MDR\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u662f\u6b27\u76df\u9488\u5bf9\u533b\u7597\u5668\u68b0\u884c\u4e1a\u9881\u5e03\u7684\u65b0\u6cd5\u89c4\uff0c\u5168\u79f0\u4e3a\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Regulation\uff09\uff0c\u5b83\u53d6\u4ee3\u4e86\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\u548c\u4e3b\u52a8\u690d\u5165\u5f0f\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08AIMDD\uff09\uff0c\u65e8\u5728\u52a0\u5f3a\u5bf9\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\uff0c\u786e\u4fdd\u5176\u5b89\u5168\u6027\u3001\u6027\u80fd\u548c\u6709\u6548\u6027\uff0c\u4ece\u800c\u66f4\u597d\u5730\u4fdd\u62a4\u60a3\u8005\u548c\u7528\u6237\u7684\u5065\u5eb7\u3002<\/p>\n<\/p>\n
MDR\u6cd5\u89c4\u7684\u51fa\u53f0\u80cc\u666f\u6e90\u4e8e\u4e00\u7cfb\u5217\u533b\u7597\u5668\u68b0\u5b89\u5168\u4e8b\u4ef6\uff0c\u8fd9\u4e9b\u4e8b\u4ef6\u66b4\u9732\u4e86\u539f\u6709\u76d1\u7ba1\u4f53\u7cfb\u7684\u4e0d\u8db3\uff0c\u6b27\u76df\u56e0\u6b64\u51b3\u5b9a\u63a8\u884c\u66f4\u4e3a\u4e25\u683c\u548c\u900f\u660e\u7684\u6cd5\u89c4\uff0c\u65b0\u6cd5\u89c4\u4e0d\u4ec5\u6269\u5927\u4e86\u533b\u7597\u5668\u68b0\u7684\u5b9a\u4e49\u8303\u56f4\uff0c\u8fd8\u52a0\u5f3a\u4e86\u5bf9\u5176\u6574\u4e2a\u751f\u547d\u5468\u671f\u7684\u76d1\u7ba1\uff0c\u5305\u62ec\u4ece\u8bbe\u8ba1\u3001\u751f\u4ea7\u5230\u4e34\u5e8a\u8bc4\u4f30\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u7b49\u5404\u4e2a\u73af\u8282\u3002<\/p>\n<\/p>\n
MDR\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u7684\u6838\u5fc3\u53d8\u5316<\/strong><\/p>\n MDR\u6cd5\u89c4\u5f15\u5165\u4e86\u591a\u9879\u91cd\u8981\u53d8\u5316\uff0c\u9996\u5148\uff0c\u5b83\u663e\u8457\u52a0\u5f3a\u4e86\u5bf9\u4e34\u5e8a\u8bc1\u636e\u7684\u8981\u6c42\uff0c\u5236\u9020\u5546\u5fc5\u987b\u63d0\u4f9b\u66f4\u5168\u9762\u548c\u6301\u7eed\u7684\u4e34\u5e8a\u6570\u636e\u6765\u8bc1\u660e\u5176\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\uff0c\u6b64\u5916\uff0c\u6cd5\u89c4\u8fd8\u5f3a\u8c03\u4e86\u5bf9\u9ad8\u98ce\u9669\u4ea7\u54c1\u7684\u4e25\u683c\u5ba1\u67e5\uff0c\u4f8b\u5982\u690d\u5165\u5f0f\u548c\u2162\u7c7b\u533b\u7597\u5668\u68b0\uff0c\u9700\u8981\u901a\u8fc7\u4e13\u5bb6\u5c0f\u7ec4\u7684\u53c2\u4e0e\u8fdb\u884c\u8bc4\u4f30\u3002<\/p>\n<\/p>\n \u53e6\u4e00\u4e2a\u5173\u952e\u53d8\u5316\u662f\u6269\u5927\u4e86\u5bf9\u533b\u7597\u5668\u68b0\u7684\u5b9a\u4e49\uff0cMDR\u5c06\u4e00\u4e9b\u6ca1\u6709\u533b\u7597\u76ee\u7684\u4f46\u5177\u6709\u7c7b\u4f3c\u7279\u6027\u7684\u4ea7\u54c1\u4e5f\u7eb3\u5165\u76d1\u7ba1\u8303\u56f4\uff0c\u4f8b\u5982\u7f8e\u5bb9\u690d\u5165\u7269\u548c\u67d0\u4e9b\u8f6f\u4ef6\u5e94\u7528\uff0c\u8fd9\u786e\u4fdd\u4e86\u66f4\u591a\u76f8\u5173\u4ea7\u54c1\u53d7\u5230\u7edf\u4e00\u6807\u51c6\u7684\u7ea6\u675f\uff0c\u4ece\u800c\u63d0\u5347\u6574\u4f53\u5e02\u573a\u5b89\u5168\u6027\u3002<\/p>\n<\/p>\n MDR\u5bf9\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u7684\u5f71\u54cd<\/strong><\/p>\n MDR\u6cd5\u89c4\u7684\u5b9e\u65bd\u5bf9\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5e26\u6765\u4e86\u6df1\u8fdc\u5f71\u54cd\uff0c\u5236\u9020\u5546\u9700\u8981\u6295\u5165\u66f4\u591a\u8d44\u6e90\u8fdb\u884c\u4e34\u5e8a\u8bc4\u4f30\u3001\u6570\u636e\u6536\u96c6\u548c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u66f4\u65b0\uff0c\u4ee5\u7b26\u5408\u65b0\u89c4\u8981\u6c42\uff0c\u8fd9\u53ef\u80fd\u5bfc\u81f4\u4ea7\u54c1\u4e0a\u5e02\u65f6\u95f4\u5ef6\u957f\u548c\u6210\u672c\u589e\u52a0\uff0c\u5c24\u5176\u662f\u5bf9\u4e2d\u5c0f\u578b\u4f01\u4e1a\u800c\u8a00\uff0c\u6311\u6218\u66f4\u4e3a\u663e\u8457\u3002<\/p>\n<\/p>\n \u6b64\u5916\uff0cMDR\u8981\u6c42\u5236\u9020\u5546\u52a0\u5f3a\u4e0a\u5e02\u540e\u76d1\u7763\u548c vigilance \u62a5\u544a\uff0c\u786e\u4fdd\u5728\u4ea7\u54c1\u6d41\u901a\u540e\u6301\u7eed\u76d1\u63a7\u5176\u6027\u80fd\u548c\u5b89\u5168\uff0c\u5236\u9020\u5546\u8fd8\u5fc5\u987b\u6307\u5b9a\u4e00\u540d\u8d1f\u8d23\u5408\u89c4\u7684\u4e13\u4eba\uff08Person Responsible for Regulatory Compliance\uff09\uff0c\u4ee5 oversight \u6574\u4e2a\u5408\u89c4\u8fc7\u7a0b\uff0c\u8fd9\u4e9b\u63aa\u65bd\u65e8\u5728\u5efa\u7acb\u66f4\u900f\u660e\u7684\u8ffd\u6eaf\u7cfb\u7edf\u548c\u5feb\u901f\u54cd\u5e94\u673a\u5236\u3002<\/p>\n<\/p>\n MDR\u6cd5\u89c4\u7684\u5408\u89c4\u6d41\u7a0b\u4e0e\u65f6\u95f4\u7ebf<\/strong><\/p>\n MDR\u6cd5\u89c4\u4e8e2017\u5e74\u6b63\u5f0f\u53d1\u5e03\uff0c\u5e76\u8bbe\u7f6e\u4e86\u8fc7\u6e21\u671f\uff0c\u539f\u5b9a\u4e8e2020\u5e74\u5168\u9762\u5b9e\u65bd\uff0c\u4f46\u7531\u4e8eCOVID-19\u75ab\u60c5\u7684\u5f71\u54cd\uff0c\u90e8\u5206\u6761\u6b3e\u7684\u622a\u6b62\u65e5\u671f\u88ab\u5ef6\u957f\uff0c\u5236\u9020\u5546\u9700\u8981\u5728\u8fc7\u6e21\u671f\u5185\u5b8c\u6210\u4ea7\u54c1\u91cd\u65b0\u8ba4\u8bc1\u548c\u4f53\u7cfb\u66f4\u65b0\uff0c\u4ee5\u786e\u4fdd\u987a\u5229\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u3002<\/p>\n<\/p>\n \u5408\u89c4\u6d41\u7a0b\u6d89\u53ca\u591a\u4e2a\u6b65\u9aa4\uff0c\u5305\u62ec\u6280\u672f\u6587\u6863\u51c6\u5907\u3001\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a\u66f4\u65b0\u3001\u4ee5\u53ca\u9009\u62e9\u5408\u683c\u7684\u516c\u544a\u673a\u6784\uff08Notified Body\uff09\u8fdb\u884c\u5ba1\u6838\uff0c\u5236\u9020\u5546\u5e94\u5c3d\u65e9\u542f\u52a8\u5408\u89c4\u5de5\u4f5c\uff0c\u907f\u514d\u6700\u540e\u4e00\u523b\u7684 rush\uff0c\u4ece\u800c\u964d\u4f4e\u5e02\u573a\u4e2d\u65ad\u98ce\u9669\u3002<\/p>\n<\/p>\n MDR\u4e0e\u5168\u7403\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u7684\u8d8b\u52bf<\/strong><\/p>\n MDR\u6cd5\u89c4\u7684\u63a8\u51fa\u53cd\u6620\u4e86\u5168\u7403\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u5411\u66f4\u4e25\u683c\u3001\u66f4\u900f\u660e\u65b9\u5411\u53d1\u5c55\u7684\u8d8b\u52bf\uff0c\u8bb8\u591a\u56fd\u5bb6\u548c\u5730\u533a\uff0c\u5982\u7f8e\u56fd\u548c\u4e2d\u56fd\uff0c\u4e5f\u5728\u66f4\u65b0\u5176\u76d1\u7ba1\u6846\u67b6\uff0c\u4ee5\u5f3a\u8c03\u6570\u636e\u9a71\u52a8\u548c\u751f\u547d\u5468\u671f\u7ba1\u7406\uff0c\u8fd9\u6709\u52a9\u4e8e\u4fc3\u8fdb\u5168\u7403\u8d38\u6613\u4e2d\u7684\u6807\u51c6\u7edf\u4e00\uff0c\u4f46\u540c\u65f6\u4e5f\u589e\u52a0\u4e86\u5236\u9020\u5546\u7684\u5408\u89c4\u8d1f\u62c5\u3002<\/p>\n<\/p>\n \u4ece\u957f\u8fdc\u770b\uff0cMDR\u7684\u5b9e\u65bd\u5c06\u63a8\u52a8\u884c\u4e1a\u521b\u65b0\uff0c\u9f13\u52b1\u5f00\u53d1\u66f4\u5b89\u5168\u548c\u9ad8\u6548\u7684\u533b\u7597\u5668\u68b0\uff0c\u540c\u65f6\u63d0\u5347\u60a3\u8005\u4fe1\u4efb\uff0c\u4f01\u4e1a\u9700\u9002\u5e94\u8fd9\u4e00\u53d8\u5316\uff0c\u901a\u8fc7\u6295\u8d44\u7814\u53d1\u548c\u5408\u89c4\u5efa\u8bbe\u6765\u4fdd\u6301\u7ade\u4e89\u529b\u3002<\/p>\n<\/p>\n \u7ed3\u8bba\uff1a\u62e5\u62b1MDR\u65f6\u4ee3\u7684\u673a\u9047\u4e0e\u6311\u6218<\/strong><\/p>\n MDR\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u4ee3\u8868\u4e86\u6b27\u76df\u5bf9\u533b\u7597\u5668\u68b0\u5b89\u5168\u7684 commitment\uff0c\u867d\u7136\u5b83\u5e26\u6765\u4e86\u6311\u6218\uff0c\u4f46\u4e5f\u4e3a\u884c\u4e1a\u63d0\u4f9b\u4e86\u5347\u7ea7\u548c\u5dee\u5f02\u5316\u7684\u673a\u4f1a\uff0c\u5236\u9020\u5546\u901a\u8fc7\u79ef\u6781\u5e94\u5bf9\uff0c\u4e0d\u4ec5\u53ef\u4ee5\u6ee1\u8db3\u6cd5\u89c4\u8981\u6c42\uff0c\u8fd8\u80fd\u589e\u5f3a\u4ea7\u54c1\u5e02\u573a\u7ade\u4e89\u529b\uff0c\u6700\u7ec8\u9020\u798f\u5168\u7403\u60a3\u8005\u3002<\/p>\n<\/p>\n \u514d\u8d23\u58f0\u660e\uff1a\u672c\u6587\u5185\u5bb9\u4ec5\u4f9b\u53c2\u8003\uff0c\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\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u662f\u6b27\u76df\u9488\u5bf9\u533b\u7597\u5668\u68b0\u884c\u4e1a\u9881\u5e03\u7684\u65b0\u6cd5\u89c4\uff0c\u5168\u79f0\u4e3a\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Reg […]<\/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":[384],"class_list":["post-4060","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\/4060","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=4060"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4060\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4060"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4060"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4060"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}