{"id":9994,"date":"2022-03-29T10:51:20","date_gmt":"2022-03-29T10:51:20","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=9994"},"modified":"2023-02-15T11:33:54","modified_gmt":"2023-02-15T11:33:54","slug":"ivdr-compliance-10-tips-for-medical-device-manufacturers","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/","title":{"rendered":"IVDR\u306e\u9075\u5b88\uff1a\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u305f\u3081\u306e10\u306e\u30d2\u30f3\u30c8"},"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-6a32cfce75197\" 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-6a32cfce75197\"><\/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\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#What_is_the_IVDR\" title=\"IVDR\u3068\u306f\uff1f\">IVDR\u3068\u306f\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\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#1_Preparing_for_IVDR_compliance_and_commercial_changes\" title=\"1.IVDR\u5bfe\u5fdc\u3068\u5546\u6d41\u5909\u66f4\u3078\u306e\u6e96\u5099\">1.IVDR\u5bfe\u5fdc\u3068\u5546\u6d41\u5909\u66f4\u3078\u306e\u6e96\u5099<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#2_Clear_understanding_of_the_classification\" title=\"2.\u5206\u985e\u306e\u660e\u78ba\u306a\u7406\u89e3\">2.\u5206\u985e\u306e\u660e\u78ba\u306a\u7406\u89e3<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#3_Involvement_of_notified_body\" title=\"3.\u5c4a\u51fa\u6a5f\u95a2\u306e\u95a2\u4e0e\u00a0\">3.\u5c4a\u51fa\u6a5f\u95a2\u306e\u95a2\u4e0e\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#4_Establishment_of_quality_management_system_QMS\" title=\"4.\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u69cb\u7bc9\">4.\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u69cb\u7bc9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#5_Be_prepared_for_disruption_in_the_supply_chain\" title=\"5.\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u6df7\u4e71\u306b\u5099\u3048\u308b\">5.\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u6df7\u4e71\u306b\u5099\u3048\u308b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#6_Ensuring_audit_and_inspection_readiness\" title=\"6.\u76e3\u67fb\u30fb\u67fb\u5bdf\u306e\u6e96\u5099\u306e\u78ba\u4fdd\">6.\u76e3\u67fb\u30fb\u67fb\u5bdf\u306e\u6e96\u5099\u306e\u78ba\u4fdd<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#7_Plan_to_handle_unannounced_audits\" title=\"7.\u629c\u304d\u6253\u3061\u76e3\u67fb\u3078\u306e\u5bfe\u5fdc\u8a08\u753b\">7.\u629c\u304d\u6253\u3061\u76e3\u67fb\u3078\u306e\u5bfe\u5fdc\u8a08\u753b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#8_Strengthen_post-market_surveillance_activities\" title=\"8.  \u5e02\u8ca9\u5f8c\u8abf\u67fb\u6d3b\u52d5\u306e\u5f37\u5316\">8.  \u5e02\u8ca9\u5f8c\u8abf\u67fb\u6d3b\u52d5\u306e\u5f37\u5316<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#9_Unique_device_identifier_UDI_EUDAMED\" title=\"9.\u30e6\u30cb\u30fc\u30af\u30c7\u30d0\u30a4\u30b9\u8b58\u5225\u5b50\uff08UDI\uff09\uff06EUDAMED\">9.\u30e6\u30cb\u30fc\u30af\u30c7\u30d0\u30a4\u30b9\u8b58\u5225\u5b50\uff08UDI\uff09\uff06EUDAMED<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#10_Requirements_for_in-house_devices\" title=\"10.  &quot;\u81ea\u793e\u88fd\u54c1 &quot;\u306b\u5bfe\u3059\u308b\u8981\u6c42\u4e8b\u9805\">10.  \"\u81ea\u793e\u88fd\u54c1 \"\u306b\u5bfe\u3059\u308b\u8981\u6c42\u4e8b\u9805<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#References\" title=\"\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\">\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>IVD\u30e1\u30fc\u30ab\u30fc\u306e\u305f\u3081\u306e\u898f\u5236\u9075\u5b88\u306e\u305f\u3081\u306e\u7db2\u7f85\u7684\u306a\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/sundeep-agarwal\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=IVDRCompliance\">Sundeep Agarwal<\/a>\u7d4c\u9a13\u8c4a\u5bcc\u306a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/ivdr?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=IVDR-compliance\">IVDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>.\u00a0<\/em><\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_is_the_IVDR\"><\/span>IVDR\u3068\u306f\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The European Commission&#8217;s (EC) In Vitro Diagnostic Regulation (EU IVDR 2017\/746) is a \u2018legislative framework\u2019 and a way forward towards global IVD safety, which assures that only reliable and effective IVDs are in the market. The European Commission is trying its best to make the <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30d8\u30eb\u30b9\u30b1\u30a2<\/a> system safer and error free in terms of diagnosis or outcomes.<\/p>\n<p><strong>\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066<\/strong> (<strong>IVDD\u306f98\/79\/EC\u304c\u6307\u4ee4\u3067\u3042\u308b\u306e\u306b\u5bfe\u3057\u3001IVDR\u306f\u6b27\u5dde\u7d4c\u6e08\u9818\u57df\uff08EEA\uff09\u5185\u306e\u88fd\u9020\u696d\u8005\u3001\u8f38\u5165\u696d\u8005\u3001\u30e6\u30fc\u30b6\u30fc\u3001\u516c\u8a8d\u6a5f\u95a2\u3001\u56fd\u5bb6\u5f53\u5c40\u3001\u304a\u3088\u3073\u6b27\u5dde\u4ee5\u5916\u306e\u88fd\u9020\u696d\u8005\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u6b27\u5dde\u5e02\u5834\u3067IVD\u3092\u8ca9\u58f2\u3059\u308b\u3001\u307e\u305f\u306f\u8ca9\u58f2\u3057\u3088\u3046\u3068\u3059\u308b\u3059\u3079\u3066\u306eEO\u306b\u9069\u7528\u3055\u308c\u308b\u6cd5\u4ee4\uff08\u898f\u5247\uff09\u3067\u3042\u308b\u3002 <\/strong><\/p>\n<p>IVDR\u306f113\u6761\uff0810\u7ae0\uff09\u300115\u4ed8\u5c5e\u66f8\u304b\u3089\u69cb\u6210\u3055\u308c\u3066\u3044\u308b\u306e\u306b\u5bfe\u3057\u3001IVDD\u306f24\u6761\u300110\u4ed8\u5c5e\u66f8\u304b\u3089\u69cb\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002IVDR\u306f\u9577\u5927\u3067\u53b3\u3057\u3044\u898f\u5236\u3067\u3042\u308b\u3053\u3068\u306f\u9593\u9055\u3044\u306a\u3044\u304c\u3001\u898f\u5236\u306e\u5909\u66f4\u3084\u8981\u6c42\u4e8b\u9805\u304c\u3088\u308a\u900f\u660e\u5316\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u304c\u826f\u3044\u70b9\u3067\u3042\u308b\u3002<\/p>\n<p>\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306b\u57fa\u3065\u304f\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u91cd\u8996\u3057\u3066\u3044\u308b\u30022022\u5e745\u670826\u65e5\u304b\u3089\u9069\u7528\u3055\u308c\u3001\u7d4c\u6e08\u4e8b\u696d\u8005\uff08EU\u57df\u5916\u306e\u30e1\u30fc\u30ab\u30fc\u3092\u542b\u3080\uff09\u306f\u3001\u305d\u306e\u8a08\u753b\u30fb\u5b9f\u65bd\u306b\u5411\u3051\u3066\u7a4d\u6975\u7684\u306b\u6e96\u5099\u3059\u308b\u3053\u3068\u304c\u671f\u5f85\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u3059\u3079\u3066\u306e\u95a2\u4fc2\u8005\u306f\u3001\u6b27\u5dde\u7d4c\u6e08\u9818\u57df\uff08EEA\uff09\u306e\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u5e02\u5834\u306b\u5bfe\u3057\u3066\u7b49\u3057\u304f\u8cac\u4efb\u3092\u8ca0\u3046\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u307e\u305a\u3001EU IVDR\u306b\u95a2\u3059\u308b\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u30d7\u30ed\u30b0\u30e9\u30e0\uff08\u30aa\u30f3\u30e9\u30a4\u30f3\u307e\u305f\u306f\u30aa\u30f3\u30b5\u30a4\u30c8\uff09\u3092\u5b9f\u65bd\u3057\u3001\u7d44\u7e54\u5185\u306e\u5168\u54e1\u304c\u5fc5\u8981\u306a\u5909\u66f4\u70b9\u3092\u8a8d\u8b58\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/li>\n<li>\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3084\u7fa9\u52d9\u306b\u3064\u3044\u3066\u3001\u3059\u3079\u3066\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3001\u4e0b\u8acb\u3051\u696d\u8005\u3001\u30b5\u30fc\u30d3\u30b9\u63d0\u4f9b\u8005\u306b\u516c\u5f0f\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7 \u30f3\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<li>EU IVDR\u3067\u8981\u6c42\u3055\u308c\u308b\u6280\u8853\u6587\u66f8\u3092\u66f4\u65b0\u3059\u308b\u305f\u3081\u306b\u3001\u5f7c\u3089\u306e\u30ea\u30bd\u30fc\u30b9\u3001\u6709\u80fd\u306a\u30c1\u30fc\u30e0\u306e\u53ef\u7528\u6027\u3092\u30c1\u30a7\u30c3\u30af\u3059\u308b\u305f\u3081\u306b\u30ae\u30e3\u30c3\u30d7\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3092\u5b9f\u884c\u3059\u308b\u3002ISO 13485: 2016\u306e\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u3068\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u7acb\u3059\u308b\u4e0a\u3067\u3055\u3089\u306b\u6709\u5229\u3068\u306a\u308b\u3002<\/li>\n<li>\u4e00\u91dd\u5165\u308c\u3070\u4e5d\u6b7b\u306b\u4e00\u751f\u3092\u5f97\u308b\u300d\u305f\u3081\u3001\u79fb\u884c\u306e\u3054\u304f\u521d\u671f\u6bb5\u968e\u304b\u3089\u4e3b\u984c\u5c02\u9580\u5bb6\u3084\u5916\u90e8\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3092\u96c7\u3046\u3053\u3068\u304c\u671b\u307e\u3057\u3044\uff08\u5fc5\u8981\u306a\u5834\u5408\uff09\u3002<\/li>\n<li>\u672c\u30d6\u30ed\u30b0\u3067\u306f\u3001EU IVDR 2017\/746\u306b\u57fa\u3065\u304f\u69d8\u3005\u306a\u6761\u6587\u3084\u9644\u5c5e\u66f8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u3084\u6240\u8f44\u5b98\u5e81\u306b\u3088\u308b\u671f\u5f85\u306b\u5fdc\u3048\u308b\u305f\u3081\u306e\u8a73\u7d30\u306a\u6982\u8981\u3068\u5b9f\u8df5\u7684\u306a\u30d2\u30f3\u30c8\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-9995\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1.jpg\" alt=\"\" width=\"1622\" height=\"980\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1.jpg 1622w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1-300x181.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1-1024x619.jpg 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1-1536x928.jpg 1536w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1-16x10.jpg 16w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1-300x181@2x.jpg 600w\" sizes=\"(max-width: 1622px) 100vw, 1622px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>\u56f31: IVDD\u3068IVDR\u306e\u6bd4\u8f03<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Preparing_for_IVDR_compliance_and_commercial_changes\"><\/span>1.IVDR\u5bfe\u5fdc\u3068\u5546\u6d41\u5909\u66f4\u3078\u306e\u6e96\u5099<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><em>\u4f01\u696d\u306b\u3068\u3063\u3066\u6700\u3082\u91cd\u8981\u306a\u7d4c\u55b6\u5224\u65ad\u306f\u3001\u81ea\u793e\u306eIVD\u3092\u5f15\u304d\u7d9a\u304d\u6b27\u5dde\u7d4c\u6e08\u9818\u57df\uff08EEA\uff09\u306b\u7f6e\u304f\u304b\u3069\u3046\u304b\u306e\u7d50\u8ad6\u3092\u51fa\u3059\u3053\u3068\u3067\u3057\u3087\u3046\u3002\u305d\u306e\u7b54\u3048\u304c\u300c\u306f\u3044\u300d\u3067\u3042\u308c\u3070\u3001\u3067\u304d\u308b\u3060\u3051\u65e9\u304fNB\u304b\u3089\u898b\u7a4d\u3082\u308a\uff08\u30b3\u30b9\u30c8\uff09\u3001\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3001\u5be9\u67fb\u7bc4\u56f2\u3001\u88fd\u54c1\u30b3\u30fc\u30c9\u306a\u3069\u3092\u5165\u624b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6307\u4ee4\u304b\u3089\u898f\u5236\u3078\u306e\u79fb\u884c\u306b\u3088\u308a\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u7acb\u8a3c\u3057\u3001CE\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306b\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u5f37\u56fa\u306a\u6280\u8853\u6587\u66f8\u304c\u8981\u6c42\u3055\u308c\u307e\u3059\u3002 <\/em>IVDR\u306f\u3001\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u306b\u5927\u304d\u304f\u4f9d\u5b58\u3057\u3066\u3044\u307e\u3059\u3002 <em>\u3059\u306a\u308f\u3061\u3001\u79d1\u5b66\u7684\u59a5\u5f53\u6027\u3001\u5206\u6790\u7684\u6027\u80fd\u3001\u81e8\u5e8a\u7684\u6027\u80fd\u3002 <\/em>\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306b<\/p>\n<p><strong>CE\u8a8d\u8a3c\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\uff08NB\uff09\u304c\u95a2\u4e0e\u3059\u308b\u3053\u3068\u306f\u3001\u3053\u306e\u898f\u5236\u306e\u9855\u8457\u306a\u7279\u5fb4\u3067\u3042\u308b\u3002\u3053\u308c\u306f\u307e\u305f\u3001\u7d4c\u6e08\u4e8b\u696d\u8005\u306b\u3068\u3063\u3066\u306e\u8ffd\u52a0\u6295\u8cc7\u3092\u610f\u5473\u3057\u3001\u9593\u63a5\u7684\u306b\u88fd\u54c1\u30b3\u30b9\u30c8\u3092\u5897\u52a0\u3055\u305b\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/strong><\/p>\n<p>\u306e\u4efb\u547d\u304c\u3042\u308a\u307e\u3057\u305f\u3002 <strong><em>\"\u898f\u5236\u9075\u5b88\u8cac\u4efb\u8005\uff08PRRC\uff09\" <\/em><\/strong>EU IVDR 2017\/746\u306e\u7b2c15\u6761\u306b\u57fa\u3065\u304d\u3001QMS\u3001\u9069\u5408\u5ba3\u8a00\u3001\u6280\u8853\u6587\u66f8\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u5831\u544a\u304cEU IVDR\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u8005\u3002\u88fd\u9020\u8005\u306f\u3001\u65e2\u5b58\u306eIVDD\u8a3c\u660e\u66f8\u307e\u305f\u306f\u81ea\u5df1\u8a8d\u8a3c\u9069\u5408\u5ba3\u8a00\u306e\u6709\u52b9\u671f\u9650\u304c\u5207\u308c\u308b\u524d\u306b\u3001\u3059\u3079\u3066\u306e\u79fb\u884c\uff08\u65b0\u898f\u8a8d\u8a3c\u7533\u8acb\u3092\u542b\u3080\uff09\u3092\u5b8c\u4e86\u3059\u308b\u3088\u3046\u306b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u30022017\u5e745\u670825\u65e5\u304b\u3089IVDD 98\/79\/EC\u306b\u5f93\u3063\u3066\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u304c\u767a\u884c\u3057\u305f\u8a3c\u660e\u66f8\u306f\u30012024\u5e745\u670827\u65e5\u4ee5\u964d\u7121\u52b9\u3068\u306a\u308b\u3002EC\u306e\u516c\u5f0f\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9[1] dtd.20\u306b\u3042\u308b\u3088\u3046\u306b\u3001\u65b0\u3057\u3044\u7533\u8acb\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306b\u6ce8\u610f\u3057\u3066\u304f\u3060\u3055\u3044\u3002<sup>th<\/sup> 2022\u5e7412\u6708<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Clear_understanding_of_the_classification\"><\/span>2.\u5206\u985e\u306e\u660e\u78ba\u306a\u7406\u89e3<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>IVDR\u306eAnnex VIII\u306b\u57fa\u3065\u304f\u65b0\u3057\u3044\u5206\u985e\u30eb\u30fc\u30eb\u3092\u518d\u8003\u3057\u3001\u4ee5\u524d\u306e\u5206\u985e\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3057\u3066\u3044\u306a\u3044\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b\u3002<\/p>\n<blockquote><p><em>CE\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u306e\u6e96\u5099\u306e\u524d\u306b\u3001\u6b63\u3057\u3044\u5206\u985e\u3092\u884c\u3046\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u305d\u308c\u304c\u3067\u304d\u306a\u3044\u9650\u308a\u3001\u9069\u5408\u30eb\u30fc\u30c8\u304c\u4e0d\u660e\u78ba\u306b\u306a\u308a\u3001IVDR\u8981\u6c42\u4e8b\u9805\u3078\u306e\u9069\u5408\u3092\u9045\u3089\u305b\u305f\u308a\u3001\u7121\u52b9\u306b\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306b\u306a\u308b\u3002<\/em><\/p><\/blockquote>\n<p>IVDR\u306f <strong>\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1<\/strong> \u306f\u3001\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u3068\u6240\u8f44\u5b98\u5e81\u306e\u7ba1\u7406\u304c\u5f37\u5316\u3055\u308c\u305f\u30c7\u30d0\u30a4\u30b9\u3092\u5206\u985e\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u898f\u5247\u3067\u306f <strong>\u30d5\u30a9\u30fc\u30ea\u30b9\u30af\u30af\u30e9\u30b9<\/strong>:\u30af\u30e9\u30b9A\uff08\u6700\u4f4e\u30ea\u30b9\u30af\uff09\u3001\u30af\u30e9\u30b9B\u3001\u30af\u30e9\u30b9C\u3001\u30af\u30e9\u30b9D\uff08\u6700\u9ad8\u30ea\u30b9\u30af\uff09\u3002 <strong>7 <\/strong><strong>\u5206\u985e\u898f\u5247<\/strong> \u3092\u6b63\u3057\u304f\u5206\u985e\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3067\u3059\u3002IVDR \u306e\u7279\u5fb4\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3082\u9644\u5c5e\u66f8 VIII \u306e\u5b9f\u65bd\u898f\u5247 1.4 \u3067\u5206\u985e\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3067\u3042\u308b\u3002\u300c\u6a5f\u5668\u3092\u99c6\u52d5\u3059\u308b\u3001\u307e\u305f\u306f\u6a5f\u5668\u306e\u4f7f\u7528\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001\u6a5f\u5668\u3068\u540c\u3058\u30af\u30e9\u30b9\u306b\u5206\u985e\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304c\u4ed6\u306e\u6a5f\u5668\u304b\u3089\u72ec\u7acb\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u305d\u308c\u81ea\u4f53\u3067\u5206\u985e\u3055\u308c\u308b\u3082\u306e\u3068\u3059\u308b\u3002<a href=\"#_ftn2\" name=\"_ftnref2\">[2]<\/a>\".\u3053\u308c\u306f\u3001IVDR \u3067\u898f\u5236\u3055\u308c\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u7bc4\u56f2\u3092\u793a\u3059\u3082\u306e\u3067\u3042\u308b\u3002\u307e\u305f\u3001\u88fd\u9020\u8005\u306f\u305d\u308c\u306b\u5fdc\u3058\u3066\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u30d9\u30ea\u30d5\u30a1\u30a4\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08\u9644\u5c5e\u66f8 II \u306e 6.4\uff09\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308b\u3002<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-9997\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure2-1.jpg\" alt=\"\" width=\"1160\" height=\"697\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure2-1.jpg 1160w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure2-1-300x180.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure2-1-1024x615.jpg 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure2-1-16x10.jpg 16w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure2-1-300x180@2x.jpg 600w\" sizes=\"(max-width: 1160px) 100vw, 1160px\" \/><\/p>\n<p>\u56f32\uff1aIVDR 2107\/746\u306b\u57fa\u3065\u304f\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u5206\u985e<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Involvement_of_notified_body\"><\/span><strong>3.\u5c4a\u51fa\u6a5f\u95a2\u306e\u95a2\u4e0e\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><em>\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\uff08NB\uff09\u306e\u5f79\u5272\u306f\u4e2d\u6838\u7684\u306a\u8981\u7d20\u306e\u3072\u3068\u3064\u3067\u3042\u308a\u3001\u3057\u305f\u304c\u3063\u3066\u3001\u5f93\u6765\u306e\u300c\u81ea\u5df1\u8a3c\u660e\u300d\u306e\u65b9\u6cd5\u306b\u5bfe\u3057\u3066\u3001\u3088\u308a\u591a\u304f\u306e\u30e1\u30fc\u30ab\u30fc\u304c\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306e\u76e3\u67fb\u3068\u8a8d\u8a3c\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u51fa\u3066\u304f\u308b\u3053\u3068\u306b\u306a\u308b\u3002<\/em>\u7d4c\u6e08\u4e8b\u696d\u8005\u306f\u3001\u9069\u5408\u6027\u8a55\u4fa1\u30eb\u30fc\u30c8\uff08EU IVDR \u306e Annex IX, X, XI\uff09\u3092\u614e\u91cd\u306b\u6c7a\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<a href=\"#_ftn3\" name=\"_ftnref3\">[3]<\/a>).<\/p>\n<p>IVDR\u3067\u306f\u3001\u8ffd\u52a0\u6295\u8cc7\u304c\u5fc5\u8981\u306a\u3060\u3051\u3067\u306a\u304f\u3001\u6280\u8853\u6587\u66f8\u3084\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u304cIVDR\u306e\u65b0\u3057\u3044\u8981\u6c42\u4e8b\u9805\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002IVDD\u3067\u306f\u3001\u307b\u3068\u3093\u3069\u306eIVD\u304c\u81ea\u5df1\u8a8d\u8a3c\uff0892%\uff09\u3067\u3042\u308a\u3001\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306e\u95a2\u4e0e\u306f\u5fc5\u8981\u3042\u308a\u307e\u305b\u3093\uff08\u5e02\u5834\u306b\u6d41\u901a\u3057\u3066\u3044\u308bIVD\u306e\u3046\u30618%\u3092\u9664\u304f\uff09[4]\u3002\u3057\u304b\u3057\u3001\u65b0\u3057\u3044IVDR\u306e\u4e0b\u3067\u306f\u3001\u3053\u306e\u30b7\u30ca\u30ea\u30aa\u306f\u540c\u3058\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n<p>\u3042\u308b\u8abf\u67fb\u306b\u3088\u308b\u3068 <em>\"The impact of new European IVD-classification rules on notified body involvement\" by National Institute for Public Health and Environment, Bilthoven (Netherlands) RIVM Letter report 2018-0082, A. van Drongelen et al, nearly 85% of all IVDs will be requiring Notified Body involvement, leaving only 15% of IVDs eligible to self certification[5]\uff0e<\/em>.<\/p>\n<p>\u307e\u305f\u3001\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u65b0\u3057\u3044\u5206\u985e\u3068\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u3092\u9075\u5b88\u3059\u308b\u305f\u3081\u306b\u5927\u304d\u306a\u5909\u5316\u3092\u7d4c\u9a13\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002  \u3055\u3089\u306b\u3001\u6a5f\u5668\u306e\u4f7f\u7528\u76ee\u7684\u3084\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u306b\u5fdc\u3058\u3066\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u81ea\u793e\u88fd\u54c1\u3092\u5be9\u67fb\u3057\u3001\u8a8d\u8a3c\u3092\u53d6\u5f97\u3067\u304d\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u6307\u5b9aNB\u3092\u7279\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6700\u3082\u30ea\u30b9\u30af\u306e\u9ad8\u3044IVD\uff08\u30af\u30e9\u30b9D\uff09\u3067\u306f\u3001\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\uff08NB\uff09\u3084\u6240\u8f44\u5b98\u5e81\uff08CA\uff09\u306e\u95a2\u4e0e\u306b\u52a0\u3048\u3066\u3001EU\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\u30e9\u30dc\u3084\u5c02\u9580\u5bb6\u30d1\u30cd\u30eb\u306b\u3088\u308b\u6027\u80fd\u4e3b\u5f35\u306e\u691c\u8a3c\u3082\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002\u73fe\u5728\u3001EU IVDR\u306b\u6307\u5b9a\u3055\u308c\u3066\u3044\u308b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\uff08Notified Body\uff09\u306f6\u6a5f\u95a2\u306e\u307f\u3067\u3059\u3002\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u304c\u5229\u7528\u3067\u304d\u306a\u3044\u3053\u3068\u306b\u3088\u308b\u4e88\u671f\u305b\u306c\u9045\u5ef6\u3092\u907f\u3051\u308b\u305f\u3081\u306b\u3082\u3001\u7533\u8acb\u624b\u7d9a\u304d\u306e\u958b\u59cb\u3092\u304a\u6025\u304e\u304f\u3060\u3055\u3044\u3002<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-9998\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1.jpg\" alt=\"\" width=\"1583\" height=\"714\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1.jpg 1583w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1-300x135.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1-1024x462.jpg 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1-1536x693.jpg 1536w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1-16x7.jpg 16w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1-300x135@2x.jpg 600w\" sizes=\"(max-width: 1583px) 100vw, 1583px\" \/><\/p>\n<p>\u56f33\uff1aIVDR\u306b\u304a\u3051\u308b\u6307\u5b9a\u5c4a\u51fa\u6a5f\u95a2\u4e00\u89a7[6]\u3002\n<h2><span class=\"ez-toc-section\" id=\"4_Establishment_of_quality_management_system_QMS\"><\/span>4.\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u69cb\u7bc9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><em>\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u88fd\u9020\u696d\u8005\u306f\u3001\u5805\u7262\u3067\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u3092\u65bd\u8a2d\u5185\u306b\u69cb\u7bc9\u3059\u308b\u3053\u3068\u304c\u671f\u5f85\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001IVDR\u7b2c10\u6761\u306b\u57fa\u3065\u304f\u88fd\u9020\u696d\u8005\u306e\u4e00\u822c\u7684\u306a\u7fa9\u52d9\u3067\u3042\u308b<\/em>.\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u69d8\u3005\u306a\u8981\u6c42\u4e8b\u9805\u306e\u4e2d\u3067\u3082\u7279\u306b\u91cd\u8981\u306a\u3082\u306e\u3067\u3042\u308a\u3001\u3053\u308c\u304c\u306a\u3051\u308c\u3070\u88fd\u9020\u8005\u306f\u8a8d\u53ef\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u306a\u3044\u3002<\/p>\n<p>QMS\u3068\u306f\u3001\u88fd\u9020\u3001\u5909\u66f4\u7ba1\u7406\u3001\u9867\u5ba2\u304b\u3089\u306e\u82e6\u60c5\u3001\u8cc7\u6e90\u7ba1\u7406\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3084\u4e0b\u8acb\u3051\u696d\u8005\u306e\u7ba1\u7406\u304a\u3088\u3073\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u6027\u80fd\u8a55\u4fa1\u3001\u54c1\u8cea\u8a66\u9a13\u3001UDI\u30e9\u30d9\u30eb\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306a\u3069\u304c\u3001\u627f\u8a8d\u3055\u308c\u305fQMS\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u8abf\u67fb\uff08PMS\uff09\u8a08\u753b\u306b\u5f93\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u3082\u306e\u3067\u3059\u3002<\/p>\n<p>PRRC\u306f\u3001\u88fd\u9020\u8005\u304c\u7b2c10\u6761\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3001\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3044\u3066\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\uff08NB\uff09\u3092\u5fc5\u8981\u3068\u3057\u306a\u3044\u5834\u5408\u3001\u30af\u30e9\u30b9A IVD\u3092\u300c\u81ea\u5df1\u8a8d\u8a3c\u300d\uff08\u9644\u5c5e\u66f8IV\u306b\u57fa\u3065\u304f\u9069\u5408\u5ba3\u8a00\u66f8\u306e\u767a\u884c\uff09\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Be_prepared_for_disruption_in_the_supply_chain\"><\/span><strong>5.\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u6df7\u4e71\u306b\u5099\u3048\u308b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5b89\u5168\u6027\u3001\u6b63\u78ba\u6027\u3001\u6709\u52b9\u6027\u306b\u512a\u308c\u305f\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u3092\u88fd\u9020\u30fb\u4f9b\u7d66\u3059\u308b\u305f\u3081\u306b\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u4e16\u754c\u4e2d\u3067\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3068\u539f\u6750\u6599\u306b\u5927\u304d\u304f\u4f9d\u5b58\u3057\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u898f\u5236\u3084\u54c1\u8cea\u306b\u95a2\u3059\u308b\u61f8\u5ff5\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3084\u4e0b\u8acb\u3051\u696d\u8005\u306e\u7ba1\u7406\u306b\u95a2\u3057\u3066\u3082\u3001\u3088\u308a\u9ad8\u3044\u30ec\u30d9\u30eb\u3078\u3068\u9032\u5316\u3057\u3066\u3044\u307e\u3059\u3002\u3057\u305f\u304c\u3063\u3066\u3001\u88fd\u9020\u8005\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u7fa9\u52d9\u3084\u8cac\u4efb\u306b\u3064\u3044\u3066\u3001\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u7a4d\u6975\u7684\u306b \u4f1d\u3048\u308b\u3053\u3068\u304c\u671f\u5f85\u3055\u308c\u308b\u3002\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u7ba1\u7406\u30fb\u76e3\u8996\u3092\u9069\u5207\u306b\u884c\u3044\u3001\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u304c IVDR \u306e\u898f\u5236\u3092\u9075\u5b88\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba \u8a8d\u3057\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u30c7\u30fc\u30bf\u306e\u6574\u5408\u6027\u3068\u54c1\u8cea\u306e\u5fc5\u8981\u6027\u3092\u518d\u8003\u3057\u3001\u5f37\u56fa\u306a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u30ea\u30b9\u30af\u7ba1\u7406\u30fb \u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u76e3\u8996\u3092\u884c\u3044\u3001\u6700\u7d42\u88fd\u54c1\u3078\u306e\u95a2\u9023\u30ea\u30b9\u30af\u306b\u57fa\u3065\u304d\u5b9a\u671f\u7684\u306b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u76e3\u67fb\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a \u3044\u3002 <strong><em>\u898f\u5236\u5f53\u5c40\u3084\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u7ba1\u7406\u306e\u30ec\u30d9\u30eb\u3092\u660e\u78ba\u306b\u6587\u66f8\u5316\u3057\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u63d0\u4f9b\u3059\u308b\u88fd\u54c1\u3084\u30b5\u30fc\u30d3\u30b9\u306e\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u3092\u6839\u62e0\u3092\u6301\u3063\u3066\u5b9f\u8a3c\u3059\u308b\u3053\u3068\u3092\u3001\u5408\u6cd5\u7684\u306a\u30e1\u30fc\u30ab\u30fc\u306b\u5f37\u8abf\u3057\u3066\u3044\u308b\u3002 <\/em><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"6_Ensuring_audit_and_inspection_readiness\"><\/span>6.\u76e3\u67fb\u30fb\u67fb\u5bdf\u306e\u6e96\u5099\u306e\u78ba\u4fdd<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>IVDR \u7b2c 88 \u6761\u300c\u5e02\u5834\u76e3\u8996\u6d3b\u52d5\u300d\u306b\u3088\u308b\u3068\u3001\u6240\u8f44\u5b98\u5e81\u306f\u3001\u7d4c\u6e08\u4e8b\u696d\u8005\u3001\u4f9b\u7d66\u696d\u8005\u3001\u4e0b\u8acb\u696d\u8005\u306e\u6577\u5730\u5185\u3001 \u304a\u3088\u3073\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u5c02\u9580\u30e6\u30fc\u30b6\u30fc\u306e\u65bd\u8a2d\u306b\u5bfe\u3057\u3066\u3001\u516c\u8868\uff08\u629c\u304d\u6253\u3061\uff09\u691c\u67fb\u3092\u884c\u3046\u3082\u306e\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u88fd\u9020\u8005\u306f\u3001\u8a2d\u8a08\u30fb\u88fd\u9020\u60c5\u5831\u306e\u6280\u8853\u6587\u66f8\u306b\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3084\u4e0b\u8acb\u3051\u696d\u8005\u3092\u542b\u3080\u3001\u88fd\u9020\u6d3b\u52d5\u304c\u884c\u308f\u308c\u308b\u3059\u3079\u3066\u306e\u62e0\u70b9\u306e\u7279\u5b9a\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u542b\u3081\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002QMS \u5be9\u67fb\u3092\u884c\u3046\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\uff08NB\uff09\u306f\u3001\u69d8\u3005\u306a\u88fd\u9020\u62e0\u70b9\u3001\u53ca\u3073\u305d\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3084\u4e0b\u8acb\u3051\u696d\u8005\u9593\u306e\u9023\u643a\u3068\u8cac\u4efb\u5206\u62c5\u3092\u660e\u3089\u304b\u306b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u306e\u60c5\u5831\u306f\u3001NB \u304c\u30b5\u30d7\u30e9\u30a4\u30e4\u307e\u305f\u306f\u4e0b\u8acb\u3051\u696d\u8005\u306e\u3044\u305a\u308c\u304b\u3001\u3042\u308b\u3044\u306f\u4e21\u65b9\u3092\u5be9\u67fb\u3059\u308b\u969b\u306b\u8003\u616e\u3055\u308c \u307e\u3059\u3002 <strong>\u88fd\u9020\u8005\u306e\u4f9b\u7d66\u8005\u306e\u65bd\u8a2d\u306f\u3001\u5b8c\u6210\u6a5f\u5668\u306e\u9069\u5408\u6027\u306b\u91cd\u5927\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3068\u8003\u3048\u3089\u308c\u308b\u5834\u5408\u3001\u57fa\u672c\u7684\u306bNB\u306e\u76e3\u67fb\u3092\u53d7\u3051\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\uff08\u7279\u306b\u3001\u88fd\u9020\u8005\u304c\u305d\u306e\u4f9b\u7d66\u8005\u3092\u5341\u5206\u306b\u7ba1\u7406\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u5b9f\u8a3c\u3067\u304d\u306a\u3044\u5834\u5408\uff09\u3002<\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"7_Plan_to_handle_unannounced_audits\"><\/span>7.\u629c\u304d\u6253\u3061\u76e3\u67fb\u3078\u306e\u5bfe\u5fdc\u8a08\u753b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u8a8d\u8a3c\u53d6\u5f97\u5f8c\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3067\u306f\u3001NB\u306f\u3001\u88fd\u54c1\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u88fd\u9020\u696d\u8005\u53ca\u3073\u305d\u306e\u4e0b\u8acb\u696d\u8005\u53c8\u306f\u4f9b\u7d66\u696d\u8005\u306b\u5bfe\u3059\u308b\u629c\u304d\u6253\u3061\u306e\u73fe\u5730\u76e3\u67fb\u3001\u4e26\u3073\u306b\u88fd\u9020\u696d\u8005\u3092\u62d8\u675f\u3057\u8a8d\u8a3c\u6c7a\u5b9a\u306b\u95a2\u9023\u3059\u308b\u6761\u4ef6\uff08\u5b9a\u3081\u3089\u308c\u305f\u9593\u9694\u3067\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u66f4\u65b0\u7b49\uff09\u304c\u9075\u5b88\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u5b9f\u65bd\u3059\u308b\u3002<strong><em>\u3055\u3089\u306b\u3001t<\/em><\/strong><strong><em>\u901a\u77e5\u6a5f\u95a2\u306f\uff0c\u88fd\u9020\u8005\u306e\u30b5\u30a4\u30c8\u53ca\u3073\uff0c\u9069\u5207\u306a\u5834\u5408\u306b\u306f\u88fd\u9020\u8005\u306e\u4f9b\u7d66\u8005\u53ca\u3073\uff0f\u53c8\u306f\u4e0b\u8acb\u696d\u8005\u306e\u30b5\u30a4\u30c8\u306b\u3064\u3044\u3066\uff0c \u5c11\u306a\u304f\u3068\u30825\u5e74\u306b1\u56de\uff0c\u7121\u4f5c\u70ba\u306b\u629c\u304d\u6253\u3061\u76e3\u67fb\u3092\u5b9f\u65bd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u305a\uff0c\u3053\u308c\u306f\u5b9a\u671f\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u5be9\u67fb\u3068\u7d44\u307f \u5408\u308f\u305b\u3066\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/em><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"8_Strengthen_post-market_surveillance_activities\"><\/span>8.  \u5e02\u8ca9\u5f8c\u8abf\u67fb\u6d3b\u52d5\u306e\u5f37\u5316<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u88fd\u9020\u696d\u8005\u306f\u3001\u5e02\u8ca9\u5f8c\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u306e\u8981\u4ef6\u3092\u5f37\u5316\u3057\u3001\u8b66\u6212\u3068\u5e02\u5834\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u306b\u3064\u3044\u3066EU\u52a0\u76df\u56fd\u9593\u3067\u8abf\u6574\u3059\u308b\u30e1\u30ab\u30cb\u30ba\u30e0\u3092\u958b\u767a\u3059\u308b\u3053\u3068\u3092\u5f37\u304f\u63a8\u5968\u3055\u308c\u308b\u3002\u30af\u30e9\u30b9C\u53ca\u3073\u30af\u30e9\u30b9D\u306e\u6a5f\u5668\u306b\u9069\u7528\u3055\u308c\u308b\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u8a55\u4fa1\uff08\u9644\u5c5e\u66f8IX\uff09\u3067\u306f\u3001\u901a\u77e5\u6a5f\u95a2\u306f\u5c11\u306a\u304f\u3068\u308212\u30f6\u6708\u306b\u4e00\u5ea6\u3001\u5b9a\u671f\u7684\u306b\u9069\u5207\u306a\u76e3\u67fb\u3068\u8a55\u4fa1\u3092\u5b9f\u65bd\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u308c\u306b\u306f\u3001\u88fd\u9020\u8005\u53ca\u3073\u4f9b\u7d66\u8005\u53ca\u3073\uff0f\u53c8\u306f\u4e0b\u8acb\u3051\u696d\u8005\u306e\u6577\u5730\u5185\u306b\u304a\u3051\u308b\u76e3\u67fb\u304c\u542b\u307e\u308c\u308b\u3082\u306e\u3068\u3057\u307e\u3059\u3002\u88fd\u9020\u696d\u8005\u306f\u3001\u57fa\u672c\u7684\u306b\u3001\u4e8b\u6545\u53ca\u3073\u73fe\u5834\u5b89\u5168\u662f\u6b63\u51e6\u7f6e\uff08FSCA\uff09\u306e\u8a18\u9332\u53ca\u3073\u5831\u544a\u306e\u305f\u3081\u306e\u624b\u9806\u3092\u958b\u767a\u3057\u306a \u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"9_Unique_device_identifier_UDI_EUDAMED\"><\/span>9.\u30e6\u30cb\u30fc\u30af\u30c7\u30d0\u30a4\u30b9\u8b58\u5225\u5b50\uff08UDI\uff09\uff06EUDAMED<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u88fd\u9020\u8005\u306f\u3001\u6a5f\u5668\u3092\u8b58\u5225\u3057\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u4fc3\u9032\u3059\u308b\u305f\u3081\u306b\u3001UDI\u306e\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u7bc9\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002UDI\u3092\u4ed8\u4e0e\u3059\u308b\u30b7\u30b9\u30c6\u30e0\u3092\u904b\u7528\u3059\u308b\u305f\u3081\u306b\u3001GS1\u3001HIBCC\u3001ICCBBA\u3001IFA GmbH\u306a\u3069\u306e\u8a8d\u5b9a\u3055\u308c\u305f\u767a\u884c\u6a5f\u95a2\uff08IE\uff09\u306e\u30ea\u30b9\u30c8\u3092\u53c2\u7167\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u73fe\u5728\u3001\u3053\u308c\u3089\u306eIE\u306f27\u65e5\u304b\u3089\u6709\u52b9\u3067\u3059\u3002<sup>th<\/sup> 2019\u5e746\u6708\u3067\u3059\u304c\u3001\u305d\u306e\u6709\u52b9\u6027\u3092\u78ba\u8a8d\u3057\u3064\u3064\u3001\u6700\u7d42\u7684\u306b\u5c0e\u5165\u3092\u6c7a\u5b9a\u3059\u308b\u306e\u304c\u8ce2\u660e\u3067\u3057\u3087\u3046\u3002<\/p>\n<p>\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\uff08EUDAMED\uff09\u306f\u3001\u6b27\u5dde\u9023\u5408\u3067\u5165\u624b\u53ef\u80fd\u306a\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u306e\u6982\u8981\u3092\u63d0\u4f9b\u3059\u308b\u4e88\u5b9a\u3067\u3059\u3002\u4ee5\u4e0b\u306e6\u3064\u306e\u30e2\u30b8\u30e5\u30fc\u30eb\u3067\u69cb\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<ol>\n<li>\u4ff3\u512a\u767b\u9332\u3002<\/li>\n<li>UDI\uff08Unique Device Identification\uff09\u3068\u6a5f\u5668\u767b\u9332\u3002<\/li>\n<li>\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u3068\u8a8d\u8a3c\u66f8\u3002<\/li>\n<li>\u81e8\u5e8a\u8a66\u9a13\u3068\u6027\u80fd\u8a66\u9a13\u3002<\/li>\n<li>\u81ea\u8b66\u56e3\u3068\u30dd\u30b9\u30c8\u30de\u30fc\u30b1\u30c3\u30c8\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9<\/li>\n<li>\u30de\u30fc\u30b1\u30c3\u30c8\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9<\/li>\n<\/ol>\n<p>\u5305\u62ec\u7684\u306aEUDAMED\u3092\u901a\u3058\u3066\u900f\u660e\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u3001\u7d4c\u6e08\u4e8b\u696d\u8005\u306e\u60c5\u5831\u306e\u4e00\u90e8\u306f\u4e00\u822c\u306b\u516c\u958b\u3055\u308c\u308b\u4e88\u5b9a\u3067\u3042\u308b\u3002\u4e00\u65b9\u3001\u6a5f\u5bc6\u60c5\u5831\u306f\u3001\u7d4c\u6e08\u4e8b\u696d\u8005\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u3001EU\u52a0\u76df\u56fd\u306e\u516c\u8a8d\u6a5f\u95a2\u304a\u3088\u3073\u6240\u8f44\u5e81\u306e\u307f\u304c\u30a2\u30af\u30bb\u30b9\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"10_Requirements_for_in-house_devices\"><\/span>10.  \"\u81ea\u793e\u88fd\u54c1 \"\u306b\u5bfe\u3059\u308b\u8981\u6c42\u4e8b\u9805<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u533b\u7642\u6a5f\u95a2\u304c\u958b\u767a\u3059\u308b\u300c\u81ea\u793e\u958b\u767a\u6a5f\u5668\u300d\uff08\u307e\u305f\u306f\u300c\u7814\u7a76\u6240\u958b\u767a\u691c\u67fb\u6a5f\u5668\u300d\uff09\u306f\u3001\u540c\u3058\u533b\u7642\u6a5f\u95a2\u3067\u4f7f\u7528\u3055\u308c\u308b\u3053\u3068\u3092\u610f\u56f3\u3057\u3066\u304a\u308a\u3001\u4ed6\u306e\u6cd5\u4eba\u306b\u8ca9\u58f2\u3057\u305f\u308a\u3001\u8ca9\u58f2\u3057\u3066\u306f\u306a\u3089\u306a\u3044\u3002\u3053\u306e\u3088\u3046\u306a\u6a5f\u5668\u306f\u3001\u7279\u306b\u5e0c\u5c11\u75be\u60a3\u306e\u8a3a\u65ad\u3084\u6cbb\u7642\u306b\u4f7f\u7528\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002\u305f\u3060\u3057\u3001\u533b\u7642\u6a5f\u95a2\u304c\u898f\u5247\u7b2c5\u67615\u9805\u306b\u5b9a\u3081\u308b\u3044\u304f\u3064\u304b\u306e\u6761\u4ef6\u3092\u6e80\u305f\u3057\u3001\u533b\u7642\u691c\u67fb\u6a5f\u95a2\u306e\u54c1\u8cea\u304a\u3088\u3073\u80fd\u529b\u306e\u8981\u4ef6\u3092\u5b9a\u3081\u305f\u56fd\u969b\u898f\u683c\uff08EN ISO 15189\uff09\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u56fd\u5185\u898f\u5b9a\u306b\u6e96\u62e0\u3057\u305f\u9069\u5207\u306a\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u6709\u3057\u3001\u5bfe\u8c61\u3068\u306a\u308b\u60a3\u8005\u30b0\u30eb\u30fc\u30d7\u306e\u7279\u5b9a\u306e\u30cb\u30fc\u30ba\u304c\u5e02\u8ca9\u306e\u540c\u7b49\u6a5f\u5668\u3067\u306f\u9069\u5207\u306b\u6e80\u305f\u305b\u306a\u3044\u3053\u3068\u3092\u6b63\u5f53\u5316\u3067\u304d\u308b\u5834\u5408\u306b\u9650\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"References\"><\/span>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n[1] EC\u516c\u5f0f\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9(20\u65e5)<sup>th<\/sup> 2021\u5e7412\u6708\u3001\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u6bb5\u968e\u7684\u306a\u5c55\u958b\u3002\u30a2\u30af\u30bb\u30b9\u306f\u3053\u3061\u3089 <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/IP_21_6965\">https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/IP_21_6965<\/a><\/p>\n[2]REGULATION (EU) 2017\/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU; ANNEX.<em> VIII <\/em>\u5206\u985e\u898f\u5247\u30011.\u5b9f\u65bd\u898f\u5247 \u30dd\u30a4\u30f3\u30c8 1.4 Page 304<\/p>\n[3]\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b2017\u5e744\u67085\u65e5\u306e\u6b27\u5dde\u8b70\u4f1a\u304a\u3088\u3073\u7406\u4e8b\u4f1a\u306e\u898f\u5247\uff08EU\uff092017\/746\u3001\u6307\u4ee498\/79\/EC\u304a\u3088\u3073\u59d4\u54e1\u4f1a\u6c7a\u5b9a2010\/227\/EU\u3092\u5ec3\u6b62\u3059\u308b\u3002<\/p>\n<p>ANNEX IX \u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u53ca\u3073\u6280\u8853\u6587\u66f8\u306e\u8a55\u4fa1\u306b\u57fa\u3065\u304f\u9069\u5408\u6027\u8a55\u4fa1, Page 306, ANNEX X \u578b\u5f0f\u691c\u67fb\u306b\u57fa\u3065\u304f\u9069\u5408\u6027\u8a55\u4fa1, Page 314, ANNEX XI \u751f\u7523\u54c1\u8cea\u4fdd\u8a3c\u306b\u57fa\u3065\u304f\u9069\u5408\u6027\u8a55\u4fa1, Page 317.<\/p>\n[4] \u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9 dtd.2021\u5e7410\u670814\u65e5\u3001\u30d6\u30ea\u30e5\u30c3\u30bb\u30eb\uff1b\u516c\u8846\u885b\u751f\u3002\u6b27\u5dde\u59d4\u54e1\u4f1a\u3001\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u65b0\u898f\u5236\u306e\u6f38\u9032\u7684\u5c0e\u5165\u3092\u63d0\u6848<\/p>\n[5]\u6b27\u5dde\u306e\u65b0\u3057\u3044IVD\u5206\u985e\u898f\u5247\u304c\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306e\u95a2\u4e0e\u306b\u4e0e\u3048\u308b\u5f71\u97ff; : \u30aa\u30e9\u30f3\u30c0\u3067\u767b\u9332\u3055\u308c\u305fIVD\u306b\u95a2\u3059\u308b\u7814\u7a76; <em>van Drongelen A, de Bruijn A, Pennings J, van der Maaden T <\/em>\u82f1\u8a9e\u724832p 2018, RIVM letter report 2018-0082<\/p>\n[6] \u4e0a\u8a18\u4e00\u89a7\u306f\u30012012\u5e743\u670831\u65e5\u6642\u70b9\u306e\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u304f\u3082\u306e\u3067\u3059\u3002\u6700\u65b0\u306e\u30ea\u30b9\u30c8\u306f\u3001EC\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/index.cfm?fuseaction=directive.notifiedbody&amp;dir_id=35\">https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/index.cfm?fuseaction=directive.notifiedbody&amp;dir_id=35<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>An exhaustive guide to regulatory compliance for IVD manufacturers, written by Sundeep Agarwal, experienced IVDR consultant.\u00a0 What is the IVDR? The European Commission&#8217;s (EC) In Vitro Diagnostic Regulation (EU IVDR 2017\/746) is a \u2018legislative framework\u2019 and a way forward towards global IVD safety, which assures that only reliable and effective IVDs are in the market. The European Commission is trying its best to make the healthcare system safer and error free in terms of diagnosis or outcomes. The in vitro diagnostic medical devices (IVDD), 98\/79\/EC was a directive while IVDR is a legislation (regulation) applicable to all Economic Operator (EO) i.e., manufacturers, importers, users, notified bodies and national authorities in<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":10000,"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>IVDR compliance: 10 tips for medical device manufacturers<\/title>\n<meta name=\"description\" content=\"An exhaustive guide to IVDR compliance, sourced from an experienced regulatory consultant. Read these 10 tips to ensure compliance.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IVDR compliance: 10 tips for medical device manufacturers\" \/>\n<meta property=\"og:description\" content=\"An exhaustive guide to IVDR compliance, sourced from an experienced regulatory consultant. Read these 10 tips to ensure compliance.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/\" \/>\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=\"2022-03-29T10:51:20+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-02-15T11:33:54+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/self-test-atk-home-covid19-negative-test-result-with-sars-cov2-rapid-antigen-test-kit.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1500\" \/>\n\t<meta property=\"og:image:height\" content=\"844\" \/>\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=\"11\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"IVDR compliance: 10 tips for medical device manufacturers","description":"An exhaustive guide to IVDR compliance, sourced from an experienced regulatory consultant. 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