MDR\u8ba4\u8bc1\u6d41\u7a0b\u662f\u533b\u7597\u5668\u68b0\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u6b65\u9aa4\uff0c\u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u7406\u89e3\u5e76\u9075\u5faa\u8fd9\u4e00\u6d41\u7a0b\u81f3\u5173\u91cd\u8981\u3002<\/p>\n<\/p>\n
\u4e00\u3001MDR\u8ba4\u8bc1\u6d41\u7a0b\u6982\u8ff0<\/strong><\/p>\n MDR\u8ba4\u8bc1\u6d41\u7a0b\u6307\u7684\u662f\u6839\u636e\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08EU\uff092017\/745\u8fdb\u884c\u7684\u7b26\u5408\u6027\u8bc4\u4f30\u7a0b\u5e8f\uff0c\u8be5\u6cd5\u89c4\u4e8e2017\u5e74\u53d1\u5e03\uff0c\u5e76\u4e8e2021\u5e745\u6708\u6b63\u5f0f\u5b9e\u65bd\uff0c\u53d6\u4ee3\u4e86\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\u3002<\/p>\n<\/p>\n \u4e8c\u3001MDR\u8ba4\u8bc1\u6d41\u7a0b\u7684\u4e3b\u8981\u9636\u6bb5<\/strong><\/p>\n MDR\u8ba4\u8bc1\u6d41\u7a0b\u901a\u5e38\u5305\u62ec\u51e0\u4e2a\u6838\u5fc3\u9636\u6bb5\uff1a\u51c6\u5907\u9636\u6bb5\u3001\u6280\u672f\u6587\u4ef6\u7f16\u8bd1\u3001\u7b26\u5408\u6027\u8bc4\u4f30\u3001\u516c\u544a\u673a\u6784\u5ba1\u6838\u3001CE\u6807\u5fd7\u9881\u53d1\u53ca\u6ce8\u518c\u540e\u76d1\u7763\u3002<\/p>\n<\/p>\n 2.1 \u51c6\u5907\u9636\u6bb5\uff1a\u786e\u5b9a\u5668\u68b0\u5206\u7c7b\u548c\u9002\u7528\u8981\u6c42<\/strong><\/p>\n \u5728MDR\u8ba4\u8bc1\u6d41\u7a0b\u7684\u521d\u59cb\u9636\u6bb5\uff0c\u5236\u9020\u5546\u5fc5\u987b\u9996\u5148\u6839\u636e\u9644\u5f55VIII\u7684\u89c4\u5219\u786e\u5b9a\u5176\u533b\u7597\u5668\u68b0\u7684\u98ce\u9669\u5206\u7c7b\uff0c\u4f8b\u5982I\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u6216III\u7c7b\uff0c\u8fd9\u76f4\u63a5\u5f71\u54cd\u540e\u7eed\u7684\u7b26\u5408\u6027\u8bc4\u4f30\u8def\u5f84\u3002<\/p>\n<\/p>\n 2.2 \u6280\u672f\u6587\u4ef6\u7f16\u8bd1\uff1a\u6784\u5efa\u5b8c\u6574\u6587\u6863\u4f53\u7cfb<\/strong><\/p>\n \u6280\u672f\u6587\u4ef6\u662fMDR\u8ba4\u8bc1\u6d41\u7a0b\u7684\u6838\u5fc3\u7ec4\u6210\u90e8\u5206\uff0c\u5fc5\u987b\u5305\u62ec\u5668\u68b0\u63cf\u8ff0\u3001\u6027\u80fd\u6570\u636e\u3001\u5b89\u5168\u4e0e\u4e34\u5e8a\u8bc1\u636e\u3001\u6807\u7b7e\u548c\u4f7f\u7528\u8bf4\u660e\u7b49\uff0c\u4ee5\u786e\u4fdd\u7b26\u5408\u9644\u5f55II\u548cIII\u7684\u8981\u6c42\u3002<\/p>\n<\/p>\n 2.3 \u7b26\u5408\u6027\u8bc4\u4f30\uff1a\u9009\u62e9\u516c\u544a\u673a\u6784\u5e76\u63d0\u4ea4\u7533\u8bf7<\/strong><\/p>\n \u6839\u636e\u5668\u68b0\u5206\u7c7b\uff0c\u5236\u9020\u5546\u9700\u9009\u62e9\u6b27\u76df\u8ba4\u53ef\u7684\u516c\u544a\u673a\u6784\u8fdb\u884c\u7b26\u5408\u6027\u8bc4\u4f30\uff0c\u8fd9\u53ef\u80fd\u6d89\u53ca\u6587\u4ef6\u5ba1\u6838\u3001\u73b0\u573a\u5ba1\u6838\u6216\u4e34\u5e8a\u8bc4\u4f30\u5ba1\u67e5\uff0c\u4ee5\u9a8c\u8bc1\u7b26\u5408MDR\u6761\u6b3e\u3002<\/p>\n<\/p>\n 2.4 \u516c\u544a\u673a\u6784\u5ba1\u6838\uff1a\u8fdb\u884c\u8be6\u7ec6\u8bc4\u4f30<\/strong><\/p>\n \u516c\u544a\u673a\u6784\u5728MDR\u8ba4\u8bc1\u6d41\u7a0b\u4e2d\u6267\u884c\u6df1\u5165\u5ba1\u6838\uff0c\u5305\u62ec\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\u5ba1\u6838\uff08\u5982ISO 13485\uff09\u3001\u6280\u672f\u6587\u4ef6\u8bc4\u5ba1\u4ee5\u53ca\u53ef\u80fd\u7684\u4ea7\u54c1\u62bd\u6837\u6d4b\u8bd5\uff0c\u4ee5\u786e\u4fdd\u6301\u7eed\u5408\u89c4\u3002<\/p>\n<\/p>\n 2.5 CE\u6807\u5fd7\u9881\u53d1\u548c\u6b27\u76df\u6ce8\u518c\uff1a\u5b8c\u6210\u5e02\u573a\u51c6\u5165<\/strong><\/p>\n \u901a\u8fc7\u5ba1\u6838\u540e\uff0c\u5236\u9020\u5546\u83b7\u5f97CE\u8bc1\u4e66\uff0c\u5e76\u5fc5\u987b\u5728EUDAMED\u6570\u636e\u5e93\u4e2d\u8fdb\u884c\u4ea7\u54c1\u6ce8\u518c\uff0c\u8fd9\u662fMDR\u8ba4\u8bc1\u6d41\u7a0b\u7684\u6700\u540e\u6b65\u9aa4\uff0c\u5141\u8bb8\u5668\u68b0\u5728\u6b27\u76df\u5e02\u573a\u6d41\u901a\u3002<\/p>\n<\/p>\n 2.6 \u6ce8\u518c\u540e\u76d1\u7763\uff1a\u7ef4\u6301\u5408\u89c4\u6027<\/strong><\/p>\n MDR\u8ba4\u8bc1\u6d41\u7a0b\u4e0d\u4ec5\u9650\u4e8e\u521d\u59cb\u8ba4\u8bc1\uff0c\u8fd8\u5305\u62ec\u6ce8\u518c\u540e\u6d3b\u52a8\uff0c\u5982\u5b9a\u671f\u5b89\u5168\u66f4\u65b0\u62a5\u544a\uff08PSUR\uff09\u3001\u4e8b\u4ef6\u76d1\u63a7\u548c vigilance \u62a5\u544a\uff0c\u4ee5\u786e\u4fdd\u957f\u671f\u5408\u89c4\u3002<\/p>\n<\/p>\n \u4e09\u3001MDR\u8ba4\u8bc1\u6d41\u7a0b\u7684\u6311\u6218\u548c\u6700\u4f73\u5b9e\u8df5<\/strong><\/p>\n MDR\u8ba4\u8bc1\u6d41\u7a0b\u53ef\u80fd\u9762\u4e34\u6311\u6218\uff0c\u5982\u66f4\u4e25\u683c\u7684\u4e34\u5e8a\u8bc1\u636e\u8981\u6c42\u3001\u66f4\u957f\u7684\u5ba1\u6838\u65f6\u95f4\u4ee5\u53ca\u66f4\u9ad8\u7684\u6210\u672c\uff0c\u56e0\u6b64\u5236\u9020\u5546\u5e94\u5c3d\u65e9\u89c4\u5212\u3001\u5bfb\u6c42\u4e13\u4e1a\u54a8\u8be2\u5e76\u91c7\u7528\u98ce\u9669\u7ba1\u7406\u65b9\u6cd5\u3002<\/p>\n<\/p>\n \u56db\u3001\u7ed3\u8bba<\/strong><\/p>\n \u603b\u4e4b\uff0cMDR\u8ba4\u8bc1\u6d41\u7a0b\u662f\u4e00\u4e2a\u7efc\u5408\u6027\u7684\u7cfb\u7edf\uff0c\u8981\u6c42\u5236\u9020\u5546\u4ece\u8bbe\u8ba1\u5230\u4e0a\u5e02\u540e\u5168\u7a0b\u4fdd\u6301\u5408\u89c4\uff0c\u901a\u8fc7\u7406\u89e3\u5e76\u6709\u6548\u6267\u884c\u8fd9\u4e9b\u6b65\u9aa4\uff0c\u4f01\u4e1a\u53ef\u4ee5\u6210\u529f\u8fdb\u5165\u5e76\u7ef4\u6301\u5728\u6b27\u6d32\u5e02\u573a\u7684\u4f4d\u7f6e\u3002<\/p>\n \u514d\u8d23\u58f0\u660e\uff1a\u4ec5\u4f9b\u53c2\u8003\uff0c\u672c\u6587\u4f5c\u8005\u53ca\u53d1\u5e03\u5e73\u53f0\u4e0d\u627f\u62c5\u56e0\u53c2\u8003\u672c\u6587\u5185\u5bb9\u800c\u4ea7\u751f\u7684\u4efb\u4f55\u8d23\u4efb\u3002<\/p>\n","protected":false},"excerpt":{"rendered":" MDR\u8ba4\u8bc1\u6d41\u7a0b\u662f\u533b\u7597\u5668\u68b0\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u6b65\u9aa4\uff0c\u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u7406\u89e3\u5e76\u9075\u5faa\u8fd9\u4e00\u6d41\u7a0b\u81f3\u5173\u91cd\u8981\u3002 \u4e00\u3001MDR\u8ba4\u8bc1\u6d41 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[273],"class_list":["post-3948","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-mdr"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/3948","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3948"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/3948\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3948"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3948"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3948"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}