CE MDR\u4f5c\u4e3a\u6b27\u76df\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u7684\u91cd\u8981\u6cd5\u89c4\uff0c\u81ea2021\u5e745\u6708\u6b63\u5f0f\u5b9e\u65bd\u4ee5\u6765\uff0c\u5df2\u6210\u4e3a\u5168\u7403\u533b\u7597\u5668\u68b0\u884c\u4e1a\u5173\u6ce8\u7684\u7126\u70b9\u3002<\/p>\n<\/p>\n
\u8fd9\u4e00\u6cd5\u89c4\u7684\u5168\u79f0\u4e3a\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Regulation\uff09\uff0c\u5176\u53d6\u4ee3\u4e86\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\uff0c\u5bf9\u533b\u7597\u5668\u68b0\u7684\u51c6\u5165\u8981\u6c42\u3001\u4e34\u5e8a\u8bc4\u4f30\u3001\u4e0a\u5e02\u540e\u76d1\u7ba1\u7b49\u73af\u8282\u8fdb\u884c\u4e86\u5168\u9762\u5347\u7ea7\u3002<\/p>\n<\/p>\n
CE MDR\u7684\u6838\u5fc3\u53d8\u5316\u4e0e\u5f71\u54cd<\/strong><\/p>\n CE MDR\u76f8\u8f83\u4e8e\u4e4b\u524d\u7684MDD\u6307\u4ee4\uff0c\u5728\u591a\u4e2a\u65b9\u9762\u63d0\u51fa\u4e86\u66f4\u4e3a\u4e25\u683c\u7684\u8981\u6c42\u3002<\/p>\n<\/p>\n \u9996\u5148\uff0c\u5728\u4e34\u5e8a\u8bc4\u4ef7\u65b9\u9762\uff0c\u65b0\u89c4\u8981\u6c42\u5236\u9020\u5546\u63d0\u4f9b\u66f4\u5145\u5206\u3001\u66f4\u79d1\u5b66\u7684\u4e34\u5e8a\u8bc1\u636e\uff0c\u4ee5\u8bc1\u660e\u533b\u7597\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/p>\n<\/p>\n \u5bf9\u4e8e\u9ad8\u98ce\u9669\u7c7b\u522b\u7684\u5668\u68b0\uff0c\u751a\u81f3\u9700\u8981\u63a5\u53d7\u6b27\u76df\u4e13\u5bb6\u5c0f\u7ec4\u7684\u989d\u5916\u5ba1\u67e5\u3002<\/p>\n<\/p>\n \u5176\u6b21\uff0cCE MDR\u6781\u5927\u5730\u52a0\u5f3a\u4e86\u5bf9\u533b\u7597\u5668\u68b0\u4e0a\u5e02\u540e\u7684\u76d1\u7ba1\u529b\u5ea6\uff0c\u8981\u6c42\u5efa\u7acb\u66f4\u5b8c\u5584\u7684\u8ffd\u6eaf\u7cfb\u7edf\uff08UDI\u7cfb\u7edf\uff09\u548c\u66f4\u4e25\u683c\u7684\u8b66\u6212\u62a5\u544a\u5236\u5ea6\u3002<\/p>\n<\/p>\n \u6b64\u5916\uff0c\u65b0\u89c4\u5bf9\u201c\u533b\u7597\u5668\u68b0\u201d\u7684\u5b9a\u4e49\u8fdb\u884c\u4e86\u6269\u5c55\uff0c\u6db5\u76d6\u4e86\u4e00\u4e9b\u6b64\u524d\u672a\u88ab\u660e\u786e\u5f52\u7c7b\u7684\u4ea7\u54c1\uff0c\u5982\u67d0\u4e9b\u6ca1\u6709\u533b\u7597\u76ee\u7684\u4f46\u5177\u6709\u7c7b\u4f3c\u529f\u80fd\u7684\u5668\u68b0\uff08\u5982\u7f8e\u77b3\u3001\u51cf\u80a5\u62bd\u8102\u8bbe\u5907\u7b49\uff09\u3002<\/p>\n<\/p>\n \u4f01\u4e1a\u5982\u4f55\u5e94\u5bf9CE MDR\u7684\u5408\u89c4\u6311\u6218<\/strong><\/p>\n \u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u800c\u8a00\uff0c\u987a\u5229\u901a\u8fc7CE MDR\u8ba4\u8bc1\u662f\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u7684\u5fc5\u7ecf\u4e4b\u8def\uff0c\u4f46\u8fd9\u65e0\u7591\u662f\u4e00\u9879\u590d\u6742\u4e14\u8017\u65f6\u7684\u7cfb\u7edf\u5de5\u7a0b\u3002<\/p>\n<\/p>\n \u4f01\u4e1a\u9996\u5148\u9700\u8981\u5168\u9762\u7406\u89e3\u65b0\u89c4\u7684\u5177\u4f53\u6761\u6b3e\uff0c\u5e76\u5bf9\u81ea\u8eab\u4ea7\u54c1\u8fdb\u884c\u91cd\u65b0\u5206\u7c7b\u548c\u5dee\u8ddd\u5206\u6790\u3002<\/p>\n<\/p>\n \u7d27\u63a5\u7740\uff0c\u66f4\u65b0\u6280\u672f\u6587\u4ef6\u3001\u8fdb\u884c\u7b26\u5408\u6027\u8bc4\u4f30\u3001\u51c6\u5907\u66f4\u8be6\u5c3d\u7684\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u662f\u5176\u4e2d\u7684\u5173\u952e\u6b65\u9aa4\u3002<\/p>\n<\/p>\n \u9009\u62e9\u4e00\u5bb6\u7ecf\u9a8c\u4e30\u5bcc\u7684\u516c\u544a\u673a\u6784\uff08Notified Body\uff09\u8fdb\u884c\u5408\u4f5c\u4e5f\u81f3\u5173\u91cd\u8981\uff0c\u56e0\u4e3a\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u8d44\u6e90\u76ee\u524d\u4f9d\u7136\u7d27\u5f20\uff0c\u63d0\u524d\u89c4\u5212\u8ba4\u8bc1\u65f6\u95f4\u7ebf\u662f\u6210\u529f\u7684\u5173\u952e\u3002<\/p>\n<\/p>\n CE MDR\u5bf9\u5168\u7403\u533b\u7597\u5668\u68b0\u5e02\u573a\u7684\u6df1\u8fdc\u610f\u4e49<\/strong><\/p>\n CE MDR\u7684\u5b9e\u65bd\u4e0d\u4ec5\u91cd\u5851\u4e86\u6b27\u76df\u5e02\u573a\u7684\u6e38\u620f\u89c4\u5219\uff0c\u5176\u5f71\u54cd\u529b\u4e5f\u8f90\u5c04\u81f3\u5168\u7403\u3002<\/p>\n<\/p>\n \u8bb8\u591a\u5176\u4ed6\u56fd\u5bb6\u548c\u5730\u533a\u5728\u5236\u5b9a\u6216\u66f4\u65b0\u81ea\u8eab\u7684\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u65f6\uff0c\u90fd\u53c2\u8003\u548c\u501f\u9274\u4e86CE MDR\u7684\u4e25\u683c\u6846\u67b6\u548c\u5148\u8fdb\u7406\u5ff5\u3002<\/p>\n<\/p>\n \u8fd9\u610f\u5473\u7740\uff0c\u6ee1\u8db3CE MDR\u7684\u8981\u6c42\uff0c\u5728\u67d0\u79cd\u7a0b\u5ea6\u4e0a\u4e3a\u5236\u9020\u5546\u6ee1\u8db3\u5176\u4ed6\u56fd\u9645\u5e02\u573a\u7684\u8981\u6c42\u5960\u5b9a\u4e86\u826f\u597d\u7684\u57fa\u7840\u3002<\/p>\n<\/p>\n \u4ece\u957f\u8fdc\u6765\u770b\uff0cCE MDR\u901a\u8fc7\u63d0\u5347\u533b\u7597\u5668\u68b0\u7684\u6574\u4f53\u5b89\u5168\u6807\u51c6\u548c\u900f\u660e\u5ea6\uff0c\u6700\u7ec8\u5c06\u60e0\u53ca\u5168\u7403\u7684\u60a3\u8005\u548c\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u8005\u3002<\/p>\n<\/p>\n \u7ed3\u8bba\uff1a\u62e5\u62b1\u53d8\u5316\uff0c\u805a\u7126\u5408\u89c4\u4e0e\u521b\u65b0<\/strong><\/p>\n \u603b\u800c\u8a00\u4e4b\uff0cCE MDR\u4ee3\u8868\u4e86\u5168\u7403\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u7684\u672a\u6765\u65b9\u5411\uff0c\u5176\u4ee5\u98ce\u9669\u4e3a\u57fa\u7840\u3001\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\u7684\u7406\u5ff5\u6b63\u5728\u6210\u4e3a\u884c\u4e1a\u5171\u8bc6\u3002<\/p>\n<\/p>\n \u867d\u7136\u5408\u89c4\u4e4b\u8def\u5145\u6ee1\u6311\u6218\uff0c\u4f46\u5b83\u4e5f\u63a8\u52a8\u7740\u4f01\u4e1a\u8fdb\u884c\u6280\u672f\u521b\u65b0\u548c\u8d28\u91cf\u4f53\u7cfb\u5347\u7ea7\uff0c\u6700\u7ec8\u4fc3\u8fdb\u884c\u4e1a\u7684\u5065\u5eb7\u4e0e\u53ef\u6301\u7eed\u53d1\u5c55\u3002<\/p>\n<\/p>\n \u5bf9\u4e8e\u6240\u6709\u76f8\u5173\u4f01\u4e1a\u6765\u8bf4\uff0c\u79ef\u6781\u5e94\u5bf9\u3001\u4e3b\u52a8\u9002\u5e94CE MDR\u7684\u8981\u6c42\uff0c\u5df2\u4e0d\u518d\u662f\u9009\u62e9\u9898\uff0c\u800c\u662f\u751f\u5b58\u4e0e\u53d1\u5c55\u7684\u5fc5\u7b54\u9898\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\u4f5c\u4e3a\u6b27\u76df\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u7684\u91cd\u8981\u6cd5\u89c4\uff0c\u81ea2021\u5e745\u6708\u6b63\u5f0f\u5b9e\u65bd\u4ee5\u6765\uff0c\u5df2\u6210\u4e3a\u5168\u7403\u533b\u7597\u5668\u68b0\u884c\u4e1a\u5173\u6ce8\u7684\u7126\u70b9\u3002 […]<\/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":[240],"class_list":["post-3914","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\/3914","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=3914"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/3914\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3914"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3914"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3914"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}