MDR\u5168\u79f0\u662fMedical Device Regulation\uff0c\u4e2d\u6587\u8bd1\u4e3a\u300a\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u300b\u3002<\/p>\n<\/p>\n
\u5b83\u662f\u6b27\u76df\u9488\u5bf9\u533b\u7597\u5668\u68b0\u9886\u57df\u5236\u5b9a\u7684\u4e00\u90e8\u65b0\u6cd5\u89c4\uff0c\u6b63\u5f0f\u53d6\u4ee3\u4e86\u539f\u5148\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\u3002<\/p>\n<\/p>\n
\u8be5\u6cd5\u89c4\u4e8e2017\u5e745\u67085\u65e5\u6b63\u5f0f\u53d1\u5e03\uff0c\u5e76\u7ecf\u8fc7\u4e86\u6f2b\u957f\u7684\u8fc7\u6e21\u671f\uff0c\u6700\u7ec8\u4e8e2021\u5e745\u670826\u65e5\u5168\u9762\u751f\u6548\u3002<\/p>\n<\/p>\n
\u8fd9\u4e00\u53d8\u9769\u6807\u5fd7\u7740\u6b27\u76df\u5bf9\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\u8fdb\u5165\u4e86\u4e00\u4e2a\u66f4\u52a0\u4e25\u683c\u3001\u900f\u660e\u7684\u65b0\u65f6\u4ee3\u3002<\/p>\n<\/p>\n
\u4e00\u3001MDR\u5168\u79f0\u7684\u6df1\u523b\u5185\u6db5\u4e0e\u51fa\u53f0\u80cc\u666f<\/strong><\/p>\n \u8981\u6df1\u5165\u7406\u89e3MDR\u5168\u79f0\uff0c\u5c31\u4e0d\u80fd\u8131\u79bb\u5176\u51fa\u53f0\u7684\u5386\u53f2\u80cc\u666f\u3002<\/p>\n<\/p>\n \u5728MDR\u751f\u6548\u4e4b\u524d\uff0c\u6b27\u76df\u5e02\u573a\u4e3b\u8981\u9075\u5faa\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\u548c\u4e3b\u52a8\u690d\u5165\u5f0f\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08AIMDD\uff09\u8fdb\u884c\u76d1\u7ba1\u3002<\/p>\n<\/p>\n \u7136\u800c\uff0c\u968f\u7740\u79d1\u6280\u7684\u98de\u901f\u53d1\u5c55\u548c\u533b\u7597\u5668\u68b0\u590d\u6742\u6027\u7684\u589e\u52a0\uff0c\u4ee5\u53ca\u4e00\u4e9b\u91cd\u5927\u7684\u533b\u7597\u5668\u68b0\u5b89\u5168\u4e8b\u4ef6\uff08\u5982PIP\u52a3\u8d28\u7845\u80f6\u4e73\u623f\u5047\u4f53\u4e8b\u4ef6\uff09\u7684\u7206\u53d1\uff0c\u539f\u6709\u7684\u6307\u4ee4\u4f53\u7cfb\u66b4\u9732\u51fa\u8bf8\u591a\u4e0d\u8db3\u3002<\/p>\n<\/p>\n \u8fd9\u4e9b\u6307\u4ee4\u5bf9\u4e34\u5e8a\u8bc1\u636e\u7684\u8981\u6c42\u3001\u4e0a\u5e02\u540e\u76d1\u7ba1\u7684\u529b\u5ea6\u4ee5\u53ca\u76d1\u7ba1\u900f\u660e\u5ea6\u65b9\u9762\u5747\u5b58\u5728\u63d0\u5347\u7a7a\u95f4\u3002<\/p>\n<\/p>\n \u56e0\u6b64\uff0c\u6b27\u76df\u59d4\u5458\u4f1a\u51b3\u5b9a\u4ee5\u5177\u6709\u76f4\u63a5\u6cd5\u5f8b\u6548\u529b\u7684\u201c\u6cd5\u89c4\u201d\uff08Regulation\uff09\u53d6\u4ee3\u4e4b\u524d\u7684\u201c\u6307\u4ee4\u201d\uff08Directive\uff09\uff0c\u65e8\u5728\u5efa\u7acb\u4e00\u500b\u66f4\u52a0\u5065\u5168\u3001\u4e00\u81f4\u7684\u76d1\u7ba1\u6846\u67b6\uff0c\u786e\u4fdd\u6240\u6709\u6210\u5458\u56fd\u6267\u884c\u7edf\u4e00\u7684\u9ad8\u6807\u51c6\uff0c\u4ece\u800c\u66f4\u597d\u5730\u4fdd\u62a4\u60a3\u8005\u3001\u4f7f\u7528\u8005\u53ca\u5176\u4ed6\u516c\u4f17\u7684\u5065\u5eb7\u4e0e\u5b89\u5168\u3002<\/p>\n<\/p>\n \u4e8c\u3001MDR\u6838\u5fc3\u5185\u5bb9\u4e0e\u91cd\u5927\u53d8\u5316\u89e3\u8bfb<\/strong><\/p>\n MDR\u5168\u6587\u7bc7\u5e45\u5197\u957f\uff0c\u6761\u6b3e\u8be6\u5c3d\uff0c\u5176\u6838\u5fc3\u5185\u5bb9\u548c\u91cd\u5927\u53d8\u5316\u4e3b\u8981\u4f53\u73b0\u5728\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\u3002<\/p>\n<\/p>\n \u9996\u5148\uff0c\u6269\u5927\u4e86\u533b\u7597\u5668\u68b0\u7684\u5b9a\u4e49\u548c\u76d1\u7ba1\u8303\u56f4\u3002<\/p>\n<\/p>\n MDR\u5c06\u8bb8\u591a\u4ee5\u524d\u672a\u660e\u786e\u5206\u7c7b\u6216\u4e0d\u53d7\u76d1\u7ba1\u7684\u4ea7\u54c1\u7eb3\u5165\u7ba1\u7406\uff0c\u4f8b\u5982\u67d0\u4e9b\u7528\u4e8e\u6e05\u6d01\u3001\u6d88\u6bd2\u6216\u706d\u83cc\u7684\u5668\u68b0\u3001\u7eb3\u7c73\u6750\u6599\u5668\u68b0\uff0c\u4ee5\u53ca\u5177\u6709\u533b\u7597\u76ee\u7684\u7684\u8f6f\u4ef6\uff08SaMD\uff09\u3002<\/p>\n<\/p>\n \u5176\u6b21\uff0c\u663e\u8457\u52a0\u5f3a\u4e86\u4e34\u5e8a\u8bc1\u636e\u7684\u8981\u6c42\u3002<\/p>\n<\/p>\n MDR\u8981\u6c42\u5236\u9020\u5546\u5fc5\u987b\u4e3a\u6240\u6709\u5668\u68b0\uff0c\u5305\u62ec\u90a3\u4e9b\u957f\u671f\u5b58\u5728\u4e8e\u5e02\u573a\u7684\u4f20\u7edf\u5668\u68b0\uff0c\u63d0\u4f9b\u66f4\u4e25\u683c\u3001\u66f4\u5168\u9762\u7684\u4e34\u5e8a\u6570\u636e\u8bc1\u660e\u5176\u5b89\u5168\u6709\u6548\u6027\u3002<\/p>\n<\/p>\n \u4e34\u5e8a\u8bc4\u4f30\u4e0d\u518d\u662f\u4e00\u6b21\u6027\u884c\u4e3a\uff0c\u800c\u662f\u4e00\u4e2a\u6301\u7eed\u7ec8\u8eab\u7684\u8fc7\u7a0b\u3002<\/p>\n<\/p>\n \u7b2c\u4e09\uff0c\u5f15\u5165\u4e86\u66f4\u4e25\u683c\u7684\u4e0a\u5e02\u540e\u76d1\u7ba1\uff08PMS\uff09\u548c\u8b66\u6212\u7cfb\u7edf\u3002<\/p>\n<\/p>\n \u5236\u9020\u5546\u5fc5\u987b\u5efa\u7acb\u3001\u5b9e\u65bd\u5e76\u7ef4\u62a4\u4e00\u4e2a\u5168\u9762\u7684\u4e0a\u5e02\u540e\u76d1\u7763\u7cfb\u7edf\uff0c\u4e3b\u52a8\u6536\u96c6\u5e76\u5206\u6790\u5176\u5668\u68b0\u5728\u771f\u5b9e\u4e16\u754c\u4e2d\u4f7f\u7528\u7684\u6570\u636e\uff0c\u53ca\u65f6\u62a5\u544a\u4e25\u91cd\u4e8b\u4ef6\u548c\u73b0\u573a\u5b89\u5168\u7ea0\u6b63\u63aa\u65bd\uff08FSCA\uff09\uff0c\u5e76\u5b9a\u671f\u66f4\u65b0\u5b89\u5168\u4e0e\u6027\u80fd\u603b\u7ed3\u62a5\u544a\uff08PSUR\uff09\u3002<\/p>\n<\/p>\n \u7b2c\u56db\uff0c\u63d0\u9ad8\u4e86\u900f\u660e\u5ea6\u548c\u53ef\u8ffd\u6eaf\u6027\u3002<\/p>\n<\/p>\n \u901a\u8fc7\u5efa\u7acb\u6b27\u76df\u533b\u7597\u5668\u68b0\u6570\u636e\u5e93\uff08EUDAMED\uff09\uff0c\u5c06\u5668\u68b0\u3001\u8ba4\u8bc1\u673a\u6784\u3001\u5236\u9020\u5546\u3001\u7b26\u5408\u6027\u58f0\u660e\u3001\u4e34\u5e8a\u8c03\u67e5\u3001\u8b66\u6212\u548c\u4e0a\u5e02\u540e\u76d1\u7763\u7b49\u4fe1\u606f\u5411\u516c\u4f17\u548c\u76d1\u7ba1\u673a\u6784\u516c\u5f00\uff0c\u589e\u5f3a\u4e86\u5e02\u573a\u900f\u660e\u5ea6\u3002<\/p>\n<\/p>\n \u540c\u65f6\uff0c\u901a\u8fc7\u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf\uff0c\u5b9e\u73b0\u4e86\u5bf9\u5668\u68b0\u4ece\u751f\u4ea7\u5230\u4f7f\u7528\u7684\u5168\u7a0b\u8ffd\u8e2a\u3002<\/p>\n<\/p>\n \u7b2c\u4e94\uff0c\u5bf9\u516c\u544a\u673a\u6784\uff08Notified Bodies\uff09\u63d0\u51fa\u4e86\u66f4\u82db\u523b\u7684\u8981\u6c42\u3002<\/p>\n<\/p>\n MDR\u5bf9\u8d1f\u8d23\u5ba1\u6838\u548c\u8ba4\u8bc1\u533b\u7597\u5668\u68b0\u7684\u516c\u544a\u673a\u6784\u8fdb\u884c\u4e86\u66f4\u4e25\u683c\u7684\u8d44\u8d28\u8ba4\u5b9a\u548c\u76d1\u7ba1\uff0c\u786e\u4fdd\u5176\u5177\u5907\u8db3\u591f\u7684\u6280\u672f\u80fd\u529b\u548c\u4e13\u4e1a\u6027\u6765\u8fdb\u884c\u7b26\u5408\u6027\u8bc4\u4f30\u3002<\/p>\n<\/p>\n \u6700\u540e\uff0c\u660e\u786e\u4e86\u5bf9\u5236\u9020\u5546\u548c\u5176\u6388\u6743\u4ee3\u8868\u7684\u8d23\u4efb\u8981\u6c42\u3002<\/p>\n<\/p>\n \u5236\u9020\u5546\u5fc5\u987b\u5728\u5176\u7ec4\u7ec7\u5185\u90e8\u914d\u5907\u5177\u5907\u76f8\u5e94\u8d44\u8d28\u7684\u4eba\u5458\uff08\u5982\u5408\u89c4\u8d1f\u8d23\u4eba\uff09\uff0c\u786e\u4fdd\u5176\u6301\u7eed\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\u3002\u6388\u6743\u4ee3\u8868\u7684\u6cd5\u5f8b\u8d23\u4efb\u4e5f\u540c\u65f6\u88ab\u52a0\u5927\u3002<\/p>\n<\/p>\n \u4e09\u3001MDR\u5bf9\u884c\u4e1a\u5404\u53c2\u4e0e\u65b9\u7684\u5f71\u54cd\u4e0e\u6311\u6218<\/strong><\/p>\n MDR\u7684\u5b9e\u65bd\u5bf9\u6574\u4e2a\u533b\u7597\u5668\u68b0\u884c\u4e1a\u7684\u751f\u6001\u7cfb\u7edf\u4ea7\u751f\u4e86\u6df1\u8fdc\u5f71\u54cd\uff0c\u7ed9\u5404\u53c2\u4e0e\u65b9\u90fd\u5e26\u6765\u4e86\u65b0\u7684\u673a\u9047\u4e0e\u6311\u6218\u3002<\/p>\n<\/p>\n \u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u5408\u89c4\u6210\u672c\u5927\u5e45\u589e\u52a0\u3002<\/p>\n<\/p>\n \u4ed6\u4eec\u9700\u8981\u6295\u5165\u5927\u91cf\u8d44\u6e90\u8fdb\u884c\u6280\u672f\u6587\u4ef6\u66f4\u65b0\u3001\u4e34\u5e8a\u6570\u636e\u6536\u96c6\u3001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5347\u7ea7\u4ee5\u53ca\u5e94\u5bf9\u66f4\u590d\u6742\u7684\u5ba1\u6279\u6d41\u7a0b\u3002<\/p>\n<\/p>\n \u4e00\u4e9b\u6280\u672f\u6587\u4ef6\u4e0d\u5168\u6216\u65e0\u6cd5\u6ee1\u8db3\u65b0\u4e34\u5e8a\u8981\u6c42\u7684\u65e7\u4ea7\u54c1\u53ef\u80fd\u9762\u4e34\u9000\u5e02\u98ce\u9669\u3002<\/p>\n<\/p>\n \u5bf9\u4e8e\u516c\u544a\u673a\u6784\u800c\u8a00\uff0c\u5176\u81ea\u8eab\u7684\u5ba1\u6838\u548c\u8ba4\u8bc1\u5de5\u4f5c\u53d8\u5f97\u66f4\u52a0\u590d\u6742\u548c\u8017\u65f6\uff0c\u5176\u8d44\u8d28\u9700\u8981\u7ecf\u8fc7\u6b27\u76df\u5b98\u65b9\u91cd\u65b0\u8ba4\u5b9a\uff0c\u5bfc\u81f4\u521d\u671f\u6709\u8d44\u683c\u7684\u516c\u544a\u673a\u6784\u6570\u91cf\u4e0d\u8db3\uff0c\u9020\u6210\u4e86\u8ba4\u8bc1\u7533\u8bf7\u7684\u79ef\u538b\u3002<\/p>\n<\/p>\n \u5bf9\u4e8e\u4e34\u5e8a\u7814\u7a76\u4eba\u5458\u548c\u533b\u7597\u673a\u6784\uff0cMDR\u610f\u5473\u7740\u9700\u8981\u8fdb\u884c\u66f4\u591a\u3001\u66f4\u89c4\u8303\u7684\u4e34\u5e8a\u8c03\u67e5\u6765\u751f\u6210\u6240\u9700\u8bc1\u636e\uff0c\u540c\u65f6\u4e5f\u4e3a\u4e34\u5e8a\u7814\u7a76\u5e26\u6765\u4e86\u66f4\u591a\u5408\u4f5c\u673a\u4f1a\u3002<\/p>\n<\/p>\n 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