{"id":10083,"date":"2022-07-08T09:56:47","date_gmt":"2022-07-08T09:56:47","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=10083"},"modified":"2023-03-06T11:50:12","modified_gmt":"2023-03-06T11:50:12","slug":"mdr-updates-2022-kolabtree","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/mdr-updates-2022-kolabtree\/","title":{"rendered":"MDR\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3068\u30c8\u30ec\u30f3\u30c9 - \u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u6c7a\u5b9a\u7248"},"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-69f1b1474de17\" 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-69f1b1474de17\"><\/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\/mdr-updates-2022-kolabtree\/#MDR_updates_you_need_to_know\" title=\"\u77e5\u3063\u3066\u304a\u304d\u305f\u3044MDR\u306e\u6700\u65b0\u60c5\u5831\">\u77e5\u3063\u3066\u304a\u304d\u305f\u3044MDR\u306e\u6700\u65b0\u60c5\u5831<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/mdr-updates-2022-kolabtree\/#TableFig_1_Highlights_of_the_major_MDR_updates\" title=\"\u8868\/\u56f31: MDR\u306e\u4e3b\u306a\u66f4\u65b0\u5185\u5bb9\u306e\u30cf\u30a4\u30e9\u30a4\u30c8\u00a0 \u00a0\">\u8868\/\u56f31: MDR\u306e\u4e3b\u306a\u66f4\u65b0\u5185\u5bb9\u306e\u30cf\u30a4\u30e9\u30a4\u30c8\u00a0 \u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/mdr-updates-2022-kolabtree\/#Keeping_up_with_the_MDCG_-_MDR_updates\" title=\"MDCG\u3068\u3064\u304d\u3042\u3046 - MDR\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\">MDCG\u3068\u3064\u304d\u3042\u3046 - MDR\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/mdr-updates-2022-kolabtree\/#MDCG_position_paper_2022-11_released_in_June_2022\" title=\"MDCG\u30dd\u30b8\u30b7\u30e7\u30f3\u30da\u30fc\u30d1\u30fc2022-11\uff082022\u5e746\u6708\u767a\u8868\uff09\">MDCG\u30dd\u30b8\u30b7\u30e7\u30f3\u30da\u30fc\u30d1\u30fc2022-11\uff082022\u5e746\u6708\u767a\u8868\uff09<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/mdr-updates-2022-kolabtree\/#How_can_hiring_expert_medical_writers_help_you\" title=\"\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306e\u5c02\u9580\u5bb6\u306b\u4f9d\u983c\u3059\u308b\u3068\u3001\u3069\u306e\u3088\u3046\u306a\u52b9\u679c\u304c\u3042\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\">\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306e\u5c02\u9580\u5bb6\u306b\u4f9d\u983c\u3059\u308b\u3068\u3001\u3069\u306e\u3088\u3046\u306a\u52b9\u679c\u304c\u3042\u308b\u306e\u3067\u3057\u3087\u3046\u304b\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\/mdr-updates-2022-kolabtree\/#Role_of_regulatory_medical_writers\" title=\"\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306e\u5f79\u5272\">\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306e\u5f79\u5272<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/mdr-updates-2022-kolabtree\/#Where_does_Kolabtree_fit_in_this\" title=\"Kolabtree\u306f\u3069\u3053\u306b\u5165\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\">Kolabtree\u306f\u3069\u3053\u306b\u5165\u308b\u306e\u3067\u3057\u3087\u3046\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\/mdr-updates-2022-kolabtree\/#References\" title=\"\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\">\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/a><\/li><\/ul><\/nav><\/div>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001EU MDR\u306e\u66f4\u65b0\u3092\u30bf\u30a4\u30e0\u30ea\u30fc\u306b\u628a\u63e1\u3059\u308b\u3053\u3068\u306f\u3001\u6b27\u5dde\u7d4c\u6e08\u9818\u57df\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306e\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u304a\u3088\u3073\u8ca9\u58f2\u3092\u898f\u5b9a\u3059\u308b\u4e00\u9023\u306e\u898f\u5236\u3092\u78ba\u5b9f\u306b\u9075\u5b88\u3059\u308b\u305f\u3081\u306b\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002 <\/span><\/p>\n<p><em><span style=\"font-weight: 400;\">This article, authored by Kolabtree&#8217;s freelance scientist <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/aditi-kandlur\">\u30a2\u30c7\u30a3\u30c6\u30a3\u30fb\u30ab\u30f3\u30c9\u30a5\u30eb\u30fc\u30eb<\/a> elaborates on the MDR updates you need to keep an eye on as we traverse 2022. Aditi is a molecular biologist with a passion for writing and changing the world one step at a time. She can be contacted on Kolabtree for freelance projects related to medical writing, molecular biology and behavioural neuroscience.<\/span><\/em><\/p>\n<p><span style=\"font-weight: 400;\">\u5168\u4e16\u754c\u3067\u3001\u533b\u7642\u6a5f\u5668\u3068 <a href=\"https:\/\/www.kolabtree.com\/blog\/pioneering-medtech-healthcare-companies-in-europe\/\">\u30e1\u30c9\u30c6\u30c3\u30af<\/a> sectors of industries aim to place high-quality products capable of delivering quality healthcare to patients. However, attaining such a status of high quality requires companies to invest their resources into strategic planning, <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> and development, engineering and compliance with <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-compliance\">\u898f\u5236\u57fa\u6e96\u3002<\/a>\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u306e\u3067\u3059\u3002 <\/span><a href=\"https:\/\/www.who.int\/activities\/prioritizing-medical-devices\"><span style=\"font-weight: 400;\">WHO<\/span><\/a><span style=\"font-weight: 400;\"> \u307e\u305f\u3001\u52a0\u76df\u56fd\u304c \"Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices\" \u3092\u901a\u3058\u3066\u305d\u306e\u3088\u3046\u306a\u63aa\u7f6e\u3084\u653f\u7b56\u3092\u958b\u767a\u3057\u5b9f\u65bd\u3059\u308b\u3053\u3068\u3092\u652f\u6301\u3057\u5f37\u8abf\u3059\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In the European region, the European Medicines Agency (EMA) oversees the regulatory process while advising on scientific matters to other designated organizations\/notified bodies. Each European Union(EU) Member State has an accredited notified body responsible for performing conformity assessments and evaluations of medical device or medtech manufacturers. Passing the inspection validates the manufacturers with the <\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/medical-devices\"><span style=\"font-weight: 400;\">CE (Conformit\u00e9 Europ\u00e9enne) (\u6b27\u5dde\u9069\u5408\u898f\u683c)<\/span><\/a><span style=\"font-weight: 400;\"> \u30de\u30fc\u30af\u3092\u533b\u7642\u6a5f\u5668\u306b\u8868\u793a\u3059\u308b\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">CE\u30de\u30fc\u30af\u8a8d\u8a3c\u306b\u3088\u308a <\/span><a href=\"https:\/\/cemarking.net\/how-do-you-benefit-from-ce-marking\/\"><span style=\"font-weight: 400;\">\u4ea4\u6613\u53ef\u80fd<\/span><\/a><span style=\"font-weight: 400;\"> \u306b\u8a8d\u5b9a\u3055\u308c\u307e\u3057\u305f\u3002\u307e\u305f\u3001\u3053\u306e\u8a8d\u5b9a\u306f\u3001\u88fd\u54c1\u304cEU\u306e\u65b0\u57fa\u6e96\u306e\u3082\u3068\u3001\u3059\u3079\u3066\u306e\u898f\u5236\u8981\u4ef6\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u3082\u306e\u3067\u3059\u3002 <\/span><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u898f\u5236\uff08MDR updates 2017\/745\uff09\u3067\u3059\u3002\u3053\u306e <\/span><a href=\"https:\/\/cemarking.net\/how-do-you-benefit-from-ce-marking\/\"><span style=\"font-weight: 400;\">CE\u30de\u30fc\u30ad\u30f3\u30b0\u306e\u30e1\u30ea\u30c3\u30c8<\/span><\/a><span style=\"font-weight: 400;\"> \u88fd\u9020\u8005\u306f\u3001\u6b27\u5dde\u7d4c\u6e08\u9818\u57df\uff08EEA\uff09\u5185\u3067\u88fd\u54c1\u3092\u8a2d\u8a08\u30fb\u88fd\u9020\u3059\u308b\u969b\u306b\u3001\u7d71\u4e00\u3055\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f93\u308f\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u304b\u3089\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u3088\u308a\u5b89\u5168\u306a\u88fd\u54c1\u304c\u30e6\u30fc\u30b6\u30fc\u306e\u624b\u306b\u6e21\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u3001\u305d\u308c\u306b\u3088\u3063\u3066\u8cac\u4efb\u3084\u640d\u5bb3\u8ce0\u511f\u306e\u8acb\u6c42\u3092\u6e1b\u3089\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u306e\u3067\u3059\u3002 <\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/medical-device-regulation-comes-application\"><span style=\"font-weight: 400;\">MDR<\/span><\/a> <span style=\"font-weight: 400;\">\u306f2017\u5e744\u6708\u306b\u5c0e\u5165\u3055\u308c\u307e\u3057\u305f\u304c\u3001\u305d\u306e\u5f8c2017\u5e745\u6708\u306b\u63a1\u7528\u3055\u308c\u307e\u3057\u305f\u3002\u95a2\u4fc2\u8005\u304c\u65b0\u4f53\u5236\u306b\u79fb\u884c\u3059\u308b\u307e\u3067\u306b\u304b\u306a\u308a\u306e\u6642\u9593\u3092\u8981\u3057\u305f\u3002MDR\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u9023\u3059\u308b\u65b0\u305f\u306a\u6cd5\u7684\u67a0\u7d44\u307f\u306e\u5909\u66f4\u3068\u6539\u8a02\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u305d\u306e\u4e00\u65b9\u3067\u3001EMA\u3068EU\u52a0\u76df\u56fd\u306e\u95a2\u9023\u901a\u77e5\u6a5f\u95a2\u306e\u6a5f\u80fd\u7684\u30fb\u53ce\u5bb9\u7684\u306a\u8cac\u4efb\u3082\u518d\u69cb\u7bc9\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"MDR_updates_you_need_to_know\"><\/span><b>\u77e5\u3063\u3066\u304a\u304d\u305f\u3044MDR\u306e\u6700\u65b0\u60c5\u5831<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">2022\u5e74\u306eMDR\u66f4\u65b0\u306f\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306b\u3088\u3063\u3066\u7279\u5b9a\u306e\u4fee\u6b63\u304c\u884c\u308f\u308c\u3001\u305d\u306e\u307b\u3068\u3093\u3069\u304c2021\u5e74\u306b\u8a2d\u5b9a\u3055\u308c\u305fMDR\u6a19\u6e96\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3078\u306e\u8ffd\u52a0\u3067\u3042\u308b\u3002\u3053\u308c\u30899\u3064\u306e\u65b0\u3057\u3044\u8ffd\u52a0\u6761\u9805\u306f\u3001\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u3001\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u3001\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3001\u305d\u3057\u3066\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\/\u307e\u305f\u306f\u95a2\u9023\u533b\u7642\u88fd\u54c1\u306e\u6ec5\u83cc\u306a\u3069\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3059\u3002 <\/span><span style=\"font-weight: 400;\">(\u88681\/\u56f31\uff09\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u6b27\u5dde\u59d4\u54e1\u4f1a\u306b\u3088\u308b\u3068\u3001\u300c\u95a2\u9023\u3059\u308b\u6574\u5408\u898f\u683c\u307e\u305f\u306f\u305d\u306e\u95a2\u9023\u90e8\u5206\uff08\u305d\u306e\u53c2\u7167\u5148\u304c\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb\u306b\u63b2\u8f09\u3055\u308c\u3066\u3044\u308b\uff09\u306b\u9069\u5408\u3057\u305f\u6a5f\u5668\u300d\u306f\u3001\u300c\u9069\u5408\u3057\u305f\u6a5f\u5668\u300d\u3068\u307f\u306a\u3055\u308c\u307e\u3059\u3002 <\/span><b>\u6b27\u5dde\u9023\u5408\u5b98\u5831<\/b><span style=\"font-weight: 400;\">\u306f\u3001\u3053\u308c\u3089\u306e\u898f\u683c\u307e\u305f\u306f\u305d\u306e\u4e00\u90e8\u304c\u5bfe\u8c61\u3068\u3059\u308b\u5f53\u8a72\u898f\u5247\u306e\u8981\u6c42\u4e8b\u9805\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3082\u306e\u3068\u63a8\u5b9a\u3055\u308c\u308b\" \u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">2022\u5e745\u6708\u3001\u30b3\u30f3\u30d1\u30cb\u30aa\u30f3\/\u306e\u65b0\u5206\u985e\u5236\u5ea6\u304c\u5c0e\u5165\u3055\u308c\u308b\u3002 <\/span><i><span style=\"font-weight: 400;\">in vitro<\/span><\/i><span style=\"font-weight: 400;\"> \u8a3a\u65ad\u85ac\u304c\u7d39\u4ecb\u3055\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u898f\u5236\u306f\u3001\u6cbb\u7642\u6cd5\u3068\u3057\u3066\u533b\u7642\u6a5f\u5668\u3092\u63d0\u4f9b\u3055\u308c\u308b\u60a3\u8005\u3068\u306e\u9069\u5408\u6027\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u30b3\u30f3\u30d1\u30cb\u30aa\u30f3\u8a3a\u65ad\u30c4\u30fc\u30eb\u306e\u5f79\u5272\u3068\u5fc5\u8981\u6027\u3092\u78ba\u7acb\u3057\u305f\u3002\u3053\u308c\u3089\u306e\u65b0\u3057\u3044\u898f\u5236\u306f\u3059\u3079\u3066\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u52b9\u7387\u7684\u306b\u898f\u683c\u306b\u6e96\u62e0\u3067\u304d\u308b\u3088\u3046\u3001\u660e\u78ba\u306a\u6a29\u9650\u3092\u4e0e\u3048\u308b\u305f\u3081\u306b\u65bd\u884c\u3055\u308c\u305f\u3082\u306e\u3067\u3059\u3002\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"TableFig_1_Highlights_of_the_major_MDR_updates\"><\/span><b>\u8868\/\u56f31: MDR\u306e\u4e3b\u306a\u66f4\u65b0\u5185\u5bb9\u306e\u30cf\u30a4\u30e9\u30a4\u30c8\u00a0 \u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>&nbsp;<\/p>\n<table>\n<tbody>\n<tr>\n<td><b>\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u540d\u79f0<\/b><\/td>\n<td><b>\u7c21\u5358\u306a\u8aac\u660e\/ \u6761\u9805<\/b><\/td>\n<td><b>\u6709\u52b9\u671f\u9650<\/b><\/td>\n<td><b>\u8981\u6c42\u3055\u308c\u308b\u79fb\u884c\u671f\u9593<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u3068\u4f75\u7528\u3059\u308b\u5834\u5408\u306e\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u306b\u95a2\u3059\u308b\u6587\u66f8\u5316\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(EMA\/CHMP\/QWP\/BWP\/259165\/2019)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u672c\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3001\u5b89\u5168\u6027\u53ca\u3073\uff0f\u53c8\u306f\u6709\u52b9\u6027\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u53ef\u80fd\u6027\u306e\u3042\u308b \u533b\u7642\u88fd\u54c1\u53c8\u306f\u6a5f\u5668\u90e8\u54c1\u306e\u88fd\u54c1\u56fa\u6709\u306e\u54c1\u8cea\u9762\u3092\u63d0\u793a\u3059\u308b\u3088\u3046\u95a2\u4fc2\u8005\u306b\u6307\u793a\u3059\u308b\u3002\u3053\u306e\u54c1\u8cea\u95a2\u9023\u60c5\u5831\u306f\u3001\u6307\u4ee4 2001\/83\/EC \u304a\u3088\u3073\/\u307e\u305f\u306f\u898f\u5247 (EC) 726\/2004 \u306b\u5f93\u3063\u3066\u3001\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u8cc7\u6599\u306e\u4e2d\u3067\u63d0\u793a\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">2022\u5e741\u67081\u65e5<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u306a\u3057<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u6b27\u5dde\u59d4\u54e1\u4f1a\u5b9f\u65bd\u6c7a\u5b9a(EU) 2022\/6<\/span><\/td>\n<td><span style=\"font-weight: 400;\">6.EN ISO 10993-9:2021- \u533b\u7642\u6a5f\u5668\u306e\u751f\u7269\u5b66\u7684\u8a55\u4fa1 - \u7b2c 9 \u90e8\uff1a\u6f5c\u5728\u7684\u52a3\u5316\u751f\u6210\u7269\u306e\u540c\u5b9a\u304a\u3088\u3073\u5b9a\u91cf\u5316\u306e\u305f\u3081\u306e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">7.EN ISO 10993-12:2021- \u533b\u7642\u6a5f\u5668\u306e\u751f\u7269\u5b66\u7684\u8a55\u4fa1 - \u7b2c 12 \u90e8: \u8a66\u6599\u8abf\u88fd\u3068\u6a19\u6e96\u7269\u8cea\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">8. EN ISO 11737-1:2018- Sterilization of health care products &#8211; Microbiological methods &#8211; Part 1: Determination of a population of microorganisms on products\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">9.EN ISO 13408-6:2021- \u30d8\u30eb\u30b9\u30b1\u30a2\u88fd\u54c1\u306e\u7121\u83cc\u51e6\u7406 - \u7b2c 6 \u90e8\uff1a\u30a2\u30a4\u30bd\u30ec\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">10. EN <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/iso-13485\" target=\"_blank\" rel=\"noopener\">ISO 13485<\/a>:2016- Medical devices &#8211; Quality management systems &#8211; Requirements for regulatory purposes<\/span><\/p>\n<p><span style=\"font-weight: 400;\">11. EN ISO 14160:2021- Sterilization of health care products &#8211; Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives &#8211; Requirements for characterization, development, validation and routine control of a sterilization process for medical devices<\/span><\/p>\n<p><span style=\"font-weight: 400;\">12.EN ISO 15223-1:2021- \u533b\u7642\u6a5f\u5668-\u88fd\u9020\u8005\u304b\u3089\u63d0\u4f9b\u3055\u308c\u308b\u60c5\u5831\u3068\u5171\u306b\u4f7f\u7528\u3055\u308c\u308b\u30b7\u30f3\u30dc\u30eb-\u7b2c 1 \u90e8:\u4e00\u822c\u8981\u6c42\u4e8b\u9805<\/span><\/p>\n<p><span style=\"font-weight: 400;\">13.EN ISO 17664-1:2021-\u30d8\u30eb\u30b9\u30b1\u30a2\u88fd\u54c1\u306e\u52a0\u5de5-\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u304c\u533b\u7642\u6a5f\u5668\u306e\u52a0\u5de5\u306e\u305f\u3081\u306b\u63d0\u4f9b\u3059\u3079\u304d\u60c5\u5831-\u7b2c1\u90e8\u3002\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u53ca\u3073\u30bb\u30df\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u306a\u533b\u7642\u6a5f\u5668<\/span><\/p>\n<p><span style=\"font-weight: 400;\">14.EN IEC 60601-2-83:2020- \u533b\u7642\u7528\u96fb\u6c17\u6a5f\u5668-\u7b2c 2-83 \u90e8:\u5bb6\u5ead\u7528\u5149\u6cbb\u7642\u5668\u306e\u57fa\u672c\u7684\u5b89\u5168\u6027\u3068\u672c\u8cea\u7684\u6027\u80fd\u306b\u95a2\u3059\u308b\u7279\u5225\u8981\u6c42\u4e8b\u9805<\/span><\/td>\n<td><span style=\"font-weight: 400;\">2022\u5e741\u67084\u65e5<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u306a\u3057<\/span><\/td>\n<\/tr>\n<tr>\n<td><i><span style=\"font-weight: 400;\">In-Vitro<\/span><\/i><span style=\"font-weight: 400;\"> \u8a3a\u65ad\u6a5f\u5668\u898f\u5236\uff08\u898f\u5247(EU)2017\/746)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u672c\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u30b3\u30f3\u30d1\u30cb\u30aa\u30f3\u306e\u5206\u985e\u30b7\u30b9\u30c6\u30e0\u3092\u65b0\u305f\u306b\u5c0e\u5165\u3057\u3066\u3044\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">in vitro<\/span><\/i><span style=\"font-weight: 400;\"> \u6cbb\u7642\u624b\u6bb5\u3068\u3057\u3066\u5f53\u8a72\u533b\u7642\u88fd\u54c1\u306b\u9069\u5408\u3059\u308b\u60a3\u8005\u3092\u7279\u5b9a\u3059\u308b\u8a3a\u65ad\u85ac\u3002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">2022\u5e745\u670826\u65e5<\/span><\/td>\n<td><span style=\"font-weight: 400;\">5\u5e74<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">MDCG 2019-9 Rev.1\u306e\u5909\u66f4\u70b9<\/span><\/td>\n<td><span style=\"font-weight: 400;\">MDR\u306f\u3001\u516c\u8a8d\u6a5f\u95a2\u306b\u3088\u3063\u3066\u8a55\u4fa1\u3055\u308c\u308b\u969b\u306b\u3001\u57cb\u3081\u8fbc\u307f\u578b\u3084\u30af\u30e9\u30b9III\u306e\u6a5f\u5668\u306a\u3069\u306e\u9ad8\u30ea\u30b9\u30af\u306e\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u81e8\u5e8a\u6027\u80fd\u306e\u30b5\u30de\u30ea\u30fc\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u306b\u95a2\u3059\u308b\u66f4\u65b0\u3092\u884c\u3044\u307e\u3057\u305f\u3002\u307e\u305f\u3001\u88fd\u9020\u696d\u8005\u306f\u305d\u306e\u3088\u3046\u306a\u8981\u7d04\u306b\u56fa\u6709\u306e\u53c2\u7167\u30b3\u30fc\u30c9\/\u756a\u53f7\u3092\u5272\u308a\u5f53\u3066\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u3082\u8a73\u8ff0\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u52d5\u304d\u306f\u3001\u3088\u308a\u900f\u660e\u6027\u3092\u9ad8\u3081\u3001\u60c5\u5831\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3092\u5bb9\u6613\u306b\u3059\u308b\u3053\u3068\u3092\u610f\u56f3\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">2022\u5e743\u670824\u65e5<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30af\u30e9\u30b9 3 \u306e\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u88fd\u54c1\u306b\u3064\u3044\u3066\u306f 2 \u5e74\u3001\u305d\u306e\u4ed6\u306b\u3064\u3044\u3066\u306f 4 \u5e74\u3002<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><\/h2>\n<h2><span class=\"ez-toc-section\" id=\"Keeping_up_with_the_MDCG_-_MDR_updates\"><\/span><strong>MDCG\u3068\u3064\u304d\u3042\u3046 - MDR\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">MDR\u306b\u3088\u3063\u3066\u533b\u7642\u6a5f\u5668\u8abf\u6574\u30b0\u30eb\u30fc\u30d7\uff08MDCG\uff09\u304c\u8a2d\u7acb\u3055\u308c\u307e\u3057\u305f\u3002MDCG\u30d1\u30cd\u30eb\u306f\u3001\u5404\u52a0\u76df\u56fd\u304b\u3089\u5c11\u306a\u304f\u3068\u30821\/2\u540d\u306e\u5c02\u9580\u5bb6\u30682\u540d\u306e\u4ee3\u7406\u4eba\u304b\u3089\u69cb\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u30d1\u30cd\u30ea\u30b9\u30c8\u306f\u3001\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u5c02\u9580\u77e5\u8b58\u306b\u57fa\u3065\u3044\u3066\u9078\u51fa\u3055\u308c\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">in vitro<\/span><\/i><span style=\"font-weight: 400;\"> \u8a3a\u65ad\u6a5f\u5668\u3002\u30d1\u30cd\u30eb\u306e\u4efb\u671f\u306f3\u5e74\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">MDCG\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u3084\u5c4a\u51fa\u898f\u5236\u6a5f\u95a2\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u69d8\u3005\u306a\u5f79\u5272\u3092\u62c5\u3063\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">MDR\u3092\u4f53\u7cfb\u7684\u306b\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u63d0\u4f9b<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u6280\u8853\u7684\u9032\u6b69\u306e\u76e3\u8996\u3068\u898f\u7bc4\u30fb\u898f\u683c\u306e\u7b56\u5b9a\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u52a0\u76df\u56fd\u306e\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u3092\u8a55\u4fa1\u3059\u308b<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Assisting competent authorities in a wide range of regulatory areas.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u7b2c49\u6761\u306b\u57fa\u3065\u304f\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u8abf\u6574\u30b0\u30eb\u30fc\u30d7\u306e\u6a5f\u80fd\u3092\u8abf\u6574\u3059\u308b\u305f\u3081\u306e\u6b27\u5dde\u59d4\u54e1\u4f1a\u306e\u30d5\u30a9\u30fc\u30ab\u30eb\u30dd\u30a4\u30f3\u30c8\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">MDCG\u306f\u3001\u898f\u5236\u306e\u5b9f\u65bd\u306b\u5426\u5b9a\u3067\u304d\u306a\u3044\u5f71\u97ff\u3092\u53ca\u307c\u3057\u3066\u304a\u308a\u3001\u305d\u308c\u3086\u3048\u904e\u5c0f\u8a55\u4fa1\u3055\u308c\u308b\u3079\u304d\u3067\u306f\u306a\u3044\u3002\u3053\u306e\u30d1\u30cd\u30eb\u306f\u3001MDD 93\/42\/EEC\u304b\u3089\u65b0\u3057\u3044MDD 93\/42\/EEC\u3078\u306e\u79fb\u884c\u3092\u5b9f\u73fe\u3059\u308b\u5f79\u5272\u3092\u62c5\u3063\u3066\u304d\u307e\u3057\u305f\u3002 <\/span><span style=\"font-weight: 400;\">MDR 2017\/745\u3067\u3059\u3002MDR\u306e\u66f4\u65b0\u3068MDCG\u306b\u3088\u308bIVDR\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u53e4\u3044MEDDEV\u306e\u6587\u66f8\u306b\u53d6\u3063\u3066\u4ee3\u308f\u308a\u307e\u3057\u305f\u3002\u88fd\u9020\u4f01\u696d\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u3053\u3068\u306f\u3001\u3053\u308c\u3089\u306eMDCG\u306b\u3088\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c <\/span><b>\u30ce\u30c3\u30c8 <\/b><span style=\"font-weight: 400;\">\u3057\u304b\u3057\u3001\u6cd5\u7684\u62d8\u675f\u529b\u304c\u3042\u308b\u306e\u3067\u3042\u308c\u3070\u3001\u614e\u91cd\u306b\u691c\u8a0e\u3057\u3001\u5fc5\u8981\u306a\u3068\u304d\u306b\u5b9f\u52d9\u7684\u306b\u5b9f\u65bd\u3059\u308b\u65b9\u304c\u30b9\u30de\u30fc\u30c8\u306a\u9078\u629e\u3067\u3042\u308d\u3046\u3002MDCG\u306f\u3001MDR\u306e\u7b2c105\u6761\u306b\u3088\u308a\u3001\"\u898f\u5236\u306e\u52b9\u679c\u7684\u304b\u3064\u8abf\u548c\u7684\u306a\u5b9f\u65bd \"\u306b\u5411\u3051\u3066\u8ca2\u732e\u3059\u308b\u8cac\u4efb\u304c\u3042\u308b\u3068\u3057\u3066\u3001\u898f\u5236\u306e\u5b9f\u65bd\u3092\u5f37\u5236\u3057\u3066\u3044\u308b\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">MDCG\u3092\u901a\u3058\u3066\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u5b9f\u8a3c\u3059\u308b\u305f\u3081\u306e\u30d9\u30f3\u30c1\u30de\u30fc\u30af\u57fa\u6e96\u304c\u5897\u52a0\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08MDD\uff09\u3068\u6bd4\u8f03\u3059\u308b\u3068\u3001\u3088\u308a\u67d4\u8edf\u3067\u5305\u62ec\u7684\u306a\u3082\u306e\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u304b\u3089\u9001\u4ed8\u3055\u308c\u308b\u54c1\u8cea\u5831\u544a\u66f8\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u30b9\u30dd\u30f3\u30b5\u30fc\u3068\u306a\u3063\u305f\u81e8\u5e8a\u8a66\u9a13\u3084\u3001\u5bfe\u8c61\u6a5f\u5668\u306b\u7279\u5316\u3057\u305f\u67fb\u8aad\u4ed8\u304d\u6587\u732e\u306b\u57fa\u3065\u3044\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306e\u30c7\u30fc\u30bf\u30bd\u30fc\u30b9\u306f\u3001\u30b4\u30fc\u30eb\u30c9\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9\u3067\u3042\u308a\u3001\u6a5f\u5668\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u6700\u3082\u76f4\u63a5\u7684\u306a\u8a3c\u62e0\u3068\u898b\u306a\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"MDCG_position_paper_2022-11_released_in_June_2022\"><\/span>MDCG\u30dd\u30b8\u30b7\u30e7\u30f3\u30da\u30fc\u30d1\u30fc2022-11\uff082022\u5e746\u6708\u767a\u8868\uff09<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">MDCG\u306f\u3001\u6cd5\u7684\u62d8\u675f\u529b\u306e\u306a\u3044\u30dd\u30b8\u30b7\u30e7\u30f3\u30da\u30fc\u30d1\u30fc\u3092\u767a\u8868\u3057\u3066\u304a\u308a\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306e\u6587\u66f8\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001\u3053\u306e\u3088\u3046\u306a\u6587\u66f8\u306f\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306e\u516c\u5f0f\u898b\u89e3\u3092\u53cd\u6620\u3057\u305f\u3082\u306e\u3068\u307f\u306a\u3055\u308c\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">On 13 June 2022, a Position paper <\/span><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-11-mdcg-position-paper-notice-manufacturers-ensure-timely-compliance-mdr-requirements-2022-06-13_en\"><span style=\"font-weight: 400;\">MDCG 2022-11<\/span><\/a><span style=\"font-weight: 400;\"> \u304c\u6b27\u5dde\u59d4\u54e1\u4f1a\u306e\u30db\u30fc\u30e0\u30da\u30fc\u30b8\u3067\u516c\u958b\u3055\u308c\u3001MDCG \u306e\u652f\u6301\u3092\u53d7\u3051\u307e\u3057\u305f\u3002MDCG 2022-11\u306f\u3001MDR\u306e\u8981\u6c42\u4e8b\u9805\u3092\u30bf\u30a4\u30e0\u30ea\u30fc\u306b\u9075\u5b88\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u3001\u30e1\u30fc\u30ab\u30fc\u3078\u306e\u901a\u77e5\u3068\u306a\u308a\u307e\u3059\u3002\u3053\u306e\u6587\u66f8\u306f\u3001\u533b\u7642\u6a5f\u5668\u304c\u4e0d\u8db3\u3059\u308b\u3053\u3068\u306a\u304f\u5e02\u5834\u306b\u6295\u5165\u3055\u308c\u7d9a\u3051\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u610f\u56f3\u3067\u8a9e\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6587\u66f8\u3067\u306f\u3001\u3059\u3079\u3066\u306e\u88fd\u9020\u696d\u8005\u306b\u3068\u3063\u3066\u3001MDR\u3078\u306e\u79fb\u884c\u3092\u5b8c\u4e86\u3055\u305b\u3001\u5b8c\u5168\u304b\u3064\u6e96\u62e0\u3057\u305f\u7533\u8acb\u66f8\u3092\u63d0\u51fa\u3057\u3066\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u306b\u7533\u8acb\u3057CE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306e\u624b\u9806\u3092\u542b\u3080\u30b7\u30b9\u30c6\u30e0\u3092\u9032\u5316\u3055\u305b\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3042\u308b\u3053\u3068\u3092\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002MDCG\u306f\u3001\u88fd\u9020\u8005\u304c\u3067\u304d\u308b\u3060\u3051\u65e9\u304f\u884c\u52d5\u3057\u3001\u79fb\u884c\u671f\u9593\u7d42\u4e86\u307e\u3067\u306b\u624b\u7d9a\u304d\u3092\u9032\u3081\u3001\u30bf\u30a4\u30e0\u30ea\u30fc\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u3092\u5f37\u8abf\u3059\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u308c\u306f\u3001\u304a\u3088\u305d\u300c70 % \u306e AIMDD\/MDD \u8a8d\u8a3c\u304c 2024 \u5e74\u306b\uff08\u9045\u304f\u3068\u3082 2024 \u5e74 5 \u6708 26 \u65e5\u307e\u3067\u306b\uff09\u671f\u9650\u5207\u308c\u3068\u306a\u308b\u300d\u6642\u671f\u306b\u3042\u305f\u308a\u307e\u3059\u30022024\u5e74\u306e\u6700\u521d\u306e\u6570\u30f6\u6708\u9593\u306b\u6587\u66f8\u304c\u6025\u5897\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u304c\u3059\u3079\u3066\u306e\u5bfe\u5fdc\u30d5\u30a1\u30a4\u30eb\u3092\u8a55\u4fa1\u3067\u304d\u306a\u3044\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001MDCG\u306f\u30e1\u30fc\u30ab\u30fc\u306b\u9069\u5207\u306a\u63aa\u7f6e\u3092\u53d6\u308b\u3088\u3046\u6307\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_can_hiring_expert_medical_writers_help_you\"><\/span><b>\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306e\u5c02\u9580\u5bb6\u306b\u4f9d\u983c\u3059\u308b\u3068\u3001\u3069\u306e\u3088\u3046\u306a\u52b9\u679c\u304c\u3042\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">MDD\u304b\u3089MDR\u3078\u306e\u79fb\u884c\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u76f4\u9762\u3059\u308b\u8ab2\u984c\u3067\u3059\u3002\u5f7c\u3089\u306f\u3001\u30d7\u30ed\u30bb\u30b9\u3092\u4f53\u7cfb\u7684\u304b\u3064\u7d44\u7e54\u7684\u306b\u884c\u3048\u308b\u3088\u3046\u306a\u8ce2\u3044\u6c7a\u5b9a\u3092\u4e0b\u3059\u5fc5\u8981\u304c\u3042\u308b\u3060\u308d\u3046\u3002\u305d\u306e\u305f\u3081\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u3068\u6b27\u5ddeMDR\u898f\u5236\uff08EU MDR 2017\/745\uff09\u306b\u7279\u5316\u3057\u3001\u79d1\u5b66\u3001\u533b\u7642\/\u81e8\u5e8a\u3001\u898f\u5236\u3001\u6280\u8853\u306e\u5404\u80fd\u529b\u3092\u878d\u5408\u3057\u3066\u4f01\u696d\u3092\u652f\u63f4\u3059\u308b\u5c02\u9580\u77e5\u8b58\u3068\u6280\u8853\u3092\u6301\u3064\u95a2\u4fc2\u8005\u3092\u96c7\u7528\u3059\u308b\u3053\u3068\u304c\u5fc5\u8981\u3067\u3057\u3087\u3046\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u308c\u3089\u306e\u30b9\u30c6\u30fc\u30af\u30db\u30eb\u30c0\u30fc\u306f\u3001\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\/<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-reports-cer\"> \u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09\u4f5c\u6210\u8005<\/a> \u81e8\u5e8a\u30c7\u30fc\u30bf\u89e3\u6790\u3084\u30a8\u30d3\u30c7\u30f3\u30b9\u3001\u3042\u308b\u3044\u306f\u30ae\u30e3\u30c3\u30d7\u5206\u6790\uff08MDD-MDR\u79fb\u884c\uff09\u3092\u884c\u3063\u305f\u4e0a\u3067\u306e\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u306a\u3069\u3092\u767a\u8868\u3057\u3066\u3044\u308b\u4eba\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">CER\u30e9\u30a4\u30bf\u30fc\u3092\u63a1\u7528\u3059\u308b\u969b\u3001\u3069\u306e\u3088\u3046\u306a\u30b9\u30ad\u30eb\u3084\u7d4c\u9a13\u3092\u91cd\u8996\u3059\u3079\u304d\u3067\u3057\u3087\u3046\u304b\u3002\u3053\u306e\u3088\u3046\u306a\u30b9\u30ad\u30eb\u3092\u6301\u3064\u5c02\u9580\u5bb6\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u3092\u898b\u3064\u3051\u308b\u3053\u3068\u306f\u3001\u5927\u304d\u306a\u624b\u9593\u3067\u3042\u308b\u3053\u3068\u306f\u5e83\u304f\u8a8d\u8b58\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u5f7c\u3089\u306f\u307e\u305f\u3001\u6b21\u306e\u3088\u3046\u306a\u6587\u66f8\u3092\u66f8\u304f\u306e\u306b\u81a8\u5927\u306a\u7d4c\u9a13\u3092\u6301\u3063\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-clinical-evaluation-report-sample-free\/\">\u81e8\u5e8a\u30d7\u30ed\u30c8\u30b3\u30eb<\/a>, informed consent documents, and clinical study reports (CSR), whilst also helping in clinical trial\/study data analyses. The challenge comes while hiring the right personnel\/team who can juggle regulatory affairs and technical medical\/CER writing. If needed, the company can recruit a team consisting of CER\/medical writers and medical doctors who can serve as the source of information about their expertise that lies in the specific therapeutic area.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Role_of_regulatory_medical_writers\"><\/span><b>\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306e\u5f79\u5272<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\">\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a> \u306f\u3001\u901a\u5e38\u3001\u79d1\u5b66\u8005\u3084\u81e8\u5e8a\u533b\u304c\u8077\u696d\u307e\u305f\u306f\u8a13\u7df4\u3092\u53d7\u3051\u3066\u3044\u307e\u3059\u3002\u5f7c\u3089\u306f\u3001\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u306e\u3055\u307e\u3056\u307e\u306a\u6bb5\u968e\u3092\u7d4c\u3066\u3001\u6280\u8853\u6587\u66f8\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002\u901a\u5e38\u3001\u533b\u85ac\u54c1\u5019\u88dc\u3068\u533b\u7642\u6a5f\u5668\u3001\u304a\u3088\u3073\u95a2\u9023\u3059\u308b\u533b\u7642\u88fd\u54c1\u306e\u6587\u66f8\u4f5c\u6210\u3092\u5c02\u9580\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306e\u4e3b\u306a\u8cac\u52d9\u306f\u3001\u9069\u5207\u306a\u533f\u540d\u5316\u6280\u8853\u306b\u3088\u3063\u3066\u6587\u66f8\u4e2d\u306e\u60a3\u8005\u30c7\u30fc\u30bf\u3092\u4fdd\u8b77\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u6c0f\u540d\u3001\u30a4\u30cb\u30b7\u30e3\u30eb\u3001\u4f4f\u6240\u306a\u3069\u3001\u7279\u5b9a\u306e\u500b\u4eba\u306b\u76f4\u63a5\u5e30\u5c5e\u3059\u308b\u8b58\u5225\u5b50\uff08ID\uff09\u306e\u4f7f\u7528\u3092\u907f\u3051\u308b\u306a\u3069\u3001\u3055\u307e\u3056\u307e\u306a\u624b\u6bb5\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">That includes even masking\/ generalizing quasi-IDs such as sex, race, birth dates etc. This is done to avoid patient re-identification or tracing back of patients. With regards to medical devices, medical writers do not provide specific details- serial numbers or any other device identifiers.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The responsibilities of medical writers are summarized as per the EMA Policy 0070: &#8220;what [we]ultimately want to achieve is to retain a maximum of scientifically useful information on medicinal products for the benefit of the public while achieving adequate anonymisation.&#8221;<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Where_does_Kolabtree_fit_in_this\"><\/span><b>Kolabtree\u306f\u3069\u3053\u306b\u5165\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Kolabtree\u306f\u3001\u4ee5\u4e0b\u306e\u3082\u306e\u3092\u3064\u306a\u3050\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3068\u3057\u3066\u6a5f\u80fd\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\">\u533b\u7642\u6a5f\u5668 <\/a><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/science-communication\">\u30d0\u30a4\u30aa\u30c6\u30c3\u30af<\/a> \u306e\u3088\u3046\u306a\u72ec\u7acb\u3057\u305f\u9ad8\u5ea6\u306a\u5c02\u9580\u5bb6\u96c6\u56e3\u306b\u59d4\u8a17\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-development\">\u79d1\u5b66\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>\u30e1\u30c7\u30a3\u30ab\u30eb\u30a8\u30c7\u30a3\u30bf\u30fc\u3068 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing\">\u4f5c\u5bb6\u9663<\/a> \u306f\u3001\u30aa\u30f3\u30c7\u30de\u30f3\u30c9\u3067\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30d5\u30ea\u30fc\u30e9\u30f3\u30b5\u30fc\u306f\u3001\u5b89\u5168\u306aKolabtree\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u5185\u306e\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u3068\u5354\u529b\u3057\u3066\u3001\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u4f01\u696d\u3001\u533b\u7642\u6a5f\u5668\u7d44\u7e54\u3001\u88fd\u85ac\u4f1a\u793e\u307e\u305f\u306f\u5951\u7d04\u7814\u7a76\u6a5f\u95a2\uff08CRO\uff09\u3001\u533b\u7642\u4fdd\u967a\u4f1a\u793e\u3001\u4fdd\u5065\u5f53\u5c40\u3001\u6148\u5584\u56e3\u4f53\u3001\u653f\u5e9c\u304a\u3088\u3073\u6e96\u653f\u5e9c\u6a5f\u95a2\u3001\u533b\u5e2b\u56e3\u4f53\u306a\u3069\u3092\u652f\u63f4\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-hire-a-remote-science-writer\/\">\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0<\/a> \u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u91cd\u8981\u306a\u8981\u6c42\u3092\u6e80\u305f\u3059\u305f\u3081\u306e\u7d20\u6674\u3089\u3057\u3044\u6226\u7565\u3067\u3042\u308b\u3053\u3068\u304c\u308f\u304b\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a> \u306f\u3001\u6700\u9ad8\u306e\u7d50\u679c\u3092\u51fa\u3059\u305f\u3081\u306b\u5b9a\u671f\u7684\u306b\u30b9\u30ad\u30eb\u3092\u5fc5\u8981\u3068\u3059\u308b\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u512a\u308c\u305f\u30ea\u30bd\u30fc\u30b9\u3067\u3042\u308b\u3053\u3068\u304c\u308f\u304b\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u5c0f\u898f\u6a21\u306a\u4f01\u696d\u3067\u306f\u3001\u65b0\u3057\u3044\u30a2\u30a4\u30c7\u30a2\u306e\u30c6\u30b9\u30c8\u3084\u4e00\u5b9a\u671f\u9593\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u5b8c\u4e86\u3059\u308b\u305f\u3081\u306b\u3001\u793e\u5185\u306e\u30ea\u30bd\u30fc\u30b9\u3092\u96c7\u7528\u3059\u308b\u3053\u3068\u306a\u304f\u3001\u5f93\u91cf\u5236\u3067\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3092\u96c7\u7528\u3059\u308b\u30c1\u30e3\u30f3\u30b9\u3082\u3042\u308a\u307e\u3059\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Kolabtree\u3001\u5b8c\u5168\u306a\u4fdd\u8a3c\u3082\u3059\u308b\u5b89\u5168\u306a\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0 <a href=\"https:\/\/www.kolabtree.com\/blog\/3-ways-kolabtree-guarantees-data-security-whilst-hiring-freelancers\/\">\u65e5\u4ed8\u306e\u6a5f\u5bc6\u6027<\/a> \u3068\u5b89\u5168\u306a\u6c7a\u6e08\u306e\u305f\u3081\u306b\u3001\u6b27\u5dde\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u5354\u4f1a\uff08EMWA\uff09\u3001\u7c73\u56fd\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u5354\u4f1a\uff08AMWA\uff09\u3001\u56fd\u969b\u30b5\u30a4\u30a8\u30f3\u30b9\u30e9\u30a4\u30bf\u30fc\u5354\u4f1a\uff08ISWA\uff09\u306e\u8a8d\u5b9a\u3092\u53d7\u3051\u305f\u5c02\u9580\u30e9\u30a4\u30bf\u30fc\u304c\u8a8d\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"References\"><\/span><strong>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.who.int\/activities\/prioritizing-medical-devices\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u512a\u5148\u9806\u4f4d\u4ed8\u3051\uff08who.int\uff09<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/medical-devices\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\uff5c\u6b27\u5dde\u533b\u85ac\u54c1\u5e81 (europa.eu)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.emergobyul.com\/resources\/europe-medical-devices-regulation-mdr-ce-marking-regulatory-process\"><span style=\"font-weight: 400;\">\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u898f\u5236\uff08MDR\uff09CE\u30de\u30fc\u30af\u898f\u5236\u306e\u6d41\u308c\uff08emergobyul.com\uff09<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.qvccert.com\/product-certification\/medical-devices-ce-marking\/\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668 - CE\u30de\u30fc\u30ad\u30f3\u30b0 - CE\u30de\u30fc\u30ad\u30f3\u30b0\u3001Ce\u30de\u30fc\u30af\u3001\u30d7\u30ed\u30c0\u30af\u30c8\u30de\u30fc\u30ad\u30f3\u30b0\u3001\u30b7\u30b9\u30c6\u30e0\u8a8d\u8a3c\uff08qvccert.com\uff09<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/cemarking.net\/how-do-you-benefit-from-ce-marking\/\"><span style=\"font-weight: 400;\">CE\u30de\u30fc\u30ad\u30f3\u30b0\u306e\u30e1\u30ea\u30c3\u30c8\u306f\u4f55\u3067\u3059\u304b\uff1f<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/biocodexphame.fi\/articles\/why-is-it-important-to-have-ce-marking-for-medical-devices\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306eCE\u30de\u30fc\u30ad\u30f3\u30b0\u304c\u91cd\u8981\u306a\u7406\u7531 - Biocodex (biocodexphame.fi)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2022\/1\/european-commission-publishes-second-batch-of-harm\"><span style=\"font-weight: 400;\">\u6b27\u5dde\u59d4\u54e1\u4f1a\u3001MDR\uff5cRAPS\u306b\u57fa\u3065\u304f\u6574\u5408\u898f\u683c\u306e\u7b2c2\u5f3e\u3092\u767a\u8868<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.celegence.com\/regulatory-challenges-writing-eumdr-compliant-clinical-evaluation-reports-cer\/\"><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8(CER)\u4f5c\u6210\u306b\u304a\u3051\u308b\u898f\u5236\u4e0a\u306e\u8ab2\u984c\uff08celegence.com\uff09<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.seleon.com\/en\/regulatory-affairs\/meddev-is-going-mdcg-is-coming-an-update-of-the-guidance-documents\/\"><span style=\"font-weight: 400;\">MEDDEV\u306f\u53bb\u308a\u3001MDCG\u306f\u6765\u308b - \u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306e\u66f4\u65b0 - seleon GmbH<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30d3\u30aa\u30cd\u30b9 \u30e9\u30af\u30a8\u30eb\"\u60c5\u5831\u958b\u793a\u6642\u4ee3\u306e\u533b\u7642\u6a5f\u5668\u3068\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306e\u5f79\u5272\" <\/span><i><span style=\"font-weight: 400;\">\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0<\/span><\/i><span style=\"font-weight: 400;\"> 26 (2017): 32-34.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/akrnconsulting.com\/the-pillars-of-successful-cer-writing\/#:~:text=Writing%20an%20exemplar%20Clinical%20Evaluation%20Report%20%28CER%29%20requires,that%20master%20such%20a%20broad%20range%20of%20experience%21\"><span style=\"font-weight: 400;\">AKRN\uff5c\u6210\u529f\u3059\u308bCER\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\u306e4\u3064\u306e\u67f1\uff5c\u533b\u7642\u6a5f\u5668CRO (akrnconsulting.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.celegence.com\/regulatory-challenges-writing-eumdr-compliant-clinical-evaluation-reports-cer\/\"><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8(CER)\u4f5c\u6210\u306b\u304a\u3051\u308b\u898f\u5236\u4e0a\u306e\u8ab2\u984c\uff08celegence.com\uff09<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.kolabtree.com\/blog\/why-outsource-biotech-website-content-to-expert-writers\/\"><span style=\"font-weight: 400;\">\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u30b5\u30a4\u30c8\u306e\u30b3\u30f3\u30c6\u30f3\u30c4\u3092\u5c02\u9580\u30e9\u30a4\u30bf\u30fc\u306b\u30a2\u30a6\u30c8\u30bd\u30fc\u30b9\u3059\u308b\u7406\u7531 - (kolabtree.com)<\/span><\/a><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>Keeping up with timely EU MDR updates is crucial for medical device companies, enabling them to ensure adherence to the set of regulations that govern the marketing and sale of medical device products in the European Economic area. This article, authored by Kolabtree&#8217;s freelance scientist Aditi Kandlur, elaborates on the MDR updates you need to keep an eye on as we traverse 2022. Aditi is a molecular biologist with a passion for writing and changing the world one step at a time. She can be contacted on Kolabtree for freelance projects related to medical writing, molecular biology and behavioural neuroscience. Across the world, the medical devices and medtech sectors of<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/mdr-updates-2022-kolabtree\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":151,"featured_media":10110,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[540],"tags":[535,483,500,474,482],"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>MDR Updates and Trends - The Definitive Guide to Medical Device Regulations - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"MDR updates 2022 - All the latest trends, guidelines and updates you need to know about in medical device regulations for 2022.\" \/>\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\/mdr-updates-2022-kolabtree\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR Updates and Trends - The Definitive Guide to Medical Device Regulations\" \/>\n<meta property=\"og:description\" content=\"MDR updates 2022 - All the latest trends, guidelines and updates you need to know about in medical device regulations for 2022.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/mdr-updates-2022-kolabtree\/\" \/>\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=\"2022-07-08T09:56:47+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-03-06T11:50:12+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/07\/shutterstock_1923647231.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"667\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Kolabtree\" \/>\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=\"Kolabtree\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"10\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"MDR Updates and Trends - The Definitive Guide to Medical Device Regulations - The Kolabtree Blog","description":"MDR updates 2022 - All the latest trends, guidelines and updates you need to know about in medical device regulations for 2022.","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\/mdr-updates-2022-kolabtree\/","og_locale":"ja_JP","og_type":"article","og_title":"MDR Updates and Trends - The Definitive Guide to Medical Device Regulations","og_description":"MDR updates 2022 - All the latest trends, guidelines and updates you need to know about in medical device regulations for 2022.","og_url":"https:\/\/www.kolabtree.com\/blog\/ja\/mdr-updates-2022-kolabtree\/","og_site_name":"The Kolabtree Blog","article_publisher":"https:\/\/www.facebook.com\/kolabtree","article_published_time":"2022-07-08T09:56:47+00:00","article_modified_time":"2023-03-06T11:50:12+00:00","og_image":[{"width":1000,"height":667,"url":"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/07\/shutterstock_1923647231.jpg","type":"image\/jpeg"}],"author":"Kolabtree","twitter_card":"summary_large_image","twitter_creator":"@kolabtree","twitter_site":"@kolabtree","twitter_misc":{"\u57f7\u7b46\u8005":"Kolabtree","\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593":"10\u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.kolabtree.com\/blog\/mdr-updates-2022-kolabtree\/#article","isPartOf":{"@id":"https:\/\/www.kolabtree.com\/blog\/mdr-updates-2022-kolabtree\/"},"author":{"name":"Kolabtree","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/39cd88be69e5687afd09ea14960d3e0b"},"headline":"MDR Updates and Trends &#8211; 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