MDR\u6ce8\u518c\u662f\u4ec0\u4e48\uff1f\u8fd9\u662f\u8bb8\u591a\u533b\u7597\u5668\u68b0\u884c\u4e1a\u4ece\u4e1a\u8005\u3001\u5236\u9020\u5546\u4ee5\u53ca\u76f8\u5173\u5229\u76ca\u65b9\u8fd1\u5e74\u6765\u9891\u7e41\u63d0\u51fa\u7684\u95ee\u9898<\/p>\n
\u968f\u7740\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Regulation, MDR\uff09\u7684\u6b63\u5f0f\u5b9e\u65bd\uff0c\u5b83\u5df2\u53d6\u4ee3\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\uff0c\u6210\u4e3a\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u7684\u5f3a\u5236\u6027\u65b0\u89c4<\/p>\n
\u7b80\u5355\u6765\u8bf4\uff0cMDR\u6ce8\u518c\u662f\u6307\u5728\u65b0\u7684\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u6846\u67b6\u4e0b\uff0c\u5236\u9020\u5546\u901a\u8fc7\u7b26\u5408\u6027\u8bc4\u4f30\u3001\u6280\u672f\u6587\u4ef6\u51c6\u5907\u3001\u516c\u544a\u673a\u6784\u5ba1\u6838\u4ee5\u53ca\u5728\u6b27\u76df\u6570\u636e\u5e93EUDAMED\u4e2d\u8fdb\u884c\u767b\u8bb0\u7b49\u4e00\u7cfb\u5217\u590d\u6742\u6d41\u7a0b\uff0c\u6700\u7ec8\u83b7\u5f97CE\u6807\u5fd7\u5e76\u5408\u6cd5\u5c06\u5176\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u6295\u653e\u6b27\u76df\u5e02\u573a\u7684\u8fc7\u7a0b<\/p>\n<\/p>\n
\u8981\u6df1\u5165\u7406\u89e3MDR\u6ce8\u518c\u662f\u4ec0\u4e48\uff0c\u6211\u4eec\u5fc5\u987b\u5148\u4e86\u89e3\u5176\u51fa\u53f0\u7684\u80cc\u666f<\/p>\n
\u6b27\u76df\u63a8\u51faMDR\uff08\u6cd5\u89c4(EU) 2017\/745\uff09\u4e3b\u8981\u662f\u4e3a\u4e86\u5e94\u5bf9\u65e5\u76ca\u590d\u6742\u7684\u533b\u7597\u5668\u68b0\u6280\u672f\u3001\u586b\u8865MDD\u65f6\u671f\u7684\u6cd5\u5f8b\u6f0f\u6d1e\uff0c\u5e76\u52a0\u5f3a\u5bf9\u60a3\u8005\u5b89\u5168\u548c\u516c\u4f17\u5065\u5eb7\u7684\u4fdd\u62a4<\/p>\n
\u4e0e\u4e4b\u524d\u7684MDD\u76f8\u6bd4\uff0cMDR\u7684\u8981\u6c42\u66f4\u4e3a\u4e25\u683c\u3001\u5ba1\u67e5\u66f4\u6df1\u5165\u3001\u900f\u660e\u5ea6\u548c\u53ef\u8ffd\u6eaf\u6027\u8981\u6c42\u4e5f\u663e\u8457\u63d0\u9ad8<\/p>\n
\u8fd9\u610f\u5473\u7740\uff0c\u5bf9\u6240\u6709\u5236\u9020\u5546\u800c\u8a00\uff0c\u201cMDR\u6ce8\u518c\u201d\u4e0d\u518d\u662f\u4e00\u4e2a\u7b80\u5355\u7684\u7a0b\u5e8f\u6027\u66f4\u65b0\uff0c\u800c\u662f\u4e00\u6b21\u5168\u9762\u7684\u4f53\u7cfb\u5347\u7ea7\u548c\u5408\u89c4\u91cd\u6784<\/p>\n<\/p>\n
MDR\u6ce8\u518c\u7684\u6838\u5fc3\u6d41\u7a0b\u4e0e\u5173\u952e\u6b65\u9aa4<\/strong><\/p>\n \u90a3\u4e48\uff0c\u5177\u4f53\u7684MDR\u6ce8\u518c\u6d41\u7a0b\u662f\u600e\u6837\u7684\u5462\uff1f\u5b83\u7edd\u975e\u4e00\u8e74\u800c\u5c31\uff0c\u800c\u662f\u4e00\u4e2a\u7cfb\u7edf\u6027\u7684\u9879\u76ee<\/p>\n \u9996\u5148\uff0c\u5236\u9020\u5546\u9700\u8981\u8fdb\u884c\u5668\u68b0\u5206\u7c7b<\/p>\n MDR\u6cbf\u7528\u4e86MDD\u7684\u89c4\u5219\u4f46\u7565\u6709\u8c03\u6574\uff0c\u51c6\u786e\u5206\u7c7b\u662f\u786e\u5b9a\u540e\u7eed\u7b26\u5408\u6027\u8bc4\u4f30\u8def\u5f84\u7684\u57fa\u7840<\/p>\n \u6839\u636e\u98ce\u9669\u7b49\u7ea7\uff0c\u5668\u68b0\u5206\u4e3aI\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u548cIII\u7c7b\uff0c\u98ce\u9669\u8d8a\u9ad8\uff0c\u76d1\u7ba1\u8981\u6c42\u8d8a\u4e25\u683c<\/p>\n<\/p>\n \u63a5\u4e0b\u6765\u662f\u6280\u672f\u6587\u4ef6\uff08Technical Documentation\uff09\u7684\u51c6\u5907<\/p>\n \u8fd9\u662fMDR\u6ce8\u518c\u7684\u6838\u5fc3\uff0c\u4e5f\u662f\u516c\u544a\u673a\u6784\u5ba1\u6838\u7684\u91cd\u70b9<\/p>\n \u6280\u672f\u6587\u4ef6\u9700\u5305\u542b\u4ea7\u54c1\u6240\u6709\u76f8\u5173\u4fe1\u606f\u548c\u6570\u636e\uff0c\u4ee5\u8bc1\u660e\u5176\u7b26\u5408MDR\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\u8981\u6c42<\/p>\n \u4e0e\u8fc7\u53bb\u76f8\u6bd4\uff0cMDR\u5bf9\u6280\u672f\u6587\u4ef6\u7684\u8981\u6c42\u6df1\u5ea6\u548c\u5e7f\u5ea6\u90fd\u6709\u6781\u5927\u63d0\u5347\uff0c\u5c24\u5176\u5f3a\u8c03\u4e34\u5e8a\u8bc4\u4ef7\uff08Clinical Evaluation\uff09\u548c\u4e0a\u5e02\u540e\u76d1\u7763\uff08Post-Market Surveillance, PMS\uff09\u6570\u636e<\/p>\n \u5236\u9020\u5546\u5fc5\u987b\u63d0\u4f9b\u8be6\u7ec6\u7684\u4e34\u5e8a\u8bc1\u636e\uff0c\u8bc1\u660e\u5668\u68b0\u7684\u9884\u671f\u53d7\u76ca\u5927\u4e8e\u98ce\u9669<\/p>\n<\/p>\n \u7136\u540e\uff0c\u9009\u62e9\u5e76\u59d4\u6258\u6b27\u76df\u516c\u544a\u673a\u6784\uff08Notified Body\uff09<\/p>\n \u9664\u4e86\u5c11\u6570I\u7c7b\u65e0\u83cc\u6216\u5177\u6709\u6d4b\u91cf\u529f\u80fd\u7684\u5668\u68b0\u5916\uff0c\u7edd\u5927\u591a\u6570\u5668\u68b0\u90fd\u9700\u8981\u7ecf\u8fc7\u516c\u544a\u673a\u6784\u7684\u7b26\u5408\u6027\u8bc4\u4f30<\/p>\n \u7531\u4e8eMDR\u6807\u51c6\u4e25\u82db\uff0c\u5177\u5907\u5ba1\u6838\u8d44\u8d28\u7684\u516c\u544a\u673a\u6784\u6570\u91cf\u6709\u9650\uff0c\u56e0\u6b64\u5c3d\u65e9\u4e0e\u516c\u544a\u673a\u6784\u63a5\u6d3d\u5e76\u5efa\u7acb\u5408\u4f5c\u81f3\u5173\u91cd\u8981<\/p>\n \u516c\u544a\u673a\u6784\u5c06\u5168\u9762\u5ba1\u6838\u5236\u9020\u5546\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\u548c\u6280\u672f\u6587\u4ef6\uff0c\u5e76\u8fdb\u884c\u73b0\u573a\u5ba1\u6838<\/p>\n<\/p>\n \u6210\u529f\u901a\u8fc7\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u540e\uff0c\u5236\u9020\u5546\u5c06\u83b7\u5f97CE\u8bc1\u4e66<\/p>\n \u6b64\u540e\uff0c\u5236\u9020\u5546\u8fd8\u9700\u5b8c\u6210\u5728EUDAMED\u6570\u636e\u5e93\u4e2d\u7684\u6ce8\u518c\u5de5\u4f5c<\/p>\n \u8fd9\u5305\u62ec\u7ecf\u6d4e\u8fd0\u8425\u8005\uff08\u5236\u9020\u5546\u3001\u6388\u6743\u4ee3\u8868\u3001\u8fdb\u53e3\u5546\u7b49\uff09\u7684\u6ce8\u518c\u3001\u5668\u68b0\u7684UDI\uff08\u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff09\u5206\u914d\u548c\u6ce8\u518c\u4ee5\u53ca\u8bc1\u4e66\u548c\u7b26\u5408\u6027\u58f0\u660e\u7684\u4e0a\u4f20<\/p>\n EUDAMED\u65e8\u5728\u63d0\u9ad8\u6574\u4e2a\u6b27\u76df\u5e02\u573a\u7684\u900f\u660e\u5ea6\u548c\u53ef\u8ffd\u6eaf\u6027<\/p>\n<\/p>\n MDR\u6ce8\u518c\u5e26\u6765\u7684\u4e3b\u8981\u6311\u6218\u4e0e\u53d8\u5316<\/strong><\/p>\n \u7406\u89e3MDR\u6ce8\u518c\u662f\u4ec0\u4e48\uff0c\u5fc5\u987b\u8ba4\u8bc6\u5230\u5176\u5e26\u6765\u7684\u5de8\u5927\u6311\u6218<\/p>\n \u9996\u5148\uff0c\u662f\u4e34\u5e8a\u8bc1\u636e\u8981\u6c42\u7684\u663e\u8457\u52a0\u5f3a<\/p>\n \u5bf9\u4e8e\u8bb8\u591a\u4f9d\u7167MDD\u83b7\u5f97CE\u6807\u5fd7\u7684\u9057\u7559\u8bbe\u5907\uff0c\u53ef\u80fd\u7f3a\u4e4f\u8db3\u591f\u7684\u4e34\u5e8a\u6570\u636e\uff0c\u73b0\u5728\u9700\u8981\u6309\u7167MDR\u7684\u8981\u6c42\u8fdb\u884c\u8865\u5145\uff0c\u8fd9\u901a\u5e38\u610f\u5473\u7740\u9700\u8981\u6295\u5165\u5927\u91cf\u8d44\u6e90\u548c\u65f6\u95f4\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u6216\u6587\u732e\u56de\u987e<\/p>\n<\/p>\n \u5176\u6b21\uff0c\u662f\u5bf9\u4f9b\u5e94\u94fe\u900f\u660e\u5ea6\u548c\u53ef\u8ffd\u6eaf\u6027\u7684\u6781\u81f4\u8ffd\u6c42<\/p>\n UDI\u7cfb\u7edf\u7684\u5168\u9762\u5f15\u5165\u8981\u6c42\u5bf9\u751f\u4ea7\u3001\u6d41\u901a\u7684\u6bcf\u4e00\u4e2a\u73af\u8282\u8fdb\u884c\u6807\u8bc6\u548c\u7ba1\u7406<\/p>\n \u6b64\u5916\uff0c\u5236\u9020\u5546\u5fc5\u987b\u5efa\u7acb\u3001\u5b9e\u65bd\u5e76\u7ef4\u62a4\u4e00\u4e2a\u5168\u9762\u7684\u4e0a\u5e02\u540e\u76d1\u7763\u7cfb\u7edf\uff0c\u5305\u62ec\u6536\u96c6\u548c\u5206\u6790\u4e0a\u5e02\u540e\u6570\u636e\u3001\u5b9a\u671f\u66f4\u65b0\u5b89\u5168\u4e0e\u6027\u80fd\u603b\u7ed3\uff08SSCP\uff09\u3001\u5e76\u53ca\u65f6\u62a5\u544a\u4e25\u91cd\u4e8b\u4ef6\u548c\u73b0\u573a\u5b89\u5168\u7ea0\u6b63\u63aa\u65bd\uff08FSCA\uff09<\/p>\n<\/p>\n \u6700\u540e\uff0c\u662f\u89d2\u8272\u548c\u8d23\u4efb\u7684\u660e\u786e\u4e0e\u52a0\u91cd<\/p>\n MDR\u660e\u786e\u89c4\u5b9a\u4e86\u5236\u9020\u5546\u3001\u6388\u6743\u4ee3\u8868\u3001\u8fdb\u53e3\u5546\u548c\u5206\u9500\u5546\u5404\u81ea\u7684\u8d23\u4efb<\/p>\n \u4f8b\u5982\uff0c\u5236\u9020\u5546\u7684\u6388\u6743\u4ee3\u8868\uff08European Authorised Representative\uff09\u7684\u6cd5\u5f8b\u8d23\u4efb\u5927\u5e45\u589e\u52a0\uff0c\u4ed6\u4eec\u9700\u8981\u66f4\u6df1\u5165\u5730\u9a8c\u8bc1\u5236\u9020\u5546\u7684\u5408\u89c4\u6027\uff0c\u800c\u4e0d\u518d\u4ec5\u4ec5\u662f\u4e00\u4e2a\u884c\u653f\u4ee3\u8868<\/p>\n<\/p>\n \u7ed3\u8bba\uff1aMDR\u6ce8\u518c\u7684\u6218\u7565\u610f\u4e49<\/strong><\/p>\n \u7efc\u4e0a\u6240\u8ff0\uff0cMDR\u6ce8\u518c\u662f\u4ec0\u4e48\uff1f\u5b83\u8fdc\u4e0d\u6b62\u662f\u4e00\u6b21\u7b80\u5355\u7684\u4ea7\u54c1\u6ce8\u518c\u6216\u8ba4\u8bc1\u66f4\u65b0<\/p>\n \u5b83\u662f\u4e00\u573a\u6df1\u523b\u7684\u76d1\u7ba1\u53d8\u9769\uff0c\u662f\u6b27\u76df\u5bf9\u533b\u7597\u5668\u68b0\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\u7684\u5168\u65b0\u7406\u5ff5\u7684\u843d\u5730<\/p>\n \u5bf9\u4e8e\u4f01\u4e1a\u800c\u8a00\uff0c\u6210\u529f\u5b8c\u6210MDR\u6ce8\u518c\u4e0d\u4ec5\u662f\u83b7\u5f97\u5e02\u573a\u51c6\u5165\u8bb8\u53ef\u7684\u5fc5\u8981\u6761\u4ef6\uff0c\u66f4\u662f\u6784\u5efa\u5f3a\u5927\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3001\u63d0\u5347\u4ea7\u54c1\u7ade\u4e89\u529b\u3001\u8d62\u5f97\u60a3\u8005\u548c\u533b\u7597\u4e13\u4e1a\u4eba\u58eb\u4fe1\u4efb\u7684\u6218\u7565\u673a\u9047<\/p>\n \u9762\u5bf9\u66f4\u957f\u7684\u51c6\u5907\u5468\u671f\u3001\u66f4\u9ad8\u7684\u6210\u672c\u548c\u66f4\u590d\u6742\u7684\u6d41\u7a0b\uff0c\u5236\u9020\u5546\u5e94\u5c3d\u65e9\u89c4\u5212\u3001\u79ef\u6781\u5e94\u5bf9\uff0c\u5c06\u5408\u89c4\u6027\u8f6c\u5316\u4e3a\u81ea\u8eab\u7684\u6838\u5fc3\u4f18\u52bf<\/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<\/p>\n","protected":false},"excerpt":{"rendered":" MDR\u6ce8\u518c\u662f\u4ec0\u4e48\uff1f\u8fd9\u662f\u8bb8\u591a\u533b\u7597\u5668\u68b0\u884c\u4e1a\u4ece\u4e1a\u8005\u3001\u5236\u9020\u5546\u4ee5\u53ca\u76f8\u5173\u5229\u76ca\u65b9\u8fd1\u5e74\u6765\u9891\u7e41\u63d0\u51fa\u7684\u95ee\u9898 \u968f\u7740\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08 […]<\/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":[300],"class_list":["post-3975","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\/3975","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=3975"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/3975\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3975"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3975"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3975"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}