{"id":3290,"date":"2021-08-20T14:37:06","date_gmt":"2021-08-20T05:37:06","guid":{"rendered":"https:\/\/clarivate.com\/ja\/?p=3290"},"modified":"2021-08-20T14:37:06","modified_gmt":"2021-08-20T05:37:06","slug":"what-europes-mdr-means-for-manufacturers-of-legacy-devices-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/what-europes-mdr-means-for-manufacturers-of-legacy-devices-2\/","title":{"rendered":"\u6b27\u5dde\u306eMDR\u304c\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u30e1\u30fc\u30ab\u30fc\u306b\u3082\u305f\u3089\u3059\u3082\u306e"},"content":{"rendered":"<p><a href=\"https:\/\/clarivate.com\/blog\/what-europes-mdr-means-for-manufacturers-of-legacy-devices\/\">\u82f1\u8a9e\u539f\u6587\u30b5\u30a4\u30c8<\/a><\/p>\n<p><span style=\"font-size: small\">\u672c\u8a18\u4e8b\u306f\u82f1\u6587\u30d6\u30ed\u30b0\u3092\u65e5\u672c\u8a9e\u306b\u7ffb\u8a33\u518d\u7de8\u96c6\uff08\u4e00\u90e8\u8ffd\u8a18\u3092\u542b\u3080\uff09\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u672c\u8a18\u4e8b\u306e\u6b63\u5f0f\u8a00\u8a9e\u306f\u82f1\u8a9e\u3067\u3042\u308a\u3001\u305d\u306e\u5185\u5bb9\u30fb\u89e3\u91c8\u306b\u3064\u3044\u3066\u306f\u82f1\u8a9e\u304c\u512a\u5148\u3057\u307e\u3059\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong>M\u00d3NICA COLINA<\/strong><br \/>\nSenior Content Specialist, Clarivate<\/p>\n<p>&nbsp;<\/p>\n<p>\u30af\u30e9\u30ea\u30d9\u30a4\u30c8\u306e\u898f\u5236\u5c02\u9580\u5bb6\u3067\u3042\u308bM\u00f3nica Colina\u304c\u3001\u5ec3\u6b62\u3055\u308c\u305f\u6307\u4ee4\u306b\u57fa\u3065\u3044\u3066\u8a8d\u8a3c\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u306e\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u76e3\u67fb\u3067\u8003\u616e\u3059\u3079\u304d\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306eMedical Device Regulation\uff08MDR\uff09\u306e\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>2017\u5e745\u6708\u306b\u521d\u3081\u3066\u767a\u8868\u3055\u308c\u305f\u6b27\u5dde\u59d4\u54e1\u4f1a\u306e\u533b\u7642\u6a5f\u5668\u898f\u5247\u306f\u3001\u4eca\u5e745\u6708\u306b\u6b27\u5dde\u306e\u5168\u52a0\u76df\u56fd\u3067\u9069\u7528\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u3053\u306e\u898f\u5247\u306f\u3001\u4eca\u5f8c\u3001\u8ca9\u58f2\u627f\u8a8d\u3092\u6c42\u3081\u308b\u3059\u3079\u3066\u306e\u6a5f\u5668\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u304c\u3001\u3059\u3067\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u88fd\u54c1\u306f\u3001\u3057\u3070\u3089\u304f\u306e\u9593\u3001\u65e7\u6765\u306eMedical Device Directive\uff08MDD\uff09\u304a\u3088\u3073Active Implantable Medical Device Directive\uff08AIMDD\uff09\u306e\u898f\u5247\u306b\u57fa\u3065\u3044\u3066\u8a8d\u8a3c\u3092\u53d7\u3051\u7d9a\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u88fd\u54c1\u306f\u300c\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u300d\u3068\u547c\u3070\u308c\u3001MDR\u306e\u7d4c\u904e\u63aa\u7f6e\u3067\u5b9a\u3081\u3089\u308c\u305f\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306b\u6cbf\u3063\u3066\u3001\u6700\u7d42\u7684\u306b\u65b0\u898f\u5236\u306b\u9069\u5408\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u305d\u308c\u307e\u3067\u306e\u9593\u3001\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u306e\u30e1\u30fc\u30ab\u30fc\u304c\u77e5\u3063\u3066\u304a\u304f\u3068\u5f79\u306b\u7acb\u3064MDR\u306e\u8981\u7d20\u304c\u3044\u304f\u3064\u304b\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>MDD\u306b\u57fa\u3065\u304f\u6709\u52b9\u306a\u8a8d\u8a3c\u3092\u6301\u3064\u533b\u7642\u6a5f\u5668\u306f\u3001MDR\u306e\u3044\u304f\u3064\u304b\u306e\u8981\u4ef6\u3092\u542b\u3080\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u76e3\u67fb\u3092\u53d7\u3051\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/strong><\/h3>\n<p>EU\u52a0\u76df\u56fd\u3067\u3053\u308c\u3089\u306e\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u306e\u8ca9\u58f2\u3084\u30b5\u30fc\u30d3\u30b9\u306b\u95a2\u308f\u308b\u88fd\u9020\u696d\u8005\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u4ee3\u7406\u4eba\u3001\u305d\u306e\u4ed6\u306e\u95a2\u9023\u7d4c\u6e08\u4e8b\u696d\u8005\u306f\u3001\u8a8d\u8a3c\u66f8\u306e\u6709\u52b9\u6027\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u3001MDR\u306e\u5b89\u5168\u304a\u3088\u3073\u6027\u80fd\u8981\u4ef6\u306b\u5f93\u3063\u3066\u6a5f\u5668\u306e\u6280\u8853\u6587\u66f8\u3092\u66f4\u65b0\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u306e\u6280\u8853\u8cc7\u6599\u306f\u3001MDD\u306b\u57fa\u3065\u3044\u3066\u8a8d\u8a3c\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u3067\u3082\u3001\u4e00\u90e8\u306eMDR\u8981\u6c42\u4e8b\u9805\u306b\u9069\u5408\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/strong><\/h3>\n<p>MDR\u304c\u767b\u5834\u3057\u305f\u304b\u3089\u3068\u3044\u3063\u3066\u3001\u4f01\u696d\u304c\u3059\u3050\u306b\u65b0\u3057\u3044\u898f\u5236\u3067\u898f\u5b9a\u3055\u308c\u3066\u3044\u308b\u5b8c\u5168\u306a\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u3092\u9069\u5fdc\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3080\u3057\u308d\u3001\u65e2\u5b58\u306e\u30d5\u30a1\u30a4\u30eb\u3092\u88dc\u5b8c\u3059\u308b\u305f\u3081\u306b\u65b0\u3057\u3044\u6587\u66f8\u3092\u8ffd\u52a0\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u304c\u3001\u6700\u7d42\u7684\u306b\u306f\u5b8c\u5168\u306a\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u3092\u9069\u5fdc\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002MDR\u304c\u65bd\u884c\u3055\u308c\u305f\u3053\u3068\u3067\u3001EC\u8a8d\u8a3c\u306e\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u5be9\u67fb\u306b\u304a\u3044\u3066\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u898f\u5236\u306e\u67a0\u7d44\u307f\u306e\u9055\u3044\uff08MDD\u304a\u3088\u3073AIMDD\u3068MDR\uff09\u306b\u3088\u308a\u3001\u4ee5\u524d\u306e\u5be9\u67fb\u3067\u306f\u7cbe\u67fb\u3055\u308c\u306a\u304b\u3063\u305f\u3044\u304f\u3064\u304b\u306e\u8981\u6c42\u4e8b\u9805\u3092\u9075\u5b88\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u8a3c\u62e0\u306e\u63d0\u793a\u3092\u6c42\u3081\u3089\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>MDR\u30dd\u30ea\u30b7\u30fc\u306b\u53ef\u80fd\u306a\u9650\u308a\u6e96\u62e0\u3059\u308b\u305f\u3081\u306b\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u542b\u307e\u308c\u308b\u4ee5\u4e0b\u306e\u6587\u66f8\u306e\u4f5c\u6210\u306b\u7279\u5225\u306a\u6ce8\u610f\u3092\u6255\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u5e02\u8ca9\u5f8c\u8abf\u67fb\u8a08\u753b<\/li>\n<li>\u5e02\u8ca9\u5f8c\u8abf\u67fb\u5831\u544a\u66f8<\/li>\n<li>\u30c8\u30ec\u30f3\u30c9\u30ec\u30dd\u30fc\u30c8<\/li>\n<li>\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u30ec\u30dd\u30fc\u30c8<\/li>\n<li>Medical Device Coordination Group (MDCG) 2020-6: Guidance on Sufficient Clinical Evidence for Legacy Devices, Apr-2020\u306b\u793a\u3055\u308c\u3066\u3044\u308b\u5e02\u5834\u76e3\u8996\u7528\u30a8\u30d3\u30c7\u30f3\u30b9\uff08\u81e8\u5e8a\u8a55\u4fa1\u304a\u3088\u3073\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u5b9f\u8a3c\uff09<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3><strong>\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u8a3c\u660e\u66f8\u306e\u6709\u52b9\u6027\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u8ffd\u52a0\u767b\u9332\u624b\u7d9a\u304d<\/strong><\/h3>\n<p>\u3055\u3089\u306b\u3001EU MDR\u3067\u306f\u3001\u88fd\u9020\u696d\u8005\u307e\u305f\u306f\u305d\u306e\u8a8d\u5b9a\u3055\u308c\u305f\u4ee3\u7406\u4eba\u304c\u3001\u7d44\u7e54\u306e\u898f\u5236\u9075\u5b88\u3092\u62c5\u5f53\u3059\u308b\u533b\u7642\u6a5f\u5668\u5c02\u9580\u5bb6\u3092\u6307\u540d\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n<p>\u3082\u30461\u3064\u306e\u91cd\u8981\u306a\u8981\u4ef6\u306f\u3001Unique Device Identification system (UDI)\u306e\u5c0e\u5165\u3068\u3001\u5bfe\u5fdc\u3059\u308bUDI\u3092\u6301\u3064\u6a5f\u5668\u3092European Database on Medical Devices (EUDAMED)\u304c\u5229\u7528\u53ef\u80fd\u306a\u5834\u5408\u306f\u305d\u3053\u306b\u767b\u9332\u3059\u308b\u3053\u3068\u3067\u3059\u3002EUDAMED\u304c\u5b8c\u5168\u306b\u7a3c\u50cd\u3057\u3066\u3044\u306a\u3044\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001UDI\u30b7\u30b9\u30c6\u30e0\u3078\u306e\u6e96\u62e0\u306f\u3001\u3059\u3067\u306b\u30af\u30e9\u30b9III\u306e\u6a5f\u5668\u306b<a href=\"https:\/\/ec.europa.eu\/health\/md_topics-interest\/unique_device_identifier_en\" target=\"_blank\" rel=\"noopener\">\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059<\/a>\u3002\u30af\u30e9\u30b9IIa\u304a\u3088\u3073IIb\u306e\u6a5f\u5668\u306f2023\u5e74\u306b\u3001\u30af\u30e9\u30b9I\u306e\u6a5f\u5668\u306f2025\u5e74\u306bUDI\u30b7\u30b9\u30c6\u30e0\u3078\u306e\u6e96\u62e0\u304c\u7fa9\u52d9\u3065\u3051\u3089\u308c\u308b\u4e88\u5b9a\u3067\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u30c7\u30d0\u30a4\u30b9\u30e1\u30fc\u30ab\u30fc\u3078\u306e\u63d0\u8a00<\/strong><\/h3>\n<p>\u30c7\u30d0\u30a4\u30b9\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u7814\u7a76\u958b\u767a\u3084\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u505c\u6ede\u3092\u907f\u3051\u308b\u305f\u3081\u306e\u6226\u7565\u3092\u7df4\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u30e9\u30f3\u30c9\u30b9\u30b1\u30fc\u30d7\u5206\u6790\u3068\u30b9\u30c6\u30fc\u30af\u30db\u30eb\u30c0\u30fc\u306e\u8996\u70b9\u306b\u57fa\u3065\u304d\u3001\u79c1\u305f\u3061\u306f\u4ee5\u4e0b\u306e\u3053\u3068\u3092\u63a8\u5968\u3057\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u76e3\u67fb\u304c\u884c\u308f\u308c\u308b\u524d\u306b\u3001MDD\u3068MDR\u306e\u8981\u6c42\u4e8b\u9805\u306e\u30ae\u30e3\u30c3\u30d7\u5206\u6790\u3092\u884c\u3046\u3053\u3068<\/li>\n<li>\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u306e\u8a8d\u8a3c\u3092\u7121\u52b9\u306b\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u3001\u8a2d\u8a08\u3001\u54c1\u8cea\u624b\u9806\u3001\u30b5\u30a4\u30c8\u306e\u5834\u6240\u3001\u91cd\u8981\u306a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3001\u91cd\u8981\u306a\u88fd\u9020\u5de5\u7a0b\u306e\u5909\u66f4\u306b\u7279\u306b\u6ce8\u610f\u3092\u6255\u3046\u3053\u3068<\/li>\n<li>ISO13485\u306a\u3069\u306e\u95a2\u9023\u898f\u683c\u3067\u6709\u52b9\u306a\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u4f01\u696d\u3067\u3042\u3063\u3066\u3082\u3001MDR\u3092\u53c2\u7167\u3057\u3066\u30ae\u30e3\u30c3\u30d7\u5206\u6790\u3092\u884c\u3044\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3092\u65b0\u3057\u3044\u8981\u6c42\u4e8b\u9805\u306b\u9069\u5408\u3055\u305b\u308b\u3053\u3068<\/li>\n<li>\u79fb\u884c\u671f\u9593\u4e2d\u306e\u591a\u91cf\u306e\u4ed5\u4e8b\u3092\u5438\u53ce\u3059\u308b\u305f\u3081\u306b\u3001\u54c1\u8cea\u4fdd\u8a3c\u304a\u3088\u3073\u898f\u5236\u95a2\u9023\u306e\u30b9\u30bf\u30c3\u30d5\u3092\u9069\u5207\u306a\u4eba\u6570\u3067\u96c7\u7528\u3057\u3066\u8a13\u7df4\u3057\u3001\u793e\u5185\u30c1\u30fc\u30e0\u306e\u6e96\u5099\u3068\u5916\u90e8\u898f\u5236\u5f53\u5c40\u3068\u306e\u95a2\u4fc2\u7ba1\u7406\u3092\u652f\u63f4\u3059\u308b\u3053\u3068<\/li>\n<li>\u8a2d\u8a08\u5909\u66f4\u306b\u3088\u308a\u65e7\u6307\u4ee4\u4e0b\u3067\u306e\u8a8d\u8a3c\u55aa\u5931\u304c\u65e9\u307e\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u3067\u304d\u308b\u3060\u3051\u65e9\u304f\u65b0\u898f\u5236\u4e0b\u3067\u306e\u8a8d\u8a3c\u53d6\u5f97\u306e\u305f\u3081\u306e\u6226\u7565\u3092\u8a08\u753b\u3059\u308b\u3053\u3068<\/li>\n<\/ul>\n<p>\u65b0\u3057\u3044\u898f\u5236\u30e2\u30c7\u30eb\u3078\u306e\u9069\u5fdc\u306f\u6c7a\u3057\u3066\u7c21\u5358\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u3053\u308c\u3089\u306e\u691c\u8a0e\u4e8b\u9805\u3092\u5ff5\u982d\u306b\u7f6e\u304d\u3001\u8ab2\u984c\u3092\u4e88\u6e2c\u3059\u308b\u305f\u3081\u306e\u30c7\u30e5\u30fc\u30c7\u30ea\u30b8\u30a7\u30f3\u30b9\u3092\u884c\u3046\u3053\u3068\u3067\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u4f59\u5206\u306a\u52b4\u529b\u3092\u7701\u304d\u3001\u79fb\u884c\u671f\u9593\u4e2d\u3082\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u6b6f\u8eca\u3092\u56de\u3057\u7d9a\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u3053\u306e\u8a18\u4e8b\u306f\u3001\u30af\u30e9\u30ea\u30d9\u30a4\u30c8\u306e\u30a2\u30ca\u30ea\u30b9\u30c8\u304c\u3001<a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence\u2122<\/a>\u306e\u30c7\u30fc\u30bf\u3068\u5206\u6790\u3092\u7528\u3044\u3066\u4f5c\u6210\u3057\u305f\u3082\u306e\u3067\u3059\u3002<a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a>\u306f\u3001\u7814\u7a76\u958b\u767a\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u305f\u3059\u3079\u3066\u306e\u898f\u5236\u5f53\u5c40\u306e\u6a5f\u80fd\u3092\u7db2\u7f85\u3059\u308b\u3001\u5305\u62ec\u7684\u3067\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u3001\u5c02\u9580\u7684\u306a\u5206\u6790\u306b\u3088\u308b\u60c5\u5831\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a>\u306f\u3001\u85ac\u4e8b\u898f\u5236\u306e\u72b6\u6cc1\u3092\u628a\u63e1\u3057\u3001\u6226\u7565\u7684\u306a\u610f\u601d\u6c7a\u5b9a\u3092\u884c\u3046\u305f\u3081\u306e\u552f\u4e00\u306e\u60c5\u5831\u6e90\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u82f1\u8a9e\u539f\u6587\u30b5\u30a4\u30c8 \u672c\u8a18\u4e8b\u306f\u82f1\u6587\u30d6\u30ed\u30b0\u3092\u65e5\u672c\u8a9e\u306b\u7ffb\u8a33\u518d\u7de8\u96c6\uff08\u4e00\u90e8\u8ffd\u8a18\u3092\u542b\u3080\uff09\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u672c\u8a18\u4e8b\u306e\u6b63\u5f0f\u8a00\u8a9e\u306f\u82f1\u8a9e\u3067\u3042\u308a\u3001\u305d\u306e\u5185\u5bb9\u30fb\u89e3\u91c8\u306b\u3064\u3044\u3066\u306f\u82f1\u8a9e\u304c\u512a\u5148\u3057\u307e\u3059\u3002 &nbsp; M\u00d3NICA COLINA Senior Content Specialist, Clarivate &nbsp; \u30af\u30e9\u30ea\u30d9\u30a4\u30c8\u306e\u898f\u5236\u5c02\u9580\u5bb6\u3067\u3042\u308bM\u00f3nica Colina\u304c\u3001\u5ec3\u6b62\u3055\u308c\u305f\u6307\u4ee4\u306b\u57fa\u3065\u3044\u3066\u8a8d\u8a3c\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u306e\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u76e3\u67fb\u3067\u8003\u616e\u3059\u3079\u304d\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306eMedical Device Regulation\uff08MDR\uff09\u306e\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u307e\u3059\u3002 &nbsp; 2017\u5e745\u6708\u306b\u521d\u3081\u3066\u767a\u8868\u3055\u308c\u305f\u6b27\u5dde\u59d4\u54e1\u4f1a\u306e\u533b\u7642\u6a5f\u5668\u898f\u5247\u306f\u3001\u4eca\u5e745\u6708\u306b\u6b27\u5dde\u306e\u5168\u52a0\u76df\u56fd\u3067\u9069\u7528\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u3053\u306e\u898f\u5247\u306f\u3001\u4eca\u5f8c\u3001\u8ca9\u58f2\u627f\u8a8d\u3092\u6c42\u3081\u308b\u3059\u3079\u3066\u306e\u6a5f\u5668\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u304c\u3001\u3059\u3067\u306b\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u88fd\u54c1\u306f\u3001\u3057\u3070\u3089\u304f\u306e\u9593\u3001\u65e7\u6765\u306eMedical Device Directive\uff08MDD\uff09\u304a\u3088\u3073Active Implantable Medical Device Directive\uff08AIMDD\uff09\u306e\u898f\u5247\u306b\u57fa\u3065\u3044\u3066\u8a8d\u8a3c\u3092\u53d7\u3051\u7d9a\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u88fd\u54c1\u306f\u300c\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u300d\u3068\u547c\u3070\u308c\u3001MDR\u306e\u7d4c\u904e\u63aa\u7f6e\u3067\u5b9a\u3081\u3089\u308c\u305f\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306b\u6cbf\u3063\u3066\u3001\u6700\u7d42\u7684\u306b\u65b0\u898f\u5236\u306b\u9069\u5408\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u305d\u308c\u307e\u3067\u306e\u9593\u3001\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u306e\u30e1\u30fc\u30ab\u30fc\u304c\u77e5\u3063\u3066\u304a\u304f\u3068\u5f79\u306b\u7acb\u3064MDR\u306e\u8981\u7d20\u304c\u3044\u304f\u3064\u304b\u3042\u308a\u307e\u3059\u3002 &nbsp; MDD\u306b\u57fa\u3065\u304f\u6709\u52b9\u306a\u8a8d\u8a3c\u3092\u6301\u3064\u533b\u7642\u6a5f\u5668\u306f\u3001MDR\u306e\u3044\u304f\u3064\u304b\u306e\u8981\u4ef6\u3092\u542b\u3080\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u76e3\u67fb\u3092\u53d7\u3051\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002 EU\u52a0\u76df\u56fd\u3067\u3053\u308c\u3089\u306e\u30ec\u30ac\u30b7\u30fc\u30c7\u30d0\u30a4\u30b9\u306e\u8ca9\u58f2\u3084\u30b5\u30fc\u30d3\u30b9\u306b\u95a2\u308f\u308b\u88fd\u9020\u696d\u8005\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u4ee3\u7406\u4eba\u3001\u305d\u306e\u4ed6\u306e\u95a2\u9023\u7d4c\u6e08\u4e8b\u696d\u8005\u306f\u3001\u8a8d\u8a3c\u66f8\u306e\u6709\u52b9\u6027\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u3001MDR\u306e\u5b89\u5168\u304a\u3088\u3073\u6027\u80fd\u8981\u4ef6\u306b\u5f93\u3063\u3066\u6a5f\u5668\u306e\u6280\u8853\u6587\u66f8\u3092\u66f4\u65b0\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002 &nbsp; 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