CE MDR\u8bc1\u4e66\u662f\u533b\u7597\u5668\u68b0\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u51c6\u5165\u51ed\u8bc1\uff0c\u5b83\u4ee3\u8868\u4ea7\u54c1\u7b26\u5408\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Regulation, MDR\uff09\u7684\u4e25\u683c\u8981\u6c42\u3002<\/p>\n<\/p>\n
\u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u800c\u8a00\uff0c\u83b7\u53d6CE MDR\u8bc1\u4e66\u4e0d\u4ec5\u662f\u6cd5\u5f8b\u4e49\u52a1\uff0c\u66f4\u662f\u8bc1\u660e\u4ea7\u54c1\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u548c\u8d28\u91cf\u53ef\u9760\u6027\u7684\u91cd\u8981\u6807\u5fd7\u3002<\/p>\n<\/p>\n
\u4e00\u3001\u4ec0\u4e48\u662fCE MDR\u8bc1\u4e66\uff1f<\/strong><\/p>\n CE MDR\u8bc1\u4e66\u662f\u6307\u6839\u636e\u6b27\u76df2017\/745\u53f7\u6cd5\u89c4\uff0c\u5373\u300a\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u300b\uff08MDR\uff09\uff0c\u7531\u516c\u544a\u673a\u6784\uff08Notified Body\uff09\u9881\u53d1\u7ed9\u5236\u9020\u5546\u7684\u7b26\u5408\u6027\u8bc1\u660e\u6587\u4ef6\u3002<\/p>\n<\/p>\n \u8be5\u8bc1\u4e66\u786e\u8ba4\u533b\u7597\u5668\u68b0\u7b26\u5408MDR\u9644\u5f55\u4e2d\u89c4\u5b9a\u7684\u901a\u7528\u5b89\u5168\u4e0e\u6027\u80fd\u8981\u6c42\uff0c\u5e76\u5141\u8bb8\u5236\u9020\u5546\u5728\u4ea7\u54c1\u4e0a\u52a0\u8d34CE\u6807\u5fd7\uff0c\u4ece\u800c\u5728\u6b27\u76df\u5e02\u573a\u53ca\u6b27\u6d32\u7ecf\u6d4e\u533a\uff08EEA\uff09\u5185\u81ea\u7531\u6d41\u901a\u3002<\/p>\n<\/p>\n \u4e8c\u3001MDR\u6cd5\u89c4\u7684\u6838\u5fc3\u53d8\u5316\u4e0e\u5f71\u54cd<\/strong><\/p>\n MDR\u6cd5\u89c4\u4e8e2017\u5e74\u53d1\u5e03\uff0c\u5e76\u4e8e2021\u5e745\u670826\u65e5\u6b63\u5f0f\u53d6\u4ee3\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\uff0c\u5176\u76d1\u7ba1\u8303\u56f4\u66f4\u5e7f\u3001\u8981\u6c42\u66f4\u4e3a\u4e25\u683c\u3002<\/p>\n<\/p>\n \u65b0\u6cd5\u89c4\u663e\u8457\u52a0\u5f3a\u4e86\u5bf9\u4e34\u5e8a\u8bc1\u636e\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u3001\u552f\u4e00\u8bbe\u5907\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf\u4ee5\u53ca\u5236\u9020\u5546\u900f\u660e\u5ea6\u7684\u8981\u6c42\uff0c\u65e8\u5728\u5168\u9762\u63d0\u5347\u60a3\u8005\u5b89\u5168\u548c\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u6c34\u5e73\u3002<\/p>\n<\/p>\n \u4e09\u3001CE MDR\u8ba4\u8bc1\u7684\u7533\u8bf7\u6d41\u7a0b<\/strong><\/p>\n CE MDR\u8ba4\u8bc1\u8fc7\u7a0b\u590d\u6742\u4e14\u8017\u65f6\uff0c\u901a\u5e38\u9700\u8981\u5236\u9020\u5546\u4e0e\u516c\u544a\u673a\u6784\u5bc6\u5207\u5408\u4f5c\u3002<\/p>\n<\/p>\n \u5173\u952e\u6b65\u9aa4\u5305\u62ec\uff1a\u5668\u68b0\u5206\u7c7b\u3001\u9009\u62e9\u516c\u544a\u673a\u6784\u3001\u51c6\u5907\u6280\u672f\u6587\u4ef6\u3001\u8fdb\u884c\u7b26\u5408\u6027\u8bc4\u4f30\u3001\u63a5\u53d7\u516c\u544a\u673a\u6784\u5ba1\u6838\uff08\u53ef\u80fd\u5305\u62ec\u73b0\u573a\u5ba1\u6838\uff09\uff0c\u4ee5\u53ca\u6700\u7ec8\u83b7\u5f97\u8bc1\u4e66\u5e76\u7b7e\u7f72\u7b26\u5408\u6027\u58f0\u660e\u3002<\/p>\n<\/p>\n \u56db\u3001\u6280\u672f\u6587\u4ef6\u4e0e\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a<\/strong><\/p>\n \u6280\u672f\u6587\u4ef6\u662fCE MDR\u8ba4\u8bc1\u7533\u8bf7\u7684\u6838\u5fc3\uff0c\u5fc5\u987b\u5168\u9762\u8be6\u5c3d\u5730\u8bc1\u660e\u5668\u68b0\u7b26\u5408MDR\u8981\u6c42\u3002<\/p>\n<\/p>\n \u5176\u5185\u5bb9\u9700\u6db5\u76d6\u5668\u68b0\u63cf\u8ff0\u4e0e\u89c4\u683c\u3001\u98ce\u9669\u7ba1\u7406\u548c\u9a8c\u8bc1\u62a5\u544a\uff0c\u4ee5\u53ca\u6700\u4e3a\u5173\u952e\u7684\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\uff08CER\uff09\uff0c\u8be5\u62a5\u544a\u9700\u8981\u63d0\u4f9b\u5145\u5206\u7684\u4e34\u5e8a\u8bc1\u636e\u6765\u8bc1\u660e\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\u3002<\/p>\n<\/p>\n \u4e94\u3001\u516c\u544a\u673a\u6784\u7684\u5173\u952e\u89d2\u8272<\/strong><\/p>\n \u516c\u544a\u673a\u6784\u662f\u7531\u6b27\u76df\u6210\u5458\u56fd\u6307\u5b9a\u5e76\u7ecf\u6b27\u76df\u59d4\u5458\u4f1a\u8ba4\u53ef\u7684\u72ec\u7acb\u673a\u6784\uff0c\u8d1f\u8d23\u8bc4\u4f30\u7b2c\u4e09\u7c7b\u548c\u9ad8\u98ce\u9669\u7c7b\u533b\u7597\u5668\u68b0\u662f\u5426\u7b26\u5408MDR\u6cd5\u89c4\u3002<\/p>\n<\/p>\n \u5236\u9020\u5546\u5fc5\u987b\u9009\u62e9\u6709\u8d44\u8d28\u7684\u516c\u544a\u673a\u6784\u8fdb\u884c\u5408\u4f5c\uff0c\u5176\u5ba1\u6838\u7ed3\u679c\u76f4\u63a5\u51b3\u5b9a\u80fd\u5426\u6210\u529f\u83b7\u5f97CE MDR\u8bc1\u4e66\u3002<\/p>\n<\/p>\n \u516d\u3001\u6210\u529f\u83b7\u53d6CE MDR\u8bc1\u4e66\u7684\u7b56\u7565\u5efa\u8bae<\/strong><\/p>\n \u4e3a\u786e\u4fdd\u8ba4\u8bc1\u8fc7\u7a0b\u987a\u5229\uff0c\u5236\u9020\u5546\u5e94\u5c3d\u65e9\u542f\u52a8\u51c6\u5907\u5de5\u4f5c\uff0c\u6df1\u5165\u7406\u89e3MDR\u6cd5\u89c4\u7684\u5177\u4f53\u8981\u6c42\u5e76\u8fdb\u884c\u5168\u9762\u5dee\u8ddd\u5206\u6790\u3002<\/p>\n<\/p>\n \u5efa\u7acb\u5b8c\u5584\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\u3001\u63d0\u524d\u89c4\u5212\u5e76\u6267\u884c\u5fc5\u8981\u7684\u4e34\u5e8a\u7814\u7a76\u3001\u4ee5\u53ca\u9009\u62e9\u7ecf\u9a8c\u4e30\u5bcc\u4e14\u53ef\u9760\u7684\u516c\u544a\u673a\u6784\u5408\u4f5c\u4f19\u4f34\u81f3\u5173\u91cd\u8981\u3002<\/p>\n<\/p>\n \u4e03\u3001\u7ed3\u8bba\uff1aCE MDR\u8bc1\u4e66\u7684\u5e02\u573a\u4ef7\u503c<\/strong><\/p>\n CE MDR\u8bc1\u4e66\u4e0d\u4ec5\u662f\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u6cd5\u5f8b\u901a\u884c\u8bc1\uff0c\u66f4\u662f\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5411\u5168\u7403\u5e02\u573a\u5c55\u793a\u5176\u627f\u8bfa\u4ea7\u54c1\u5b89\u5168\u4e0e\u8d28\u91cf\u7684\u91cd\u8981\u8d44\u4ea7\u3002<\/p>\n<\/p>\n \u968f\u7740\u5168\u7403\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u8d8b\u540c\u5316\uff0c\u7b26\u5408MDR\u6807\u51c6\u4e5f\u4e3a\u4ea7\u54c1\u8fdb\u5165\u5176\u4ed6\u56fd\u9645\u5e02\u573a\u5960\u5b9a\u4e86\u575a\u5b9e\u57fa\u7840\u3002<\/p>\n<\/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":" CE MDR\u8bc1\u4e66\u662f\u533b\u7597\u5668\u68b0\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u51c6\u5165\u51ed\u8bc1\uff0c\u5b83\u4ee3\u8868\u4ea7\u54c1\u7b26\u5408\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Devi […]<\/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":[269],"class_list":["post-3944","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-ce-mdr"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/3944","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=3944"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/3944\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3944"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3944"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3944"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}