\u533b\u7597\u5668\u68b0MDR\u5982\u4f55\u7533\u8bf7\u662f\u8bb8\u591a\u5236\u9020\u5546\u548c\u5206\u9500\u5546\u8fdb\u5165\u6216\u7ef4\u6301\u5728\u6b27\u6d32\u5e02\u573a\u8fd0\u8425\u65f6\u5fc5\u987b\u9762\u5bf9\u7684\u5173\u952e\u95ee\u9898<\/p>\n<\/p>\n
\u968f\u7740\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff09\u7684\u5168\u9762\u5b9e\u65bd\uff0c\u53d6\u4ee3\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\uff0c\u7533\u8bf7\u6d41\u7a0b\u53d8\u5f97\u66f4\u52a0\u4e25\u683c\u548c\u590d\u6742<\/p>\n<\/p>\n
\u672c\u6587\u5c06\u8be6\u7ec6\u89e3\u6790\u533b\u7597\u5668\u68b0MDR\u7533\u8bf7\u7684\u5168\u8fc7\u7a0b\uff0c\u5e2e\u52a9\u76f8\u5173\u4f01\u4e1a\u66f4\u597d\u5730\u7406\u89e3\u548c\u51c6\u5907<\/p>\n<\/p>\n
\u4e00\u3001\u7406\u89e3\u533b\u7597\u5668\u68b0MDR\u7684\u6838\u5fc3\u8981\u6c42<\/strong><\/p>\n MDR\u7684\u6838\u5fc3\u76ee\u6807\u662f\u786e\u4fdd\u533b\u7597\u5668\u68b0\u7684\u5b89\u5168\u6027\u3001\u6027\u80fd\u548c\u900f\u660e\u5ea6\uff0c\u4e3a\u60a3\u8005\u548c\u7528\u6237\u63d0\u4f9b\u66f4\u9ad8\u6c34\u5e73\u7684\u4fdd\u62a4<\/p>\n<\/p>\n \u5b83\u6269\u5927\u4e86\u76d1\u7ba1\u8303\u56f4\uff0c\u5305\u62ec\u8bb8\u591a\u4ee5\u524d\u4e0d\u53d7MDD\u7ba1\u8f96\u7684\u4ea7\u54c1\uff0c\u5982\u67d0\u4e9b\u7f8e\u5bb9\u4ea7\u54c1\u548c\u7528\u4e8e\u6e05\u6d01\u3001\u6d88\u6bd2\u6216\u706d\u83cc\u7684\u5668\u68b0<\/p>\n<\/p>\n \u6b64\u5916\uff0cMDR\u52a0\u5f3a\u4e86\u5bf9\u4e34\u5e8a\u8bc1\u636e\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u548c\u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf\u7684\u8981\u6c42<\/p>\n<\/p>\n \u56e0\u6b64\uff0c\u5728\u5f00\u59cb\u7533\u8bf7\u4e4b\u524d\uff0c\u4f01\u4e1a\u5fc5\u987b\u5f7b\u5e95\u7406\u89e3\u8fd9\u4e9b\u65b0\u8981\u6c42\uff0c\u5e76\u8bc4\u4f30\u5176\u4ea7\u54c1\u662f\u5426\u5c5e\u4e8eMDR\u7684\u7ba1\u8f96\u8303\u56f4<\/p>\n<\/p>\n \u4e8c\u3001\u786e\u5b9a\u5668\u68b0\u7684\u5206\u7c7b\u548c\u7b26\u5408\u6027\u8bc4\u4f30\u8def\u5f84<\/strong><\/p>\n \u533b\u7597\u5668\u68b0MDR\u5982\u4f55\u7533\u8bf7\u7684\u7b2c\u4e00\u6b65\u662f\u6b63\u786e\u5206\u7c7b\u5668\u68b0<\/p>\n<\/p>\n MDR\u6839\u636e\u98ce\u9669\u5c06\u5668\u68b0\u5206\u4e3aI\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u548cIII\u7c7b\uff0c\u98ce\u9669\u9010\u7ea7\u589e\u52a0<\/p>\n<\/p>\n \u5206\u7c7b\u89c4\u5219\u5728MDR Annex VIII\u4e2d\u6709\u8be6\u7ec6\u8bf4\u660e\uff0c\u6d89\u53ca\u5668\u68b0\u7684\u4fb5\u5165\u6027\u3001\u4f7f\u7528\u6301\u7eed\u65f6\u95f4\u3001\u80fd\u91cf\u4f9b\u5e94\u7b49\u56e0\u7d20<\/p>\n<\/p>\n \u5206\u7c7b\u51b3\u5b9a\u4e86\u7b26\u5408\u6027\u8bc4\u4f30\u7684\u8def\u5f84\uff0c\u5373\u4f01\u4e1a\u9700\u8981\u9009\u62e9\u516c\u544a\u673a\u6784\u5e76\u9075\u5faa\u76f8\u5e94\u7684\u7a0b\u5e8f\u6765\u8bc1\u660e\u7b26\u5408MDR\u8981\u6c42<\/p>\n<\/p>\n \u4f8b\u5982\uff0cI\u7c7b\u65e0\u83cc\u6216\u5177\u6709\u6d4b\u91cf\u529f\u80fd\u7684\u5668\u68b0\u53ef\u80fd\u9700\u8981\u516c\u544a\u673a\u6784\u53c2\u4e0e\uff0c\u800c\u975e\u65e0\u83ccI\u7c7b\u5668\u68b0\u53ef\u80fd\u4e0d\u9700\u8981<\/p>\n<\/p>\n \u4e09\u3001\u9009\u62e9\u5e76\u59d4\u6258\u516c\u544a\u673a\u6784<\/strong><\/p>\n \u5bf9\u4e8e\u5927\u591a\u6570\u5668\u68b0\uff08\u9664\u90e8\u5206\u4f4e\u98ce\u9669I\u7c7b\u5668\u68b0\u5916\uff09\uff0c\u4f01\u4e1a\u9700\u8981\u9009\u62e9\u4e00\u5bb6\u7ecf\u6b27\u76df\u59d4\u5458\u4f1a\u6307\u5b9a\u7684\u516c\u544a\u673a\u6784\u6765\u8fdb\u884c\u7b26\u5408\u6027\u8bc4\u4f30<\/p>\n<\/p>\n \u516c\u544a\u673a\u6784\u5c06\u5ba1\u6838\u6280\u672f\u6587\u6863\u3001\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\u3001\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a\u7b49\uff0c\u4ee5\u786e\u4fdd\u5668\u68b0\u7b26\u5408MDR\u8981\u6c42<\/p>\n<\/p>\n \u9009\u62e9\u516c\u544a\u673a\u6784\u65f6\uff0c\u4f01\u4e1a\u5e94\u8003\u8651\u5176\u4e13\u4e1a\u9886\u57df\u3001\u8d44\u8d28\u3001\u58f0\u8a89\u548c\u53ef\u7528\u6027\uff0c\u56e0\u4e3aMDR\u5b9e\u65bd\u540e\u516c\u544a\u673a\u6784\u8d44\u6e90\u53ef\u80fd\u7d27\u5f20<\/p>\n<\/p>\n \u59d4\u6258\u540e\uff0c\u53cc\u65b9\u5c06\u7b7e\u8ba2\u5408\u540c\uff0c\u516c\u544a\u673a\u6784\u5f00\u59cb\u5ba1\u6838\u8fc7\u7a0b<\/p>\n<\/p>\n \u56db\u3001\u51c6\u5907\u6280\u672f\u6587\u6863<\/strong><\/p>\n \u6280\u672f\u6587\u6863\u662f\u533b\u7597\u5668\u68b0MDR\u5982\u4f55\u7533\u8bf7\u7684\u6838\u5fc3\u90e8\u5206\uff0c\u5b83\u5fc5\u987b\u5168\u9762\u8bc1\u660e\u5668\u68b0\u7b26\u5408MDR\u7684\u5b89\u5168\u548c\u6027\u80fd\u8981\u6c42<\/p>\n<\/p>\n \u6587\u6863\u5e94\u5305\u62ec\u5668\u68b0\u63cf\u8ff0\u3001\u8bbe\u8ba1\u4fe1\u606f\u3001\u5236\u9020\u8fc7\u7a0b\u3001\u6807\u7b7e\u3001\u4f7f\u7528\u8bf4\u660e\u3001\u98ce\u9669\u5206\u6790\u3001\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u8ba1\u5212\u7b49<\/p>\n<\/p>\n MDR\u8981\u6c42\u6280\u672f\u6587\u6863\u66f4\u52a0\u8be6\u7ec6\u548c\u900f\u660e\uff0c\u7279\u522b\u662f\u4e34\u5e8a\u8bc1\u636e\u5fc5\u987b\u6301\u7eed\u66f4\u65b0\u5e76\u57fa\u4e8e\u66f4\u4e25\u683c\u7684\u6807\u51c6<\/p>\n<\/p>\n \u4f01\u4e1a\u9700\u786e\u4fdd\u6587\u6863\u5b8c\u6574\u3001\u51c6\u786e\u4e14\u6613\u4e8e\u5bfc\u822a\uff0c\u4ee5\u4fbf\u516c\u544a\u673a\u6784\u5ba1\u6838<\/p>\n<\/p>\n \u4e94\u3001\u5b9e\u65bd\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf<\/strong><\/p>\n \u9664\u975e\u5668\u68b0\u5c5e\u4e8eI\u7c7b\u975e\u65e0\u83cc\u4e14\u65e0\u6d4b\u91cf\u529f\u80fd\uff0c\u5426\u5219\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u5e76\u7ef4\u62a4\u7b26\u5408MDR Article 10(9)\u7684\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\uff08QMS\uff09<\/p>\n<\/p>\n QMS\u5e94\u8986\u76d6\u6240\u6709\u65b9\u9762\uff0c\u4ece\u8bbe\u8ba1\u548c\u5f00\u53d1\u5230\u751f\u4ea7\u3001\u5305\u88c5\u3001\u50a8\u5b58\u3001\u5206\u9500\u3001\u5b89\u88c5\u3001\u670d\u52a1\u548c\u6700\u7ec8\u505c\u7528<\/p>\n<\/p>\n \u516c\u544a\u673a\u6784\u5c06\u5ba1\u6838QMS\u4ee5\u786e\u4fdd\u5176\u6709\u6548\u8fd0\u884c\uff0c\u5305\u62ec\u8fdb\u884c\u73b0\u573a\u68c0\u67e5<\/p>\n<\/p>\n \u4f01\u4e1a\u53ef\u80fd\u9700\u8981\u6839\u636eMDR\u8981\u6c42\u66f4\u65b0\u73b0\u6709QMS\uff0c\u4f8b\u5982\u52a0\u5f3a\u4e0a\u5e02\u540e\u76d1\u7763\u548c vigilance \u62a5\u544a\u6d41\u7a0b<\/p>\n<\/p>\n \u516d\u3001\u8fdb\u884c\u4e34\u5e8a\u8bc4\u4f30<\/strong><\/p>\n \u4e34\u5e8a\u8bc4\u4f30\u662f\u533b\u7597\u5668\u68b0MDR\u5982\u4f55\u7533\u8bf7\u7684\u5173\u952e\u73af\u8282\uff0c\u65e8\u5728\u8bc1\u660e\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd<\/p>\n<\/p>\n MDR\u8981\u6c42\u4e34\u5e8a\u8bc1\u636e\u66f4\u52a0 robust \u548c\u6301\u7eed\u66f4\u65b0\uff0c\u5373\u4f7f\u5bf9\u4e8e\u5df2\u6709\u957f\u671f\u4f7f\u7528\u5386\u53f2\u7684\u5668\u68b0\u4e5f\u662f\u5982\u6b64<\/p>\n<\/p>\n \u4f01\u4e1a\u5fc5\u987b\u51c6\u5907\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a\uff08CER\uff09\uff0c\u57fa\u4e8e\u4e34\u5e8a\u6570\u636e\uff08\u5982\u6587\u732e\u56de\u987e\u3001\u81ea\u8eab\u4e34\u5e8a\u7ecf\u9a8c\u6216\u65b0\u4e34\u5e8a\u8bd5\u9a8c\uff09\u6765\u8bc4\u4f30\u98ce\u9669-\u53d7\u76ca\u6bd4<\/p>\n<\/p>\n \u5bf9\u4e8e\u9ad8\u98ce\u9669\u5668\u68b0\uff0c\u53ef\u80fd\u8fd8\u9700\u8981\u54a8\u8be2\u4e13\u5bb6\u5c0f\u7ec4\u6216\u8fdb\u884c\u66f4\u4e25\u683c\u7684\u4e34\u5e8a\u8c03\u67e5<\/p>\n<\/p>\n \u4e03\u3001\u7533\u8bf7\u7b26\u5408\u6027\u8bc4\u4f30\u5e76\u83b7\u53d6\u8bc1\u4e66<\/strong><\/p>\n \u5b8c\u6210\u51c6\u5907\u540e\uff0c\u4f01\u4e1a\u5411\u516c\u544a\u673a\u6784\u63d0\u4ea4\u7b26\u5408\u6027\u8bc4\u4f30\u7533\u8bf7\uff0c\u5305\u62ec\u6280\u672f\u6587\u6863\u3001QMS\u4fe1\u606f\u548c\u5176\u4ed6 required \u6750\u6599<\/p>\n<\/p>\n \u516c\u544a\u673a\u6784\u8fdb\u884c\u6587\u6863\u5ba1\u6838\u548c\u53ef\u80fd\u73b0\u573a audit\uff0c\u5982\u679c\u7b26\u5408\u8981\u6c42\uff0c\u5c06\u9881\u53d1\u6b27\u76df\u7b26\u5408\u6027\u8bc1\u4e66\uff0c\u5141\u8bb8\u4f01\u4e1a\u4f7f\u7528CE\u6807\u5fd7<\/p>\n<\/p>\n \u8bc1\u4e66\u6709\u6548\u671f\u901a\u5e38\u4e3a5\u5e74\uff0c\u4f46\u9700\u6301\u7eed\u76d1\u7763\u548c\u66f4\u65b0<\/p>\n<\/p>\n \u4f01\u4e1a then \u7b7e\u7f72\u7b26\u5408\u6027\u58f0\u660e\uff0c\u5e76\u5c06\u5668\u68b0\u6ce8\u518c\u5728\u6b27\u76df\u6570\u636e\u5e93\uff08EUDAMED\uff09\u4e2d<\/p>\n<\/p>\n \u516b\u3001\u7ef4\u62a4\u4e0a\u5e02\u540e\u76d1\u7763\u548c vigilance<\/strong><\/p>\n \u533b\u7597\u5668\u68b0MDR\u5982\u4f55\u7533\u8bf7\u5e76\u4e0d\u4ee5\u83b7\u53d6\u8bc1\u4e66\u7ed3\u675f\uff1b\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u7cfb\u7edf\u6765\u6301\u7eed\u76d1\u63a7\u5668\u68b0\u5b89\u5168\u548c\u6027\u80fd<\/p>\n<\/p>\n \u8fd9\u5305\u62ec\u6536\u96c6\u548c\u5206\u6790\u7528\u6237\u53cd\u9988\u3001\u4e8b\u6545\u62a5\u544a\u3001\u5b9a\u671f\u66f4\u65b0\u4e34\u5e8a\u8bc4\u4f30\u548c\u98ce\u9669\u5206\u6790\uff0c\u4ee5\u53ca\u5411\u4e3b\u7ba1\u5f53\u5c40\u62a5\u544a\u4e25\u91cd\u4e8b\u4ef6<\/p>\n<\/p>\n MDR\u8981\u6c42\u66f4\u4e25\u683c\u7684 PMS \u548c vigilance \u4e49\u52a1\uff0c\u4ee5\u786e\u4fdd\u5668\u68b0\u5728\u6574\u4e2a\u751f\u547d\u5468\u671f\u4e2d\u7684\u5b89\u5168\u6027<\/p>\n<\/p>\n \u4f01\u4e1a\u9700\u51c6\u5907\u5b9a\u671f\u5b89\u5168\u66f4\u65b0\u62a5\u544a\uff08PSUR\uff09\u548c\u5fc5\u8981\u65f6\u91c7\u53d6\u7ea0\u6b63\u63aa\u65bd<\/p>\n<\/p>\n \u4e5d\u3001\u603b\u7ed3\u4e0e\u5efa\u8bae<\/strong><\/p>\n 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