\u533b\u7597\u5668\u68b0mdd\u548cmdr\u662f\u6b27\u76df\u5e02\u573a\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u4f53\u7cfb\u4e2d\u7684\u4e24\u4e2a\u6838\u5fc3\u6307\u4ee4\u548c\u6cd5\u89c4\uff0c\u5bf9\u4e8e\u4efb\u4f55\u5e0c\u671b\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u7684\u5236\u9020\u5546\u6765\u8bf4\uff0c\u7406\u89e3\u5b83\u4eec\u4e4b\u95f4\u7684\u5dee\u5f02\u548c\u6f14\u53d8\u81f3\u5173\u91cd\u8981\u3002<\/p>\n<\/p>\n
\u4e00\u3001 \u533b\u7597\u5668\u68b0MDD\u548cMDR\u6982\u8ff0\uff1a\u4ece\u6307\u4ee4\u5230\u6cd5\u89c4\u7684\u6f14\u53d8<\/strong><\/p>\n MDD\uff0c\u5373\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08Medical Devices Directive\uff09\uff0c\u5176\u6307\u4ee4\u7f16\u53f7\u4e3a93\/42\/EEC\uff0c\u662f\u6b27\u76df\u81ea20\u4e16\u7eaa90\u5e74\u4ee3\u8d77\u5b9e\u65bd\u7684\u76d1\u7ba1\u6846\u67b6\u3002<\/p>\n \u5b83\u4e3a\u6838\u5fc3\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u8bbe\u5b9a\u4e86\u57fa\u672c\u7684\u5b89\u5168\u4e0e\u5065\u5eb7\u8981\u6c42\uff0c\u901a\u8fc7\u7b26\u5408\u6027\u8bc4\u5b9a\u7a0b\u5e8f\u540e\uff0c\u4ea7\u54c1\u5373\u53ef\u52a0\u8d34CE\u6807\u5fd7\uff0c\u5728\u6b27\u76df\u8303\u56f4\u5185\u81ea\u7531\u6d41\u901a\u3002<\/p>\n \u7136\u800c\uff0c\u968f\u7740\u533b\u7597\u6280\u672f\u7684\u98de\u901f\u53d1\u5c55\u548c\u4e00\u4e9b\u91cd\u5927\u533b\u7597\u5668\u68b0\u5b89\u5168\u4e8b\u4ef6\u7684\u66dd\u5149\uff0cMDD\u7684\u5c40\u9650\u6027\u9010\u6e10\u663e\u73b0\uff0c\u5176\u76d1\u7ba1\u7684\u5e7f\u5ea6\u548c\u6df1\u5ea6\u5df2\u4e0d\u8db3\u4ee5\u5e94\u5bf9\u65e5\u76ca\u590d\u6742\u7684\u5e02\u573a\u73af\u5883\u3002<\/p>\n<\/p>\n MDR\uff0c\u5373\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Devices Regulation\uff09\uff0c\u6cd5\u89c4\u7f16\u53f7\u4e3a(EU) 2017\/745\uff0c\u4e8e2017\u5e74\u6b63\u5f0f\u53d1\u5e03\u5e76\u9010\u6b65\u53d6\u4ee3MDD\u3002<\/p>\n \u4e0e\u4f5c\u4e3a\u201c\u6307\u4ee4\u201d\u7684MDD\u4e0d\u540c\uff0cMDR\u662f\u76f4\u63a5\u9002\u7528\u4e8e\u6240\u6709\u6b27\u76df\u6210\u5458\u56fd\u7684\u201c\u6cd5\u89c4\u201d\uff0c\u8fd9\u610f\u5473\u7740\u5b83\u65e0\u9700\u50cf\u6307\u4ee4\u90a3\u6837\u88ab\u5404\u56fd\u8f6c\u5316\u4e3a\u56fd\u5185\u6cd5\uff0c\u4ece\u800c\u51cf\u5c11\u4e86\u6267\u884c\u5c42\u9762\u7684\u5dee\u5f02\uff0c\u786e\u4fdd\u4e86\u76d1\u7ba1\u6807\u51c6\u7684\u9ad8\u5ea6\u7edf\u4e00\u3002<\/p>\n \u8fd9\u4e00\u8f6c\u53d8\u6807\u5fd7\u7740\u6b27\u76df\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u8fdb\u5165\u4e86\u4e00\u4e2a\u66f4\u4e25\u683c\u3001\u66f4\u900f\u660e\u3001\u66f4\u5168\u9762\u7684\u65b0\u65f6\u4ee3\u3002<\/p>\n<\/p>\n \u4e8c\u3001 MDD\u4e0eMDR\u7684\u6838\u5fc3\u5dee\u5f02\u5bf9\u6bd4<\/strong><\/p>\n MDD\u548cMDR\u4e4b\u95f4\u7684\u53d8\u5316\u662f\u6839\u672c\u6027\u7684\uff0c\u6db5\u76d6\u4e86\u76d1\u7ba1\u7684\u65b9\u65b9\u9762\u9762\uff0c\u5236\u9020\u5546\u5fc5\u987b\u5168\u9762\u5ba1\u89c6\u8fd9\u4e9b\u5dee\u5f02\u3002<\/p>\n<\/p>\n 1. \u76d1\u7ba1\u8303\u56f4\u6269\u5927<\/strong><\/p>\n MDR\u6781\u5927\u5730\u6269\u5c55\u4e86\u533b\u7597\u5668\u68b0\u7684\u5b9a\u4e49\u548c\u76d1\u7ba1\u8303\u56f4\u3002<\/p>\n \u4f8b\u5982\uff0c\u4e00\u4e9b\u6ca1\u6709\u533b\u7597\u76ee\u7684\u4f46\u5177\u6709\u7c7b\u4f3c\u529f\u80fd\u7684\u4ea7\u54c1\uff0c\u5982\u7528\u4e8e\u7f8e\u5bb9\u7684\u5f69\u8272\u9690\u5f62\u773c\u955c\u3001\u51cf\u80a5\u80c3\u7403\u56ca\u7b49\uff0c\u73b0\u5728\u88ab\u660e\u786e\u7eb3\u5165MDR\u7684\u76d1\u7ba1\u4e4b\u4e0b\u3002<\/p>\n \u6b64\u5916\uff0c\u5bf9\u542b\u6709\u836f\u7269\u6210\u5206\u7684\u5668\u68b0\u3001\u7eb3\u7c73\u6750\u6599\u5668\u68b0\u7b49\u4e5f\u63d0\u51fa\u4e86\u66f4\u5177\u4f53\u7684\u8981\u6c42\u3002<\/p>\n<\/p>\n 2. \u4e34\u5e8a\u8bc1\u636e\u8981\u6c42\u663e\u8457\u52a0\u5f3a<\/strong><\/p>\n MDR\u5bf9\u4e34\u5e8a\u8bc4\u4ef7\u548c\u4e34\u5e8a\u8bc1\u636e\u7684\u8981\u6c42\u8fbe\u5230\u4e86\u524d\u6240\u672a\u6709\u7684\u9ad8\u5ea6\u3002<\/p>\n \u5b83\u8981\u6c42\u5236\u9020\u5546\u5fc5\u987b\u4e3a\u6240\u6709\u5668\u68b0\uff0c\u5305\u62ec\u4ee5\u524d\u6839\u636eMDD\u8ba4\u8bc1\u7684\u5668\u68b0\uff0c\u63d0\u4f9b\u6301\u7eed\u66f4\u65b0\u7684\u3001\u4e25\u683c\u7684\u4e34\u5e8a\u8bc1\u636e\u4ee5\u8bc1\u660e\u5176\u5b89\u5168\u6027\u548c\u6027\u80fd\u3002<\/p>\n \u4e34\u5e8a\u8bc4\u4ef7\u4e0d\u518d\u662f\u4e00\u6b21\u6027\u6d3b\u52a8\uff0c\u800c\u662f\u4e00\u4e2a\u8d2f\u7a7f\u533b\u7597\u5668\u68b0\u6574\u4e2a\u751f\u547d\u5468\u671f\u7684\u6301\u7eed\u8fc7\u7a0b\u3002<\/p>\n<\/p>\n 3. \u8ffd\u6eaf\u6027\u548c\u900f\u660e\u5ea6\u63d0\u5347<\/strong><\/p>\n MDR\u5efa\u7acb\u4e86\u66f4\u5b8c\u5584\u7684\u533b\u7597\u5668\u68b0\u8ffd\u6eaf\u7cfb\u7edf\uff08UDI – Unique Device Identification\uff09\u3002<\/p>\n \u6bcf\u4e2a\u5668\u68b0\u90fd\u5c06\u62e5\u6709\u552f\u4e00\u7684\u8bbe\u5907\u6807\u8bc6\u7b26\uff0c\u5e76\u5c06\u5176\u4fe1\u606f\u5f55\u5165\u6b27\u6d32\u533b\u7597\u5668\u68b0\u6570\u636e\u5e93\uff08EUDAMED\uff09\u3002<\/p>\n \u8fd9\u4f7f\u5f97\u4ece\u5236\u9020\u5546\u5230\u60a3\u8005\u7684\u6574\u4e2a\u4f9b\u5e94\u94fe\u6d41\u7a0b\u90fd\u53ef\u8ffd\u6eaf\uff0c\u4e00\u65e6\u53d1\u751f\u5b89\u5168\u95ee\u9898\uff0c\u53ef\u4ee5\u8fc5\u901f\u91c7\u53d6\u884c\u52a8\uff0c\u540c\u65f6\u4e5f\u6781\u5927\u589e\u5f3a\u4e86\u5bf9\u516c\u4f17\u7684\u900f\u660e\u5ea6\u3002<\/p>\n<\/p>\n 4. \u5bf9\u7ecf\u6d4e\u8fd0\u8425\u5546\u7684\u804c\u8d23\u754c\u5b9a\u66f4\u6e05\u6670<\/strong><\/p>\n MDR\u660e\u786e\u5e76\u5f3a\u5316\u4e86\u4f9b\u5e94\u94fe\u4e2d\u6240\u6709\u201c\u7ecf\u6d4e\u8fd0\u8425\u5546\u201d\uff08\u5305\u62ec\u5236\u9020\u5546\u3001\u6388\u6743\u4ee3\u8868\u3001\u8fdb\u53e3\u5546\u548c\u5206\u9500\u5546\uff09\u7684\u8d23\u4efb\u3002<\/p>\n \u7279\u522b\u662f\u201c\u6388\u6743\u4ee3\u8868\u201d\u7684\u8d23\u4efb\u88ab\u5927\u5e45\u52a0\u91cd\uff0c\u4ed6\u4eec\u9700\u8981\u5bf9\u5236\u9020\u5546\u7684\u4ea7\u54c1\u627f\u62c5\u8fde\u5e26\u6cd5\u5f8b\u8d23\u4efb\uff0c\u800c\u4e0d\u518d\u4ec5\u4ec5\u662f\u884c\u653f\u4e0a\u7684\u8054\u7cfb\u4eba\u3002<\/p>\n<\/p>\n 5. \u4e3b\u7ba1\u673a\u6784\u548c\u516c\u544a\u673a\u6784\u76d1\u7ba1\u66f4\u4e25\u683c<\/p>\n MDR\u5bf9\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u6807\u51c6\u548c\u6d41\u7a0b\u66f4\u52a0\u4e25\u683c\uff0c\u4ee5\u786e\u4fdd\u5176\u5ba1\u6838\u7684\u4e00\u81f4\u6027\u548c\u4e25\u8c28\u6027\u3002<\/p>\n \u540c\u65f6\uff0c\u5b83\u4e5f\u8d4b\u4e88\u4e86\u5404\u56fd\u4e3b\u7ba1\u673a\u6784\u66f4\u5927\u7684\u5e02\u573a\u76d1\u7ba1\u548c\u4ea7\u54c1\u62bd\u6837\u68c0\u6d4b\u6743\u529b\u3002<\/p>\n<\/p>\n \u4e09\u3001 \u4eceMDD\u8fc7\u6e21\u5230MDR\u7684\u6311\u6218\u4e0e\u7b56\u7565<\/strong><\/p>\n \u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u4eceMDD\u8fc7\u6e21\u5230MDR\u662f\u4e00\u9879\u590d\u6742\u4e14\u8d44\u6e90\u5bc6\u96c6\u7684\u7cfb\u7edf\u5de5\u7a0b\u3002<\/p>\n \u9996\u8981\u6311\u6218\u662f\u6280\u672f\u6587\u4ef6\u7684\u66f4\u65b0\uff0c\u5fc5\u987b\u6309\u7167MDR\u7684\u9644\u5f55\u8981\u6c42\u91cd\u65b0\u7f16\u5199\u548c\u6574\u7406\u6240\u6709\u6280\u672f\u6587\u6863\uff0c\u7279\u522b\u662f\u52a0\u5f3a\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u3002<\/p>\n \u5176\u6b21\uff0c\u662f\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u5347\u7ea7\uff0cQMS\u5fc5\u987b\u8fdb\u884c\u76f8\u5e94\u8c03\u6574\u4ee5\u6ee1\u8db3MDR\u7684\u65b0\u8981\u6c42\u3002<\/p>\n \u6b64\u5916\uff0c\u7531\u4e8e\u516c\u544a\u673a\u6784\u5ba1\u6838\u4efb\u52a1\u6fc0\u589e\u4e14\u6d41\u7a0b\u53d8\u957f\uff0c\u7533\u8bf7\u8ba4\u8bc1\u7684\u65f6\u95f4\u5468\u671f\u4e5f\u5927\u5927\u5ef6\u957f\uff0c\u5236\u9020\u5546\u9700\u8981\u5c3d\u65e9\u89c4\u5212\uff0c\u7559\u51fa\u5145\u8db3\u7684\u7f13\u51b2\u65f6\u95f4\u3002<\/p>\n<\/p>\n \u5236\u5b9a\u4e00\u4e2a\u8be6\u5c3d\u7684\u8fc7\u6e21\u8ba1\u5212\u662f\u6210\u529f\u7684\u5173\u952e\u3002<\/p>\n \u8fd9\u5305\u62ec\uff1a\u5168\u9762\u5dee\u8ddd\u5206\u6790\uff0c\u8bc6\u522b\u73b0\u6709\u4f53\u7cfb\u4e0eMDR\u8981\u6c42\u4e4b\u95f4\u7684\u6240\u6709\u5dee\u5f02\uff1b\u7ec4\u5efa\u4e00\u4e2a\u8de8\u90e8\u95e8\u7684MDR\u8fc7\u6e21\u56e2\u961f\uff1b\u5c3d\u65e9\u4e0e\u516c\u544a\u673a\u6784\u6c9f\u901a\u5e76\u63d0\u4ea4\u7533\u8bf7\uff1b\u4ee5\u53ca\u5bc6\u5207\u5173\u6ce8EUDAMED\u6570\u636e\u5e93\u7684\u66f4\u65b0\u548c\u5b9e\u65bd\u6307\u5357\u7684\u53d1\u5e03\u3002<\/p>\n<\/p>\n \u56db\u3001 \u603b\u7ed3\uff1a\u62e5\u62b1\u66f4\u4e25\u683c\u7684\u76d1\u7ba1\u65b0\u65f6\u4ee3<\/strong><\/p>\n \u533b\u7597\u5668\u68b0mdd\u548cmdr\u7684\u6f14\u8fdb\uff0c\u672c\u8d28\u4e0a\u662f\u5168\u7403\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u8d8b\u4e25\u5927\u8d8b\u52bf\u4e0b\u7684\u4e00\u4e2a\u7f29\u5f71\u3002<\/p>\n MDR\u867d\u7136\u5e26\u6765\u4e86\u5de8\u5927\u7684\u5408\u89c4\u6311\u6218\u548c\u6210\u672c\uff0c\u4f46\u5176\u6700\u7ec8\u76ee\u6807\u662f\u786e\u4fdd\u6295\u653e\u6b27\u76df\u5e02\u573a\u7684\u6240\u6709\u533b\u7597\u5668\u68b0\u90fd\u5177\u6709\u66f4\u9ad8\u7684\u5b89\u5168\u6027\u3001\u6027\u80fd\u548c\u900f\u660e\u5ea6\uff0c\u4ece\u800c\u66f4\u597d\u5730\u4fdd\u62a4\u60a3\u8005\u3001\u4f7f\u7528\u8005\u53ca\u516c\u4f17\u7684\u5065\u5eb7\u3002<\/p>\n \u5bf9\u4e8e\u5236\u9020\u5546\u6765\u8bf4\uff0c\u79ef\u6781\u9002\u5e94\u5e76\u6ee1\u8db3MDR\u7684\u8981\u6c42\uff0c\u4e0d\u4ec5\u662f\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u7684\u5f3a\u5236\u6027\u901a\u884c\u8bc1\uff0c\u66f4\u662f\u6784\u5efa\u4f01\u4e1a\u957f\u671f\u4fe1\u8a89\u548c\u6838\u5fc3\u7ade\u4e89\u529b\u7684\u6218\u7565\u6295\u8d44\u3002<\/p>\n \u53ea\u6709\u4e3b\u52a8\u62e5\u62b1\u8fd9\u79cd\u53d8\u5316\uff0c\u624d\u80fd\u5728\u65e5\u76ca\u6fc0\u70c8\u7684\u5168\u7403\u5e02\u573a\u7ade\u4e89\u4e2d\u7acb\u4e8e\u4e0d\u8d25\u4e4b\u5730\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":" \u533b\u7597\u5668\u68b0mdd\u548cmdr\u662f\u6b27\u76df\u5e02\u573a\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u4f53\u7cfb\u4e2d\u7684\u4e24\u4e2a\u6838\u5fc3\u6307\u4ee4\u548c\u6cd5\u89c4\uff0c\u5bf9\u4e8e\u4efb\u4f55\u5e0c\u671b\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u7684\u5236\u9020\u5546\u6765\u8bf4\uff0c […]<\/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":[372],"class_list":["post-4048","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-mddmdr"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4048","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=4048"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4048\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4048"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4048"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4048"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}