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\u8fd9\u4e9b\u5206\u7c7b\u89c4\u5219\u4e3b\u8981\u8f7d\u4e8e\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff0cRegulation (EU) 2017\/745\uff09\u7684\u9644\u5f55VIII\u4e2d\uff0c\u53d6\u4ee3\u4e86\u539f\u5148\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\uff0c\u5e76\u5f15\u5165\u4e86\u66f4\u4e3a\u4e25\u683c\u548c\u7ec6\u81f4\u7684\u5206\u7c7b\u8981\u6c42\u3002<\/p>\n<\/p>\n
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\u6b27\u76df\u533b\u7597\u5668\u68b0\u5206\u7c7b\u7684\u6838\u5fc3\u89c4\u5219\u4e0e\u7c7b\u522b<\/strong><\/p>\n<\/p>\n \u6b27\u76dfMDR\u5c06\u533b\u7597\u5668\u68b0\u5206\u4e3a\u56db\u5927\u7c7b\uff1aI\u7c7b\uff08\u5305\u62ecIs\uff08\u65e0\u83cc\uff09\u3001Im\uff08\u6d4b\u91cf\u529f\u80fd\uff09\uff09\u3001IIa\u7c7b\u3001IIb\u7c7b\u548cIII\u7c7b\uff0c\u7c7b\u522b\u8d8a\u9ad8\uff0c\u610f\u5473\u7740\u98ce\u9669\u8d8a\u5927\uff0c\u76d1\u7ba1\u4e5f\u8d8a\u4e25\u683c\u3002<\/p>\n<\/p>\n \u5206\u7c7b\u5e76\u975e\u51ed\u4e3b\u89c2\u81c6\u65ad\uff0c\u800c\u662f\u57fa\u4e8e\u4e00\u5957\u8be6\u5c3d\u7684\u5206\u7c7b\u89c4\u5219\uff0c\u8fd9\u4e9b\u89c4\u5219\u5171\u5305\u542b22\u6761\uff0c\u9488\u5bf9\u4e0d\u540c\u7279\u6027\u7684\u4ea7\u54c1\u5236\u5b9a\u4e86\u5177\u4f53\u7684\u5212\u5206\u6807\u51c6\u3002<\/p>\n<\/p>\n 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