\u533b\u7597\u5668\u68b0MDR\u7533\u8bf7\u8981\u6c42\u662f\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5236\u9020\u5546\u5fc5\u987b\u9762\u5bf9\u7684\u6838\u5fc3\u5408\u89c4\u6311\u6218\uff0c\u5176\u590d\u6742\u6027\u548c\u4e25\u683c\u6027\u8fdc\u8d85\u4e4b\u524d\u7684MDD\u6307\u4ee4<\/p>\n<\/p>\n
\u81ea2021\u5e745\u670826\u65e5\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff09\u6b63\u5f0f\u53d6\u4ee3\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\u4ee5\u6765\uff0c\u6574\u4e2a\u884c\u4e1a\u7684\u76d1\u7ba1\u73af\u5883\u53d1\u751f\u4e86\u6839\u672c\u6027\u53d8\u9769<\/p>\n
\u672c\u6587\u65e8\u5728\u7cfb\u7edf\u68b3\u7406MDR\u6846\u67b6\u4e0b\u7684\u5173\u952e\u7533\u8bf7\u8981\u6c42\uff0c\u4e3a\u5236\u9020\u5546\u63d0\u4f9b\u6e05\u6670\u7684\u8def\u5f84\u6307\u5f15\u548c\u51c6\u5907\u5efa\u8bae<\/p>\n<\/p>\n
\u4e00\u3001\u7406\u89e3MDR\u6cd5\u89c4\u7684\u6838\u5fc3\u53d8\u9769\u4e0e\u9002\u7528\u8303\u56f4<\/strong><\/p>\n MDR\u5e76\u975e\u5bf9MDD\u7684\u7b80\u5355\u4fee\u8ba2\uff0c\u800c\u662f\u4e00\u6b21\u5168\u9762\u7684\u6cd5\u89c4\u5347\u7ea7\uff0c\u5176\u9002\u7528\u8303\u56f4\u6269\u5927\uff0c\u76d1\u7ba1\u66f4\u4e3a\u4e25\u683c<\/p>\n \u5b83\u9002\u7528\u4e8e\u5728\u6b27\u76df\u5e02\u573a\u9500\u552e\u7684\u533b\u7597\u5668\u68b0\u3001\u914d\u4ef6\u4ee5\u53ca\u67d0\u4e9b\u65e0\u533b\u7597\u5668\u68b0\u9884\u671f\u7528\u9014\u4f46\u5177\u6709\u7c7b\u4f3c\u529f\u80fd\u7684\u4ea7\u54c1<\/p>\n \u4e0eMDD\u76f8\u6bd4\uff0cMDR\u663e\u8457\u52a0\u5f3a\u4e86\u5bf9\u4e34\u5e8a\u8bc1\u636e\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u3001\u4f9b\u5e94\u94fe\u53ef\u8ffd\u6eaf\u6027\u4ee5\u53ca\u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf\u7684\u8981\u6c42<\/p>\n \u5236\u9020\u5546\u9996\u5148\u5fc5\u987b\u51c6\u786e\u5224\u65ad\u5176\u4ea7\u54c1\u662f\u5426\u5c5e\u4e8eMDR\u7684\u7ba1\u8f96\u8303\u56f4\uff0c\u5e76\u786e\u5b9a\u76f8\u5e94\u7684\u98ce\u9669\u5206\u7c7b\uff0c\u8fd9\u662f\u540e\u7eed\u6240\u6709\u5408\u89c4\u5de5\u4f5c\u7684\u57fa\u7840<\/p>\n<\/p>\n \u4e8c\u3001\u786e\u5b9a\u5668\u68b0\u5206\u7c7b\u4e0e\u7b26\u5408\u6027\u8bc4\u4f30\u8def\u5f84<\/strong><\/p>\n MDR\u6cbf\u7528\u4e86\u57fa\u4e8e\u98ce\u9669\u7684\u5206\u7c7b\u89c4\u5219\uff0c\u5c06\u5668\u68b0\u5206\u4e3aI\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u548cIII\u7c7b\uff0c\u4f46\u5206\u7c7b\u89c4\u5219\u672c\u8eab\u66f4\u52a0\u8be6\u7ec6\u548c\u4e25\u683c<\/p>\n \u8bb8\u591a\u5728MDD\u4e0b\u53ef\u80fd\u88ab\u5212\u5206\u4e3a\u4f4e\u98ce\u9669\u7684\u4ea7\u54c1\uff0c\u5728MDR\u4e0b\u53ef\u80fd\u88ab\u91cd\u65b0\u5212\u5206\u4e3a\u66f4\u9ad8\u98ce\u9669\u7c7b\u522b<\/p>\n \u5206\u7c7b\u7ed3\u679c\u76f4\u63a5\u51b3\u5b9a\u4e86\u5236\u9020\u5546\u9700\u8981\u9009\u62e9\u7684\u7b26\u5408\u6027\u8bc4\u4f30\u8def\u5f84<\/p>\n \u5bf9\u4e8e\u9664\u5c11\u6570\u65e0\u83cc\u6216\u5177\u6709\u6d4b\u91cf\u529f\u80fd\u7684I\u7c7b\u5668\u68b0\u5916\u7684\u7edd\u5927\u591a\u6570\u5668\u68b0\uff0c\u5236\u9020\u5546\u90fd\u5fc5\u987b\u4e0e\u516c\u544a\u673a\u6784\u5408\u4f5c\uff0c\u901a\u8fc7\u5176\u5ba1\u6838\u624d\u80fd\u83b7\u5f97CE\u8bc1\u4e66<\/p>\n \u9009\u62e9\u4e00\u5bb6\u6709\u8d44\u8d28\u4e14\u7ecf\u9a8c\u4e30\u5bcc\u7684\u516c\u544a\u673a\u6784\u662f\u6210\u529f\u7533\u8bf7\u7684\u5173\u952e\u7b2c\u4e00\u6b65<\/p>\n<\/p>\n \u4e09\u3001\u6784\u5efa\u5b8c\u5584\u7684\u6280\u672f\u6587\u6863<\/strong><\/p>\n \u6280\u672f\u6587\u6863\u662fMDR\u7533\u8bf7\u7684\u6838\u5fc3\uff0c\u662f\u8bc1\u660e\u5668\u68b0\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u5168\u90e8\u8bc1\u636e\u7684\u96c6\u5408<\/p>\n MDR\u5bf9\u6280\u672f\u6587\u6863\u7684\u6df1\u5ea6\u548c\u5e7f\u5ea6\u63d0\u51fa\u4e86\u6781\u9ad8\u8981\u6c42\uff0c\u5176\u5185\u5bb9\u5fc5\u987b\u5305\u62ec\u5668\u68b0\u8bf4\u660e\u4e0e\u89c4\u683c\u3001\u5236\u9020\u5546\u63d0\u4f9b\u7684\u4fe1\u606f\u3001\u8bbe\u8ba1\u4e0e\u5236\u9020\u4fe1\u606f\u3001\u901a\u7528\u5b89\u5168\u4e0e\u6027\u80fd\u8981\u6c42\uff08GSPR\uff09\u7684\u7b26\u5408\u6027\u8bc1\u636e\u3001\u98ce\u9669\u6536\u76ca\u5206\u6790\u548c\u98ce\u9669\u7ba1\u7406\u6587\u4ef6\u3001\u4e34\u5e8a\u524d\u4e0e\u4e34\u5e8a\u6570\u636e\u4ee5\u53ca\u4e0a\u5e02\u540e\u76d1\u7763\u6570\u636e\u7b49<\/p>\n \u6240\u6709\u4e34\u5e8a\u8bc1\u636e\u90fd\u9700\u8981\u7ecf\u8fc7\u4e25\u683c\u7684\u8bc4\u4f30\uff0c\u5e76\u5f62\u6210\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\uff08CER\uff09\uff0c\u8be5\u62a5\u544a\u9700\u8981\u6301\u7eed\u66f4\u65b0<\/p>\n \u6280\u672f\u6587\u6863\u5e76\u975e\u4e00\u6b21\u6027\u5de5\u4f5c\uff0c\u800c\u9700\u8981\u5728\u6574\u4e2a\u5668\u68b0\u751f\u547d\u5468\u671f\u5185\u6839\u636e\u4e0a\u5e02\u540e\u76d1\u7763\u6570\u636e\u4e0d\u65ad\u66f4\u65b0\u548c\u7ef4\u62a4<\/p>\n<\/p>\n \u56db\u3001\u5efa\u7acb\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09<\/strong><\/p>\n \u9664\u975e\u662fI\u7c7b\u5668\u68b0\uff0c\u5426\u5219\u5236\u9020\u5546\u5fc5\u987b\u5efa\u7acb\u5e76\u5b9e\u65bd\u7b26\u5408MDR\u9644\u5f55IX Chapter I\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb<\/p>\n \u8be5\u4f53\u7cfb\u5fc5\u987b\u8986\u76d6\u6240\u6709\u4e0e\u5668\u68b0\u5b89\u5168\u6027\u548c\u6027\u80fd\u76f8\u5173\u7684\u6d41\u7a0b\uff0c\u5305\u62ec\u653f\u7b56\u5236\u5b9a\u3001\u7a0b\u5e8f\u3001\u5236\u9020\u3001\u5ba1\u8ba1\u3001\u7ea0\u6b63\u63aa\u65bd\u548c\u4e0a\u5e02\u540e\u76d1\u7763\u7b49<\/p>\n \u516c\u544a\u673a\u6784\u5c06\u5bf9\u6b64\u8fdb\u884c\u4e25\u683c\u5ba1\u6838\uff08\u901a\u5e38\u79f0\u4e3aQMS\u5ba1\u6838\uff09\uff0c\u4ee5\u786e\u4fdd\u5176\u6301\u7eed\u7b26\u5408\u6cd5\u89c4\u8981\u6c42<\/p>\n \u4e00\u4e2a\u5065\u5168\u4e14\u6709\u6548\u8fd0\u884c\u7684QMS\u4e0d\u4ec5\u662f\u83b7\u5f97CE\u8bc1\u4e66\u7684\u524d\u63d0\uff0c\u66f4\u662f\u786e\u4fdd\u4f01\u4e1a\u80fd\u591f\u6301\u7eed\u5408\u89c4\u3001\u5e94\u5bf9\u5e02\u573a\u76d1\u7763\u7684\u57fa\u77f3<\/p>\n<\/p>\n \u4e94\u3001\u51c6\u5907\u7b26\u5408\u6027\u58f0\u660e\uff08DoC\uff09\u4e0eUDI\u6ce8\u518c<\/strong><\/p>\n \u5728\u516c\u544a\u673a\u6784\u5b8c\u6210\u7b26\u5408\u6027\u8bc4\u4f30\u5e76\u9881\u53d1CE\u8bc1\u4e66\u540e\uff0c\u5236\u9020\u5546\u9700\u8d77\u8349\u6b27\u76df\u7b26\u5408\u6027\u58f0\u660e\uff08DoC\uff09<\/p>\n \u8fd9\u662f\u4e00\u4efd\u5177\u6709\u6cd5\u5f8b\u6548\u529b\u7684\u6587\u4ef6\uff0c\u58f0\u660e\u5176\u5668\u68b0\u5b8c\u5168\u7b26\u5408MDR\u7684\u6240\u6709\u9002\u7528\u8981\u6c42<\/p>\n \u540c\u65f6\uff0c\u5236\u9020\u5546\u5fc5\u987b\u6309\u7167MDR\u8981\u6c42\u4e3a\u5176\u5668\u68b0\u5206\u914d\u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\uff0c\u5e76\u5c06\u6838\u5fc3\u6570\u636e\u4e0a\u4f20\u81f3\u6b27\u76df\u533b\u7597\u5668\u68b0\u6570\u636e\u5e93\uff08EUDAMED\uff09<\/p>\n UDI\u7cfb\u7edf\u5b9e\u73b0\u4e86\u5668\u68b0\u5728\u6574\u4e2a\u4f9b\u5e94\u94fe\u4e2d\u7684\u53ef\u8ffd\u6eaf\uff0c\u6781\u5927\u5730\u589e\u5f3a\u4e86\u900f\u660e\u5ea6\u548c\u5e02\u573a\u76d1\u7ba1\u6548\u7387<\/p>\n \u5c3d\u7ba1EUDAMED\u7684\u90e8\u5206\u6a21\u5757\u4ecd\u5728\u9010\u6b65\u5b8c\u5584\uff0c\u4f46\u9075\u5b88UDI\u8981\u6c42\u5df2\u662f\u5f3a\u5236\u6027\u7684<\/p>\n<\/p>\n \u516d\u3001\u89c4\u5212\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u4e0e\u8b66\u60d5\u6027\u6d3b\u52a8<\/p>\n MDR\u5c06\u4e0a\u5e02\u540e\u76d1\u7763\u63d0\u5347\u5230\u4e86\u524d\u6240\u672a\u6709\u7684\u91cd\u8981\u9ad8\u5ea6\uff0c\u8981\u6c42\u5236\u9020\u5546\u5efa\u7acb\u79ef\u6781\u4e3b\u52a8\u3001\u7cfb\u7edf\u5316\u7684PMS\u4f53\u7cfb<\/p>\n \u8be5\u4f53\u7cfb\u65e8\u5728\u6536\u96c6\u548c\u8bc4\u4f30\u5668\u68b0\u4e0a\u5e02\u540e\u7684\u7ecf\u9a8c\u548c\u6570\u636e\uff0c\u4ee5\u8bc6\u522b\u4efb\u4f55\u9700\u8981\u7acb\u5373\u91c7\u53d6\u9884\u9632\u6216\u7ea0\u6b63\u63aa\u65bd\u7684\u98ce\u9669<\/p>\n \u6839\u636e\u5668\u68b0\u7684\u98ce\u9669\u7b49\u7ea7\uff0c\u5236\u9020\u5546\u9700\u8981\u5236\u5b9a\u76f8\u5e94\u7684PMS\u8ba1\u5212\u3001\u5b9a\u671f\u66f4\u65b0PMS\u62a5\u544a\u6216\u5b9a\u671f\u5b89\u5168\u66f4\u65b0\u62a5\u544a\uff08PSUR\uff09<\/p>\n \u540c\u65f6\uff0c\u5fc5\u987b\u53ca\u65f6\u62a5\u544a\u6240\u6709\u4e25\u91cd\u4e8b\u4ef6\u548c\u73b0\u573a\u5b89\u5168\u7ea0\u6b63\u63aa\u65bd\uff08FSCA\uff09\u81f3\u5404\u56fd\u7684\u4e3b\u7ba1\u5f53\u5c40\u548cEUDAMED<\/p>\n \u8fd9\u4e9b\u6301\u7eed\u7684\u5408\u89c4\u6d3b\u52a8\u662f\u7ef4\u6301CE\u8bc1\u4e66\u6709\u6548\u6027\u7684\u5fc5\u8981\u6761\u4ef6<\/p>\n<\/p>\n \u4e03\u3001\u6307\u5b9a\u6388\u6743\u4ee3\u8868\uff08\u6b27\u4ee3\uff09<\/strong><\/p>\n \u5bf9\u4e8e\u4f4d\u4e8e\u6b27\u76df\u4ee5\u5916\u7684\u5236\u9020\u5546\uff0cMDR\u5f3a\u5236\u8981\u6c42\u5176\u6307\u5b9a\u4e00\u5bb6\u4f4d\u4e8e\u6b27\u76df\u5883\u5185\u7684\u6388\u6743\u4ee3\u8868\uff08European Authorised Representative\uff09<\/p>\n \u6b27\u4ee3\u5728\u5236\u9020\u5546\u548c\u6b27\u76df\u4e3b\u7ba1\u5f53\u5c40\u4e4b\u95f4\u626e\u6f14\u7740\u81f3\u5173\u91cd\u8981\u7684\u6865\u6881\u89d2\u8272\uff0c\u5176\u540d\u79f0\u548c\u5730\u5740\u5fc5\u987b\u51fa\u73b0\u5728\u4ea7\u54c1\u6807\u7b7e\u3001\u5305\u88c5\u548c\u7b26\u5408\u6027\u58f0\u660e\u4e0a<\/p>\n \u6b27\u4ee3\u627f\u62c5\u7740\u91cd\u8981\u7684\u6cd5\u5f8b\u8d23\u4efb\uff0c\u5305\u62ec\u9a8c\u8bc1\u6280\u672f\u6587\u6863\u548c\u7b26\u5408\u6027\u58f0\u660e\u662f\u5426\u53ef\u7528\uff0c\u914d\u5408\u4e3b\u7ba1\u5f53\u5c40\u5904\u7406\u4e8b\u4ef6\u548c\u7ea0\u6b63\u63aa\u65bd\uff0c\u5e76\u4fdd\u7559\u4e00\u5957\u6280\u672f\u6587\u6863\u4f9b\u5f53\u5c40\u68c0\u67e5<\/p>\n \u56e0\u6b64\uff0c\u9009\u62e9\u4e00\u5bb6\u4e13\u4e1a\u3001\u53ef\u9760\u7684\u6b27\u4ee3\u5408\u4f5c\u4f19\u4f34\u81f3\u5173\u91cd\u8981<\/p>\n<\/p>\n 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