MDR CE\u8bc1\u4e66\u662f\u533b\u7597\u5668\u68b0\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u51c6\u5165\u51ed\u8bc1\uff0c\u5176\u5168\u79f0\u4e3aMedical Device Regulation CE Certification\uff0c\u4f9d\u636e\u6b27\u76df2017\/745\u53f7\u6cd5\u89c4\uff08MDR\uff09\u5b9e\u65bd<\/p>\n<\/p>\n
\u8be5\u8bc1\u4e66\u53d6\u4ee3\u4e86\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\uff0c\u663e\u8457\u63d0\u5347\u4e86\u76d1\u7ba1\u8981\u6c42\u7684\u4e25\u683c\u6027\u548c\u900f\u660e\u5ea6\uff0c\u65e8\u5728\u786e\u4fdd\u6295\u653e\u6b27\u76df\u5e02\u573a\u7684\u533b\u7597\u5668\u68b0\u5177\u6709\u66f4\u9ad8\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\u53ef\u9760\u6027<\/p>\n<\/p>\n
\u4e00\u3001MDR CE\u8bc1\u4e66\u7684\u6838\u5fc3\u610f\u4e49\u4e0e\u9002\u7528\u8303\u56f4<\/strong><\/p>\n MDR CE\u8bc1\u4e66\u4e0d\u4ec5\u662f\u4e00\u79cd\u7b26\u5408\u6027\u6807\u5fd7\uff0c\u66f4\u662f\u5236\u9020\u5546\u5bf9\u4ea7\u54c1\u7b26\u5408\u6b27\u76df\u6cd5\u89c4\u8981\u6c42\u7684\u5177\u6709\u6cd5\u5f8b\u7ea6\u675f\u529b\u7684\u627f\u8bfa<\/p>\n<\/p>\n \u5b83\u9002\u7528\u4e8e\u5728\u6b27\u76df\u5e02\u573a\u4e0a\u9500\u552e\u7684\u5404\u7c7b\u533b\u7597\u5668\u68b0\uff0c\u4ece\u4f4e\u98ce\u9669\u7684\u65e0\u83cc\u7eb1\u5e03\u5230\u9ad8\u98ce\u9669\u7684\u690d\u5165\u5f0f\u5668\u68b0\uff0c\u5982\u5fc3\u810f\u8d77\u640f\u5668\u548c\u4eba\u5de5\u5173\u8282\uff0c\u5747\u9700\u4f9d\u636e\u5176\u98ce\u9669\u7b49\u7ea7\u901a\u8fc7\u76f8\u5e94\u7684\u7b26\u5408\u6027\u8bc4\u4f30\u7a0b\u5e8f<\/p>\n<\/p>\n \u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u65b0\u6cd5\u89c4\u6269\u5927\u4e86\u76d1\u7ba1\u8303\u56f4\uff0c\u5c06\u67d0\u4e9b\u975e\u533b\u7597\u7528\u9014\u7684\u5668\u68b0\uff08\u5982\u7f8e\u5bb9\u9690\u5f62\u773c\u955c\u548c\u62bd\u8102\u8bbe\u5907\uff09\u4e5f\u7eb3\u5165\u7ba1\u8f96<\/p>\n<\/p>\n \u4e8c\u3001MDR\u76f8\u8f83\u4e8eMDD\u7684\u4e3b\u8981\u53d8\u5316\u4e0e\u521b\u65b0\u8981\u6c42<\/strong><\/p>\n MDR\u6cd5\u89c4\u5f15\u5165\u4e86\u4e00\u7cfb\u5217\u9769\u65b0\u6027\u8981\u6c42\uff0c\u5bf9\u5236\u9020\u5546\u6784\u6210\u4e86\u66f4\u4e3a\u4e25\u5cfb\u7684\u5408\u89c4\u6311\u6218<\/p>\n<\/p>\n \u9996\u5148\uff0c\u5728\u4e34\u5e8a\u8bc1\u636e\u65b9\u9762\uff0cMDR\u8981\u6c42\u63d0\u4f9b\u66f4\u5145\u5206\u3001\u66f4\u4e25\u683c\u7684\u4e34\u5e8a\u6570\u636e\u6765\u8bc1\u660e\u5668\u68b0\u7684\u5b89\u5168\u4e0e\u6027\u80fd\uff0c\u5373\u4f7f\u662f\u4e4b\u524d\u4f9d\u636eMDD\u5df2\u83b7\u8ba4\u8bc1\u7684\u4ea7\u54c1\uff0c\u4e5f\u9700\u91cd\u65b0\u8bc4\u4f30\u4ee5\u6ee1\u8db3\u65b0\u89c4<\/p>\n<\/p>\n \u5176\u6b21\uff0c\u52a0\u5f3a\u4e86\u5bf9\u5668\u68b0\u552f\u4e00\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf\u7684\u6267\u884c\u89c4\u5b9a\uff0c\u8981\u6c42\u6240\u6709\u5668\u68b0\u90fd\u5fc5\u987b\u62e5\u6709UDI\u6807\u8bc6\uff0c\u4ee5\u5b9e\u73b0\u4ece\u751f\u4ea7\u5230\u4f7f\u7528\u7684\u5168\u94fe\u6761\u8ffd\u6eaf<\/p>\n<\/p>\n \u6b64\u5916\uff0cMDR\u663e\u8457\u63d0\u5347\u4e86\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u6807\u51c6\uff0c\u5bf9\u6280\u672f\u6587\u4ef6\u5ba1\u67e5\u548c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5ba1\u6838\u7684\u6df1\u5ea6\u548c\u5e7f\u5ea6\u90fd\u63d0\u51fa\u4e86\u66f4\u9ad8\u8981\u6c42<\/p>\n<\/p>\n \u4e09\u3001\u83b7\u53d6MDR CE\u8bc1\u4e66\u7684\u5173\u952e\u6d41\u7a0b\u4e0e\u6b65\u9aa4<\/strong><\/p>\n \u83b7\u53d6MDR CE\u8bc1\u4e66\u662f\u4e00\u4e2a\u7cfb\u7edf\u4e14\u590d\u6742\u7684\u8fc7\u7a0b\uff0c\u901a\u5e38\u9700\u8981\u5236\u9020\u5546\u6295\u5165\u5927\u91cf\u7684\u8d44\u6e90\u548c\u65f6\u95f4\u8fdb\u884c\u51c6\u5907<\/p>\n<\/p>\n \u7b2c\u4e00\u6b65\u662f\u8fdb\u884c\u5668\u68b0\u5206\u7c7b\uff0c\u6839\u636eMDR\u9644\u5f55VIII\u7684\u89c4\u5219\u51c6\u786e\u5212\u5206\u4ea7\u54c1\u7684\u98ce\u9669\u7b49\u7ea7\uff08I\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u6216III\u7c7b\uff09\uff0c\u8fd9\u5c06\u51b3\u5b9a\u7b26\u5408\u6027\u8bc4\u4f30\u7684\u5177\u4f53\u8def\u5f84<\/p>\n<\/p>\n \u7b2c\u4e8c\u6b65\u662f\u51c6\u5907\u8be6\u5c3d\u7684\u6280\u672f\u6587\u6863\uff0c\u5176\u5185\u5bb9\u9700\u6db5\u76d6\u5668\u68b0\u8bf4\u660e\u4e0e\u89c4\u683c\u3001\u98ce\u9669\u6536\u76ca\u5206\u6790\u3001\u5236\u9020\u4fe1\u606f\u4ee5\u53ca\u6700\u4e3a\u5173\u952e\u7684\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a\uff08CER\uff09<\/p>\n<\/p>\n \u7b2c\u4e09\u6b65\u662f\u5efa\u7acb\u5e76\u5b9e\u65bd\u7b26\u5408MDR\u9644\u5f55IX\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\uff0c\u901a\u5e38\u9700\u8981\u6ee1\u8db3ISO 13485\u6807\u51c6<\/p>\n<\/p>\n \u7b2c\u56db\u6b65\u662f\u9009\u62e9\u4e00\u5bb6\u5177\u6709\u76f8\u5e94\u8d44\u8d28\u7684\u516c\u544a\u673a\u6784\uff08Notified Body\uff09\u5e76\u63d0\u51fa\u7533\u8bf7\uff0c\u7531\u5176\u8fdb\u884c\u4e25\u683c\u7684\u5ba1\u6838<\/p>\n<\/p>\n \u6700\u540e\uff0c\u5728\u901a\u8fc7\u5ba1\u6838\u540e\uff0c\u5236\u9020\u5546\u9700\u7b7e\u7f72\u6b27\u76df\u7b26\u5408\u6027\u58f0\u660e\uff08DoC\uff09\uff0c\u5e76\u4e3a\u5176\u4ea7\u54c1\u52a0\u8d34CE\u6807\u5fd7\uff0c\u4ece\u800c\u5408\u6cd5\u5730\u8fdb\u5165\u6b27\u76df\u5e02\u573a<\/p>\n<\/p>\n \u56db\u3001\u5236\u9020\u5546\u9762\u4e34\u7684\u5e38\u89c1\u6311\u6218\u4e0e\u5e94\u5bf9\u7b56\u7565<\/strong><\/p>\n \u5411MDR\u8fc7\u6e21\u7684\u8fc7\u7a0b\u4e2d\uff0c\u5236\u9020\u5546\u666e\u904d\u9762\u4e34\u4e34\u5e8a\u6570\u636e\u4e0d\u8db3\u3001\u516c\u544a\u673a\u6784\u8d44\u6e90\u7d27\u5f20\u4ee5\u53ca\u4f9b\u5e94\u94fe\u4fe1\u606f\u6574\u5408\u7b49\u91cd\u5927\u6311\u6218<\/p>\n<\/p>\n \u4e3a\u89e3\u51b3\u4e34\u5e8a\u6570\u636e\u7f3a\u53e3\uff0c\u5236\u9020\u5546\u5e94\u5c3d\u65e9\u542f\u52a8\u4e34\u5e8a\u8bc4\u4f30\uff0c\u7cfb\u7edf\u6536\u96c6\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u6570\u636e\uff0c\u5e76\u79ef\u6781\u63a2\u7d22\u5229\u7528\u7b49\u6548\u5668\u68b0\u6570\u636e\u6216\u73b0\u6709\u6587\u732e\u7684\u53ef\u80fd\u6027<\/p>\n<\/p>\n \u9488\u5bf9\u516c\u544a\u673a\u6784\u5ba1\u6838\u80fd\u529b\u6709\u9650\u7684\u95ee\u9898\uff0c\u5efa\u8bae\u5236\u9020\u5546\u63d0\u524d\u89c4\u5212\uff0c\u5c3d\u65e9\u4e0e\u516c\u544a\u673a\u6784\u63a5\u6d3d\u5e76\u6392\u961f\uff0c\u540c\u65f6\u786e\u4fdd\u5185\u90e8\u6587\u4ef6\u548c\u8d28\u91cf\u4f53\u7cfb\u51c6\u5907\u5c31\u7eea\uff0c\u4ee5\u52a0\u901f\u5ba1\u6838\u8fdb\u7a0b<\/p>\n<\/p>\n \u6b64\u5916\uff0c\u5efa\u7acb\u5f3a\u5927\u7684\u4f9b\u5e94\u5546\u7ba1\u7406\u4f53\u7cfb\u81f3\u5173\u91cd\u8981\uff0c\u786e\u4fdd\u80fd\u591f\u4ece\u4e0a\u6e38\u4f9b\u5e94\u5546\u5904\u83b7\u53d6\u6240\u6709\u5fc5\u8981\u7684\u7b26\u5408\u6027\u8bc1\u636e\uff0c\u4ee5\u6ee1\u8db3MDR\u7684\u8ffd\u6eaf\u6027\u8981\u6c42<\/p>\n<\/p>\n \u4e94\u3001MDR CE\u8bc1\u4e66\u7684\u7ef4\u62a4\u4e0e\u6301\u7eed\u5408\u89c4<\/strong><\/p>\n \u83b7\u5f97MDR CE\u8bc1\u4e66\u5e76\u975e\u4e00\u52b3\u6c38\u9038\uff0c\u5236\u9020\u5546\u5fc5\u987b\u5efa\u7acb\u6301\u7eed\u7684\u5408\u89c4\u673a\u5236\u4ee5\u7ef4\u6301\u8bc1\u4e66\u7684\u6709\u6548\u6027<\/p>\n<\/p>\n \u8fd9\u5305\u62ec\u6301\u7eed\u8fdb\u884c\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\uff0c\u4e3b\u52a8\u6536\u96c6\u548c\u5206\u6790\u7528\u6237\u53cd\u9988\u3001\u6295\u8bc9\u548c\u4e0d\u826f\u4e8b\u4ef6\u6570\u636e\uff0c\u5e76\u5b9a\u671f\u66f4\u65b0\u4e0a\u5e02\u540e\u76d1\u7763\u62a5\u544a\uff08PMSR\uff09\u548c\u5b9a\u671f\u5b89\u5168\u6027\u66f4\u65b0\u62a5\u544a\uff08PSUR\uff09<\/p>\n<\/p>\n \u4efb\u4f55\u5bf9\u5668\u68b0\u8bbe\u8ba1\u3001\u6807\u7b7e\u3001\u5236\u9020\u8fc7\u7a0b\u6216\u9884\u671f\u7528\u9014\u7684\u53d8\u66f4\uff0c\u90fd\u5fc5\u987b\u8fdb\u884c\u8bc4\u4f30\uff0c\u5fc5\u8981\u65f6\u9700\u901a\u77e5\u516c\u544a\u673a\u6784\u5e76\u83b7\u5f97\u6279\u51c6<\/p>\n<\/p>\n \u540c\u65f6\uff0c\u5236\u9020\u5546\u5fc5\u987b\u79ef\u6781\u5e94\u5bf9MDR\u6cd5\u89c4\u672c\u8eab\u7684\u66f4\u65b0\u548c\u53d8\u5316\uff0c\u786e\u4fdd\u81ea\u8eab\u5b9e\u8df5\u59cb\u7ec8\u4e0e\u6700\u65b0\u7684\u76d1\u7ba1\u6307\u5357\u548c\u8981\u6c42\u4fdd\u6301\u4e00\u81f4<\/p>\n<\/p>\n \u7ed3\u8bba<\/strong><\/p>\n \u603b\u800c\u8a00\u4e4b\uff0cMDR CE\u8bc1\u4e66\u662f\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u6253\u5f00\u5e76\u7ef4\u6301\u6b27\u6d32\u5e02\u573a\u51c6\u5165\u4e0d\u53ef\u6216\u7f3a\u7684\u901a\u884c\u8bc1<\/p>\n<\/p>\n \u65b0\u6cd5\u89c4\u4f53\u7cfb\u4ee5\u5176\u5168\u9762\u6027\u548c\u4e25\u683c\u6027\uff0c\u5bf9\u5236\u9020\u5546\u7684\u5408\u89c4\u80fd\u529b\u548c\u4ea7\u54c1\u8d28\u91cf\u63d0\u51fa\u4e86\u524d\u6240\u672a\u6709\u7684\u9ad8\u6807\u51c6<\/p>\n<\/p>\n \u9762\u5bf9\u8fd9\u4e00\u6311\u6218\uff0c\u5236\u9020\u5546\u5fc5\u987b\u91c7\u53d6\u79ef\u6781\u4e3b\u52a8\u7684\u7b56\u7565\uff0c\u6df1\u5165\u7406\u89e3\u6cd5\u89c4\u8981\u6c42\uff0c\u7cfb\u7edf\u89c4\u5212\u8ba4\u8bc1\u8def\u5f84\uff0c\u5e76\u5efa\u7acb\u7a33\u5065\u7684\u6301\u7eed\u5408\u89c4\u6d41\u7a0b\uff0c\u4ece\u800c\u5728\u7ade\u4e89\u6fc0\u70c8\u7684\u5168\u7403\u5e02\u573a\u4e2d\u7a33\u56fa\u5730\u4f4d\uff0c\u8d62\u5f97\u4fe1\u4efb<\/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 CE\u8bc1\u4e66\u662f\u533b\u7597\u5668\u68b0\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u51c6\u5165\u51ed\u8bc1\uff0c\u5176\u5168\u79f0\u4e3aMedical Device Regulatio […]<\/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":[348],"class_list":["post-4024","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-mdr-ce"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4024","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=4024"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4024\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4024"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4024"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4024"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}