MDR\u662f\u4ec0\u4e48\u8ba4\u8bc1\uff1f\u8fd9\u662f\u4e00\u4e2a\u5728\u533b\u7597\u5668\u68b0\u9886\u57df\u5185\u7ecf\u5e38\u88ab\u63d0\u53ca\u7684\u95ee\u9898\uff0c\u5c24\u5176\u5bf9\u4e8e\u76f8\u5173\u884c\u4e1a\u7684\u4ece\u4e1a\u8005\u3001\u5236\u9020\u5546\u4ee5\u53ca\u51fa\u53e3\u5546\u800c\u8a00\uff0c\u7406\u89e3MDR\u8ba4\u8bc1\u7684\u542b\u4e49\u3001\u6d41\u7a0b\u548c\u91cd\u8981\u6027\u81f3\u5173\u91cd\u8981\u3002<\/p>\n<\/p>\n
\u4e00\u3001MDR\u8ba4\u8bc1\u7684\u57fa\u672c\u5b9a\u4e49\u4e0e\u6838\u5fc3\u6982\u5ff5<\/strong><\/p>\n MDR\u662f\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Regulation\uff09\u7684\u82f1\u6587\u7f29\u5199\uff0c\u5176\u6b63\u5f0f\u540d\u79f0\u4e3a\u6b27\u76df2017\/745\u53f7\u6cd5\u89c4\u3002<\/p>\n \u8be5\u6cd5\u89c4\u4e8e2017\u5e745\u6708\u6b63\u5f0f\u53d1\u5e03\uff0c\u5e76\u53d6\u4ee3\u4e86\u539f\u5148\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\u548c\u6709\u6e90\u690d\u5165\u5f0f\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08AIMDD\uff09\uff0c\u6210\u4e3a\u6b27\u76df\u5e02\u573a\u533b\u7597\u5668\u68b0\u51c6\u5165\u7684\u65b0\u6cd5\u5f8b\u6846\u67b6\u3002<\/p>\n MDR\u8ba4\u8bc1\u5e76\u975e\u4e00\u4e2a\u7b80\u5355\u7684\u201c\u8bc1\u4e66\u201d\uff0c\u800c\u662f\u4e00\u4e2a\u8bc1\u660e\u60a8\u7684\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u7b26\u5408\u6b27\u76dfMDR\u6cd5\u89c4\u8981\u6c42\uff0c\u4ece\u800c\u83b7\u5f97CE\u6807\u5fd7\u5e76\u5141\u8bb8\u5728\u6b27\u76df\u7ecf\u6d4e\u533a\uff08EEA\uff09\u5185\u81ea\u7531\u6d41\u901a\u7684\u7b26\u5408\u6027\u8bc4\u5b9a\u8fc7\u7a0b\u3002<\/p>\n \u5176\u6838\u5fc3\u76ee\u7684\u5728\u4e8e\u5efa\u7acb\u4e00\u5957\u66f4\u4e25\u683c\u3001\u66f4\u900f\u660e\u3001\u66f4\u53ef\u6301\u7eed\u7684\u76d1\u7ba1\u4f53\u7cfb\uff0c\u4ee5\u786e\u4fdd\u6295\u653e\u6b27\u76df\u5e02\u573a\u7684\u533b\u7597\u5668\u68b0\u5177\u6709\u66f4\u9ad8\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u4ece\u800c\u66f4\u597d\u5730\u4fdd\u62a4\u60a3\u8005\u3001\u4f7f\u7528\u8005\u4ee5\u53ca\u516c\u4f17\u7684\u5065\u5eb7\u3002<\/p>\n<\/p>\n \u4e8c\u3001MDR\u4e0eMDD\u7684\u4e3b\u8981\u533a\u522b\u4e0e\u91cd\u5927\u53d8\u9769<\/strong><\/p>\n \u4e0e\u5b83\u6240\u53d6\u4ee3\u7684MDD\u6307\u4ee4\u76f8\u6bd4\uff0cMDR\u6cd5\u89c4\u5e26\u6765\u4e86\u9769\u547d\u6027\u7684\u53d8\u5316\uff0c\u5176\u8981\u6c42\u66f4\u4e3a\u4e25\u82db\u548c\u5168\u9762\u3002<\/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\u5177\u6709\u7c7b\u4f3c\u529f\u80fd\u7684\u4ea7\u54c1\uff08\u5982\u7528\u4e8e\u51cf\u80a5\u7684\u80c3\u675f\u5e26\u3001\u7f8e\u5bb9\u690d\u5165\u7269\u7b49\uff09\u4e5f\u7eb3\u5165\u76d1\u7ba1\uff0c\u8fd9\u4e9b\u4ea7\u54c1\u88ab\u79f0\u4e3a\u201c\u975e\u533b\u7597\u76ee\u7684\u533b\u7597\u5668\u68b0\u201d\u3002<\/p>\n \u5176\u6b21\uff0c\u5bf9\u4e34\u5e8a\u8bc1\u636e\u7684\u8981\u6c42\u663e\u8457\u63d0\u9ad8\u3002\u5236\u9020\u5546\u5fc5\u987b\u63d0\u4f9b\u66f4\u5145\u5206\u3001\u66f4\u4e25\u683c\u7684\u4e34\u5e8a\u6570\u636e\u6765\u8bc1\u660e\u5176\u4ea7\u54c1\u7684\u5b89\u5168\u548c\u6027\u80fd\uff0c\u5bf9\u4e8e\u5df2\u6709\u4ea7\u54c1\u4e5f\u9700\u8981\u8fdb\u884c\u4e34\u5e8a\u8bc4\u4ef7\u66f4\u65b0\uff0c\u751a\u81f3\u8fdb\u884c\u65b0\u7684\u4e34\u5e8a\u7814\u7a76\u3002<\/p>\n \u7b2c\u4e09\uff0c\u52a0\u5f3a\u4e86\u4ea7\u54c1\u4e0a\u5e02\u540e\u7684\u76d1\u7ba1\u548c\u8ffd\u6eaf\u6027\u3002\u5efa\u7acb\u4e86\u66f4\u5b8c\u5584\u7684\u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf\uff0c\u8981\u6c42\u5bf9\u4f9b\u5e94\u94fe\u4e2d\u7684\u6240\u6709\u7ecf\u6d4e\u8fd0\u8425\u5546\uff08\u5236\u9020\u5546\u3001\u6388\u6743\u4ee3\u8868\u3001\u8fdb\u53e3\u5546\u3001\u5206\u9500\u5546\uff09\u8fdb\u884c\u66f4\u660e\u786e\u7684\u8d23\u4efb\u5212\u5206\uff0c\u5e76\u5f3a\u5316\u4e86vigilance\uff08\u8b66\u6212\uff09\u62a5\u544a\u548c\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u7684\u8981\u6c42\u3002<\/p>\n \u6700\u540e\uff0c\u5bf9\u516c\u544a\u673a\u6784\uff08Notified Bodies\uff09\u7684\u5ba1\u6838\u6807\u51c6\u548c\u8d44\u8d28\u8981\u6c42\u4e5f\u53d8\u5f97\u66f4\u52a0\u4e25\u683c\uff0c\u8fd9\u4f7f\u5f97\u8ba4\u8bc1\u8fc7\u7a0b\u66f4\u5177\u6311\u6218\u6027\u3002<\/p>\n<\/p>\n \u4e09\u3001\u8c01\u9700\u8981\u7533\u8bf7MDR\u8ba4\u8bc1\uff1f<\/strong><\/p>\n \u4efb\u4f55\u5e0c\u671b\u5c06\u5176\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u6295\u653e\u81f3\u6b27\u76df\u5e02\u573a\u4ee5\u53ca\u6b27\u6d32\u7ecf\u6d4e\u533a\uff08\u5305\u62ec\u632a\u5a01\u3001\u51b0\u5c9b\u3001\u5217\u652f\u6566\u58eb\u767b\uff09\u7684\u5236\u9020\u5546\uff0c\u90fd\u5fc5\u987b\u786e\u4fdd\u5176\u4ea7\u54c1\u7b26\u5408MDR\u6cd5\u89c4\u5e76\u83b7\u5f97CE\u8ba4\u8bc1\u3002<\/p>\n \u8fd9\u6db5\u76d6\u4e86\u4ece\u4f4e\u98ce\u9669\uff08I\u7c7b\uff09\u5230\u9ad8\u98ce\u9669\uff08III\u7c7b\uff09\u7684\u6240\u6709\u7c7b\u522b\u7684\u533b\u7597\u5668\u68b0\uff0c\u4f8b\u5982\u5916\u79d1\u624b\u672f\u5668\u68b0\u3001\u8bca\u65ad\u8bbe\u5907\u3001\u690d\u5165\u7269\u3001\u8f6f\u4ef6\uff08SaMD\uff09\u4ee5\u53ca\u4e0a\u8ff0\u63d0\u5230\u7684\u975e\u533b\u7597\u76ee\u7684\u5668\u68b0\u7b49\u3002<\/p>\n \u5bf9\u4e8e\u4f4d\u4e8e\u6b27\u76df\u4ee5\u5916\u7684\u5236\u9020\u5546\uff08\u4f8b\u5982\u4e2d\u56fd\u3001\u7f8e\u56fd\u7684\u5236\u9020\u5546\uff09\uff0c\u4ed6\u4eec\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u4f4d\u4e8e\u6b27\u76df\u5883\u5185\u7684\u6388\u6743\u4ee3\u8868\uff08European Authorised Representative\uff09\u6765\u5c65\u884c\u6cd5\u89c4\u89c4\u5b9a\u7684\u7279\u5b9a\u4e49\u52a1\u3002<\/p>\n<\/p>\n \u56db\u3001MDR\u8ba4\u8bc1\u7684\u6838\u5fc3\u6d41\u7a0b\u4e0e\u5173\u952e\u6b65\u9aa4<\/strong><\/p>\n MDR\u8ba4\u8bc1\u662f\u4e00\u4e2a\u590d\u6742\u4e14\u6f2b\u957f\u7684\u8fc7\u7a0b\uff0c\u901a\u5e38\u9700\u8981\u5236\u9020\u5546\u6295\u5165\u5927\u91cf\u7684\u8d44\u6e90\u548c\u65f6\u95f4\u8fdb\u884c\u51c6\u5907\u3002<\/p>\n \u7b2c\u4e00\u6b65\u662f\u5668\u68b0\u5206\u7c7b\u3002\u6839\u636eMDR\u9644\u5f55VIII\u7684\u89c4\u5219\uff0c\u51c6\u786e\u786e\u5b9a\u5668\u68b0\u7684\u98ce\u9669\u7b49\u7ea7\uff08I\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u6216III\u7c7b\uff09\uff0c\u8fd9\u5c06\u76f4\u63a5\u51b3\u5b9a\u7b26\u5408\u6027\u8bc4\u5b9a\u7684\u8def\u5f84\u3002<\/p>\n \u7b2c\u4e8c\u6b65\u662f\u5efa\u7acb\u5e76\u5b9e\u65bd\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\u3002\u901a\u5e38\u9700\u8981\u5efa\u7acb\u7b26\u5408MDR\u6cd5\u89c4\u548cISO 13485\u6807\u51c6\u7684\u8d28\u91cf\u4f53\u7cfb\uff0c\u8fd9\u662f\u540e\u7eed\u6240\u6709\u6280\u672f\u6587\u4ef6\u7684\u57fa\u7840\u3002<\/p>\n \u7b2c\u4e09\u6b65\u662f\u51c6\u5907\u8be6\u5c3d\u7684\u6280\u672f\u6587\u6863\uff08Technical Documentation\uff09\u3002\u8fd9\u662f\u8ba4\u8bc1\u7684\u6838\u5fc3\uff0c\u9700\u5305\u542b\u5668\u68b0\u63cf\u8ff0\u3001\u89c4\u683c\u3001\u6807\u7b7e\u3001\u8bbe\u8ba1\u4fe1\u606f\u3001\u98ce\u9669\u5206\u6790\u3001\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\uff08CER\uff09\u3001\u9a8c\u8bc1\u548c\u786e\u8ba4\u6570\u636e\u7b49\u6240\u6709\u8bc1\u660e\u4ea7\u54c1\u5b89\u5168\u6709\u6548\u7684\u8bc1\u636e\u3002<\/p>\n \u7b2c\u56db\u6b65\u662f\u9009\u62e9\u5e76\u7533\u8bf7\u516c\u544a\u673a\u6784\uff08Notified Body\uff09\u3002\u5bf9\u4e8e\u9664\u90e8\u5206I\u7c7b\u5668\u68b0\u5916\u7684\u7edd\u5927\u591a\u6570\u5668\u68b0\uff0c\u90fd\u9700\u8981\u7ecf\u8fc7\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u3002\u5236\u9020\u5546\u9700\u5411\u6709\u8d44\u8d28\u7684\u516c\u544a\u673a\u6784\u63d0\u51fa\u7533\u8bf7\uff0c\u7531\u5176\u8fdb\u884c\u6587\u4ef6\u5ba1\u6838\u548c\u73b0\u573a\u5ba1\u6838\u3002<\/p>\n \u7b2c\u4e94\u6b65\u662f\u516c\u544a\u673a\u6784\u5ba1\u6838\u4e0e\u9881\u53d1\u8bc1\u4e66\u3002\u5ba1\u6838\u901a\u8fc7\u540e\uff0c\u516c\u544a\u673a\u6784\u4f1a\u9881\u53d1MDR\u7b26\u5408\u6027\u8bc1\u4e66\uff0c\u5236\u9020\u5546\u636e\u6b64\u7b7e\u7f72\u7b26\u5408\u6027\u58f0\u660e\uff08DoC\uff09\uff0c\u5e76\u4e3a\u4ea7\u54c1\u52a0\u8d34CE\u6807\u5fd7\u3002<\/p>\n \u6700\u540e\u4e00\u6b65\u662f\u5c65\u884c\u4e0a\u5e02\u540e\u4e49\u52a1\u3002\u5305\u62ec\u6301\u7eed\u8fdb\u884c\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u3001\u5efa\u7acb\u4e0a\u5e02\u540e\u6027\u80fd\u8ddf\u8e2a\uff08PMPF\uff09\u3001\u53ca\u65f6\u62a5\u544a\u4e0d\u826f\u4e8b\u4ef6\u548c\u73b0\u573a\u5b89\u5168\u7ea0\u6b63\u63aa\u65bd\uff08FSCA\uff09\u7b49\u3002<\/p>\n<\/p>\n \u4e94\u3001MDR\u8ba4\u8bc1\u9762\u4e34\u7684\u6311\u6218\u4e0e\u5e94\u5bf9\u7b56\u7565<\/strong><\/p>\n 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