{"id":9323,"date":"2021-07-28T16:53:27","date_gmt":"2021-07-28T16:53:27","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=9323"},"modified":"2022-02-21T13:17:14","modified_gmt":"2022-02-21T13:17:14","slug":"what-is-a-technical-file-and-what-should-it-contain","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/","title":{"rendered":"\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3068\u306f\u4f55\u304b\u3001\u4f55\u3092\u5165\u308c\u308b\u3079\u304d\u304b\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-69f1baca6f884\" 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-69f1baca6f884\"><\/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-technical-file-and-what-should-it-contain\/#What_is_a_medical_device_technical_file\" title=\"\u533b\u7642\u6a5f\u5668\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f\">\u533b\u7642\u6a5f\u5668\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/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-technical-file-and-what-should-it-contain\/#Does_the_medical_device_technical_file_need_to_be_approved\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u627f\u8a8d\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f\">\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u627f\u8a8d\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/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-technical-file-and-what-should-it-contain\/#What_does_a_medical_device_technical_file_include\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u4f55\u304c\u542b\u307e\u308c\u307e\u3059\u304b\uff1f\">\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u4f55\u304c\u542b\u307e\u308c\u307e\u3059\u304b\uff1f<\/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-technical-file-and-what-should-it-contain\/#Is_there_a_major_difference_from_the_technical_file_submitted_before_MDR\" title=\"MDR\u306e\u524d\u306b\u63d0\u51fa\u3057\u305f\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3068\u306e\u5927\u304d\u306a\u9055\u3044\u306f\u3042\u308a\u307e\u3059\u304b\uff1f\">MDR\u306e\u524d\u306b\u63d0\u51fa\u3057\u305f\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3068\u306e\u5927\u304d\u306a\u9055\u3044\u306f\u3042\u308a\u307e\u3059\u304b\uff1f<\/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-technical-file-and-what-should-it-contain\/#How_different_is_the_PMS_under_MDR\" title=\"MDR\u306ePMS\u3068\u306e\u9055\u3044\u306f\uff1f\">MDR\u306ePMS\u3068\u306e\u9055\u3044\u306f\uff1f<\/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-technical-file-and-what-should-it-contain\/#What_exactly_is_a_Post-Market_Clinical_Follow-Up_PMCF\" title=\"\u5e02\u8ca9\u5f8c\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08PMCF\uff09\u3068\u306f\u4e00\u4f53\u4f55\u306a\u306e\u304b\uff1f\">\u5e02\u8ca9\u5f8c\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08PMCF\uff09\u3068\u306f\u4e00\u4f53\u4f55\u306a\u306e\u304b\uff1f<\/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-technical-file-and-what-should-it-contain\/#Does_the_Clinical_Evaluation_Report_CER_need_to_be_updated\" title=\"\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09\u3092\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u304b\uff1f\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09\u3092\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/#Are_there_any_other_technicalities_in_the_new_technical_file\" title=\"\u65b0\u3057\u3044\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u4ed6\u306b\u3082\u6280\u8853\u7684\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u304b\uff1f\">\u65b0\u3057\u3044\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u4ed6\u306b\u3082\u6280\u8853\u7684\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/#How_is_the_medical_device_technical_file_reviewed\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306f\u3069\u306e\u3088\u3046\u306b\u5be9\u67fb\u3055\u308c\u308b\u306e\u3067\u3059\u304b\uff1f\">\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306f\u3069\u306e\u3088\u3046\u306b\u5be9\u67fb\u3055\u308c\u308b\u306e\u3067\u3059\u304b\uff1f<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/#Is_there_anything_else_needed_for_approval_besides_the_medical_device_technical_file\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u4ee5\u5916\u306b\u3001\u627f\u8a8d\u306b\u5fc5\u8981\u306a\u3082\u306e\u306f\u3042\u308a\u307e\u3059\u304b\uff1f\">\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u4ee5\u5916\u306b\u3001\u627f\u8a8d\u306b\u5fc5\u8981\u306a\u3082\u306e\u306f\u3042\u308a\u307e\u3059\u304b\uff1f<\/a><\/li><\/ul><\/nav><\/div>\n<p><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/catarina-carrao\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=technicalfile\">Catarina Carr\u00e3o<\/a>,\u00a0<a href=\"https:\/\/www.kolabtree.com\/services\/medical-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=technicalfile\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a> on Kolabtree, provides an overview of what a <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> technical file is and what it should contain.<\/em><\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_is_a_medical_device_technical_file\"><\/span>\u533b\u7642\u6a5f\u5668\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u533b\u7642\u6a5f\u5668\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3068\u306f\u3001\u7279\u5b9a\u306e\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u793a\u3059\u305f\u3081\u306b\u3001\u88fd\u9020\u8005\u304c\u660e\u78ba\u306b\u3001\u3088\u304f\u6574\u7406\u3055\u308c\u3001\u5bb9\u6613\u306b\u691c\u7d22\u53ef\u80fd\u3067\u3001\u66d6\u6627\u3055\u306e\u306a\u3044\u65b9\u6cd5\u3067\u4f5c\u6210\u3057\u305f\u8981\u7d04\u6587\u66f8\u306e\u3053\u3068\u3067\u3042\u308b\u3002<sup>1]<\/sup>.\u6a5f\u5668\u306e\u30af\u30e9\u30b9\u3001\u4f7f\u7528\u76ee\u7684\u3001\u30c7\u30b6\u30a4\u30f3\u3001\u3055\u3089\u306b\u306f\u6a5f\u5668\u306e\u5b89\u5168\u6027\u306e\u5c65\u6b74\u306b\u304b\u304b\u308f\u3089\u305a\u3001\u88fd\u9020\u8005\u306f\u3001\u6cd5\u5f8b\u306e\u4e00\u822c\u7684\u306a\u5b89\u5168\u6027\u3068\u6027\u80fd\u306e\u8981\u4ef6\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306b\u3001\u3053\u306e\u6280\u8853\u6587\u66f8\u3092\u4f5c\u6210\u3057\u3001\u5e38\u306b\u6700\u65b0\u306e\u72b6\u614b\u306b\u4fdd\u3064\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Does_the_medical_device_technical_file_need_to_be_approved\"><\/span>\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u627f\u8a8d\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u306f\u3044\u3001\u3082\u3061\u308d\u3093\u3067\u3059\u3002MDR\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306f\u3001\u30ec\u30d3\u30e5\u30fc\u3068\u627f\u8a8d\u306e\u305f\u3081\u306b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\uff08NB\uff09\u307e\u305f\u306f\u6240\u8f44\u5b98\u5e81\u306b\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u82f1\u8a9e\u307e\u305f\u306fEU\u52a0\u76df\u56fd\u306e\u516c\u7528\u8a9e\u3067\u4f5c\u6210\u3055\u308c\u3001\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\uff08\u4f4e\u30ea\u30b9\u30af\u306e\u5834\u5408\u306f5\u5e74\u3001\u9ad8\u30ea\u30b9\u30af\u306e\u5834\u5408\u306f16\u5e74\uff09\u306b\u308f\u305f\u308a\u3001\u8981\u6c42\u306b\u5fdc\u3058\u3066\u5229\u7528\u53ef\u80fd\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<sup>2]<\/sup>).\u91cd\u8981\u306a\u3053\u3068\u306f\u3001EU\u57df\u5916\u306e\u88fd\u9020\u696d\u8005\u306f\u3001\u8981\u6c42\u304c\u3042\u308c\u3070\u3044\u3064\u3067\u3082\u76f8\u8ac7\u3067\u304d\u308b\u3088\u3046\u306b\u3001EU\u57df\u5185\u306e\u516c\u8a8d\u4ee3\u7406\u4eba\u306b\u30d5\u30a1\u30a4\u30eb\u3092\u9810\u3051\u308b\u5fc5\u8981\u304c\u3042\u308b\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002<sup>3]<\/sup>.<\/p>\n<div class='mailmunch-forms-short-code mailmunch-forms-widget-1073033' style='display: none !important;'><\/div>\n<h2><span class=\"ez-toc-section\" id=\"What_does_a_medical_device_technical_file_include\"><\/span>\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u4f55\u304c\u542b\u307e\u308c\u307e\u3059\u304b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>EU MDR 2017\/745\u306e\u9644\u5c5e\u66f8II\u306b\u3088\u308b\u3068[<sup>4]<\/sup>\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u9805\u76ee\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<sup>5<\/sup>:<\/p>\n<ul>\n<li>\u30c7\u30d0\u30a4\u30b9\u306e\u8aac\u660e\u3068\u4ed5\u69d8\u3001\u3059\u3079\u3066\u306e\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u3068\u30a2\u30af\u30bb\u30b5\u30ea\u30fc\u3092\u542b\u307f\u307e\u3059\u3002<\/li>\n<li>\u5358\u54c1\u8ca9\u58f2\u3084\u7279\u5b9a\u306e\u7ba1\u7406\u6761\u4ef6\u304c\u3042\u308b\u5834\u5408\u306e\u8f38\u9001\u7528\u30d1\u30c3\u30b1\u30fc\u30b8\u306a\u3069\u3001\u5b8c\u5168\u306a\u30e9\u30d9\u30eb\u3068\u30d1\u30c3\u30b1\u30fc\u30b8\u60c5\u5831\u3002<\/li>\n<li>\u533b\u7642\u6a5f\u5668\u306e\u8ca9\u58f2\u304c\u4e88\u5b9a\u3055\u308c\u3066\u3044\u308b\u52a0\u76df\u56fd\u3067\u53d7\u3051\u5165\u308c\u3089\u308c\u3066\u3044\u308b\u3059\u3079\u3066\u306e\u8a00\u8a9e\u306e\u4f7f\u7528\u8aac\u660e\u66f8\u3002<\/li>\n<li>\u8a2d\u8a08\u56f3\u3084\u3001\u8a2d\u8a08\u30fb\u88fd\u9020\u6d3b\u52d5\u304c\u884c\u308f\u308c\u3066\u3044\u308b\u3059\u3079\u3066\u306e\u30b5\u30a4\u30c8\u306b\u95a2\u3059\u308b\u30c7\u30fc\u30bf\u306a\u3069\u306e\u8a2d\u8a08\u30fb\u88fd\u9020\u60c5\u5831\u3002<\/li>\n<li>\u3059\u3079\u3066\u306e\u4e00\u822c\u7684\u306a\u5b89\u5168\u304a\u3088\u3073\u6027\u80fd\u8981\u4ef6\u3001\u3059\u3079\u3066\u306e\u95a2\u9023\u3059\u308b\u8abf\u548c\u304a\u3088\u3073\u975e\u8abf\u548c\u898f\u683c\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u6587\u66f8\u3002<\/li>\n<li>\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u5206\u6790\u3068\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u30d5\u30a1\u30a4\u30eb\u3067\u3059\u3002<\/li>\n<li>\u88fd\u54c1\u306e\u691c\u8a3c\u304a\u3088\u3073\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30ec\u30dd\u30fc\u30c8\u3001\u305d\u306e\u4ed6\u306e\u95a2\u9023\u6587\u66f8\u3002<\/li>\n<li>\u30c6\u30b9\u30c8\u7d50\u679c\u306a\u3069\u306e\u524d\u81e8\u5e8a\u304a\u3088\u3073\u81e8\u5e8a\u30c7\u30fc\u30bf\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/what-is-a-clinical-evaluation-report\/\">\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8<\/a> (CER)\u3068\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7(PMCF)\u306e\u8a55\u4fa1\u30d7\u30e9\u30f3\u3092\u4f5c\u6210\u3057\u307e\u3057\u305f\u3002<\/li>\n<li>\u5e02\u8ca9\u5f8c\u8abf\u67fb\uff08PMS\uff09\u306e\u8a08\u753b\u3068\u5831\u544a\u3002<\/li>\n<li>\u9069\u5408\u5ba3\u8a00\u66f8[<sup>5]<\/sup>.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Is_there_a_major_difference_from_the_technical_file_submitted_before_MDR\"><\/span>MDR\u306e\u524d\u306b\u63d0\u51fa\u3057\u305f\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3068\u306e\u5927\u304d\u306a\u9055\u3044\u306f\u3042\u308a\u307e\u3059\u304b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u6280\u8853\u6587\u66f8\u306b\u542b\u307e\u308c\u308b\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u7dcf\u6570\u306f\u307b\u307c\u540c\u3058\u3067\u3059\u304c\u3001\u552f\u4e00\u306e\u9055\u3044\u306fPMS\u30d7\u30e9\u30f3\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u3053\u3068\u3067\u3059\u3002<br \/>\n\u5b9a\u671f\u7684\u306a\u5b89\u5168\u6027\u66f4\u65b0\u5831\u544a\u66f8\uff08PSUR\u3001\u30af\u30e9\u30b9I\u4ee5\u4e0a\u306e\u6a5f\u5668\u306e\u5834\u5408\u3001\u7b2c86\u6761\uff09\u307e\u305f\u306fPMS\u5831\u544a\u66f8\uff08\u30af\u30e9\u30b9I\u306e\u6a5f\u5668\u306e\u5834\u5408\u3001\u7b2c85\u6761\uff09\u3002<sup>3<\/sup>.\u898f\u5236\u5f53\u5c40\u306e\u898b\u89e3\u3067\u306f\u3001\u88fd\u9020\u696d\u8005\u306f\u5e02\u8ca9\u5f8c\u306e\u6bb5\u968e\u3067\u7a4d\u6975\u7684\u306a\u5f79\u5272\u3092\u679c\u305f\u3059\u3079\u304d\u3067\u3042\u308a\u3001\u6280\u8853\u6587\u66f8\u3092\u66f4\u65b0\u3057\u3001\u76e3\u8996\u30fb\u5e02\u5834\u8abf\u67fb\u6d3b\u52d5\u306b\u5354\u529b\u3059\u308b\u305f\u3081\u306b\u3001\u5e02\u8ca9\u5f8c\u306e\u6a5f\u5668\u306e\u4f7f\u7528\u7d4c\u9a13\u304b\u3089\u4f53\u7cfb\u7684\u304b\u3064\u7a4d\u6975\u7684\u306b\u60c5\u5831\u3092\u53ce\u96c6\u3059\u3079\u304d\u3067\u3042\u308b\u3002PMS\u3092\u901a\u3058\u3066\u53ce\u96c6\u3055\u308c\u305f\u95a2\u9023\u30c7\u30fc\u30bf\u53ca\u3073\u60c5\u5831\u3001\u4e26\u3073\u306b\u5b9f\u65bd\u3055\u308c\u305f\u4e88\u9632\u63aa\u7f6e\u53ca\u3073\uff0f\u53c8\u306f\u662f\u6b63\u63aa\u7f6e\u304b\u3089\u5f97\u3089\u308c\u305f\u6559\u8a13\u306f\u3001\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3084\u81e8\u5e8a\u8a55\u4fa1\u306b\u95a2\u9023\u3059\u308b\u6280\u8853\u6587\u66f8\u3092\u66f4\u65b0\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308a\u3001\u3055\u3089\u306b\u3001\u900f\u660e\u6027\u3092\u9ad8\u3081\u308b\u76ee\u7684\u3067\u3082\u4f7f\u7528\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002<sup>4<\/sup>.<\/p>\n<p>PMS\u306e\u6d3b\u52d5\u3068\u5831\u544a\u306b\u52a0\u3048\u3066\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306e\u4e3b\u306a\u5909\u66f4\u70b9\u306f\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306b\u6c42\u3081\u3089\u308c\u308b\u54c1\u8cea\u304c\u5927\u5e45\u306b\u5411\u4e0a\u3057\u305f\u3053\u3068\u3067\u3059\u3002<sup>3<\/sup>.\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u7d99\u7d9a\u7684\u306b\u5e02\u5834\u3078\u306e\u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306b\u3001\u6280\u8853\u6587\u66f8\u306e\u79d1\u5b66\u7684\u54c1\u8cea\u3068\u5206\u304b\u308a\u3084\u3059\u3055\u3092\u5411\u4e0a\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_different_is_the_PMS_under_MDR\"><\/span>MDR\u306ePMS\u3068\u306e\u9055\u3044\u306f\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u300c\u4e00\u822c\u7684\u306a\u5b89\u5168\u6027\u304a\u3088\u3073\u6027\u80fd\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805\uff08GSPR\uff09\u300d\u3078\u306e\u9069\u5408\u6027\u3092\u6587\u66f8\u5316\u3057\u3001\u5b9f\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001PMS\u6d3b\u52d5\u306b\u5fdc\u3058\u3066\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u7b2c2\u6761(60)\u3067\u306f\u3001MDR\u306e\u4e00\u822c\u7fa9\u52d9\u306e\u4e00\u3064\u3068\u3057\u3066\u3001\u30e1\u30fc\u30ab\u30fc\u306fPMS\u30b7\u30b9\u30c6\u30e0\u3092\u5305\u62ec\u7684\u304b\u3064\u4f53\u7cfb\u7684\u306b\u7a4d\u6975\u7684\u306b\u66f4\u65b0\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u305f\u3068\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002PMS\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805\u306f\u3001\u6a5f\u5668\u306b\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u306b\u76f4\u63a5\u6bd4\u4f8b\u3059\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u305a\u3001\u88fd\u9020\u8005\u306b\u3088\u308b\u662f\u6b63\uff0f\u4e88\u9632\u884c\u70ba\u3092\u53ef\u80fd\u306b\u3059\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u884c\u70ba\u306f\u3001\u6a5f\u5668\u306e\u7a2e\u985e\u3068\u66f4\u65b0\u3055\u308c\u305f\u81e8\u5e8a\u8a55\u4fa1\u306b\u6bd4\u4f8b\u3059\u3079\u304d\u3067\u3042\u308b[<sup>6]<\/sup>.\u3064\u307e\u308a\u3001\u5f37\u529b\u306aPMS\u30d7\u30ed\u30b0\u30e9\u30e0\u306f\u3001\u518d\u8ca9\u8a66\u9a13\u306e\u67a0\u3092\u8d85\u3048\u3066\u3001\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08PMCF\uff09\u3067\u5e45\u5e83\u3044\u5b9f\u4f53\u9a13\u3092\u63d0\u4f9b\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u3067\u306f\u3001\u6a5f\u5668\u306e\u9577\u671f\u7684\u306a\u6027\u80fd\u3092\u7d99\u7d9a\u7684\u306b\u76e3\u8996\u3059\u308b\u3053\u3068\u3067\u3001\u554f\u984c\u3092\u65e9\u671f\u306b\u767a\u898b\u3057\u3001\u5bfe\u7b56\u3092\u8b1b\u3058\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002  \u91cd\u8981\u306a\u3053\u3068\u306f\u3001\u3053\u308c\u3089\u306e\u3059\u3079\u3066\u306e\u30a2\u30af\u30b7\u30e7\u30f3\u304c\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u8d85\u3048\u305f\u4ed8\u52a0\u4fa1\u5024\u3092\u3082\u305f\u3089\u3057\u3001\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u5f37\u3044\u4fe1\u983c\u611f\u3092\u69cb\u7bc9\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_exactly_is_a_Post-Market_Clinical_Follow-Up_PMCF\"><\/span>\u5e02\u8ca9\u5f8c\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08PMCF\uff09\u3068\u306f\u4e00\u4f53\u4f55\u306a\u306e\u304b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>PMCF\u306f\u3001PMS\u6d3b\u52d5\u306e\u8981\u7d20\u306e\u4e00\u3064\u3067\u3042\u308a\u3001\u81e8\u5e8a\u8a66\u9a13\u3001\u9069\u5207\u306a\u30ec\u30b8\u30b9\u30c8\u30ea\u3001\u9867\u5ba2\u8abf\u67fb\u3001\u3042\u308b\u3044\u306f\u6a5f\u5668\u3092\u4f7f\u7528\u3057\u305f\u60a3\u8005\u3078\u306e\u8a08\u753b\u7684\u306a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u30a2\u30f3\u30b1\u30fc\u30c8\u306a\u3069\u306e\u5f62\u614b\u3092\u3068\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u305d\u308c\u305e\u308c\u306e\u6a5f\u5668\u306b\u5408\u308f\u305b\u305f\u3082\u306e\u3067\u3001\u6a5f\u5668\u306e\u81e8\u5e8a\u6027\u80fd\u3068\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3057\u3001\u4f7f\u7528\u6642\u306e\u30ea\u30b9\u30af\u304c\u7d99\u7d9a\u7684\u306b\u9069\u5207\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u6027\u80fd\u3084\u5b89\u5168\u6027\u306e\u7279\u5b9a\u306e\u5206\u91ce\u306b\u7126\u70b9\u3092\u5f53\u3066\u305f\u3001\u30e1\u30fc\u30ab\u30fc\u306b\u3088\u308b\u7a4d\u6975\u7684\u306a\u5bfe\u7b56\u3067\u3042\u308a\u3001\u4e8b\u524d\u306b\u627f\u8a8d\u3055\u308c\u305f\u4e00\u5b9a\u306e\u7d50\u679c\u3084\u53d7\u3051\u5165\u308c\u57fa\u6e96\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u6e2c\u5b9a\u306f\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3001CER\uff08Clinical Evaluation Report\uff09\u3001\u307e\u305f\u306f\u5b9f\u969b\u306e\u81e8\u5e8a\u4f7f\u7528\u306b\u3088\u308b\u65b0\u3057\u3044PMS\u30c7\u30fc\u30bf\u304b\u3089\u63a8\u9032\u3055\u308c\u307e\u3059\u3002PMCF\u306f\u3001CE\u5e02\u5834\u627f\u8a8d\u6642\u306b\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u9650\u3089\u308c\u3066\u3044\u308b\u5834\u5408\u3084\u3001\u7279\u5b9a\u306e\u9069\u5fdc\u75c7\u3084\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u306e\u65b0\u6a5f\u80fd\u306b\u95a2\u9023\u3057\u3066\u3001\u9577\u671f\u7684\u306a\u30c7\u30fc\u30bf\u30ae\u30e3\u30c3\u30d7\u3084\u672a\u89e3\u6c7a\u306e\u554f\u984c\u304c\u3042\u308b\u5834\u5408\u306b\u7279\u306b\u91cd\u8981\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u7406\u7531\u304b\u3089\u3001\u9069\u5207\u306aPMCF\u306e\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3068\u3001\u81e8\u5e8a\u7684\u8a3c\u62e0\u306e\u30ae\u30e3\u30c3\u30d7\u3092\u57cb\u3081\u308b\u7d71\u8a08\u7684\u6839\u62e0\u3092\u9078\u629e\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3068\u306a\u308a\u307e\u3059\u3002\u91cd\u8981\u306a\u306e\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u4e88\u60f3\u3055\u308c\u308b\u8010\u7528\u5e74\u6570\u3092\u901a\u3058\u3066\u3001\u597d\u307e\u3057\u3044\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u30fb\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u7d99\u7d9a\u7684\u306b\u793a\u3059\u3053\u3068\u3067\u3059\u3002<sup>7]<\/sup>.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Does_the_Clinical_Evaluation_Report_CER_need_to_be_updated\"><\/span>\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09\u3092\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u3082\u3061\u308d\u3093\u3001\u3053\u306e\u4ef6\u306b\u95a2\u3057\u3066\u306f\u3001EU MDR\u306e\u30d7\u30ed\u30ed\u30fc\u30b0\u306b\u3042\u308b\u30dd\u30a4\u30f3\u30c874\u304c\u300c\u6c34\u306e\u3088\u3046\u306b\u660e\u78ba\u300d\u3067\u3059\u3002<sup>4<\/sup>. <em>\u3059\u3079\u3066\u306eR<\/em><em>\u3092\u901a\u3057\u3066\u53ce\u96c6\u3055\u308c\u305f\u30c7\u30fc\u30bf\u3084\u60c5\u5831\u306f\u3001\u9ad8\u54c1\u8cea\u306a\u3082\u306e\u3067\u3042\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002 <\/em><em>PMS<\/em><em>\u307e\u305f\u3001\u5b9f\u65bd\u3055\u308c\u305f\u4e88\u9632\u63aa\u7f6e\u3084\u662f\u6b63\u63aa\u7f6e\u304b\u3089\u5f97\u3089\u308c\u305f\u6559\u8a13\u306f\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u3084\u81e8\u5e8a\u8a55\u4fa1\u306b\u95a2\u9023\u3059\u308b\u3082\u306e\u306a\u3069\u3001\u6280\u8853\u6587\u66f8\u306e\u95a2\u9023\u90e8\u5206\u3092\u66f4\u65b0\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/em><em> \u30ec\u30dd\u30fc\u30c8\uff08CERs<\/em><em>.<\/em><em> \u305d\u308c\u306b\u52a0\u3048\u3066\u3001\u30bb\u30af\u30b7\u30e7\u30f3 <\/em>\u4ed8\u5c5e\u66f8XIV\u306e6.2.3(b)\u3067\u306f\u3001PMS\u30c7\u30fc\u30bf\u3092\u660e\u78ba\u306b\u3057\u3066\u3044\u307e\u3059\u3002 <em>\u6a5f\u5668\u306e\u30ea\u30b9\u30af\uff0f\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3001\u81e8\u5e8a\u6027\u80fd\u3001\u81e8\u5e8a\u5b89\u5168\u6027\u306e\u8a55\u4fa1\u3092\u5909\u3048\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u60c5\u5831\u3092\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/em><em><sup>8<\/sup><\/em>.\u00a0<em>\u305d\u308c\u3089\u306e\u30c7\u30fc\u30bf\u306f\u3001\u81e8\u5e8a\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u306b\u53cd\u6620\u3055\u308c\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/em>\u00a0<em>\u30bf\u30a4\u30e0\u30ea\u30fc\u306b<\/em><em>\u306a\u3069\u306a\u3069\u3002<\/em><em> \u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306f\u3001\u5e02\u8ca9\u5f8c\u306b\u5f97\u3089\u308c\u305f\u30c7\u30fc\u30bf\u3067\u7a4d\u6975\u7684\u306b\u66f4\u65b0\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/em><em>.<\/em>\u00a0\u305d\u306e\u305f\u3081\u306b\u306f\u3001\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\u3092\u5f37\u8abf\u3057\u305f\u8868\u3092\u8ffd\u52a0\u3057\u3001\u6a5f\u5668\u306e\u4f5c\u7528\u6a5f\u5e8f\u306b\u57fa\u3065\u3044\u3066\u3053\u308c\u3089\u304c\u4e88\u6e2c\u3067\u304d\u305f\u304b\u3069\u3046\u304b\u306b\u3064\u3044\u3066\u306e\u89e3\u8aac\u3092\u52a0\u3048\u308b\u306e\u304c\u826f\u3044\u65b9\u6cd5\u3067\u3059\u3002\u307e\u305f\u3001FSCA\uff08Field Safety Corrective Actions\uff09\u306b\u3064\u3044\u3066\u3082\u3001\u5831\u544a\u3059\u3079\u304d\u4e8b\u8c61\u3084\u30ea\u30b3\u30fc\u30eb\u3068\u540c\u69d8\u306b\u5831\u544a\u3059\u3079\u304d\u3067\u3059\u3002\u3069\u306e\u7a0b\u5ea6\u306e\u30c7\u30fc\u30bf\u3092\u8a18\u8f09\u3059\u308b\u304b\u306f\u30e1\u30fc\u30ab\u30fc\u306e\u5224\u65ad\u306b\u3088\u308a\u307e\u3059\u304c\u3001\u88fd\u54c1\u306e\u4fe1\u983c\u6027\u3092\u9ad8\u3081\u308b\u3053\u3068\u304c\u76ee\u7684\u3067\u3042\u308b\u305f\u3081\u3001\u900f\u660e\u6027\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<em><sup>8<\/sup><\/em>.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Are_there_any_other_technicalities_in_the_new_technical_file\"><\/span>\u65b0\u3057\u3044\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u4ed6\u306b\u3082\u6280\u8853\u7684\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u306f\u3044\u3001\u305d\u306e\u901a\u308a\u3067\u3059\u3002\u30c7\u30d0\u30a4\u30b9\u306e\u8aac\u660e\u3068\u4ed5\u69d8\u300d\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u57fa\u672c\u7684\u306aUnique Device Identification-Device Identifier (UDI-DI)\u306b\u3064\u3044\u3066\u8a00\u53ca\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u3053\u308c\u306f\u30c7\u30d0\u30a4\u30b9\u306e\u30e9\u30d9\u30eb\u3084\u305d\u308c\u4ee5\u4e0a\u306e\u30ec\u30d9\u30eb\u306e\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u3082\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059<sup>9<\/sup>.\u3055\u3089\u306b\u3001\u518d\u5229\u7528\u53ef\u80fd\u306a\u624b\u8853\u5668\u5177\u3084\u79fb\u690d\u53ef\u80fd\u306a\u5668\u5177\u306e\u5834\u5408\u3001UDI-DI\u306b\u95a2\u3059\u308b\u4ed5\u69d8\u304c\u5b9a\u3081\u3089\u308c\u3066\u304a\u308a\u3001\u3069\u306e\u3088\u3046\u306a\u72b6\u6cc1\u3067\u3082\u3053\u306e\u30b3\u30fc\u30c9\u756a\u53f7\u306b\u7c21\u5358\u306b\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u5358\u56de\u4f7f\u7528\u6a5f\u5668\uff08SUD\uff09\u306e\u5834\u5408\u3001\u7279\u306b\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u6587\u66f8\u306b\u304a\u3044\u3066\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u305d\u306e\u6a5f\u5668\u304c\u306a\u305c\u305d\u306e\u3088\u3046\u306b\u88fd\u9020\u3055\u308c\u3066\u3044\u308b\u306e\u304b\u3092\u8a3c\u660e\u3057\u3001\u7acb\u8a3c\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044-\u3064\u307e\u308a\u3001\u305d\u306e\u6a5f\u5668\u304c\u306a\u305c\u518d\u51e6\u7406\u3067\u304d\u306a\u3044\u306e\u304b\u3092\u660e\u78ba\u306b\u898f\u5b9a\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044<sup>3<\/sup>.<\/p>\n<p>\u3082\u3046\u4e00\u3064\u306e\u6280\u8853\u7684\u306a\u554f\u984c\u306f\u3001\u3059\u3079\u3066\u306e\u30af\u30e9\u30b9\u306e\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u4ed8\u5c5e\u66f8II\u306b\u57fa\u3065\u304d\u3001\u305d\u306e\u6a5f\u5668\u306b\u9069\u7528\u3055\u308c\u305f\u8a2d\u8a08\u6bb5\u968e\u3068\u624b\u9806\u3092\u8aac\u660e\u3059\u308b\u60c5\u5831\u3092\u6280\u8853\u6587\u66f8\u306b\u63d0\u4f9b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u4ee5\u524d\u306f\u3001\u30af\u30e9\u30b9III\u306e\u533b\u7642\u6a5f\u5668\u3060\u3051\u304c\u3053\u306e\u3088\u3046\u306a\u8981\u6c42\u3092\u3057\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u73fe\u5728\u306f\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u304c\u3053\u306e\u70b9\u3067\u300c\u540c\u3058\u8239\u306b\u4e57\u3063\u3066\u3044\u308b\u300d\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_is_the_medical_device_technical_file_reviewed\"><\/span>\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306f\u3069\u306e\u3088\u3046\u306b\u5be9\u67fb\u3055\u308c\u308b\u306e\u3067\u3059\u304b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u9069\u5408\u6027\u8a55\u4fa1\u306e\u305f\u3081\u306b\u3001NB\u306f\u6a5f\u5668\u306e\u5206\u985e\u306b\u5f93\u3063\u3066\u6280\u8853\u6587\u66f8\u3092\u5be9\u67fb\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u91cd\u8981\u306a\u306e\u306f\u3001\u533b\u7642\u6a5f\u5668\u306f\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3067NB\u306b\u3088\u3063\u3066\u8a55\u4fa1\u3055\u308c\u308b\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u3064\u307e\u308a\u3001\u30e1\u30ea\u30c3\u30c8\u304c\u30ea\u30b9\u30af\u3092\u4e0a\u56de\u308b\u304b\u3001\u3042\u308b\u3044\u306f\u30ea\u30b9\u30af\u304c\u53ef\u80fd\u306a\u9650\u308a\u4f4e\u6e1b\u3055\u308c\u3001\u73fe\u5728\u306e\u6700\u5148\u7aef\u6280\u8853\u306b\u7167\u3089\u3057\u3066\u8a31\u5bb9\u3067\u304d\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u305a\u3001\u4ed8\u4e0e\u3055\u308c\u305f\u8a3c\u660e\u66f8\u306e\u6709\u52b9\u671f\u9593\u5185\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<sup>3,10<\/sup>.\u30af\u30e9\u30b9III\u690d\u8fbc\u307f\u578b\u6a5f\u5668\u3001\u30af\u30e9\u30b9III\u6a5f\u5668\u3001\u30af\u30e9\u30b9IIb\u690d\u8fbc\u307f\u578b\u6a5f\u5668\uff08\u4e00\u90e8\u4f8b\u5916\u3042\u308a\uff09\u3001\u307e\u305f\u306f\u30af\u30e9\u30b9IIb\u30a2\u30af\u30c6\u30a3\u30d6\u6a5f\u5668\u306f\u3001\u6a5f\u5668\u3054\u3068\u306b\u500b\u5225\u306b\u8a55\u4fa1\u3055\u308c\u307e\u3059<sup>3<\/sup>.\u305d\u306e\u4ed6\u306e\u3059\u3079\u3066\u306e\u30af\u30e9\u30b9IIb\u30c7\u30d0\u30a4\u30b9\u306f\u3001\u5c11\u306a\u304f\u3068\u30821\u3064\u306e\u4ee3\u8868\u7684\u306a\u30c7\u30d0\u30a4\u30b9\u306b\u3064\u3044\u3066\u8a55\u4fa1\u3055\u308c\u307e\u3059\u3002 <em>\u306b\u3042\u305f\u308a\u307e\u3059\u3002<\/em> \u4e00\u65b9\u3001\u30af\u30e9\u30b9IIa\u306f\u3001\u6a5f\u5668\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3054\u3068\u306b\u4ee3\u8868\u7684\u306a\u6a5f\u5668\u30921\u53f0\u4ee5\u4e0a\u5be9\u67fb\u3057\u307e\u3059\u3002<\/p>\n<p>\u4e00\u65b9\u3001\u7121\u83cc\u72b6\u614b\u3067\u5e02\u8ca9\u3055\u308c\u308b\u30af\u30e9\u30b9I\u6a5f\u5668\u3001\u6e2c\u5b9a\u6a5f\u80fd\u3092\u6301\u3064\u6a5f\u5668\u3001\u518d\u4f7f\u7528\u53ef\u80fd\u306a\u624b\u8853\u5668\u5177\u306a\u3069\u306f\u3001\u305d\u306e\u6a5f\u5668\u306e\u7279\u5b9a\u306e\u6a5f\u80fd\u306e\u307f\u304c\u8a55\u4fa1\u3055\u308c\u307e\u3059\u3002 <em>e.g,<\/em> \u6ec5\u83cc\u3001\u6e2c\u5b9a\u3001\u307e\u305f\u306f\u518d\u4f7f\u7528\u3002\u305d\u306e\u4ed6\u306e\u30af\u30e9\u30b9I\u6a5f\u5668\u306b\u3064\u3044\u3066\u306f\u3001NB\u306f\u9069\u5408\u6027\u8a55\u4fa1\u306b\u95a2\u4e0e\u305b\u305a\u3001\u30e1\u30fc\u30ab\u30fc\u306f\"<em>\u7b2c19\u6761\u306eEU\u9069\u5408\u5ba3\u8a00\u66f8\u3092\u767a\u884c\u3057\u3066\u3001\u88fd\u54c1\u306e\u9069\u5408\u6027\u3092\u5ba3\u8a00\u3059\u308b\u3053\u3068\u3002<\/em><sup>3<\/sup>.<\/p>\n<p>NB\u307e\u305f\u306f\u6240\u8f44\u5b98\u5e81\u306f\u3001\u63d0\u51fa\u3055\u308c\u305f\u7533\u8acb\u66f8\u3092\u614e\u91cd\u306b\u5be9\u67fb\u3057\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u9069\u5207\u306a\u65bd\u8a2d\u3067\u3055\u3089\u306a\u308b\u8a66\u9a13\u3092\u884c\u3063\u305f\u308a\u3001\u88fd\u9020\u8005\u306b\u8ffd\u52a0\u306e\u8a3c\u62e0\u3092\u8981\u6c42\u3057\u305f\u308a\u3057\u307e\u3059\u3002\u81e8\u5e8a\u7684\u8a3c\u62e0\u304c\u3001\u8a55\u4fa1\u5bfe\u8c61\u6a5f\u5668\u3068\u540c\u7b49\u3067\u3042\u308b\u3068\u4e3b\u5f35\u3055\u308c\u3066\u3044\u308b\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u3044\u3066\u3044\u308b\u5834\u5408\u3001NB\u306e\u5c02\u9580\u5bb6\u306f\u3001\u305d\u306e\u3088\u3046\u306a\u30c7\u30fc\u30bf\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u306e\u59a5\u5f53\u6027\u3092\u8a55\u4fa1\u3057\u3001\u4e3b\u5f35\u3055\u308c\u3066\u3044\u308b\u540c\u7b49\u6027\u306b\u3064\u3044\u3066\u306e\u7d50\u8ad6\u3092\u6587\u66f8\u5316\u3057\u3001\u9069\u5408\u6027\u8a55\u4fa1\u306e\u7d50\u679c\u3092\u81e8\u5e8a\u8a55\u4fa1\u8a55\u4fa1\u5831\u544a\u66f8\u306b\u8a18\u8f09\u3057\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u304c\u95a2\u9023\u3059\u308b\u8981\u6c42\u4e8b\u9805\u306b\u9069\u5408\u3057\u3066\u3044\u308c\u3070\u3001NB\u306fEU\u6280\u8853\u6587\u66f8\u8a55\u4fa1\u8a3c\u660e\u66f8\u3092\u767a\u884c\u3057\u3001\u5e02\u5834\u3078\u306e\u627f\u8a8d\u3092\u4e0e\u3048\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Is_there_anything_else_needed_for_approval_besides_the_medical_device_technical_file\"><\/span>\u533b\u7642\u6a5f\u5668\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u4ee5\u5916\u306b\u3001\u627f\u8a8d\u306b\u5fc5\u8981\u306a\u3082\u306e\u306f\u3042\u308a\u307e\u3059\u304b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u9593\u9055\u3044\u306a\u304f\u3001\u305d\u3046\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306b\u52a0\u3048\u3066\u3001\u9069\u5207\u306a\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u3092\u69cb\u7bc9\u3001\u6587\u66f8\u5316\u3001\u5b9f\u65bd\u3057\u3001\u305d\u306e\u6709\u52b9\u6027\u3092\u5f53\u8a72\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u7dad\u6301\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<sup>5<\/sup>.\u30e1\u30fc\u30ab\u30fc\u306f\u3001PMS\u8a08\u753b\u306b\u57fa\u3065\u3044\u3066\u3001QMS\u306e\u4e0b\u306b\u8a2d\u7acb\u3055\u308c\u305f\u5305\u62ec\u7684\u306aPMS\u30b7\u30b9\u30c6\u30e0\u3092\u78ba\u7acb\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u5e02\u5834\u306b\u900f\u660e\u6027\u3068\u5b89\u5168\u6027\u304c\u3082\u305f\u3089\u3055\u308c\u3001\u5c06\u6765\u7684\u306b\u30e1\u30fc\u30ab\u30fc\u306e\u554f\u984c\u304c\u5c11\u306a\u304f\u306a\u308b\u3053\u3068\u304c\u671f\u5f85\u3055\u308c\u307e\u3059\u3002<\/p>\n<p>\u306e\u3067\u3059\u3002 <em>\u30e2\u30c3\u30c8\u30fc<\/em> \u65b0\u3057\u3044\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u3068MDR\u306e\u57fa\u672c\u7684\u306a\u8003\u3048\u65b9\u306f\u3001\u300c\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u300d\u3068\u300cMDR\u300d\u3067\u3042\u308b\u3002<em>\u4e88\u9632\u306f\u6cbb\u7642\u306b\u52dd\u308b<\/em>\".\u5e02\u8ca9\u5f8c\u306e\u76e3\u8996\u306b\u76ee\u3092\u914d\u308a\u3001\u5f37\u529b\u306a\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3067\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u3092\u8fc5\u901f\u304b\u3064\u5b9a\u671f\u7684\u306b\u66f4\u65b0\u3059\u308b\u3053\u3068\u3067\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u73fe\u4ee3\u306e\u30d8\u30eb\u30b9\u30b1\u30a2\u306e\u57fa\u672c\u539f\u5247\u3092\u5b9f\u8df5\u3057\u3001\u3088\u308a\u5065\u5eb7\u306a\u793e\u4f1a\u3092\u652f\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u3067\u3059\u3002<\/p>\n<p><u>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/u><\/p>\n<p>1 I3CGlobal.\u533b\u7642\u6a5f\u5668\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3002 <a href=\"https:\/\/www.i3cglobal.com\/medical-device-technical-file\/\"><em>https:\/\/www.i3cglobal.com\/medical-device-technical-file\/<\/em><\/a> (2021).<\/p>\n<p>2 EC.\u533b\u7642\u6a5f\u5668 - \u30bb\u30af\u30bf\u30fc <a href=\"https:\/\/ec.europa.eu\/health\/md_sector\/overview_en\"><em>https:\/\/ec.europa.eu\/health\/md_sector\/overview_en<\/em><\/a> <strong>2021<\/strong> (2021).<\/p>\n<p>3 Julianne Bobela, B. F., Kim Rochat, Michael Maier.A Guide for Manufacturers to Ensure Technical Documentation Complies with EU Medical Device Regulation 2017\/745. <em>BSI<\/em> <strong>BSI Standards Ltd.<\/strong> (2021).<\/p>\n<p>4 EU.\u30a4\u30f3 <em>\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08MDR\uff09 \u6b27\u5dde\u9023\u5408\uff08EU\uff09\u898f\u5247 2017\/745<\/em> Vol.EU2017\/745 MDR\uff08\u7de8 \u6b27\u5dde\u59d4\u54e1\u4f1a\uff09\uff08European Commission, <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32017R0745\">https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32017R0745<\/a>, 2017).<\/p>\n<p>5 CleverCompliance.MDR\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u305f\u3081\u306e\u533b\u7642\u6a5f\u5668\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3002 <a href=\"https:\/\/blog.clevercompliance.io\/ce-marking\/medical-device-technical-file-for-mdr-compliance\/\"><em>https:\/\/blog.clevercompliance.io\/ce-marking\/medical-device-technical-file-for-mdr-compliance\/<\/em><\/a> (2021).<\/p>\n<p>6 Celegence.Effective Post-Market Surveillance for Medical Devices. <a href=\"https:\/\/www.celegence.com\/post-market-surveillance-pms-medical-devices\/\"><em>https:\/\/www.celegence.com\/post-market-surveillance-pms-medical-devices\/<\/em><\/a> <strong>2021\u5e747\u67089\u65e5<\/strong> (2021).<\/p>\n<p>7 Celegence.EU\u306eMDR\u306b\u57fa\u3065\u304f\u5e02\u8ca9\u5f8c\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08PMCF\uff09\u306e\u8981\u4ef6\u3002 <a href=\"https:\/\/www.celegence.com\/post-market-clinical-follow-up-requirements-eu-mdr\/\"><em>https:\/\/www.celegence.com\/post-market-clinical-follow-up-requirements-eu-mdr\/<\/em><\/a> <strong>2021\u5e747\u67089\u65e5<\/strong> (2021).<\/p>\n<p>8 OrielSTAT.\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306b\u306f\u3069\u306e\u7a0b\u5ea6\u306ePMS\u30c7\u30fc\u30bf\u3092\u8a18\u8f09\u3059\u3079\u304d\u304b\uff1f <a href=\"https:\/\/www.orielstat.com\/blog\/purpose-of-pms-data-in-cer-vs-psur\/\"><em>https:\/\/www.orielstat.com\/blog\/purpose-of-pms-data-in-cer-vs-psur\/<\/em><\/a> <strong>2021\u5e747\u67089\u65e5<\/strong> (2021).<\/p>\n<p>9 EC\u3067\u3059\u3002EU\u533b\u7642\u6a5f\u5668\u898f\u52472017\/745\u304a\u3088\u30732017\/746\u306b\u57fa\u3065\u304fUnique Device Identification(UDI)\u30b7\u30b9\u30c6\u30e0\u3002 <a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_topics-interest\/docs\/md_faq_udi_en.pdf\"><em>https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_topics-interest\/docs\/md_faq_udi_en.pdf<\/em><\/a> <strong>\u6b27\u5dde\u59d4\u54e1\u4f1a<\/strong> (2020).<\/p>\n<p>10 Smirthwaite, A. (ed BSI) (<a href=\"https:\/\/www.bsigroup.com\/globalassets\/meddev\/localfiles\/en-gb\/webinars\/bsi-md-tech-doc-mdr-uk-en.pdf\">https:\/\/www.bsigroup.com\/globalassets\/meddev\/localfiles\/en-gb\/webinars\/bsi-md-tech-doc-mdr-uk-en.pdf<\/a>, 2017).<\/p>","protected":false},"excerpt":{"rendered":"<p>Catarina Carr\u00e3o,\u00a0freelance medical writer on Kolabtree, provides an overview of what a medical device technical file is and what it should contain. What is a medical device technical file? A medical device technical file is a summary document prepared by the manufacturer in a clear, well-organized, readily searchable, and unambiguous manner to demonstrate the safety and performance of the specific device[1]. Regardless of a device class, or its intended use, design, or even the safety history of the device, the manufacturer must have &#8211; and keep up-to-date &#8211; this technical documentation, in order to demonstrate the compliance with general safety and performance requirements of the legislation. Does the medical device<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":9326,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>What is a technical file and what should it contain? - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"What is a medical device technical file? What does it contain? What&#039;s changed under the EU MDR? Read this expert guide to find out.\" \/>\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-technical-file-and-what-should-it-contain\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What is a technical file and what should it contain?\" \/>\n<meta property=\"og:description\" content=\"What is a medical device technical file? What does it contain? What&#039;s changed under the EU MDR? Read this expert guide to find out.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/\" \/>\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=\"2021-07-28T16:53:27+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-02-21T13:17:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/07\/welcome-here-joyful-good-looking-man-smiling-you-while-welcoming-you-his-office.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1500\" \/>\n\t<meta property=\"og:image:height\" content=\"1000\" \/>\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=\"9\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"What is a technical file and what should it contain? - The Kolabtree Blog","description":"What is a medical device technical file? What does it contain? What's changed under the EU MDR? Read this expert guide to find out.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/","og_locale":"ja_JP","og_type":"article","og_title":"What is a technical file and what should it contain?","og_description":"What is a medical device technical file? What does it contain? What's changed under the EU MDR? Read this expert guide to find out.","og_url":"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/","og_site_name":"The Kolabtree Blog","article_publisher":"https:\/\/www.facebook.com\/kolabtree","article_published_time":"2021-07-28T16:53:27+00:00","article_modified_time":"2022-02-21T13:17:14+00:00","og_image":[{"width":1500,"height":1000,"url":"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/07\/welcome-here-joyful-good-looking-man-smiling-you-while-welcoming-you-his-office.jpg","type":"image\/jpeg"}],"author":"Ramya Sriram","twitter_card":"summary_large_image","twitter_creator":"@kolabtree","twitter_site":"@kolabtree","twitter_misc":{"\u57f7\u7b46\u8005":"Ramya Sriram","\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593":"9\u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/#article","isPartOf":{"@id":"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/"},"author":{"name":"Ramya Sriram","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/81992f5863a1b06d132a47822e7b4400"},"headline":"What is a technical file and what should it contain?","datePublished":"2021-07-28T16:53:27+00:00","dateModified":"2022-02-21T13:17:14+00:00","mainEntityOfPage":{"@id":"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/"},"wordCount":2007,"commentCount":0,"publisher":{"@id":"https:\/\/www.kolabtree.com\/blog\/#organization"},"articleSection":["Medical Devices"],"inLanguage":"ja","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/","url":"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/","name":"What is a technical file and what should it contain? - The Kolabtree Blog","isPartOf":{"@id":"https:\/\/www.kolabtree.com\/blog\/#website"},"datePublished":"2021-07-28T16:53:27+00:00","dateModified":"2022-02-21T13:17:14+00:00","description":"What is a medical device technical file? What does it contain? What's changed under the EU MDR? Read this expert guide to find out.","breadcrumb":{"@id":"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/#breadcrumb"},"inLanguage":"ja","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-a-technical-file-and-what-should-it-contain\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.kolabtree.com\/blog\/"},{"@type":"ListItem","position":2,"name":"What is a technical file and what should it contain?"}]},{"@type":"WebSite","@id":"https:\/\/www.kolabtree.com\/blog\/#website","url":"https:\/\/www.kolabtree.com\/blog\/","name":"The Kolabtree Blog","description":"Expert Views on Science, Innovation and Product Development","publisher":{"@id":"https:\/\/www.kolabtree.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.kolabtree.com\/blog\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"ja"},{"@type":"Organization","@id":"https:\/\/www.kolabtree.com\/blog\/#organization","name":"Kolabtree","url":"https:\/\/www.kolabtree.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"Kolabtree"},"image":{"@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/kolabtree","https:\/\/twitter.com\/kolabtree","https:\/\/instagram.com\/kolabtree","https:\/\/www.linkedin.com\/company\/kolabtree","https:\/\/en.m.wikipedia.org\/wiki\/Kolabtree"]},{"@type":"Person","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/81992f5863a1b06d132a47822e7b4400","name":"Ramya Sriram","image":{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/8100b45c960ebbbbe420e8b3f250515f?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/8100b45c960ebbbbe420e8b3f250515f?s=96&d=mm&r=g","caption":"Ramya Sriram"},"description":"Ramya Sriram manages digital content and communications at Kolabtree (kolabtree.com), the world's largest freelancing platform for scientists. She has over a decade of experience in publishing, advertising and digital content creation.","url":"https:\/\/www.kolabtree.com\/blog\/ja\/author\/ramyas\/"}]}},"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/9323"}],"collection":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/comments?post=9323"}],"version-history":[{"count":2,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/9323\/revisions"}],"predecessor-version":[{"id":9947,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/9323\/revisions\/9947"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/media\/9326"}],"wp:attachment":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/media?parent=9323"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/categories?post=9323"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/tags?post=9323"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}