u6a5f\u5668\u306e\u4e88\u60f3\u3055\u308c\u308b\u5bff\u547d\u3092\u901a\u3057\u3066\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3001\u7279\u5b9a\u3055\u308c\u305f\u30ea\u30b9\u30af\u306e\u7d99\u7d9a\u7684\u306a\u53d7\u5bb9\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u3001\u4e8b\u5b9f\u306b\u57fa\u3065\u304f\u8a3c\u62e0\u3067\u65b0\u305f\u306a\u30ea\u30b9\u30af\u3092\u691c\u51fa\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">PMCF\u30d7\u30e9\u30f3\u3092\u63d0\u793a\u3057\u3066\u3001\u6226\u7565\u306e\u6839\u62e0\u3092\u660e\u78ba\u306b\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u3060\u304b\u3089\u3068\u3044\u3063\u3066\u3001\u3059\u3050\u306b\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u3092\u6c42\u3081\u3089\u308c\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\uff08\u57cb\u3081\u8fbc\u307f\u578b\u3084\u30af\u30e9\u30b9III\u306e\u6a5f\u5668\u306a\u3069\u3001\u9ad8\u30ea\u30b9\u30af\u306e\u6a5f\u5668\u3067\u306f\u306a\u3044\u5834\u5408\uff09\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">MDR\u3067\u306f\u3001PMCF\u7814\u7a76\u306e\u53ef\u80fd\u306a\u30eb\u30fc\u30c8\u3092\u6b21\u306e\u3088\u3046\u306b\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\"[...]\u5f97\u3089\u308c\u305f\u81e8\u5e8a\u7d4c\u9a13\u306e\u53ce\u96c6\u3001\u30e6\u30fc\u30b6\u30fc\u304b\u3089\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3001\u79d1\u5b66\u6587\u732e\u306e\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3001\u304a\u3088\u3073\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u4ed6\u306e\u30bd\u30fc\u30b9[...]\u3002<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">\u3057\u305f\u304c\u3063\u3066\u3001\u3088\u308a\u660e\u78ba\u306b\u8a00\u3048\u3070\u3001PMCF\u306e\u5074\u9762\u306b\u95a2\u3059\u308b\u81e8\u5e8a\u7684\u8a3c\u62e0\u3092\u53ce\u96c6\u3059\u308b\u305f\u3081\u306e\u3088\u308a\u6b63\u78ba\u306a\u30eb\u30fc\u30c8\u3067\u3042\u308c\u3070\u3001\u30e6\u30fc\u30b6\u30fc\u8abf\u67fb\u3001\u79d1\u5b66\u6587\u732e\u306e\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3001\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u30bd\u30fc\u30b9\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">PMCF\u306f\u81e8\u5e8a\u8a55\u4fa1\u306e\u4e2d\u3067\u3082\u6700\u3082\u5165\u672d\u306e\u591a\u3044\u30c6\u30fc\u30de\u306e\u4e00\u3064\u3067\u3042\u308a\u3001\u3082\u3057\u81e8\u5e8a\u8abf\u67fb\u304c\u5fc5\u8981\u306b\u306a\u3063\u305f\u5834\u5408\u306b\u306f\u975e\u5e38\u306b\u9ad8\u984d\u306a\u8cbb\u7528\u304c\u304b\u304b\u308a\u307e\u3059\u306e\u3067\u3001\u3088\u308a\u614e\u91cd\u3092\u671f\u3059\u305f\u3081\u306b\u3082\u3001\u3053\u308c\u3089\u306e\u6d3b\u52d5\u3092\u884c\u3046\u524d\u306b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u3068\u9023\u643a\u3057\u3001\u4e21\u8005\u304c\u540c\u3058\u8003\u3048\u3092\u6301\u3063\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"10_DONT_Forget_that_Medical_Device_Regulation_now_covers_more_than_Medical_Devices\"><\/span>10.DON'T\u533b\u7642\u6a5f\u5668\u898f\u5236\u300d\u306f\u4eca\u3084\u300c\u533b\u7642\u6a5f\u5668\u300d\u4ee5\u4e0a\u306e\u3082\u306e\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u5fd8\u308c\u3066\u306f\u306a\u3089\u306a\u3044\u3002<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u300d\u898f\u5247\u306f\u3001\u7b2c1\u6761\u3067\u8a00\u53ca\u3055\u308c\u3066\u3044\u308b\u300c\u533b\u7642\u76ee\u7684\u4ee5\u5916\u306e\u88fd\u54c1\u300d\u3068\u547c\u3070\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u305f\u533b\u7642\u6a5f\u5668\u4ee5\u4e0a\u306e\u3082\u306e\u3092\u5bfe\u8c61\u3068\u3057\u3066\u304a\u308a\u3001\u4ed8\u5c5e\u66f8XVI\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u3053\u308c\u3089\u306e\u88fd\u54c1\u306b\u306f <\/span><i><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1<\/span><\/i><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u306e\u30e1\u30fc\u30ab\u30fc\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30b3\u30f3\u30bf\u30af\u30c8\u30ec\u30f3\u30ba\u306a\u3069\u3001\u773c\u7403\u5185\u3078\u306e\u5c0e\u5165\u3084\u773c\u7403\u4e0a\u3078\u306e\u88c5\u7740\u3092\u610f\u56f3\u3057\u305f\u3082\u306e<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u523a\u9752\u3084\u30d4\u30a2\u30b9\u3092\u9664\u304d\u3001\u89e3\u5256\u5b66\u7684\u4fee\u6b63\u3084\u8eab\u4f53\u306e\u4e00\u90e8\u3092\u56fa\u5b9a\u3059\u308b\u76ee\u7684\u3067\u3001\u5916\u79d1\u7684\u4fb5\u8972\u6027\u306e\u3042\u308b\u624b\u6bb5\u306b\u3088\u308a\u4eba\u4f53\u306b\u5b8c\u5168\u307e\u305f\u306f\u90e8\u5206\u7684\u306b\u5c0e\u5165\u3055\u308c\u308b\u3053\u3068\u3092\u610f\u56f3\u3057\u305f\u88fd\u54c1<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u76ae\u4e0b\u6ce8\u5c04\u3001\u7c98\u819c\u4e0b\u6ce8\u5c04\u3001\u76ae\u5185\u6ce8\u5c04\u306a\u3069\u306e\u5c0e\u5165\u306b\u3088\u308a\u3001\u9854\u9762\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u76ae\u819a\u3084\u7c98\u819c\u3078\u306e\u5145\u586b\u3092\u76ee\u7684\u3068\u3057\u305f\u7269\u8cea\u3001\u7269\u8cea\u306e\u7d44\u307f\u5408\u308f\u305b\u3001\u307e\u305f\u306f\u30a2\u30a4\u30c6\u30e0\u3067\u3001\u5165\u308c\u58a8\u7528\u306e\u3082\u306e\u3092\u9664\u304f\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u8102\u80aa\u7d44\u7e54\u306e\u6e1b\u5c11\u3001\u9664\u53bb\u3001\u7834\u58ca\u3092\u76ee\u7684\u3068\u3057\u305f\u6a5f\u5668\uff08\u8102\u80aa\u5438\u5f15\u3001\u8102\u80aa\u5206\u89e3\u3001\u8102\u80aa\u5f62\u6210\u306e\u305f\u3081\u306e\u6a5f\u5668\u306a\u3069\uff09\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u4eba\u4f53\u306b\u4f7f\u7528\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u9ad8\u5f37\u5ea6\u96fb\u78c1\u653e\u5c04\uff08\u8d64\u5916\u7dda\u3001\u53ef\u8996\u5149\u7dda\u3001\u7d2b\u5916\u7dda\u306a\u3069\uff09\u3092\u767a\u3059\u308b\u88c5\u7f6e\u3067\u3001\u30b3\u30d2\u30fc\u30ec\u30f3\u30c8\u304a\u3088\u3073\u975e\u30b3\u30d2\u30fc\u30ec\u30f3\u30c8\u5149\u6e90\u3001\u5358\u8272\u304a\u3088\u3073\u5e83\u30b9\u30da\u30af\u30c8\u30eb\u3092\u542b\u307f\u3001\u30ec\u30fc\u30b6\u30fc\u3084\u9ad8\u5f37\u5ea6\u30d1\u30eb\u30b9\u5149\u88c5\u7f6e\u306a\u3069\u3001\u30b9\u30ad\u30f3\u30ea\u30b5\u30fc\u30d5\u30a7\u30b7\u30f3\u30b0\u3001\u30bf\u30c8\u30a5\u30fc\u3084\u8131\u6bdb\u306a\u3069\u306e\u76ae\u819a\u6cbb\u7642\u306b\u4f7f\u7528\u3055\u308c\u308b\u3082\u306e<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u8133\u5185\u306e\u795e\u7d4c\u7d30\u80de\u306e\u6d3b\u52d5\u3092\u5909\u5316\u3055\u305b\u308b\u305f\u3081\u306b\u3001\u982d\u84cb\u3092\u8cab\u901a\u3059\u308b\u96fb\u6d41\u307e\u305f\u306f\u78c1\u754c\u3001\u96fb\u78c1\u754c\u3092\u5370\u52a0\u3059\u308b\u8133\u523a\u6fc0\u7528\u306e\u6a5f\u5668<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">\u88fd\u54c1\u306e\u81e8\u5e8a\u7684\u6709\u7528\u6027\uff08MDR\u306e\u7b2c61\u6761\u3067\u8a00\u53ca\u3055\u308c\u3066\u3044\u308b\uff09\u3092\u300c\u6027\u80fd\u300d\u306e\u89b3\u70b9\u304b\u3089\u8a3c\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002MDR\u306f\u3055\u3089\u306b\u6b21\u306e\u3088\u3046\u306b\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u300c\u3053\u308c\u3089\u306e\u88fd\u54c1\u306e\u81e8\u5e8a\u8a55\u4fa1\u306f\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3001PMCF\u3001\u304a\u3088\u3073\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u7279\u5b9a\u306e\u81e8\u5e8a\u8a66\u9a13\u304b\u3089\u5f97\u3089\u308c\u305f\u30c7\u30fc\u30bf\u3092\u542b\u3080\u3001\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u95a2\u9023\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u3044\u3066\u884c\u308f\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u985e\u4f3c\u306e\u533b\u7642\u6a5f\u5668\u306e\u65e2\u5b58\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u306b\u4f9d\u62e0\u3059\u308b\u3053\u3068\u304c\u6b63\u5f53\u5316\u3055\u308c\u308b\u5834\u5408\u3092\u9664\u304d\u3001\u3053\u308c\u3089\u306e\u88fd\u54c1\u306b\u3064\u3044\u3066\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\"<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">\u307e\u305f\u3001MDR\u3067\u306f\u3001\u3053\u308c\u3089\u306e\u88fd\u54c1\u306e\u300c\u6027\u80fd\u300d\u8981\u4ef6\u306b\u95a2\u9023\u3059\u308bGSPR\u306f\u3001GSPR1\u304b\u3089GSPR8\u307e\u3067\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u57fa\u672c\u7684\u306b\u3001\u3053\u308c\u3089\u306e\u88fd\u54c1\u306e\u81e8\u5e8a\u8a55\u4fa1\u306f\u3001\u610f\u56f3\u3055\u308c\u305f\u6761\u4ef6\u304a\u3088\u3073\u76ee\u7684\u3067\u4f7f\u7528\u3055\u308c\u305f\u5834\u5408\u306b\u3001\u30ea\u30b9\u30af\u304c\u5168\u304f\u306a\u3044\u3053\u3068\u3001\u307e\u305f\u306f\u4eba\u306e\u5b89\u5168\u3068\u5065\u5eb7\u3092\u9ad8\u3044\u30ec\u30d9\u30eb\u3067\u4fdd\u8b77\u3059\u308b\u3053\u3068\u306b\u5408\u81f4\u3059\u308b\u88fd\u54c1\u306e\u4f7f\u7528\u306b\u95a2\u3059\u308b\u6700\u5927\u8a31\u5bb9\u30ea\u30b9\u30af\u3092\u8d85\u3048\u306a\u3044\u3053\u3068\u3092\u793a\u3059\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<blockquote><p><strong>\u56f0\u3063\u305f\u3068\u304d\u306f <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CER-DosDonts\">\u81e8\u5e8a\u8a55\u4fa1<\/a> \u306e\u305f\u3081\u306b<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CER-DosDonts\"> EU MDR\u5bfe\u5fdc<\/a> \u3042\u306a\u305f\u306e\u533b\u7642\u6a5f\u5668\u306e\uff1fKolabtree\u306e\u4fe1\u983c\u3067\u304d\u308b\u5c02\u9580\u5bb6\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3055\u308c\u305f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u8a55\u4fa1\u3084\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3001CER\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\u306a\u3069\u306e\u30b5\u30dd\u30fc\u30c8\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u4eca\u3059\u3050\u5c02\u9580\u5bb6\u306b\u4f9d\u983c\u3057\u307e\u3057\u3087\u3046\u3002\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<\/strong><\/p><\/blockquote>\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=CER-DosDonts\">\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=CER-DosDonts\">\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=CER-DosDonts\">\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=CER-DosDonts\">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=CER-DosDonts\">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=CER-DosDonts\">\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=CER-DosDonts\">\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=CER-DosDonts\">\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=CER-DosDonts\">\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=CER-DosDonts\">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=CER-DosDonts\">PMCF\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c4<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CER-DosDonts\">\u751f\u7269\u7d71\u8a08\u5b66\u306e\u5c02\u9580\u5bb6<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Basak Erpolat, MDR consultant and freelance CER writer for Kolabtree, lists best practices to follow for a\u00a0medical device clinical evaluation plan for EU MDR compliance. Basak has worked on over 80 MDD\/MDR projects. The new European Medical Device Regulation (MDR 2017\/745) will soon replace the current Medical Device Directive MDD 93\/42\/EEC amended by 2007\/47\/EC. This new regulation comes with several considerable revisions of the regulatory aspects currently covered by the MDD and launches brand new requirements for the manufacturers who seek CE-mark approval for their products and the Competent Authority\/Notified Body reviewers. From the moment MDR was published in 2017, the medical device sector has been working hard to understand<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":6967,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[304,443,540],"tags":[498,535],"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>Clinical Evaluation Plan for EU MDR Compliance: 5 Dos and Don\u2019ts<\/title>\n<meta name=\"description\" content=\"A comprehensive checklist of best practices and common mistakes to avoid while making a clinical evaluation plan for EU MDR compliance.\" \/>\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\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical Evaluation for EU MDR Compliance: 5 Dos and Don\u2019ts\" \/>\n<meta property=\"og:description\" content=\"A comprehensive checklist of best practices and common mistakes to avoid while making a clinical evaluation plan for EU MDR compliance.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/\" \/>\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=\"2020-02-17T12:56:43+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-10-28T11:30:13+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/02\/clinical-evaluation-eu-mdr-compliance.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"805\" \/>\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=\"16\u5206\" \/>\n<!-- \/ Yoast SEO Premium 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