\u533b\u7597\u5668\u68b0MDR\u89e3\u8bfb\u662f\u5f53\u524d\u533b\u7597\u5668\u68b0\u884c\u4e1a\u4ece\u4e1a\u8005\u53ca\u76d1\u7ba1\u673a\u6784\u5173\u6ce8\u7684\u7126\u70b9\uff0c\u968f\u7740\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Regulation, MDR\uff09\u7684\u6b63\u5f0f\u5b9e\u65bd\uff0c\u5176\u5bf9\u5168\u7403\u533b\u7597\u5668\u68b0\u5e02\u573a\u7684\u5f71\u54cd\u65e5\u76ca\u663e\u8457\u3002<\/p>\n
\u672c\u6587\u65e8\u5728\u5168\u9762\u89e3\u6790MDR\u7684\u6838\u5fc3\u5185\u5bb9\u3001\u5173\u952e\u53d8\u5316\u53ca\u5408\u89c4\u8def\u5f84\uff0c\u4e3a\u76f8\u5173\u4f01\u4e1a\u63d0\u4f9b\u53c2\u8003\u3002<\/p>\n<\/p>\n
\u6b27\u76dfMDR\uff08Regulation (EU) 2017\/745\uff09\u4e8e2017\u5e745\u67085\u65e5\u53d1\u5e03\uff0c\u5e76\u4e8e2021\u5e745\u670826\u65e5\u6b63\u5f0f\u53d6\u4ee3\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\u548c\u6709\u6e90\u690d\u5165\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08AIMDD\uff09\u3002<\/p>\n
\u8fd9\u4e00\u6cd5\u89c4\u7684\u51fa\u53f0\u80cc\u666f\u4e3b\u8981\u662f\u4e3a\u4e86\u5e94\u5bf9\u533b\u7597\u5668\u68b0\u6280\u672f\u7684\u5feb\u901f\u53d1\u5c55\u548c\u65e2\u5f80\u76d1\u7ba1\u4e2d\u66b4\u9732\u7684\u4e0d\u8db3\uff0c\u65e8\u5728\u52a0\u5f3a\u533b\u7597\u5668\u68b0\u7684\u5168\u751f\u547d\u5468\u671f\u76d1\u7ba1\uff0c\u63d0\u9ad8\u900f\u660e\u5ea6\u548c\u8ffd\u6eaf\u6027\uff0c\u786e\u4fdd\u60a3\u8005\u5b89\u5168\u3002<\/p>\n<\/p>\n
\u4e00\u3001MDR\u6cd5\u89c4\u7684\u4e3b\u8981\u53d8\u5316\u4e0e\u6838\u5fc3\u8981\u6c42<\/strong><\/p>\n MDR\u76f8\u8f83\u4e8e\u4e4b\u524d\u7684\u6307\u4ee4\uff0c\u5728\u8303\u56f4\u3001\u5206\u7c7b\u89c4\u5219\u3001\u4e34\u5e8a\u8bc4\u4ef7\u3001\u4e0a\u5e02\u540e\u76d1\u7ba1\u7b49\u65b9\u9762\u5747\u6709\u663e\u8457\u53d8\u5316\u3002<\/p>\n \u9996\u5148\uff0c\u6cd5\u89c4\u9002\u7528\u8303\u56f4\u6269\u5927\uff0c\u6db5\u76d6\u4e86\u4e00\u4e9b\u6b64\u524d\u672a\u660e\u786e\u76d1\u7ba1\u7684\u4ea7\u54c1\uff0c\u5982\u67d0\u4e9b\u7f8e\u5b66\u7528\u9014\u5668\u68b0\u548c\u7eb3\u7c73\u6750\u6599\u5668\u68b0\u3002<\/p>\n \u5176\u6b21\uff0c\u5668\u68b0\u5206\u7c7b\u89c4\u5219\u66f4\u52a0\u7ec6\u5316\uff0c\u7279\u522b\u662f\u9488\u5bf9\u8f6f\u4ef6\u3001\u6709\u6e90\u5668\u68b0\u7b49\uff0c\u98ce\u9669\u5206\u7c7b\u66f4\u4e25\u683c\uff0c\u8bb8\u591a\u539f\u672c\u5c5e\u4e8e\u4f4e\u98ce\u9669\u7c7b\u522b\u7684\u5668\u68b0\u53ef\u80fd\u88ab\u91cd\u65b0\u5212\u5206\u4e3a\u9ad8\u98ce\u9669\u7c7b\u522b\u3002<\/p>\n \u4e34\u5e8a\u8bc4\u4ef7\u8981\u6c42\u5927\u5e45\u63d0\u5347\uff0c\u8981\u6c42\u5236\u9020\u5546\u63d0\u4f9b\u66f4\u5168\u9762\u3001\u6301\u7eed\u7684\u4e34\u5e8a\u8bc1\u636e\uff0c\u8bc1\u660e\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\uff0c\u4e14\u9700\u5b9a\u671f\u66f4\u65b0\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u3002<\/p>\n \u6b64\u5916\uff0cMDR\u5f3a\u8c03\u4e0a\u5e02\u540e\u76d1\u7ba1\uff08PMS\uff09\u548c\u8b66\u6212\u7cfb\u7edf\uff0c\u8981\u6c42\u5236\u9020\u5546\u5efa\u7acb\u5168\u9762\u7684\u76d1\u63a7\u4f53\u7cfb\uff0c\u53ca\u65f6\u62a5\u544a\u4e0d\u826f\u4e8b\u4ef6\u548c\u91c7\u53d6\u7ea0\u6b63\u63aa\u65bd\u3002<\/p>\n \u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf\u7684\u5f15\u5165\u4e5f\u662fMDR\u7684\u4e00\u5927\u4eae\u70b9\uff0c\u65e8\u5728\u589e\u5f3a\u5668\u68b0\u7684\u53ef\u8ffd\u6eaf\u6027\uff0c\u4fbf\u4e8e\u76d1\u7ba1\u548c\u53ec\u56de\u3002<\/p>\n<\/p>\n \u4e8c\u3001MDR\u5bf9\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u7684\u5f71\u54cd\u4e0e\u6311\u6218<\/strong><\/p>\n MDR\u7684\u5b9e\u65bd\u5bf9\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u63d0\u51fa\u4e86\u66f4\u9ad8\u7684\u5408\u89c4\u8981\u6c42\uff0c\u6d89\u53ca\u6280\u672f\u6587\u6863\u3001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3001\u4e34\u5e8a\u6570\u636e\u7ba1\u7406\u7b49\u591a\u4e2a\u65b9\u9762\u3002<\/p>\n \u5236\u9020\u5546\u9700\u91cd\u65b0\u8bc4\u4f30\u4ea7\u54c1\u5206\u7c7b\uff0c\u66f4\u65b0\u6280\u672f\u6587\u4ef6\uff0c\u786e\u4fdd\u7b26\u5408\u65b0\u7684\u9644\u5f55I\u901a\u7528\u5b89\u5168\u4e0e\u6027\u80fd\u8981\u6c42\uff08GSPR\uff09\u3002<\/p>\n \u4e34\u5e8a\u8bc4\u4ef7\u8fc7\u7a0b\u53d8\u5f97\u66f4\u52a0\u590d\u6742\uff0c\u53ef\u80fd\u9700\u8981\u8fdb\u884c\u989d\u5916\u7684\u4e34\u5e8a\u7814\u7a76\u6216\u6587\u732e\u56de\u987e\uff0c\u8fd9\u589e\u52a0\u4e86\u65f6\u95f4\u548c\u6210\u672c\u6295\u5165\u3002<\/p>\n \u5bf9\u4e8e\u4e2d\u5c0f\u578b\u4f01\u4e1a\uff0c\u8d44\u6e90\u9650\u5236\u53ef\u80fd\u6210\u4e3a\u91cd\u5927\u6311\u6218\uff0c\u9700\u8981\u5bfb\u6c42\u4e13\u4e1a\u54a8\u8be2\u6216\u5916\u5305\u670d\u52a1\u3002<\/p>\n \u6b64\u5916\uff0c\u516c\u544a\u673a\u6784\uff08Notified Bodies\uff09\u7684\u6570\u91cf\u548c\u80fd\u529b\u5728MDR\u8fc7\u6e21\u521d\u671f\u4e0d\u8db3\uff0c\u5bfc\u81f4\u8ba4\u8bc1\u6d41\u7a0b\u5ef6\u957f\uff0c\u4f01\u4e1a\u9700\u63d0\u524d\u89c4\u5212\u8ba4\u8bc1\u65f6\u95f4\u3002<\/p>\n \u4f9b\u5e94\u94fe\u7ba1\u7406\u4e5f\u9700\u52a0\u5f3a\uff0c\u8981\u6c42\u5bf9\u4f9b\u5e94\u5546\u8fdb\u884c\u66f4\u4e25\u683c\u7684\u5ba1\u6838\uff0c\u786e\u4fdd\u6574\u4e2a\u4f9b\u5e94\u94fe\u7b26\u5408MDR\u8981\u6c42\u3002<\/p>\n<\/p>\n \u4e09\u3001MDR\u5408\u89c4\u8def\u5f84\u4e0e\u7b56\u7565\u5efa\u8bae<\/strong><\/p>\n \u4e3a\u5e94\u5bf9MDR\uff0c\u5236\u9020\u5546\u5e94\u91c7\u53d6\u7cfb\u7edf\u5316\u7684\u5408\u89c4\u7b56\u7565\uff0c\u9996\u5148\u8fdb\u884c\u5dee\u8ddd\u5206\u6790\uff0c\u8bc6\u522b\u73b0\u6709\u4f53\u7cfb\u4e0eMDR\u8981\u6c42\u4e4b\u95f4\u7684\u5dee\u5f02\u3002<\/p>\n \u5efa\u7acb\u6216\u66f4\u65b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\uff0c\u786e\u4fdd\u7b26\u5408MDR Article 10\u548c\u9644\u5f55IX\u7684\u8981\u6c42\uff0c\u6574\u5408\u98ce\u9669\u7ba1\u7406\u548c\u4e0a\u5e02\u540e\u76d1\u7ba1\u6d41\u7a0b\u3002<\/p>\n \u4e34\u5e8a\u8bc4\u4ef7\u5e94\u5c3d\u65e9\u542f\u52a8\uff0c\u6536\u96c6\u548c\u8bc4\u4f30\u4e34\u5e8a\u6570\u636e\uff0c\u5fc5\u8981\u65f6\u4e0e\u4e34\u5e8a\u4e13\u5bb6\u5408\u4f5c\uff0c\u786e\u4fdd\u6570\u636e\u5145\u5206\u652f\u6301\u5668\u68b0\u7684\u9884\u671f\u7528\u9014\u3002<\/p>\n UDI\u7cfb\u7edf\u7684\u5b9e\u65bd\u9700\u4e0e\u751f\u4ea7\u3001\u6807\u7b7e\u548c\u6570\u636e\u5e93\u63d0\u4ea4\u540c\u6b65\u8fdb\u884c\uff0c\u63d0\u524d\u4e0eUDI\u53d1\u884c\u673a\u6784\u5bf9\u63a5\u3002<\/p>\n \u4e0e\u516c\u544a\u673a\u6784\u4fdd\u6301\u5bc6\u5207\u6c9f\u901a\uff0c\u63d0\u524d\u63d0\u4ea4\u7533\u8bf7\uff0c\u907f\u514d\u8ba4\u8bc1\u5ef6\u8fdf\u5f71\u54cd\u5e02\u573a\u51c6\u5165\u3002<\/p>\n \u6301\u7eed\u5173\u6ce8\u6b27\u76df\u5b98\u65b9\u6307\u5357\u548c\u66f4\u65b0\uff0c\u5982MDCG\uff08Medical Device Coordination Group\uff09\u53d1\u5e03\u7684\u6587\u4ef6\uff0c\u4ee5\u786e\u4fdd\u5408\u89c4\u7b56\u7565\u7684\u65f6\u6548\u6027\u3002<\/p>\n<\/p>\n \u56db\u3001MDR\u5728\u5168\u7403\u5e02\u573a\u7684\u5f71\u54cd\u4e0e\u672a\u6765\u5c55\u671b<\/strong><\/p>\n MDR\u4e0d\u4ec5\u5f71\u54cd\u6b27\u76df\u5e02\u573a\uff0c\u4e5f\u5bf9\u5168\u7403\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u4ea7\u751f\u8f90\u5c04\u6548\u5e94\uff0c\u8bb8\u591a\u56fd\u5bb6\u6b63\u5728\u501f\u9274MDR\u6846\u67b6\u52a0\u5f3a\u672c\u56fd\u6cd5\u89c4\u3002<\/p>\n \u5b83\u63a8\u52a8\u4e86\u884c\u4e1a\u5411\u66f4\u9ad8\u5b89\u5168\u6807\u51c6\u548c\u900f\u660e\u5ea6\u8f6c\u578b\uff0c\u9f13\u52b1\u521b\u65b0\u4e0e\u98ce\u9669\u5e73\u8861\u3002<\/p>\n \u672a\u6765\uff0c\u968f\u7740\u6570\u5b57\u5065\u5eb7\u548cAI\u533b\u7597\u5668\u68b0\u7684\u53d1\u5c55\uff0cMDR\u53ef\u80fd\u4f1a\u8fdb\u4e00\u6b65\u66f4\u65b0\uff0c\u4ee5\u9002\u5e94\u65b0\u6280\u672f\u6311\u6218\u3002<\/p>\n \u5236\u9020\u5546\u9700\u4fdd\u6301\u7075\u6d3b\u6027\uff0c\u6295\u8d44\u4e8e\u6301\u7eed\u5408\u89c4\uff0c\u4ee5\u7ef4\u6301\u5168\u7403\u5e02\u573a\u7ade\u4e89\u529b\u3002<\/p>\n \u603b\u4f53\u800c\u8a00\uff0cMDR\u89e3\u8bfb\u662f\u533b\u7597\u5668\u68b0\u9886\u57df\u4e0d\u53ef\u6216\u7f3a\u7684\u4e00\u73af\uff0c\u6df1\u5165\u7406\u89e3\u5176\u8981\u6c42\u6709\u52a9\u4e8e\u4f01\u4e1a navigate \u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002<\/p>\n<\/p>\n \u514d\u8d23\u58f0\u660e\uff1a\u672c\u6587\u5185\u5bb9\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":" 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[…]<\/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":[346],"class_list":["post-4022","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\/4022","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=4022"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4022\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}