\u4ec0\u4e48\u662fMDR\u8ba4\u8bc1\uff1f\u8fd9\u662f\u8bb8\u591a\u533b\u7597\u5668\u68b0\u884c\u4e1a\u4ece\u4e1a\u8005\u53ca\u5173\u6ce8\u6b27\u76df\u5e02\u573a\u7684\u4f01\u4e1a\u7ecf\u5e38\u63d0\u51fa\u7684\u7591\u95ee<\/p>\n
MDR\uff0c\u5168\u79f0\u4e3aMedical Device Regulation\uff0c\u5373\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff0c\u5176\u6b63\u5f0f\u540d\u79f0\u4e3a\u6b27\u76df2017\/745\u53f7\u6cd5\u89c4<\/p>\n
\u5b83\u53d6\u4ee3\u4e86\u539f\u5148\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\u548c\u6709\u6e90\u690d\u5165\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08AIMDD\uff09\uff0c\u6210\u4e3a\u6b27\u76df\u8303\u56f4\u5185\u76d1\u7ba1\u533b\u7597\u5668\u68b0\u7684\u65b0\u6cd5\u5f8b\u6846\u67b6<\/p>\n
\u8be5\u6cd5\u89c4\u4e8e2017\u5e745\u67085\u65e5\u6b63\u5f0f\u53d1\u5e03\uff0c\u5e76\u4e8e2021\u5e745\u670826\u65e5\u8d77\u5168\u9762\u5b9e\u65bd\uff0c\u65e8\u5728\u52a0\u5f3a\u5bf9\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\uff0c\u786e\u4fdd\u5176\u66f4\u9ad8\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u4ece\u800c\u66f4\u597d\u5730\u4fdd\u62a4\u60a3\u8005\u3001\u4f7f\u7528\u8005\u53ca\u5176\u4ed6\u516c\u4f17\u7684\u5065\u5eb7<\/p>\n<\/p>\n
MDR\u8ba4\u8bc1\u7684\u80cc\u666f\u4e0e\u91cd\u8981\u6027<\/strong><\/p>\n MDR\u8ba4\u8bc1\u7684\u5b9e\u65bd\u5e76\u975e\u5076\u7136\uff0c\u800c\u662f\u6b27\u76df\u5bf9\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u4f53\u7cfb\u8fdb\u884c\u73b0\u4ee3\u5316\u6539\u9769\u7684\u5fc5\u7136\u7ed3\u679c<\/p>\n \u8fd1\u5e74\u6765\uff0c\u968f\u7740\u533b\u7597\u6280\u672f\u7684\u5feb\u901f\u53d1\u5c55\u548c\u533b\u7597\u5668\u68b0\u590d\u6742\u6027\u7684\u589e\u52a0\uff0c\u4e00\u4e9b\u91cd\u5927\u533b\u7597\u5668\u68b0\u5b89\u5168\u4e8b\u4ef6\uff08\u5982PIP\u7845\u80f6\u4e73\u623f\u690d\u5165\u7269\u4e11\u95fb\uff09\u66b4\u9732\u4e86\u539f\u6709\u76d1\u7ba1\u4f53\u7cfb\u7684\u4e0d\u8db3<\/p>\n MDD\u4f5c\u4e3a\u6307\u4ee4\uff0c\u5141\u8bb8\u6b27\u76df\u5404\u6210\u5458\u56fd\u901a\u8fc7\u672c\u56fd\u6cd5\u5f8b\u8fdb\u884c\u8f6c\u6362\u5b9e\u65bd\uff0c\u5bfc\u81f4\u76d1\u7ba1\u8981\u6c42\u5b58\u5728\u5dee\u5f02\uff1b\u800cMDR\u4f5c\u4e3a\u6cd5\u89c4\uff0c\u76f4\u63a5\u5728\u6b27\u76df\u5168\u4f53\u6210\u5458\u56fd\u751f\u6548\uff0c\u5177\u6709\u66f4\u5f3a\u7684\u6cd5\u5f8b\u7ea6\u675f\u529b\u548c\u7edf\u4e00\u6027<\/p>\n \u56e0\u6b64\uff0cMDR\u8ba4\u8bc1\u7684\u91cd\u8981\u6027\u4e0d\u8a00\u800c\u55bb\uff1a\u5b83\u662f\u4efb\u4f55\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u5e76\u8fdb\u884c\u5546\u4e1a\u6d41\u901a\u7684\u5f3a\u5236\u6027\u901a\u884c\u8bc1<\/p>\n \u6ca1\u6709\u83b7\u5f97MDR\u8ba4\u8bc1\u7684\u4ea7\u54c1\u5c06\u65e0\u6cd5\u5728\u6b27\u76df\u5e02\u573a\u9500\u552e\uff0c\u8fd9\u5bf9\u4e8e\u5168\u7403\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u6765\u8bf4\uff0c\u662f\u5fc5\u987b\u8de8\u8d8a\u7684\u4e00\u9053\u95e8\u69db<\/p>\n<\/p>\n MDR\u4e0eMDD\u7684\u4e3b\u8981\u5dee\u5f02<\/strong><\/p>\n \u4e0e\u4e4b\u524d\u7684MDD\u76f8\u6bd4\uff0cMDR\u8ba4\u8bc1\u7684\u8981\u6c42\u66f4\u4e3a\u4e25\u683c\u548c\u5168\u9762<\/p>\n \u9996\u5148\uff0cMDR\u5927\u5927\u6269\u5927\u4e86\u533b\u7597\u5668\u68b0\u7684\u5b9a\u4e49\u8303\u56f4\uff0c\u5c06\u8bb8\u591a\u6ca1\u6709\u533b\u7597\u76ee\u7684\u4f46\u529f\u80fd\u7c7b\u4f3c\u7684\u4ea7\u54c1\uff08\u5982\u7528\u4e8e\u51cf\u80a5\u7684\u80c3\u675f\u5e26\u3001\u7f8e\u77b3\u7b49\u9690\u5f62\u773c\u955c\uff09\u4e5f\u7eb3\u5165\u76d1\u7ba1<\/p>\n \u5176\u6b21\uff0c\u5bf9\u4e34\u5e8a\u8bc1\u636e\u7684\u8981\u6c42\u663e\u8457\u63d0\u9ad8<\/p>\n \u5236\u9020\u5546\u5fc5\u987b\u4e3a\u6240\u6709\u5668\u68b0\uff0c\u5305\u62ec\u4ee5\u524d\u6839\u636eMDD\u8ba4\u8bc1\u7684\u5668\u68b0\uff0c\u63d0\u4f9b\u66f4\u5145\u5206\u3001\u66f4\u4e25\u683c\u7684\u4e34\u5e8a\u6570\u636e\u8bc1\u660e\u5176\u5b89\u5168\u6027\u548c\u6027\u80fd<\/p>\n \u7b2c\u4e09\uff0c\u52a0\u5f3a\u4e86\u5668\u68b0\u4e0a\u5e02\u540e\u7684\u76d1\u7ba1\u548c\u8ffd\u6eaf\u6027<\/p>\n MDR\u8981\u6c42\u5efa\u7acb\u66f4\u5b8c\u5584\u7684\u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf\uff0c\u4ee5\u4fbf\u4e8e\u5668\u68b0\u5728\u6574\u4e2a\u751f\u547d\u5468\u671f\u5185\u7684\u8ffd\u8e2a<\/p>\n \u6b64\u5916\uff0c\u5bf9\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u4e5f\u66f4\u4e3a\u4e25\u683c\uff0c\u5176\u8d44\u8d28\u8981\u6c42\u66f4\u9ad8\uff0c\u4ee5\u786e\u4fdd\u5ba1\u6838\u7684\u516c\u6b63\u6027\u548c\u4e13\u4e1a\u6027<\/p>\n \u6700\u540e\uff0cMDR\u6781\u5927\u5730\u63d0\u9ad8\u4e86\u900f\u660e\u5ea6\u548c\u516c\u4f17\u53ef\u53ca\u6027\uff0c\u901a\u8fc7\u5efa\u7acb\u6b27\u6d32\u533b\u7597\u5668\u68b0\u6570\u636e\u5e93\uff08EUDAMED\uff09\uff0c\u5411\u516c\u4f17\u5f00\u653e\u5927\u90e8\u5206\u5668\u68b0\u4fe1\u606f\u548c\u8ba4\u8bc1\u6570\u636e<\/p>\n<\/p>\n MDR\u8ba4\u8bc1\u7684\u9002\u7528\u8303\u56f4<\/strong><\/p>\n MDR\u8ba4\u8bc1\u9002\u7528\u4e8e\u6240\u6709\u610f\u56fe\u5728\u6b27\u76df\u5e02\u573a\u9500\u552e\u7684\u533b\u7597\u5668\u68b0<\/p>\n \u8fd9\u6db5\u76d6\u4e86\u4ece\u7b80\u5355\u7684\u7eb1\u5e03\u3001\u538b\u820c\u677f\u5230\u590d\u6742\u7684\u8d77\u640f\u5668\u3001\u4eba\u5de5\u5173\u8282\u3001\u8bca\u65ad\u8bbe\u5907\u7b49\u6240\u6709\u98ce\u9669\u7b49\u7ea7\u7684\u5668\u68b0<\/p>\n \u6839\u636e\u98ce\u9669\u7b49\u7ea7\uff0c\u533b\u7597\u5668\u68b0\u88ab\u5206\u4e3aI\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u548cIII\u7c7b\uff0c\u98ce\u9669\u8d8a\u9ad8\uff0c\u76d1\u7ba1\u8981\u6c42\u8d8a\u4e25\u683c<\/p>\n \u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0cMDR\u8fd8\u660e\u786e\u6db5\u76d6\u67d0\u4e9b\u836f\u68b0\u7ed3\u5408\u4ea7\u54c1\u4ee5\u53ca\u57fa\u4e8e\u975e\u6d3b\u6027\u6216\u5de5\u7a0b\u5904\u7406\u52a8\u7269\u7ec4\u7ec7\u7684\u5668\u68b0<\/p>\n \u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u51c6\u786e\u5224\u65ad\u5176\u4ea7\u54c1\u662f\u5426\u5c5e\u4e8eMDR\u7684\u7ba1\u8f96\u8303\u56f4\u4ee5\u53ca\u5177\u4f53\u5c5e\u4e8e\u54ea\u4e2a\u5206\u7c7b\uff0c\u662f\u542f\u52a8\u8ba4\u8bc1\u6d41\u7a0b\u7684\u7b2c\u4e00\u6b65\uff0c\u901a\u5e38\u9700\u8981\u4e13\u4e1a\u54a8\u8be2\u673a\u6784\u7684\u534f\u52a9<\/p>\n<\/p>\n MDR\u8ba4\u8bc1\u7684\u5177\u4f53\u6d41\u7a0b<\/strong><\/p>\n \u83b7\u5f97MDR\u8ba4\u8bc1\u662f\u4e00\u4e2a\u590d\u6742\u4e14\u8017\u65f6\u7684\u8fc7\u7a0b\uff0c\u901a\u5e38\u9700\u8981\u5236\u9020\u5546\u4e0e\u6b27\u76df\u516c\u544a\u673a\u6784\u7d27\u5bc6\u5408\u4f5c<\/p>\n \u6d41\u7a0b\u5927\u81f4\u53ef\u5206\u4e3a\u4ee5\u4e0b\u51e0\u4e2a\u5173\u952e\u6b65\u9aa4\uff1a\u9996\u5148\uff0c\u5236\u9020\u5546\u9700\u8fdb\u884c\u5668\u68b0\u5206\u7c7b\u548c\u786e\u5b9a\u9002\u7528\u7684\u7b26\u5408\u6027\u8def\u5f84<\/p>\n \u5176\u6b21\uff0c\u5efa\u7acb\u5e76\u5b9e\u65bd\u7b26\u5408MDR\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09<\/p>\n \u7b2c\u4e09\uff0c\u51c6\u5907\u8be6\u5c3d\u7684\u6280\u672f\u6587\u6863\uff0c\u5305\u62ec\u5668\u68b0\u63cf\u8ff0\u3001\u8bbe\u8ba1\u4fe1\u606f\u3001\u57fa\u672c\u8981\u6c42\u68c0\u67e5\u8868\u3001\u98ce\u9669\u6536\u76ca\u5206\u6790\u3001\u9a8c\u8bc1\u548c\u786e\u8ba4\uff08\u5982\u4e34\u5e8a\u8bc4\u4ef7\uff09\u6570\u636e\u7b49<\/p>\n \u7b2c\u56db\uff0c\u8fdb\u884c\u4e25\u683c\u7684\u4e34\u5e8a\u8bc4\u4ef7\uff0c\u8bc1\u660e\u5668\u68b0\u7684\u4e34\u5e8a\u5b89\u5168\u6027\u548c\u6027\u80fd\uff0c\u5fc5\u8981\u65f6\u8fd8\u9700\u8fdb\u884c\u4e34\u5e8a\u8c03\u67e5<\/p>\n \u7b2c\u4e94\uff0c\u9009\u62e9\u4e00\u5bb6\u6709\u8d44\u8d28\u7684\u6b27\u76df\u516c\u544a\u673a\u6784\u5e76\u63d0\u51fa\u7533\u8bf7\uff0c\u8be5\u673a\u6784\u5c06\u5ba1\u6838\u6280\u672f\u6587\u6863\u548cQMS\uff0c\u5e76\u53ef\u80fd\u8fdb\u884c\u73b0\u573a\u5ba1\u6838<\/p>\n \u5ba1\u6838\u901a\u8fc7\u540e\uff0c\u516c\u544a\u673a\u6784\u5c06\u9881\u53d1MDR\u8bc1\u4e66<\/p>\n \u6700\u540e\uff0c\u5236\u9020\u5546\u8fd8\u9700\u5c65\u884c\u4e0a\u5e02\u540e\u76d1\u7763\u3001 vigilance\u62a5\u544a\u548c\u5b9a\u671f\u5b89\u5168\u66f4\u65b0\u62a5\u544a\uff08PSUR\uff09\u7b49\u4e49\u52a1<\/p>\n<\/p>\n \u4f01\u4e1a\u9762\u4e34\u7684\u6311\u6218\u4e0e\u5e94\u5bf9\u7b56\u7565<\/strong><\/p>\n \u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u4f01\u4e1a\uff0c\u5c24\u5176\u662f\u4e2d\u5c0f\u578b\u4f01\u4e1a\uff0cMDR\u8ba4\u8bc1\u5e26\u6765\u4e86\u5de8\u5927\u7684\u6311\u6218<\/p>\n \u8fd9\u4e9b\u6311\u6218\u5305\u62ec\uff1a\u9ad8\u6602\u7684\u5408\u89c4\u6210\u672c\u3001\u51c6\u5907\u590d\u6742\u6280\u672f\u6587\u6863\u548c\u4e34\u5e8a\u8bc1\u636e\u7684\u96be\u5ea6\u3001\u516c\u544a\u673a\u6784\u8d44\u6e90\u7d27\u5f20\u5bfc\u81f4\u7684\u5ba1\u6838\u6392\u961f\u3001\u4ee5\u53ca\u5185\u90e8\u4eba\u624d\u548c\u77e5\u8bc6\u7684\u77ed\u7f3a<\/p>\n 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