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\u4e00\u3001\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u6838\u5fc3\u6846\u67b6\u6982\u8ff0<\/strong><\/p>\n \u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u4f53\u7cfb\u4e3b\u8981\u75312017\u5e74\u53d1\u5e03\u7684\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR (EU) 2017\/745\uff09\u548c\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08IVDR (EU) 2017\/746\uff09\u6784\u6210\u3002<\/p>\n<\/p>\n MDR\u5168\u9762\u53d6\u4ee3\u4e86\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD 93\/42\/EEC\uff09\u548c\u6709\u6e90\u690d\u5165\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08AIMDD 90\/385\/EEC\uff09\uff0c\u800cIVDR\u5219\u53d6\u4ee3\u4e86\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08IVDD 98\/79\/EC\uff09\u3002<\/p>\n<\/p>\n 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\u56db\u3001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\u8981\u6c42<\/strong><\/p>\n \u5236\u9020\u5546\u5fc5\u987b\u4f9d\u636eMDR\u7b2c10\u7ae0\u548c\u9644\u5f55IX\u7684\u8981\u6c42\uff0c\u5efa\u7acb\u5e76\u5b9e\u65bd\u5168\u9762\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\u3002<\/p>\n<\/p>\n QMS\u9700\u8986\u76d6\u6240\u6709\u6d41\u7a0b\uff0c\u5305\u62ec\u7b56\u7565\u5236\u5b9a\u3001\u4ea7\u54c1\u89c4\u5212\u3001\u8bbe\u8ba1\u5f00\u53d1\u3001\u751f\u4ea7\u3001\u50a8\u5b58\u3001\u5206\u9500\u3001\u5b89\u88c5\u3001\u552e\u540e\u670d\u52a1\u4ee5\u53ca\u6700\u7ec8\u505c\u7528\u548c\u5904\u7f6e\u3002<\/p>\n<\/p>\n \u4f53\u7cfb\u5fc5\u987b\u786e\u4fdd\u4ea7\u54c1\u6279\u6b21\u7684\u4e00\u81f4\u6027\u5e76\u6ee1\u8db3\u6cd5\u89c4\u8981\u6c42\uff0c\u901a\u5e38\u9700\u8981\u7b26\u5408EN ISO 13485:2016\u6807\u51c6\uff0c\u5e76\u901a\u8fc7\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u3002<\/p>\n<\/p>\n 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CER\u9700\u8981\u5b9a\u671f\u66f4\u65b0\uff0c\u9ad8\u98ce\u9669\u5668\u68b0\u7684\u66f4\u65b0\u9891\u7387\u66f4\u9ad8\uff0c\u8fd9\u662f\u7ef4\u6301\u8bc1\u4e66\u6709\u6548\u6027\u7684\u6838\u5fc3\u5de5\u4f5c\u4e4b\u4e00\u3002<\/p>\n<\/p>\n \u516d\u3001\u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\u4e0e\u4ea7\u54c1\u6ce8\u518c<\/strong><\/p>\n \u6839\u636eMDR\u7b2c27\u6761\u53ca\u9644\u5f55VI\uff0c\u9664\u5b9a\u5236\u5668\u68b0\u548c\u7814\u7a76\u7528\u9014\u5668\u68b0\u5916\uff0c\u6240\u6709\u533b\u7597\u5668\u68b0\u90fd\u5fc5\u987b\u62e5\u6709\u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\u3002<\/p>\n<\/p>\n UDI-DI\uff08\u5668\u68b0\u6807\u8bc6\u7b26\uff09\u548cUDI-PI\uff08\u751f\u4ea7\u6807\u8bc6\u7b26\uff09\u4fe1\u606f\u5fc5\u987b\u6807\u6ce8\u5728\u6807\u7b7e\u548c\u5305\u88c5\u4e0a\uff0c\u5e76\u5728EUDAMED\u6570\u636e\u5e93\u4e2d\u8fdb\u884c\u6ce8\u518c\u3002<\/p>\n<\/p>\n \u5236\u9020\u5546\u9700\u5c06\u5668\u68b0\u7684\u6838\u5fc3\u6570\u636e\uff08Core Data Elements\uff09\u63d0\u4ea4\u81f3EUDAMED\uff0c\u5b9e\u73b0\u4ea7\u54c1\u5728\u6574\u4e2a\u6b27\u76df\u5e02\u573a\u7684\u900f\u660e\u5316\u548c\u53ef\u8ffd\u6eaf\u5316\u3002<\/p>\n<\/p>\n \u4e03\u3001\u7ecf\u6d4e\u8fd0\u8425\u5546\u804c\u8d23\u4e0e\u6807\u7b7e\u8bed\u8a00\u8981\u6c42<\/strong><\/p>\n \u6cd5\u89c4\u660e\u786e\u89c4\u5b9a\u4e86\u5236\u9020\u5546\u3001\u6388\u6743\u4ee3\u8868\u3001\u8fdb\u53e3\u5546\u548c\u5206\u9500\u5546\u7b49\u6240\u6709\u7ecf\u6d4e\u8fd0\u8425\u5546\u7684\u804c\u8d23\u3002<\/p>\n<\/p>\n \u5236\u9020\u5546\u4f4d\u4e8e\u6b27\u76df\u5883\u5916\u7684\uff0c\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u4f4d\u4e8e\u6b27\u76df\u5883\u5185\u7684\u6388\u6743\u4ee3\u8868\uff08European Authorised Representative\uff09\uff0c\u7531\u5176\u5c65\u884c\u7279\u5b9a\u7684\u6cd5\u5f8b\u4e49\u52a1\u3002<\/p>\n<\/p>\n 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