MDR\u8ba4\u8bc1\u662f\u533b\u7597\u5668\u68b0\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u95e8\u69db\uff0c\u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u7406\u89e3\u5176\u6db5\u76d6\u7684\u5177\u4f53\u5185\u5bb9\u81f3\u5173\u91cd\u8981\u3002<\/p>\n<\/p>\n
\u672c\u6587\u5c06\u8be6\u7ec6\u89e3\u6790MDR\u8ba4\u8bc1\u6240\u5305\u542b\u7684\u6838\u5fc3\u8981\u7d20\uff0c\u5e2e\u52a9\u76f8\u5173\u4f01\u4e1a\u5168\u9762\u4e86\u89e3\u5176\u8981\u6c42\u4e0e\u6d41\u7a0b\u3002<\/p>\n<\/p>\n
\u4e00\u3001MDR\u8ba4\u8bc1\u6982\u8ff0\uff1a\u65b0\u6cd5\u89c4\u4e0b\u7684\u6df1\u523b\u53d8\u9769<\/strong><\/p>\n MDR\uff08Medical Device Regulation\uff09\u5373\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff0c\u4e8e2017\u5e74\u6b63\u5f0f\u53d1\u5e03\u5e76\u53d6\u4ee3\u4e86\u539f\u6709\u7684MDD\u6307\u4ee4\u3002<\/p>\n<\/p>\n \u4e0eMDD\u76f8\u6bd4\uff0cMDR\u8ba4\u8bc1\u7684\u8303\u56f4\u66f4\u5e7f\u3001\u8981\u6c42\u66f4\u4e25\u683c\uff0c\u5176\u6838\u5fc3\u76ee\u6807\u662f\u786e\u4fdd\u6295\u653e\u6b27\u76df\u5e02\u573a\u7684\u533b\u7597\u5668\u68b0\u5177\u6709\u66f4\u9ad8\u7684\u5b89\u5168\u6027\u548c\u900f\u660e\u5ea6\u3002<\/p>\n<\/p>\n \u56e0\u6b64\uff0cMDR\u8ba4\u8bc1\u4e0d\u4ec5\u4ec5\u662f\u4e00\u4e2a\u7b80\u5355\u7684\u4ea7\u54c1\u6d4b\u8bd5\u6216\u6ce8\u518c\u8fc7\u7a0b\uff0c\u5b83\u662f\u4e00\u4e2a\u8d2f\u7a7f\u4ea7\u54c1\u6574\u4e2a\u751f\u547d\u5468\u671f\u7684\u7efc\u5408\u6027\u5408\u89c4\u6846\u67b6\u3002<\/p>\n<\/p>\n \u4e8c\u3001MDR\u8ba4\u8bc1\u6db5\u76d6\u7684\u6838\u5fc3\u5185\u5bb9<\/strong><\/p>\n MDR\u8ba4\u8bc1\u662f\u4e00\u4e2a\u7cfb\u7edf\u5de5\u7a0b\uff0c\u5176\u5305\u542b\u7684\u5185\u5bb9\u8fdc\u4e0d\u6b62\u4e00\u4efd\u8bc1\u4e66\uff0c\u4e3b\u8981\u6db5\u76d6\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/p>\n<\/p>\n 1. \u66f4\u5e7f\u6cdb\u7684\u5668\u68b0\u8303\u56f4\u4e0e\u5206\u7c7b<\/strong><\/p>\n MDR\u6269\u5927\u4e86\u533b\u7597\u5668\u68b0\u7684\u5b9a\u4e49\u8303\u56f4\uff0c\u660e\u786e\u5c06\u8bb8\u591a\u6ca1\u6709\u533b\u7597\u76ee\u7684\u4f46\u529f\u80fd\u76f8\u4f3c\u7684\u4ea7\u54c1\u7eb3\u5165\u76d1\u7ba1\u3002<\/p>\n<\/p>\n \u4f8b\u5982\uff0c\u7528\u4e8e\u7f8e\u5bb9\u7684\u9690\u5f62\u773c\u955c\u3001\u62bd\u8102\u8bbe\u5907\u7b49\u73b0\u5728\u90fd\u88ab\u5212\u5206\u4e3a\u533b\u7597\u5668\u68b0\u3002<\/p>\n<\/p>\n \u540c\u65f6\uff0c\u5668\u68b0\u7684\u5206\u7c7b\u89c4\u5219\u4e5f\u66f4\u52a0\u7ec6\u5316\uff0c\u57fa\u4e8e\u4ea7\u54c1\u7684\u98ce\u9669\u7b49\u7ea7\uff08I\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u3001III\u7c7b\uff09\uff0c\u5176\u7b26\u5408\u6027\u8bc4\u4f30\u8def\u5f84\u548c\u4e25\u683c\u8981\u6c42\u4e5f\u6709\u6240\u4e0d\u540c\u3002<\/p>\n<\/p>\n 2. \u6280\u672f\u6587\u4ef6\u8981\u6c42<\/strong><\/p>\n \u6280\u672f\u6587\u4ef6\u662fMDR\u8ba4\u8bc1\u7684\u6838\u5fc3\uff0c\u662f\u8bc1\u660e\u4ea7\u54c1\u7b26\u5408\u57fa\u672c\u8981\u6c42\u7684\u5173\u952e\u8bc1\u636e\u3002<\/p>\n<\/p>\n \u5176\u5185\u5bb9\u5fc5\u987b\u8be6\u5c3d\uff0c\u901a\u5e38\u5305\u62ec\uff1a\u5668\u68b0\u8bf4\u660e\u4e0e\u89c4\u683c\u3001\u6807\u7b7e\u548c\u8bf4\u660e\u4e66\u3001\u8bbe\u8ba1\u4e0e\u5236\u9020\u4fe1\u606f\u3001\u901a\u7528\u5b89\u5168\u4e0e\u6027\u80fd\u8981\u6c42\uff08GSPR\uff09\u7684\u7b26\u5408\u6027\u8bc1\u636e\u3001\u98ce\u9669\u7ba1\u7406\u548c\u53d7\u76ca-\u98ce\u9669\u5206\u6790\u62a5\u544a\u3001\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\uff08CER\uff09\u53ca\u5176\u8ba1\u5212\u3001\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u8ba1\u5212\u7b49\u3002<\/p>\n<\/p>\n MDR\u5bf9\u6280\u672f\u6587\u4ef6\u7684\u6df1\u5ea6\u548c\u5e7f\u5ea6\u8981\u6c42\u8fdc\u9ad8\u4e8eMDD\u3002<\/p>\n<\/p>\n 3. \u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\uff08QMS\uff09<\/strong><\/p>\n \u5236\u9020\u5546\u5fc5\u987b\u5efa\u7acb\u5e76\u5b9e\u65bd\u7b26\u5408MDR\u9644\u5f55IX Chapter I\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\u3002<\/p>\n<\/p>\n \u8fd9\u901a\u5e38\u610f\u5473\u7740\u9700\u8981\u83b7\u5f97ISO 13485:2016\u8ba4\u8bc1\uff0c\u4f46MDR\u7684\u8981\u6c42\u66f4\u4e3a\u5177\u4f53\uff0c\u5c24\u5176\u5f3a\u8c03\u4e0e\u4e0a\u5e02\u540e\u76d1\u7763\u3001 vigilance\u7cfb\u7edf\u3001UDI\u6807\u8bc6\u7b49\u8981\u6c42\u7684\u6574\u5408\u3002<\/p>\n<\/p>\n \u516c\u544a\u673a\u6784\u5ba1\u6838QMS\u662f\u7b26\u5408\u6027\u8bc4\u4f30\u8fc7\u7a0b\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\u3002<\/p>\n<\/p>\n 4. \u4e34\u5e8a\u8bc4\u4ef7\u4e0e\u4e34\u5e8a\u8c03\u67e5<\/strong><\/p>\n \u4e34\u5e8a\u8bc4\u4ef7\u662fMDR\u7684\u91cd\u4e2d\u4e4b\u91cd\u3002<\/p>\n<\/p>\n \u5b83\u8981\u6c42\u5236\u9020\u5546\u57fa\u4e8e\u4e34\u5e8a\u6570\u636e\uff0c\u6301\u7eed\u8bc4\u4f30\u548c\u8bc1\u660e\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\u3002<\/p>\n<\/p>\n \u5bf9\u4e8e\u9ad8\u98ce\u9669\u5668\u68b0\u6216\u65b0\u578b\u5668\u68b0\uff0c\u53ef\u80fd\u9700\u8981\u8fdb\u884c\u65b0\u7684\u4e34\u5e8a\u8c03\u67e5\uff08\u4e34\u5e8a\u8bd5\u9a8c\uff09\u6765\u751f\u6210\u5fc5\u8981\u7684\u6570\u636e\u3002<\/p>\n<\/p>\n \u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u9700\u8981\u5b9a\u671f\u66f4\u65b0\uff0c\u5f62\u6210\u4e00\u4e2a\u52a8\u6001\u7684\u5faa\u73af\u8fc7\u7a0b\u3002<\/p>\n<\/p>\n 5. \u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u3001 Vigilance\u548cPMCF<\/strong><\/p>\n MDR\u5f3a\u8c03\u5bf9\u533b\u7597\u5668\u68b0\u7684\u7ec8\u8eab\u76d1\u63a7\u3002<\/p>\n<\/p>\n \u4e0a\u5e02\u540e\u76d1\u7763\u8ba1\u5212\u8981\u6c42\u5236\u9020\u5546\u7cfb\u7edf\u6027\u5730\u6536\u96c6\u548c\u5206\u6790\u4ea7\u54c1\u4e0a\u5e02\u540e\u7684\u7ecf\u9a8c\u548c\u6570\u636e\u3002<\/p>\n<\/p>\n Vigilance\u7cfb\u7edf\u5219\u8981\u6c42\u5236\u9020\u5546\u53ca\u65f6\u5411\u4e3b\u7ba1\u5f53\u5c40\u62a5\u544a\u4e25\u91cd\u4e8b\u6545\u548c\u73b0\u573a\u5b89\u5168\u7ea0\u6b63\u63aa\u65bd\u3002<\/p>\n<\/p>\n \u6b64\u5916\uff0c\u8bb8\u591a\u5668\u68b0\u8fd8\u9700\u8981\u8fdb\u884c\u4e0a\u5e02\u540e\u4e34\u5e8a\u8ddf\u8e2a\uff08PMCF\uff09\uff0c\u4ee5\u4e3b\u52a8\u6536\u96c6\u548c\u8bc4\u4f30\u4e34\u5e8a\u6570\u636e\uff0c\u786e\u8ba4\u4ea7\u54c1\u7684\u957f\u671f\u5b89\u5168\u6027\u548c\u6027\u80fd\u3002<\/p>\n<\/p>\n 6. \u7ecf\u6d4e\u8fd0\u8425\u5546\u7684\u8d23\u4efb<\/strong><\/p>\n MDR\u660e\u786e\u4e86\u4f9b\u5e94\u94fe\u4e2d\u6240\u6709\u201c\u7ecf\u6d4e\u8fd0\u8425\u5546\u201d\u7684\u8d23\u4efb\uff0c\u5305\u62ec\u5236\u9020\u5546\u3001\u6388\u6743\u4ee3\u8868\u3001\u8fdb\u53e3\u5546\u548c\u5206\u9500\u5546\u3002<\/p>\n<\/p>\n \u6bcf\u4e2a\u89d2\u8272\u90fd\u6709\u5176\u7279\u5b9a\u7684\u6cd5\u5f8b\u4e49\u52a1\uff0c\u4f8b\u5982\u8fdb\u53e3\u5546\u9700\u8981\u9a8c\u8bc1\u5236\u9020\u5546\u662f\u5426\u5df2\u5b8c\u6210\u7b26\u5408\u6027\u8bc4\u4f30\u7a0b\u5e8f\uff0c\u5e76\u786e\u4fdd\u5668\u68b0\u5177\u6709UDI\u6807\u8bc6\u3002<\/p>\n<\/p>\n 7. \u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf<\/strong><\/p>\n UDI\u7cfb\u7edf\u662fMDR\u5f15\u5165\u7684\u91cd\u8981\u8ffd\u6eaf\u5de5\u5177\u3002<\/p>\n<\/p>\n \u8981\u6c42\u5236\u9020\u5546\u4e3a\u5176\u5668\u68b0\u5206\u914d\u552f\u4e00\u7684UDI-DI\u548cUDI-PI\u4ee3\u7801\uff0c\u5e76\u5c06\u76f8\u5173\u4fe1\u606f\u63d0\u4ea4\u81f3\u6b27\u76df\u7684EUDAMED\u6570\u636e\u5e93\u3002<\/p>\n<\/p>\n \u8fd9\u6781\u5927\u5730\u589e\u5f3a\u4e86\u533b\u7597\u5668\u68b0\u5728\u6574\u4e2a\u4f9b\u5e94\u94fe\u4e2d\u7684\u53ef\u8ffd\u6eaf\u6027\uff0c\u4fbf\u4e8e\u5e02\u573a\u76d1\u7763\u548c\u4ea7\u54c1\u53ec\u56de\u3002<\/p>\n<\/p>\n 8. \u6b27\u76df\u6570\u636e\u5e93\uff08EUDAMED\uff09<\/strong><\/p>\n EUDAMED\u662f\u4e00\u4e2a\u65e8\u5728\u63d0\u9ad8\u900f\u660e\u5ea6\u7684IT\u7cfb\u7edf\uff0c\u5b83\u5c06\u6574\u5408\u533b\u7597\u5668\u68b0\u76f8\u5173\u7684\u6240\u6709\u4fe1\u606f\u3002<\/p>\n<\/p>\n \u867d\u7136\u76ee\u524d\u662f\u5206\u9636\u6bb5\u542f\u7528\uff0c\u4f46\u6700\u7ec8\u5b83\u5c06\u5305\u542b\u5668\u68b0\u6ce8\u518c\u3001UDI\u3001\u8ba4\u8bc1\u673a\u6784\u3001\u4e34\u5e8a\u8c03\u67e5\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u3001 Vigilance\u62a5\u544a\u7b49\u591a\u9879\u529f\u80fd\uff0c\u6210\u4e3a\u76d1\u7ba1\u673a\u6784\u548c\u516c\u4f17\u67e5\u8be2\u4fe1\u606f\u7684\u91cd\u8981\u5e73\u53f0\u3002<\/p>\n<\/p>\n \u4e09\u3001MDR\u8ba4\u8bc1\u6d41\u7a0b\u6982\u89c8<\/strong><\/p>\n MDR\u8ba4\u8bc1\u7684\u5178\u578b\u6d41\u7a0b\u5305\u62ec\uff1a\u786e\u5b9a\u5668\u68b0\u5206\u7c7b\uff1b\u9009\u62e9\u516c\u544a\u673a\u6784\uff1b\u51c6\u5907\u6280\u672f\u6587\u4ef6\u548cQMS\uff1b\u63d0\u4ea4\u7b26\u5408\u6027\u8bc4\u4f30\u7533\u8bf7\uff1b\u63a5\u53d7\u516c\u544a\u673a\u6784\u5ba1\u6838\uff08\u5305\u62ec\u6587\u4ef6\u8bc4\u5ba1\u548c\u73b0\u573a\u5ba1\u6838\uff09\uff1b\u83b7\u5f97MDR\u8bc1\u4e66\uff1b\u5728EUDAMED\u548c\u56fd\u5bb6\u4e3b\u7ba1\u5f53\u5c40\u8fdb\u884c\u4ea7\u54c1\u6ce8\u518c\uff1b\u6301\u7eed\u5c65\u884c\u4e0a\u5e02\u540e\u4e49\u52a1\u3002<\/p>\n<\/p>\n \u6574\u4e2a\u8fc7\u7a0b\u590d\u6742\u4e14\u8017\u65f6\uff0c\u9700\u8981\u4f01\u4e1a\u6295\u5165\u5927\u91cf\u7684\u8d44\u6e90\u548c\u4e13\u4e1a\u77e5\u8bc6\u3002<\/p>\n<\/p>\n \u56db\u3001\u603b\u7ed3<\/strong><\/p>\n \u603b\u800c\u8a00\u4e4b\uff0cMDR\u8ba4\u8bc1\u662f\u4e00\u4e2a\u5168\u9762\u3001\u4e25\u683c\u4e14\u6301\u7eed\u6027\u7684\u5408\u89c4\u4f53\u7cfb\u3002<\/p>\n<\/p>\n \u5b83\u4e0d\u4ec5\u5305\u62ec\u5bf9\u4ea7\u54c1\u672c\u8eab\u7684\u6280\u672f\u6587\u4ef6\u5ba1\u67e5\uff0c\u8fd8\u6db5\u76d6\u4e86\u5bf9\u5236\u9020\u5546\u8d28\u91cf\u4f53\u7cfb\u3001\u4e34\u5e8a\u8bc1\u636e\u3001\u4e0a\u5e02\u540e\u76d1\u7ba1\u4ee5\u53ca\u4f9b\u5e94\u94fe\u6240\u6709\u53c2\u4e0e\u8005\u8d23\u4efb\u7684\u5168\u9762\u8981\u6c42\u3002<\/p>\n<\/p>\n \u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u800c\u8a00\uff0c\u6df1\u523b\u7406\u89e3MDR\u8ba4\u8bc1\u6240\u5305\u542b\u7684\u5168\u90e8\u5185\u5bb9\uff0c\u662f\u6210\u529f\u8fdb\u5165\u5e76\u4fdd\u6709\u6b27\u76df\u5e02\u573a\u7684\u57fa\u77f3\u3002<\/p>\n<\/p>\n \u5efa\u8bae\u4f01\u4e1a\u5c3d\u65e9\u89c4\u5212\uff0c\u79ef\u6781\u5bfb\u6c42\u4e13\u4e1a\u6cd5\u89c4\u987e\u95ee\u7684\u5e2e\u52a9\uff0c\u4ee5\u786e\u4fdd\u987a\u5229\u901a\u8fc7MDR\u8ba4\u8bc1\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":" MDR\u8ba4\u8bc1\u662f\u533b\u7597\u5668\u68b0\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u95e8\u69db\uff0c\u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u7406\u89e3\u5176\u6db5\u76d6\u7684\u5177\u4f53\u5185\u5bb9\u81f3\u5173\u91cd\u8981\u3002 \u672c\u6587\u5c06\u8be6\u7ec6\u89e3\u6790MD […]<\/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":[391],"class_list":["post-4067","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\/4067","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=4067"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4067\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4067"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4067"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4067"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}