MDR\u8ba4\u8bc1\u662f\u533b\u7597\u5668\u68b0\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u51c6\u5165\u6761\u4ef6\uff0c\u5168\u79f0\u4e3a\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Regulation\uff09\uff0c\u5176\u6cd5\u5f8b\u4f9d\u636e\u4e3a\u6b27\u76df2017\/745\u53f7\u6cd5\u89c4\uff0c\u8be5\u6cd5\u89c4\u4e8e2021\u5e745\u6708\u6b63\u5f0f\u53d6\u4ee3\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\u548c\u6709\u6e90\u690d\u5165\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08AIMDD\uff09\u3002<\/p>\n<\/p>\n
\u4e0e\u4e4b\u524d\u7684\u6307\u4ee4\u76f8\u6bd4\uff0cMDR\u8ba4\u8bc1\u4e0d\u4ec5\u6269\u5927\u4e86\u76d1\u7ba1\u8303\u56f4\uff0c\u8fd8\u663e\u8457\u52a0\u5f3a\u4e86\u5bf9\u533b\u7597\u5668\u68b0\u5168\u751f\u547d\u5468\u671f\u7684\u8ddf\u8e2a\u4e0e\u98ce\u9669\u7ba1\u7406\u8981\u6c42\uff0c\u65e8\u5728\u5168\u9762\u63d0\u5347\u60a3\u8005\u5b89\u5168\u53ca\u4e34\u5e8a\u900f\u660e\u5ea6\u3002<\/p>\n<\/p>\n
\u4e00\u3001MDR\u8ba4\u8bc1\u7684\u6838\u5fc3\u8981\u6c42\u4e0e\u9002\u7528\u8303\u56f4<\/strong><\/p>\n MDR\u8ba4\u8bc1\u9002\u7528\u4e8e\u6240\u6709\u5e0c\u671b\u5728\u6b27\u6d32\u7ecf\u6d4e\u533a\uff08EEA\uff09\u9500\u552e\u533b\u7597\u5668\u68b0\u7684\u5236\u9020\u5546\uff0c\u65e0\u8bba\u5176\u4f4d\u4e8e\u6b27\u76df\u5883\u5185\u6216\u5883\u5916\u3002<\/p>\n<\/p>\n \u5176\u76d1\u7ba1\u8303\u56f4\u9664\u4f20\u7edf\u533b\u7597\u5668\u68b0\u5916\uff0c\u8fd8\u660e\u786e\u7eb3\u5165\u4e86\u67d0\u4e9b\u65e0\u533b\u7597\u76ee\u7684\u4f46\u5177\u6709\u7c7b\u4f3c\u529f\u80fd\u548c\u7279\u5f81\u7684\u4ea7\u54c1\uff0c\u4f8b\u5982\u7f8e\u77b3\u3001\u62bd\u8102\u8bbe\u5907\u7b49\uff0c\u540c\u65f6\u52a0\u5f3a\u4e86\u5bf9\u7eb3\u7c73\u6750\u6599\u3001\u8f6f\u4ef6\u53ca\u4e00\u6b21\u6027\u4f7f\u7528\u518d\u5904\u7406\u5668\u68b0\u7684\u76d1\u7ba1\u3002<\/p>\n<\/p>\n \u6838\u5fc3\u8981\u6c42\u4e3b\u8981\u5305\u62ec\uff1a\u5efa\u7acb\u5b8c\u5584\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\u3001\u63d0\u4f9b\u7b26\u5408\u6027\u8bc4\u4f30\u6240\u9700\u7684\u6280\u672f\u6587\u4ef6\u3001\u8fdb\u884c\u4e25\u683c\u7684\u4e34\u5e8a\u8bc4\u4ef7\u5e76\u63d0\u4f9b\u4e34\u5e8a\u8bc1\u636e\u3001\u6307\u5b9a\u4e00\u5bb6\u6b27\u76df\u6388\u6743\u4ee3\u8868\uff08\u5bf9\u4e8e\u975e\u6b27\u76df\u5236\u9020\u5546\uff09\u3001\u5b8c\u6210\u4ea7\u54c1\u5728EUDAMED\u6570\u636e\u5e93\u7684\u6ce8\u518c\u4ee5\u53ca\u5b9e\u65bd\u66f4\u4e25\u683c\u7684\u552e\u540e\u76d1\u7763\u548c\u8b66\u60d5\u6027\u62a5\u544a\u5236\u5ea6\u3002<\/p>\n<\/p>\n \u4e8c\u3001MDR\u8ba4\u8bc1\u6d41\u7a0b\u8be6\u89e3\uff1a\u4ece\u51c6\u5907\u5230\u83b7\u8bc1<\/strong><\/p>\n MDR\u8ba4\u8bc1\u8fc7\u7a0b\u590d\u6742\u4e14\u4e25\u8c28\uff0c\u901a\u5e38\u53ef\u6982\u62ec\u4e3a\u51e0\u4e2a\u5173\u952e\u9636\u6bb5\u3002<\/p>\n<\/p>\n \u9996\u5148\uff0c\u5236\u9020\u5546\u9700\u8fdb\u884c\u5dee\u8ddd\u5206\u6790\uff0c\u5168\u9762\u8bc4\u4f30\u73b0\u6709\u4f53\u7cfb\u53ca\u4ea7\u54c1\u6280\u672f\u6587\u4ef6\u4e0eMDR\u65b0\u8981\u6c42\u7684\u5dee\u8ddd\uff0c\u5e76\u5236\u5b9a\u8be6\u7ec6\u7684\u6267\u884c\u8ba1\u5212\u3002<\/p>\n<\/p>\n \u968f\u540e\uff0c\u5fc5\u987b\u51c6\u5907\u5e76\u66f4\u65b0\u6280\u672f\u6587\u4ef6\uff0c\u5176\u4e2d\u9700\u5305\u542b\u4ea7\u54c1\u6807\u8bc6\u4e0e\u63cf\u8ff0\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 benefit \u5206\u6790\u3001\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\uff08CER\uff09\u4ee5\u53ca\u6807\u7b7e\u548c\u4f7f\u7528\u8bf4\u660e\u7b49\u3002<\/p>\n<\/p>\n \u63a5\u4e0b\u6765\uff0c\u5236\u9020\u5546\u9700\u8981\u9009\u62e9\u5e76\u59d4\u6258\u4e00\u5bb6\u7ecf\u6b27\u76df\u6307\u5b9a\u7684\u516c\u544a\u673a\u6784\uff08Notified Body\uff09\uff0c\u5e76\u5411\u5176\u63d0\u4ea4\u7b26\u5408\u6027\u8bc4\u4f30\u7533\u8bf7\u3002<\/p>\n<\/p>\n \u516c\u544a\u673a\u6784\u5c06\u8fdb\u884c\u4e25\u683c\u7684\u5ba1\u6838\uff0c\u5305\u62ec\u5bf9\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u5ba1\u6838\u548c\u6280\u672f\u6587\u4ef6\u7684\u8bc4\u4f30\uff0c\u5fc5\u8981\u65f6\u8fd8\u4f1a\u8fdb\u884c\u73b0\u573a\u5ba1\u6838\u6216\u62bd\u6837\u68c0\u6d4b\u3002<\/p>\n<\/p>\n \u5ba1\u6838\u901a\u8fc7\u540e\uff0c\u516c\u544a\u673a\u6784\u5c06\u9881\u53d1MDR\u7b26\u5408\u6027\u8bc1\u4e66\uff0c\u5236\u9020\u5546\u5373\u53ef\u7b7e\u7f72\u7b26\u5408\u6027\u58f0\u660e\uff08DoC\uff09\uff0c\u5e76\u5728\u4ea7\u54c1\u4e0a\u52a0\u8d34CE\u6807\u5fd7\uff0c\u4ece\u800c\u83b7\u5f97\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u7684\u8bb8\u53ef\u3002<\/p>\n<\/p>\n \u4e09\u3001MDR\u4e0eMDD\u7684\u5173\u952e\u5dee\u5f02\u4e0e\u8fc7\u6e21\u6311\u6218<\/strong><\/p>\n MDR\u8ba4\u8bc1\u5e76\u975e\u5bf9MDD\u7684\u7b80\u5355\u5347\u7ea7\uff0c\u800c\u662f\u4e00\u6b21\u6839\u672c\u6027\u7684\u53d8\u9769\uff0c\u5176\u4e25\u82db\u7a0b\u5ea6\u8fdc\u8d85\u4ee5\u5f80\u3002<\/p>\n<\/p>\n \u5173\u952e\u5dee\u5f02\u4f53\u73b0\u5728\uff1a\u4e34\u5e8a\u8bc1\u636e\u8981\u6c42\u5927\u5e45\u63d0\u9ad8\uff0c\u5236\u9020\u5546\u5fc5\u987b\u4e3a\u6240\u6709\u98ce\u9669\u7b49\u7ea7\u7684\u4ea7\u54c1\u63d0\u4f9b\u66f4\u5145\u5206\u3001\u66f4\u4e25\u683c\u7684\u4e34\u5e8a\u6570\u636e\uff0c\u751a\u81f3\u5bf9\u9057\u7559\u4ea7\u54c1\u4e5f\u9700\u8fdb\u884c\u91cd\u65b0\u8bc4\u4f30\u3002<\/p>\n<\/p>\n \u4f9b\u5e94\u94fe\u900f\u660e\u5ea6\u589e\u5f3a\uff0c\u901a\u8fc7\u5f15\u5165\u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf\u548c\u5168\u9762\u5347\u7ea7\u7684EUDAMED\u6570\u636e\u5e93\uff0c\u5b9e\u73b0\u4e86\u5bf9\u5668\u68b0\u4ece\u751f\u4ea7\u5230\u4f7f\u7528\u7684\u5168\u94fe\u6761\u8ffd\u8e2a\u3002<\/p>\n<\/p>\n \u6b64\u5916\uff0c\u5bf9\u516c\u544a\u673a\u6784\u7684\u76d1\u7ba1\u4e5f\u66f4\u4e3a\u4e25\u683c\uff0c\u5176\u5ba1\u6838\u6807\u51c6\u7edf\u4e00\u6027\u66f4\u9ad8\uff0c\u5bfc\u81f4\u8ba4\u8bc1\u5468\u671f\u5ef6\u957f\u4e14\u8d39\u7528\u589e\u52a0\u3002<\/p>\n<\/p>\n \u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u6700\u5927\u7684\u6311\u6218\u5728\u4e8e\u5e94\u5bf9\u8fc7\u6e21\u671f\u65f6\u9650\u3001\u5e94\u5bf9\u516c\u544a\u673a\u6784\u80fd\u529b\u4e0e\u6570\u91cf\u4e0d\u8db3\u7684\u5c40\u9762\uff0c\u4ee5\u53ca\u4e3a\u91cd\u65b0\u8ba4\u8bc1\u6216\u9996\u6b21\u8ba4\u8bc1\u51c6\u5907\u7b26\u5408\u65b0\u89c4\u7684\u8be6\u5c3d\u6280\u672f\u6587\u4ef6\u548c\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u3002<\/p>\n<\/p>\n \u56db\u3001\u6210\u529f\u901a\u8fc7MDR\u8ba4\u8bc1\u7684\u7b56\u7565\u4e0e\u6700\u4f73\u5b9e\u8df5<\/strong><\/p>\n \u9762\u5bf9MDR\u8ba4\u8bc1\u7684\u4e25\u5cfb\u6311\u6218\uff0c\u5236\u9020\u5546\u9700\u91c7\u53d6\u79ef\u6781\u4e3b\u52a8\u7684\u7b56\u7565\u4ee5\u786e\u4fdd\u987a\u5229\u8fc7\u6e21\u548c\u65b0\u4ea7\u54c1\u4e0a\u5e02\u3002<\/p>\n<\/p>\n \u9996\u8981\u4efb\u52a1\u662f\u5c3d\u65e9\u542f\u52a8\u9879\u76ee\uff0c\u7ec4\u5efa\u4e00\u4e2a\u8de8\u90e8\u95e8\u7684\u4e13\u9879\u56e2\u961f\uff0c\u6210\u5458\u5e94\u6db5\u76d6\u6cd5\u89c4\u4e8b\u52a1\u3001\u8d28\u91cf\u4fdd\u8bc1\u3001\u7814\u53d1\u3001\u4e34\u5e8a affairs \u7b49\u5173\u952e\u804c\u80fd\u3002<\/p>\n<\/p>\n \u8fdb\u884c\u5f7b\u5e95\u7684\u5dee\u8ddd\u5206\u6790\u662f\u6210\u529f\u7684\u57fa\u7840\uff0c\u5e94\u9010\u4e00\u6838\u5bf9MDR\u6761\u6b3e\uff0c\u8bc6\u522b\u6240\u6709\u9700\u6539\u8fdb\u6216\u8865\u5145\u7684\u73af\u8282\uff0c\u7279\u522b\u662f\u4e34\u5e8a\u8bc4\u4ef7\u548c\u4e0a\u5e02\u540e\u76d1\u7763\u8ba1\u5212\u3002<\/p>\n<\/p>\n \u4e0e\u516c\u544a\u673a\u6784\u5efa\u7acb\u65e9\u671f\u6c9f\u901a\u81f3\u5173\u91cd\u8981\uff0c\u5c3d\u65e9\u4e86\u89e3\u5176\u5177\u4f53\u671f\u671b\u548c\u8981\u6c42\uff0c\u53ef\u4ee5\u907f\u514d\u540e\u7eed\u6d41\u7a0b\u4e2d\u7684\u53cd\u590d\u4e0e\u5ef6\u8bef\u3002<\/p>\n<\/p>\n \u540c\u65f6\uff0c\u79ef\u6781\u5229\u7528UDI\u7cfb\u7edf\uff0c\u63d0\u524d\u89c4\u5212\u4ea7\u54c1\u6807\u8bc6\u548c\u6570\u636e\u63d0\u4ea4\u5de5\u4f5c\uff0c\u4e0d\u4ec5\u80fd\u6ee1\u8db3\u6cd5\u89c4\u8981\u6c42\uff0c\u4e5f\u80fd\u4f18\u5316\u81ea\u8eab\u7684\u4f9b\u5e94\u94fe\u7ba1\u7406\u3002<\/p>\n<\/p>\n \u6700\u540e\uff0c\u6295\u8d44\u4e8e\u5f3a\u5927\u7684\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u7cfb\u7edf\uff0c\u5efa\u7acb\u5305\u62ec\u4e0a\u5e02\u540e\u4e34\u5e8a\u8ddf\u8e2a\uff08PMCF\uff09\u5728\u5185\u7684\u6301\u7eed\u76d1\u63a7\u673a\u5236\uff0c\u786e\u4fdd\u4ea7\u54c1\u5728\u6574\u4e2a\u751f\u547d\u5468\u671f\u5185\u6301\u7eed\u7b26\u5408MDR\u8981\u6c42\u3002<\/p>\n<\/p>\n \u4e94\u3001MDR\u8ba4\u8bc1\u5bf9\u5168\u7403\u533b\u7597\u5668\u68b0\u5e02\u573a\u7684\u6df1\u8fdc\u5f71\u54cd<\/strong><\/p>\n MDR\u8ba4\u8bc1\u7684\u5b9e\u65bd\u5176\u5f71\u54cd\u65e9\u5df2\u8d85\u8d8a\u6b27\u76df\u8fb9\u754c\uff0c\u5bf9\u5168\u7403\u533b\u7597\u5668\u68b0\u4ea7\u4e1a\u683c\u5c40\u4ea7\u751f\u4e86\u91cd\u5851\u6548\u5e94\u3002<\/p>\n<\/p>\n \u5b83\u6811\u7acb\u4e86\u5168\u7403\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u7684\u65b0\u6807\u6746\uff0c\u8bb8\u591a\u5176\u4ed6\u56fd\u5bb6\u548c\u5730\u533a\u5728\u5236\u5b9a\u6216\u66f4\u65b0\u5176\u6cd5\u89c4\u65f6\u90fd\u4e0d\u540c\u7a0b\u5ea6\u5730\u53c2\u8003\u4e86MDR\u7684\u4e25\u683c\u6846\u67b6\u3002<\/p>\n<\/p>\n \u9ad8\u989d\u7684\u5408\u89c4\u6210\u672c\u548c\u65f6\u95f4\u6295\u5165\u52a0\u901f\u4e86\u5e02\u573a\u6d17\u724c\uff0c\u90e8\u5206\u4e2d\u5c0f\u578b\u4f01\u4e1a\u53ef\u80fd\u56e0\u65e0\u6cd5\u627f\u62c5\u800c\u9009\u62e9\u9000\u51fa\u6b27\u6d32\u5e02\u573a\u6216\u88ab\u6536\u8d2d\uff0c\u4ece\u800c\u4fc3\u8fdb\u4e86\u884c\u4e1a\u6574\u5408\u3002<\/p>\n<\/p>\n \u53e6\u4e00\u65b9\u9762\uff0c\u5b83\u6781\u5927\u5730\u63a8\u52a8\u4e86\u884c\u4e1a\u5bf9\u4e34\u5e8a\u6570\u636e\u771f\u5b9e\u6027\u548c\u4ea7\u54c1\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\u7684\u91cd\u89c6\uff0c\u4fc3\u4f7f\u4f01\u4e1a\u52a0\u5927\u5728\u7814\u53d1\u3001\u8d28\u91cf\u7ba1\u7406\u548c\u771f\u5b9e\u4e16\u754c\u6570\u636e\u7814\u7a76\u65b9\u9762\u7684\u6295\u5165\uff0c\u6700\u7ec8\u63a8\u52a8\u4e86\u6574\u4e2a\u884c\u4e1a\u5411\u66f4\u5b89\u5168\u3001\u66f4\u900f\u660e\u3001\u66f4\u521b\u65b0\u7684\u65b9\u5411\u53d1\u5c55\u3002<\/p>\n<\/p>\n \u5bf9\u4e8e\u60a3\u8005\u800c\u8a00\uff0c\u8fd9\u610f\u5473\u7740\u5728\u672a\u6765\u80fd\u591f\u4f7f\u7528\u5230\u7ecf\u8fc7\u66f4\u4e25\u683c\u8bc4\u4f30\u3001\u5b89\u5168\u6027\u66f4\u9ad8\u7684\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u3002<\/p>\n<\/p>\n MDR\u8ba4\u8bc1\u4f5c\u4e3a\u4e00\u5957\u5168\u9762\u4e14\u4e25\u683c\u7684\u6cd5\u89c4\u4f53\u7cfb\uff0c\u5176\u6838\u5fc3\u76ee\u6807\u5728\u4e8e\u786e\u4fdd\u6295\u653e\u6b27\u76df\u5e02\u573a\u7684\u533b\u7597\u5668\u68b0\u5177\u6709\u6700\u9ad8\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\u6807\u51c6\u3002<\/p>\n<\/p>\n \u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u800c\u8a00\uff0c\u6df1\u5165\u7406\u89e3\u5176\u8981\u6c42\u3001\u5468\u5bc6\u89c4\u5212\u8ba4\u8bc1\u8def\u5f84\u3001\u5e76\u79ef\u6781\u5e94\u5bf9\u6311\u6218\uff0c\u5df2\u4e0d\u518d\u662f\u53ef\u9009\u9879\uff0c\u800c\u662f\u5728\u6b27\u6d32\u5e02\u573a\u751f\u5b58\u4e0e\u53d1\u5c55\u7684\u5fc5\u7531\u4e4b\u8def\u3002<\/p>\n<\/p>\n \u5c3d\u7ba1\u8fc7\u7a0b\u5145\u6ee1\u6311\u6218\uff0c\u4f46\u6210\u529f\u901a\u8fc7\u8ba4\u8bc1\u4e0d\u4ec5\u610f\u5473\u7740\u5408\u89c4\uff0c\u66f4\u4ee3\u8868\u7740\u4f01\u4e1a\u7684\u4ea7\u54c1\u8d28\u91cf\u548c\u7ba1\u7406\u6c34\u5e73\u8fbe\u5230\u4e86\u56fd\u9645\u9886\u5148\u6807\u51c6\uff0c\u4e3a\u5176\u5728\u5168\u7403\u5e02\u573a\u4e2d\u8d62\u5f97\u4e86\u5b9d\u8d35\u7684\u58f0\u8a89\u548c\u7ade\u4e89\u4f18\u52bf\u3002<\/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\u3002<\/p>\n","protected":false},"excerpt":{"rendered":" MDR\u8ba4\u8bc1\u662f\u533b\u7597\u5668\u68b0\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u51c6\u5165\u6761\u4ef6\uff0c\u5168\u79f0\u4e3a\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Regula […]<\/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":[264],"class_list":["post-3939","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-mdr-"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/3939","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=3939"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/3939\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3939"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3939"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3939"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}