{"id":44930,"date":"2022-01-31T00:00:00","date_gmt":"2022-01-30T23:00:00","guid":{"rendered":""},"modified":"2023-10-02T09:14:38","modified_gmt":"2023-10-02T09:14:38","slug":"mdr%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e3%80%81%e3%82%af%e3%83%a9%e3%82%b9%e2%85%b0-%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ab%e5%af%be%e3%81%99%e3%82%8b%e6%96%b0%e3%81%9f%e3%81%aa%e8%a6%81","status":"publish","type":"post","link":"https:\/\/biorius.com\/ja\/cosmetic-news\/mdr%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e3%80%81%e3%82%af%e3%83%a9%e3%82%b9%e2%85%b0-%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ab%e5%af%be%e3%81%99%e3%82%8b%e6%96%b0%e3%81%9f%e3%81%aa%e8%a6%81\/","title":{"rendered":"MDR\u306b\u304a\u3051\u308b\u3001\u30af\u30e9\u30b9\u2160 \u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u65b0\u305f\u306a\u8981\u6c42\u4e8b\u9805"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\">\u6b27\u5dde\u3067\u306e\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e 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Ir\uff09\uff1a\u5916\u79d1\u624b\u8853\u306b\u4f7f\u7528\u3055\u308c\u308b\u624b\u8853\u7528\u30cf\u30b5\u30df\u3084\u9257\u5b50\u306a\u3069\u306e\u518d\u4f7f\u7528\u578b\u624b\u8853\u5668\u5177\u3067\u3001\u9069\u5207\u306a\u5c40\u6240\u6d17\u6d44\u3068\u6ec5\u83cc\u306e\u5f8c\u306b\u518d\u4f7f\u7528\u3055\u308c\u308b\u3082\u306e<\/li><\/ul>\n\n\n\n<p>\u6ec5\u83cc\u3055\u308c\u3066\u304a\u3089\u305a\u3001\u6e2c\u5b9a\u6a5f\u80fd\u304c\u306a\u304f\u3001\u518d\u4f7f\u7528\u53ef\u80fd\u306a\u624b\u8853\u5668\u5177\u3067\u306a\u3044\u30af\u30e9\u30b9\u2160\uff08\u4f8b\u3048\u3070\u3001\u77ef\u6b63\u7528\u773c\u93e1\u3001\u88c5\u5177\u3001\u677e\u8449\u6756\u306a\u3069\uff09\u3092\u9664\u304d\u3001\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u306f\u9069\u5408\u6027\u8a55\u4fa1\u306e\u305f\u3081\u306b<a href=\"https:\/\/biorius.com\/ja\/choice-of-your-notified-body\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3<\/a>\u306e\u95a2\u4e0e\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/eyeglasses-pexels-karolina-grabowska-4226880-freeofrights-1024x487-1.jpg\" alt=\"\" class=\"wp-image-18621\"\/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">CE\u30de\u30fc\u30af\u30684\u6841\u306e\u6570\u5b57<\/h3>\n\n\n\n<p>\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306e\u4ecb\u5165\u304c\u5fc5\u8981\u306a\u533b\u7642\u6a5f\u5668\u306b\u306f\u3001CE\u30de\u30fc\u30af\u306e\u4ed6\u306b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306b\u5bfe\u5fdc\u3059\u308b4\u6841\u306e\u756a\u53f7\u304c\u8868\u793a\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3057\u304b\u3057\u3001\u4f4e\u30ea\u30b9\u30af\u306e\u30af\u30e9\u30b9\u2160\u6a5f\u5668\uff08\u4f8b\u3048\u3070\u3001\u77ef\u6b63\u7528\u773c\u93e1\u3001\u88c5\u5177\u3001\u677e\u8449\u6756\u306a\u3069\uff09\u306e\u88fd\u9020\u8005\u306f\u3001\u65b0\u898f\u5247\u306b\u9069\u5408\u3059\u308b\u305f\u3081\u306b\u4f55\u3082\u3057\u306a\u304f\u3066\u3088\u3044\u3067\u3057\u3087\u3046\u304b\uff1f\u3082\u3061\u308d\u3093\u3001\u305d\u3093\u306a\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u30eb\u30fc\u30eb\u306f\u3001\u533b\u7642\u6a5f\u5668\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30b7\u30e7\u30f3\u30fb\u30b0\u30eb\u30fc\u30d7\u306b\u3088\u308a\u3001\u6587\u66f8MDCG 2019-15 rev.1\u3001\u304a\u3088\u3073\u6b21\u306e\u8981\u7d04\u3067\u660e\u78ba\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3064\u307e\u308a\u3001\u30af\u30e9\u30b9\u2160\u6a5f\u5668\u306e\u88fd\u9020\u696d\u8005\u306f\u3001\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u3068\u307b\u307c\u540c\u3058\u6280\u8853\u6587\u66f8\u3092\u7528\u610f\u3057\u3001\u540c\u69d8\u306e\u6ce8\u610f\u3092\u6255\u3063\u3066\u88fd\u9020\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>\u5b9f\u969b\u3001\u65e7\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08MDD\uff09\u6bd4\u3079\u3066\u539f\u5247\u306e\u5909\u66f4\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u898f\u5236\u5909\u66f4\u306b\u4f34\u3044\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08EU\uff092017\/745\u306b\u6e96\u62e0\u3059\u308b\u3088\u3046\u306b\u6280\u8853\u6587\u66f8\u3068\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u533b\u7642\u6a5f\u5668\u3092EU\u5e02\u5834\u3067\u8ca9\u58f2\u3059\u308b\u305f\u3081\u306e\u6761\u4ef6<\/h3>\n\n\n\n<p>\u3057\u305f\u304c\u3063\u3066\u3001MDR\u306b\u5bfe\u3059\u308b\u6e96\u62e0\u5ba3\u8a00\u66f8\uff08DoC\uff09\u3092\u65b0\u898f\u4f5c\u6210\u3059\u308b\u306a\u3069\u3001\u6a5f\u5668\u3092\u4e0a\u5e02\u3059\u308b\u524d\u306b\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u4ee5\u4e0b\u306e\u69d8\u306a\u3044\u304f\u3064\u304b\u306e\u4f5c\u696d\u3092\u5b8c\u4e86\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\" id=\"block-cc9781e5-8746-4d43-a8d4-ca90590f5ac5\"><li>\u88fd\u54c1\u304c\u533b\u7642\u6a5f\u5668\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3001\u66f4\u306b\u306f\uff08\u5206\u985e\u898f\u5247\u304c\u5909\u66f4\u3055\u308c\u305f\u305f\u3081\uff09\u305d\u306e\u5206\u985e\u3092\u78ba\u8a8d\u3059\u308b<\/li><li>\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08ISO 13485\uff09\u306e\u5c0e\u5165\u3002\u8a8d\u5b9a\u6a5f\u95a2\u307e\u305f\u306f\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306b\u3088\u308b\u8a8d\u8a3c\u304c\u671b\u307e\u3057\u3044<\/li><li>\u81e8\u5e8a\u8a55\u4fa1\u306e\u5b9f\u65bd<\/li><li>\u6280\u8853\u6587\u66f8\u3067\u30c7\u30d0\u30a4\u30b9\u306e\u9069\u5408\u6027\u3092\u8a55\u4fa1\u3059\u308b\u3002\u3059\u306a\u308f\u3061\u3001\u4e00\u822c\u5b89\u5168\u6027\u80fd\u8981\u4ef6\uff08GSPR\uff09\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068<\/li><li>\u30ea\u30b9\u30af\u5206\u6790\u306e\u5b9f\u65bd\u3068\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165<\/li><li>\u751f\u7269\u5b66\u7684\u5b89\u5168\u6027\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u66f4\u65b0\uff08\u9069\u7528\u898f\u683c\u304c\u5927\u5e45\u306b\u5909\u66f4\u3055\u308c\u305f\u305f\u3081\uff09<\/li><li>\u6280\u8853\u8cc7\u6599\u3092\u5e38\u306b\u6700\u65b0\u306e\u72b6\u614b\u306b\u4fdd\u3064<\/li><\/ul>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-style-default\"><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/pexels-mart-production-7088526-clinical-investigations-e1643646020964-1024x986-1.jpg\" alt=\"\" class=\"wp-image-18622 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<ul class=\"wp-block-list\"><li>\u6a5f\u5668\u306b\u6dfb\u4ed8\u3059\u308b\u5fc5\u8981\u306a\u60c5\u5831\u3092\u3059\u3079\u3066\u6e96\u5099\u3059\u308b\u3002\u65e2\u5b58\u88fd\u54c1\u306b\u3064\u3044\u3066\u306f\u3001IFU\u3068\u30e9\u30d9\u30eb\u306f\u3001\u65b0\u305f\u306b\u8981\u6c42\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u5909\u66f4\uff08\u9644\u5c5e\u66f8\u2160\u306e\u7b2c23\u6761\uff09\u3092\u53cd\u6620\u3057\u3001\u6a5f\u5668\u306e\u5229\u7528\u304c\u60f3\u5b9a\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u8a00\u8a9e\u3067\u6539\u8a02\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b<\/li><li>\u7b56\u5b9a\u3057\u305f\u8a08\u753b\u306b\u57fa\u3065\u304d\u3001QMS\u306b\u7d71\u5408\u3057\u305f\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306e\u5b9f\u65bd<\/li><li>\u30d3\u30b8\u30e9\u30f3\u30b9\u5831\u544a\u30fb\u767b\u9332\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165<\/li><li>EUDAMED\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306b\u7d4c\u6e08\u4e8b\u696d\u8005\u3068\u3057\u3066\u767b\u9332<\/li><\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-media-text has-media-on-the-right is-stacked-on-mobile is-style-default\"><figure class=\"wp-block-media-text__media\"><img fetchpriority=\"high\" decoding=\"async\" width=\"706\" height=\"429\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/eudamed-eo.jpg\" alt=\"\" class=\"wp-image-18623 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<ul class=\"wp-block-list\" id=\"block-b74de0d4-b60d-4c01-aeea-b2d55865bf9b\"><li>2025\u5e745\u670826\u65e5\u307e\u3067\u306b\u6a5f\u5668\u3068\u305d\u306e\u5305\u88c5\u306bUDI\u3092\u4ed8\u4e0e\u3059\u308b<\/li><li><a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2020-09\/md_mdcg_2019_7_guidance_art15_mdr_ivdr_en_0.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u7b2c15\u6761\u306e\u8cc7\u683c\u8981\u4ef6<\/a>\u3092\u6e80\u305f\u3059\u898f\u5236\u9075\u5b88\u8cac\u4efb\u8005\u3092\u6307\u5b9a\u3059\u308b<\/li><li>EU\u57df\u5916\u306e\u30e1\u30fc\u30ab\u30fc\u306e\u5834\u5408\u3001EU\u52a0\u76df\u56fd\u306b\u6240\u5728\u3059\u308b\u8a8d\u5b9a\u4ee3\u7406\u5e97\u3068\u5951\u7d04\u3092\u7de0\u7d50\u3059\u308b<\/li><\/ul>\n<\/div><\/div>\n\n\n\n<h3 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href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2020-07\/md_transitional-provisions-art-3-and-4_en_0.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u7336\u4e88\u671f\u9593<\/a>\u306e\u6069\u6075\u3092\u53d7\u3051\u308b\u6a5f\u5668\u306b\u3064\u3044\u3066\u306f\u3001\u3044\u304f\u3064\u304b\u306e\u8981\u6c42\u4e8b\u9805\u304c\u76f4\u3061\u306b\u9069\u7528\u3055\u308c\u307e\u3059\uff1a\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3001\u8b66\u6212\u5831\u544a\u3001\u767b\u9332\u3001\u304a\u3088\u3073<a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2020-09\/md_mdcg_guidance_significant_changes_annexes_en_0.pdf\" target=\"_blank\" rel=\"noreferrer 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