{"id":6086,"date":"2019-10-16T16:26:34","date_gmt":"2019-10-16T16:26:34","guid":{"rendered":"https:\/\/kolabtree.com\/blog\/?p=6086"},"modified":"2020-05-13T13:49:22","modified_gmt":"2020-05-13T13:49:22","slug":"prepare-your-medical-device-for-eu-mdr-8-trusted-resources","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/prepare-your-medical-device-for-eu-mdr-8-trusted-resources\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306eEU MDR\u3078\u306e\u5bfe\u5fdc\uff1a\u4fe1\u983c\u3067\u304d\u308b8\u3064\u306e\u30ea\u30bd\u30fc\u30b9"},"content":{"rendered":"

Preparing your \u533b\u7642\u6a5f\u5668<\/a> for EU MDR can be a complex process. Work with trusted MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u3067 \u30b3\u30e9\u30d6\u30c4\u30ea\u30fc<\/a> \u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u4f5c\u6210\u3084MDR\u3078\u306e\u9069\u5408\u6027\u306e\u78ba\u8a8d\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u3061\u3089\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002\u00a0<\/em><\/span><\/p>\n

2020\u5e745\u670813\u65e5\u66f4\u65b0\u3002EU\u306eMDR\u306f\u3001COVID-19\u306e\u5f71\u97ff\u30672021\u5e745\u670826\u65e5\u306b\u5ef6\u671f\u3055\u308c\u307e\u3057\u305f\u3002\u00a0<\/strong><\/p><\/blockquote>\n

\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u306e\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08EU MDR\uff09\u306f\u3001\u73fe\u884c\u306e\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08MDD\uff09\u306b\u4ee3\u308f\u308b\u65b0\u3057\u3044\u898f\u5247\u30fb\u898f\u5236\u3067\u3059\u3002EU\u5e02\u5834\u306b\u6a5f\u5668\u3092\u6295\u5165\u3057\u3088\u3046\u3068\u3059\u308b\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001MDR\u3092\u9075\u5b88\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002MDR\u306f\u3001\u4ee5\u4e0b\u306e\u65e5\u306b\u767a\u52b9\u3057\u307e\u3059\u3002 2021\u5e745\u670826\u65e5<\/strong>.\u88fd\u54c1\u3092EU MDR\u306b\u5bfe\u5fdc\u3055\u305b\u308b\u306b\u306f\u3001\u8907\u96d1\u306a\u6280\u8853\u6587\u66f8\u3092\u4f5c\u6210\u3057\u305f\u308a\u3001\u88fd\u54c1\u306e\u518d\u8a8d\u8a3c\u3092\u53d7\u3051\u305f\u308a\u3068\u3001\u8907\u96d1\u306a\u30d7\u30ed\u30bb\u30b9\u304c\u5fc5\u8981\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n

\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u81ea\u793e\u306e\u88fd\u54c1\u304cMDD\/MDR\u306e\u8981\u6c42\u4e8b\u9805\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u300cCE\u30de\u30fc\u30af\u300d\u3092\u53d6\u5f97\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002CE\u30de\u30fc\u30af\u306f\u3001EU\u57df\u5185\u3067\u533b\u7642\u6a5f\u5668\u3092\u8ca9\u58f2\u3059\u308b\u4e8b\u696d\u8005\u304c\u6cd5\u7684\u306b\u53d6\u5f97\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002CE\u30de\u30fc\u30af\u3092\u7533\u8acb\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u7279\u5b9a\u306e\u88fd\u54c1\u306e\u9069\u5408\u6027\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u653f\u5e9c\u304b\u3089\u6307\u5b9a\u3055\u308c\u305f\u4e00\u9023\u306e\u898f\u5236\u6a5f\u95a2\u3067\u3042\u308b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306b\u7533\u8acb\u66f8\u3092\u63d0\u51fa\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n

CE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u307e\u305a\u81ea\u793e\u88fd\u54c1\u306b\u3069\u306eMDR\u898f\u5247\u304c\u9069\u7528\u3055\u308c\u308b\u304b\u3092\u5224\u65ad\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6b21\u306b\u3001\u88fd\u54c1\u306e\u8a55\u4fa1\u3092\u5fb9\u5e95\u7684\u306b\u884c\u3044\u3001\u5404\u6307\u4ee4\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3001\u898f\u5236\u57fa\u6e96\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u6307\u4ee4\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u78ba\u8a8d\u3067\u304d\u305f\u3089\u3001\u88fd\u54c1\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u6280\u8853\u6587\u66f8\u3092\u300c\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u300d\u306b\u307e\u3068\u3081\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u53d6\u6271\u8aac\u660e\u66f8\u3001\u54c1\u8cea\u7ba1\u7406\u624b\u9806\u66f8\u3001\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09\u306a\u3069\u3068\u3068\u3082\u306b\u3001\u88fd\u54c1\u3092\u5305\u62ec\u7684\u306b\u628a\u63e1\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n

CER\u30ec\u30d3\u30e5\u30fc\u306f\u3001MDR\u8981\u4ef6\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u5fc5\u8981\u306a\u6700\u3082\u91cd\u8981\u306a\u6587\u66f8\u306e\u4e00\u3064\u3067\u3059\u3002CER\u306b\u306f\u3001\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3057\u3066\u5b9a\u671f\u7684\u306b\u884c\u308f\u308c\u308b\u3001\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a55\u4fa1\u306e\u7d50\u8ad6\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002CER\u306b\u306f\u3001\u65e2\u5b58\u306e\u6587\u732e\u3084\u81e8\u5e8a\u8a66\u9a13\u304b\u3089\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3057\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u8a3c\u62e0\u3092\u793a\u3059\u3053\u3068\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u30d1\u30fc\u30c8\u30ca\u30fc\u4f01\u696d\u3068\u306e\u9023\u643a \u30a8\u30ad\u30b9\u30d1\u30fc\u30c8CER\u30e9\u30a4\u30bf\u30fc<\/a> \u306f\u3001\u6642\u9593\u3068\u52b4\u529b\u3092\u7bc0\u7d04\u3057\u3001\u3088\u308a\u65e9\u304f\u627f\u8a8d\u3055\u308c\u308b\u53ef\u80fd\u6027\u3092\u9ad8\u3081\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u00a0<\/span><\/p>\n

\u7de0\u3081\u5207\u308a\u304c\u9593\u8fd1\u306b\u8feb\u3063\u3066\u3044\u308b\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001MDR\u3078\u306e\u6e96\u62e0\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306b\u3069\u306e\u3088\u3046\u306b\u884c\u52d5\u3059\u3079\u304d\u304b\u306b\u3064\u3044\u3066\u306f\u3001\u307e\u3060\u6df7\u4e71\u3057\u3066\u304a\u308a\u3001\u660e\u78ba\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u3053\u3067\u306f\u3001EU MDR\u306e\u57fa\u672c\u3092\u7406\u89e3\u3057\u3001\u6b21\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u8a08\u753b\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3001\u4fe1\u983c\u3067\u304d\u308b8\u3064\u306e\u30ea\u30bd\u30fc\u30b9\u3092\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002\u00a0<\/span><\/p>\n

    \n
  1. \u6b27\u5dde\u59d4\u54e1\u4f1a\u306b\u3088\u308b\u65b0\u898f\u5236\u306e\u30ac\u30a4\u30c9\u3067\u3059\u3002 <\/span>
    \n<\/span>    https:\/\/ec.europa.eu\/growth\/sectors\/medical-devices\/new-regulations_en<\/span><\/a><\/li>\n
  2. EU\u306b\u3088\u308bCE\u30de\u30fc\u30ad\u30f3\u30b0\u306e\u624b\u5f15\u304d <\/span>
    \n<\/span>    https:\/\/europa.eu\/youreurope\/business\/product-requirements\/labels-markings\/ce-marking\/index_en.htm<\/span><\/a><\/li>\n
  3. MHRA\u304c\u4f5c\u6210\u3057\u305fMDR\u3068IVDR\u306e\u5165\u9580\u30ac\u30a4\u30c9\u00a0 <\/span>
    \n<\/span>    https:\/\/www.gov.uk\/guidance\/medical-devices-eu-regulations-for-mdr-and-ivdr<\/a><\/li>\n
  4. MDR\u3067\u4f55\u304c\u5909\u308f\u3063\u305f\u306e\u304b\u3001\u3069\u306e\u3088\u3046\u306b\u6e96\u5099\u3059\u308c\u3070\u3088\u3044\u306e\u304b\u3092\u307e\u3068\u3081\u305fBSI\u306e\u30db\u30ef\u30a4\u30c8\u30da\u30fc\u30d1\u30fc\u3092\u8aad\u3080\u3002 <\/span>
    \n<\/span>    https:\/\/www.bsigroup.com\/en-GB\/medical-devices\/resources\/whitepapers\/downloads\/<\/span><\/a><\/li>\n
  5. \u533b\u7642\u6a5f\u5668\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u57fa\u3065\u304f\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3 <\/span>
    \n<\/span>    https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/medical-devices<\/span><\/a><\/li>\n
  6. Greenlight Guru\u306e\u30af\u30a4\u30c3\u30af\u30ac\u30a4\u30c9\u3002\"MDR\u306b\u95a2\u3059\u308b7\u3064\u306e\u8cea\u554f\u306b\u56de\u7b54\" <\/span>
    \n<\/b>    https:\/\/www.greenlight.guru\/blog\/7-questions-about-european-mdr-answered<\/span><\/a><\/li>\n
  7. \u30af\u30ea\u30b9\u30c1\u30e3\u30f3\u30fb\u30b8\u30e7\u30ca\u30fc\u6559\u6388\u306b\u3088\u308b\u3001MDR\u306b\u5c0e\u5165\u3055\u308c\u305f5\u3064\u306e\u4e3b\u306a\u5909\u66f4\u70b9\u306e\u8aac\u660e\u30d3\u30c7\u30aa<\/span>
    \n<\/span>    https:\/\/www.youtube.com\/watch?v=RN9-IqZAqyM<\/span><\/a><\/li>\n
  8. \u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08MDD\uff09\u304b\u3089\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08MDR\uff09\u3078\u306e\u79fb\u884c\u306b\u3064\u3044\u3066\u3002\u7121\u6599\u30a6\u30a7\u30d3\u30ca\u30fc <\/span>
    \n<\/span>    https:\/\/www.youtube.com\/watch?v=KD2PKDYGzOY<\/span><\/a><\/li>\n<\/ol>\n

    \u4e16\u754c\u4e2d\u306e\u4e2d\u5c0f\u898f\u6a21\u306e\u533b\u7642\u6a5f\u5668\u4e8b\u696d\u8005\u306f\u3001\u6700\u3082\u6642\u9593\u306e\u304b\u304b\u308b\u6280\u8853\u6587\u66f8\u3092\u6700\u65b0\u306e\u72b6\u614b\u306b\u3059\u308b\u305f\u3081\u306b\u52aa\u529b\u3057\u3066\u3044\u307e\u3059\u3002\u77ed\u671f\u9593\u3067\u3001\u3057\u304b\u3082\u9ad8\u5ea6\u306a\u5c02\u9580\u77e5\u8b58\u3092\u5fc5\u8981\u3068\u3059\u308b\u4f5c\u696d\u3067\u3042\u308b\u3053\u3068\u304b\u3089\u3001\u591a\u304f\u306e\u4f01\u696d\u304c\u8981\u6c42\u4e8b\u9805\u3092\u6e80\u305f\u3059\u3053\u3068\u306b\u82e6\u52b4\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u4f01\u696d\u306e\u591a\u304f\u306f\u3001\u7533\u8acb\u66f8\u304c\u5374\u4e0b\u3055\u308c\u305f\u308a\u3001\u624b\u76f4\u3057\u3092\u6c42\u3081\u3089\u308c\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u7d76\u5bfe\u306b\u8a31\u3055\u308c\u307e\u305b\u3093\u3002 \u3092\u63a1\u7528\u3059\u308b \u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a> \u307e\u305f\u306fA \u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u4f5c\u6210<\/a> \u306f\u3001\u4f01\u696d\u304cEU MDR\u306b\u6e96\u62e0\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u3082\u306e\u3092\u7c21\u5358\u306b\u307e\u3068\u3081\u3001\u8feb\u308a\u6765\u308b\u671f\u9650\u5185\u306b\u88fd\u54c1\u306e\u8a8d\u8a3c\u3092\u5f97\u308b\u305f\u3081\u306e\u6642\u9593\u3092\u77ed\u7e2e\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n

     <\/p>\n

    \u95a2\u9023\u3059\u308b\u5c02\u9580\u5bb6<\/p>\n

    \u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>\u00a0|\u00a0\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a>\u00a0|\u00a0\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\u30e9\u30a4\u30bf\u30fc<\/a>\u00a0|\u00a0EU MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>\u00a0|\u00a0FDA\u63d0\u51fa\u66f8\u985e<\/a>\u00a0|\u00a0\u6587\u732e\u691c\u7d22\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a>\u00a0|\u00a0\u898f\u5236\u9075\u5b88\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a>\u00a0|\u00a0\u30af\u30ea\u30cb\u30ab\u30eb\u30fb\u30c8\u30e9\u30a4\u30a2\u30eb\u30fb\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a>\u00a0|\u00a0\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30e9\u30a4\u30bf\u30fc<\/a>\u00a0|\u00a0PMS\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c4<\/a>\u00a0|\u00a0PMCF\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c4<\/a>\u00a0|\u00a0\u751f\u7269\u7d71\u8a08\u5b66\u306e\u5c02\u9580\u5bb6<\/a>\u00a0|\u00a0\u88fd\u54c1\u958b\u767a\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u00a0<\/a><\/strong><\/p>\n

    \u00a0<\/span><\/p>","protected":false},"excerpt":{"rendered":"

    Preparing your medical device for EU MDR can be a complex process. Work with trusted MDR consultants on Kolabtree to get help with writing a clinical evaluation report and make sure your device is MDR-compliant.\u00a0 Update 13 May 2020: The EU MDR Is now postponed to 26 May 2021 in light of COVID-19.\u00a0 The European Union’s Medical Device Regulations (EU MDR) is a new set of rules and regulations that will replace the current Medical Device Directive (MDD). Every medical device company that wants to place a device in the EU market has to comply with the MDR, which will come into effect on 26 May 2021. Getting your product<\/p>\n

    \u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":6089,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[317,443,540,433],"tags":[],"acf":[],"yoast_head":"\nPrepare your medical device for EU MDR: 8 trusted resources<\/title>\n<meta name=\"description\" content=\"8 trusted resources and guides to help you prepare your medical device for EU MDR, which will come into effect on 26 May 2020.\" \/>\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\/prepare-your-medical-device-for-eu-mdr-8-trusted-resources\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Prepare your medical device for EU MDR: 8 trusted resources\" \/>\n<meta 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