{"id":3979,"date":"2025-09-04T13:58:00","date_gmt":"2025-09-04T05:58:00","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=3979"},"modified":"2025-09-04T13:58:00","modified_gmt":"2025-09-04T05:58:00","slug":"%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0mdr%e8%ae%a4%e8%af%81%e6%80%8e%e4%b9%88%e8%ae%a4%e8%af%81","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=3979","title":{"rendered":"\u533b\u7597\u5668\u68b0mdr\u8ba4\u8bc1\u600e\u4e48\u8ba4\u8bc1"},"content":{"rendered":"

\u4e00\u3001\u533b\u7597\u5668\u68b0MDR\u8ba4\u8bc1\u600e\u4e48\u8ba4\u8bc1\uff1a\u5168\u9762\u6307\u5357\u4e0e\u6b65\u9aa4\u89e3\u6790<\/strong><\/p>\n

\u533b\u7597\u5668\u68b0MDR\u8ba4\u8bc1\u600e\u4e48\u8ba4\u8bc1\u662f\u8bb8\u591a\u5236\u9020\u5546\u548c\u51fa\u53e3\u5546\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u65f6\u5fc5\u987b\u9762\u5bf9\u7684\u5173\u952e\u95ee\u9898\uff0cMDR\uff08Medical Device Regulation\uff09\u662f\u6b27\u76df\u4e8e2017\u5e74\u53d1\u5e03\u7684\u65b0\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff0c\u53d6\u4ee3\u4e86\u539f\u6709\u7684MDD\uff08Medical Device Directive\uff09\u548cAIMDD\uff08Active Implantable Medical Device Directive\uff09\uff0c\u65e8\u5728\u63d0\u9ad8\u533b\u7597\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u900f\u660e\u5ea6\uff0c\u8be5\u6cd5\u89c4\u4e8e2021\u5e745\u6708\u6b63\u5f0f\u5b9e\u65bd\uff0c\u8981\u6c42\u6240\u6709\u76f8\u5173\u4ea7\u54c1\u5fc5\u987b\u901a\u8fc7\u4e25\u683c\u8bc4\u4f30\u624d\u80fd\u83b7\u5f97CE\u6807\u5fd7\u5e76\u5728\u6b27\u76df\u9500\u552e\uff0c\u5bf9\u4e8e\u4f01\u4e1a\u6765\u8bf4\uff0c\u7406\u89e3MDR\u8ba4\u8bc1\u7684\u6d41\u7a0b\u81f3\u5173\u91cd\u8981\uff0c\u56e0\u4e3a\u5b83\u6d89\u53ca\u590d\u6742\u7684\u6b65\u9aa4\uff0c\u5305\u62ec\u6280\u672f\u6587\u4ef6\u51c6\u5907\u3001\u4e34\u5e8a\u8bc4\u4f30\u3001\u8d28\u91cf\u4f53\u7cfb\u5ba1\u6838\u7b49\uff0c\u672c\u6587\u5c06\u8be6\u7ec6\u89e3\u6790\u533b\u7597\u5668\u68b0MDR\u8ba4\u8bc1\u7684\u5168\u8fc7\u7a0b\uff0c\u5e2e\u52a9\u60a8\u7cfb\u7edf\u5316\u5730\u5e94\u5bf9\u8fd9\u4e00\u6311\u6218\u3002<\/p>\n<\/p>\n

\u4e8c\u3001MDR\u8ba4\u8bc1\u7684\u6838\u5fc3\u8981\u6c42\u4e0e\u51c6\u5907\u9636\u6bb5<\/strong><\/p>\n

\u5728\u5f00\u59cb\u533b\u7597\u5668\u68b0MDR\u8ba4\u8bc1\u600e\u4e48\u8ba4\u8bc1\u7684\u5177\u4f53\u6d41\u7a0b\u524d\uff0c\u4f01\u4e1a\u9996\u5148\u9700\u8981\u4e86\u89e3MDR\u7684\u6838\u5fc3\u8981\u6c42\uff0cMDR\u5f3a\u8c03\u751f\u547d\u5468\u671f\u7ba1\u7406\uff0c\u8981\u6c42\u5236\u9020\u5546\u4ece\u8bbe\u8ba1\u3001\u751f\u4ea7\u5230\u552e\u540e\u76d1\u63a7\u90fd\u786e\u4fdd\u4ea7\u54c1\u5b89\u5168\uff0c\u5173\u952e\u51c6\u5907\u5305\u62ec\u786e\u5b9a\u4ea7\u54c1\u5206\u7c7b\uff08\u57fa\u4e8e\u98ce\u9669\u5206\u4e3aI\u3001IIa\u3001IIb\u3001III\u7c7b\uff09\u3001\u9009\u62e9\u5408\u683c\u7684\u516c\u544a\u673a\u6784\uff08Notified Body\uff09\uff0c\u4ee5\u53ca\u5efa\u7acb\u5b8c\u5584\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08\u5982\u7b26\u5408ISO 13485\u6807\u51c6\uff09\uff0c\u4f01\u4e1a\u8fd8\u9700\u51c6\u5907\u6280\u672f\u6587\u4ef6\uff0c\u5305\u62ec\u4ea7\u54c1\u63cf\u8ff0\u3001\u8bbe\u8ba1\u4fe1\u606f\u3001\u6027\u80fd\u6570\u636e\u3001\u98ce\u9669\u8bc4\u4f30\u548c\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a\uff0c\u4e34\u5e8a\u8bc4\u4f30\u662fMDR\u7684\u91cd\u70b9\uff0c\u8981\u6c42\u63d0\u4f9b\u66f4\u4e25\u683c\u7684\u8bc1\u636e\u6765\u8bc1\u660e\u4ea7\u54c1\u5b89\u5168\u548c\u6709\u6548\uff0c\u5c24\u5176\u662f\u5bf9\u4e8e\u9ad8\u98ce\u9669\u4ea7\u54c1\uff0c\u53ef\u80fd\u9700\u8981\u8fdb\u884c\u4e0a\u5e02\u540e\u4e34\u5e8a\u8ddf\u8e2a\uff0c\u63d0\u524d\u89c4\u5212\u8fd9\u4e9b\u8981\u7d20\u53ef\u4ee5\u907f\u514d\u540e\u7eed\u5ef6\u8bef\uff0c\u786e\u4fdd\u8ba4\u8bc1\u8fc7\u7a0b\u987a\u5229\u8fdb\u884c\u3002<\/p>\n<\/p>\n

\u4e09\u3001MDR\u8ba4\u8bc1\u7684\u5177\u4f53\u6b65\u9aa4\uff1a\u4ece\u7533\u8bf7\u5230\u83b7\u8bc1<\/strong><\/p>\n

\u533b\u7597\u5668\u68b0MDR\u8ba4\u8bc1\u600e\u4e48\u8ba4\u8bc1\u7684\u5b9e\u64cd\u6b65\u9aa4\u53ef\u5206\u4e3a\u591a\u4e2a\u9636\u6bb5\uff0c\u9996\u5148\uff0c\u4f01\u4e1a\u9700\u5411\u9009\u5b9a\u7684\u516c\u544a\u673a\u6784\u63d0\u4ea4\u7533\u8bf7\uff0c\u5305\u62ec\u6280\u672f\u6587\u4ef6\u548c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u4fe1\u606f\uff0c\u516c\u544a\u673a\u6784\u4f1a\u8fdb\u884c\u6587\u6863\u8bc4\u5ba1\u548c\u73b0\u573a\u5ba1\u6838\uff0c\u4ee5\u8bc4\u4f30\u7b26\u5408\u6027\uff0c\u5ba1\u6838\u901a\u8fc7\u540e\uff0c\u4f01\u4e1a\u53ef\u80fd\u9700\u8981\u8fdb\u884c\u4e34\u5e8a\u8bc4\u4f30\u5ba1\u67e5\u6216\u9644\u52a0\u6d4b\u8bd5\uff0c\u4f8b\u5982\u5bf9\u4e8eIII\u7c7b\u6216\u690d\u5165\u5f0f\u5668\u68b0\uff0cMDR\u8981\u6c42\u66f4\u6df1\u5165\u7684\u4e34\u5e8a\u6570\u636e\u5ba1\u67e5\uff0c\u4e00\u65e6\u901a\u8fc7\uff0c\u516c\u544a\u673a\u6784\u4f1a\u9881\u53d1CE\u8bc1\u4e66\uff0c\u5141\u8bb8\u4ea7\u54c1\u52a0\u8d34CE\u6807\u5fd7\u5e76\u8fdb\u5165\u6b27\u76df\u5e02\u573a\uff0c\u4f46\u8ba4\u8bc1\u540e\uff0c\u4f01\u4e1a\u8fd8\u5fc5\u987b\u5c65\u884c\u4e0a\u5e02\u540e\u76d1\u7763\u4e49\u52a1\uff0c\u5305\u62ec incident \u62a5\u544a\u3001\u5b9a\u671f\u5b89\u5168\u66f4\u65b0\u548c\u6301\u7eed\u4e34\u5e8a\u8bc4\u4f30\uff0c\u6574\u4e2a\u6d41\u7a0b\u53ef\u80fd\u9700\u8981\u6570\u6708\u5230\u6570\u5e74\uff0c\u53d6\u51b3\u4e8e\u4ea7\u54c1\u590d\u6742\u6027\u548c\u51c6\u5907\u7a0b\u5ea6\uff0c\u56e0\u6b64\u5efa\u8bae\u4f01\u4e1a\u5c3d\u65e9\u542f\u52a8\uff0c\u5e76\u4e0e\u4e13\u4e1a\u987e\u95ee\u5408\u4f5c\u4ee5\u63d0\u9ad8\u6548\u7387\u3002<\/p>\n<\/p>\n

\u56db\u3001\u5e38\u89c1\u6311\u6218\u4e0e\u5e94\u5bf9\u7b56\u7565<\/strong><\/p>\n

\u533b\u7597\u5668\u68b0MDR\u8ba4\u8bc1\u600e\u4e48\u8ba4\u8bc1\u8fc7\u7a0b\u4e2d\uff0c\u4f01\u4e1a\u5e38\u9762\u4e34\u8bf8\u591a\u6311\u6218\uff0c\u5982\u4e34\u5e8a\u6570\u636e\u4e0d\u8db3\u3001\u6280\u672f\u6587\u4ef6\u4e0d\u5b8c\u6574\u6216\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u672a\u8fbe\u6807\uff0cMDR\u5bf9\u4e34\u5e8a\u8bc1\u636e\u7684\u8981\u6c42\u66f4\u9ad8\uff0c\u8bb8\u591a\u65e7\u4ea7\u54c1\u53ef\u80fd\u9700\u8981\u8865\u5145\u7814\u7a76\u6216\u6570\u636e\uff0c\u8fd9\u589e\u52a0\u4e86\u65f6\u95f4\u548c\u6210\u672c\uff0c\u6b64\u5916\uff0c\u516c\u544a\u673a\u6784\u8d44\u6e90\u6709\u9650\uff0c\u53ef\u80fd\u5bfc\u81f4\u5ba1\u6838\u5ef6\u8fdf\uff0c\u4e3a\u5e94\u5bf9\u8fd9\u4e9b\uff0c\u4f01\u4e1a\u5e94\u63d0\u524d\u8fdb\u884c\u5dee\u8ddd\u5206\u6790\uff0c\u8bc6\u522b\u5f31\u70b9\u5e76\u5236\u5b9a\u6539\u8fdb\u8ba1\u5212\uff0c\u6295\u8d44\u4e8e\u5458\u5de5\u57f9\u8bad\u548c\u5916\u90e8\u4e13\u5bb6\u54a8\u8be2\u4e5f\u5f88\u91cd\u8981\uff0c\u4f8b\u5982\uff0c\u8058\u8bf7MDR\u987e\u95ee\u53ef\u4ee5\u5e2e\u52a9\u5bfc\u822a\u590d\u6742\u8981\u6c42\uff0c\u540c\u65f6\uff0c\u5229\u7528\u6570\u5b57\u5316\u5de5\u5177\u7ba1\u7406\u6587\u6863\u548c\u6d41\u7a0b\u53ef\u4ee5\u63d0\u5347\u6548\u7387\uff0c\u4fdd\u6301\u4e0e\u516c\u544a\u673a\u6784\u7684\u6c9f\u901a\uff0c\u5e76\u5173\u6ce8\u6b27\u76df\u6570\u636e\u5e93\uff08\u5982EUDAMED\uff09\u7684\u66f4\u65b0\uff0c\u4e5f\u80fd\u786e\u4fdd\u5408\u89c4\u6027\u3002<\/p>\n<\/p>\n

\u4e94\u3001\u7ed3\u8bba\uff1a\u6210\u529f\u83b7\u5f97MDR\u8ba4\u8bc1\u7684\u5173\u952e<\/strong><\/p>\n

\u603b\u4e4b\uff0c\u533b\u7597\u5668\u68b0MDR\u8ba4\u8bc1\u600e\u4e48\u8ba4\u8bc1\u662f\u4e00\u4e2a\u7cfb\u7edf\u5316\u8fc7\u7a0b\uff0c\u8981\u6c42\u4f01\u4e1a\u4ece\u6218\u7565\u5c42\u9762\u91cd\u89c6\u5408\u89c4\u6027\uff0c\u901a\u8fc7\u5145\u5206\u51c6\u5907\u3001\u4e25\u683c\u9075\u5faa\u6b65\u9aa4\u548c\u79ef\u6781\u5e94\u5bf9\u6311\u6218\uff0c\u5236\u9020\u5546\u53ef\u4ee5\u6210\u529f\u83b7\u5f97\u8ba4\u8bc1\u5e76\u7ef4\u6301\u5e02\u573a\u51c6\u5165\uff0c\u8bb0\u4f4f\uff0cMDR\u4e0d\u4ec5\u662f\u6cd5\u89c4\u8981\u6c42\uff0c\u66f4\u662f\u63d0\u5347\u4ea7\u54c1\u5b89\u5168\u548c\u4f01\u4e1a\u4fe1\u8a89\u7684\u673a\u4f1a\uff0c\u5efa\u8bae\u6301\u7eed\u5b66\u4e60\u6cd5\u89c4\u53d8\u5316\uff0c\u5e76\u878d\u5165\u4f01\u4e1a\u65e5\u5e38\u8fd0\u8425\uff0c\u4ee5\u786e\u4fdd\u957f\u671f\u6210\u529f\u3002<\/p>\n

\u514d\u8d23\u58f0\u660e\uff1a\u672c\u6587\u5185\u5bb9\u4ec5\u4f9b\u53c2\u8003\uff0c\u4e0d\u6784\u6210\u4e13\u4e1a\u6cd5\u5f8b\u6216\u533b\u7597\u5efa\u8bae\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":"

\u4e00\u3001\u533b\u7597\u5668\u68b0MDR\u8ba4\u8bc1\u600e\u4e48\u8ba4\u8bc1\uff1a\u5168\u9762\u6307\u5357\u4e0e\u6b65\u9aa4\u89e3\u6790 \u533b\u7597\u5668\u68b0MDR\u8ba4\u8bc1\u600e\u4e48\u8ba4\u8bc1\u662f\u8bb8\u591a\u5236\u9020\u5546\u548c\u51fa\u53e3\u5546\u8fdb\u5165\u6b27\u6d32\u5e02\u573a […]<\/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":[304],"class_list":["post-3979","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\/3979","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=3979"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/3979\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3979"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3979"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3979"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}