{"id":3985,"date":"2025-09-04T13:58:01","date_gmt":"2025-09-04T05:58:01","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=3985"},"modified":"2025-09-04T13:58:01","modified_gmt":"2025-09-04T05:58:01","slug":"%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0mdr%e7%94%b3%e8%af%b7%e7%9a%84%e6%9d%a1%e4%bb%b6","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=3985","title":{"rendered":"\u533b\u7597\u5668\u68b0mdr\u7533\u8bf7\u7684\u6761\u4ef6"},"content":{"rendered":"

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\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff09\u4e8e2017\u5e74\u53d1\u5e03\uff0c\u5e76\u4e8e2021\u5e74\u6b63\u5f0f\u53d6\u4ee3\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\uff0c\u5176\u6838\u5fc3\u76ee\u6807\u662f\u786e\u4fdd\u6295\u653e\u5230\u6b27\u76df\u5e02\u573a\u7684\u533b\u7597\u5668\u68b0\u5177\u6709\u66f4\u9ad8\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u6807\u51c6\u3002<\/p>\n<\/p>\n

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MDR\u5ef6\u7eed\u4e86\u57fa\u4e8e\u98ce\u9669\u7684\u5206\u7c7b\u89c4\u5219\uff0c\u4f46\u89c4\u5219\u66f4\u52a0\u8be6\u7ec6\u548c\u4e25\u683c\uff0c\u533b\u7597\u5668\u68b0\u6839\u636e\u5176\u9884\u671f\u7528\u9014\u3001\u4f7f\u7528\u6301\u7eed\u65f6\u95f4\u3001\u4fb5\u5165\u7a0b\u5ea6\u7b49\u56e0\u7d20\u88ab\u5206\u4e3aI\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u548cIII\u7c7b\uff0c\u98ce\u9669\u9010\u7ea7\u9012\u589e\u3002<\/p>\n<\/p>\n

\u4e09\u3001\u6280\u672f\u6587\u4ef6\u51c6\u5907\u7684\u5177\u4f53\u8981\u6c42<\/strong><\/p>\n

\u6280\u672f\u6587\u4ef6\u662fMDR\u7533\u8bf7\u7684\u6838\u5fc3\uff0c\u5176\u6df1\u5ea6\u548c\u5e7f\u5ea6\u8fdc\u8d85MDD\u65f6\u671f\u7684\u8981\u6c42\uff0c\u5b83\u5fc5\u987b\u63d0\u4f9b\u5168\u9762\u7684\u8bc1\u636e\u8bc1\u660e\u533b\u7597\u5668\u68b0\u7b26\u5408MDR\u9644\u5f55I\u4e2d\u89c4\u5b9a\u7684\u4e00\u822c\u5b89\u5168\u4e0e\u6027\u80fd\u8981\u6c42\uff08GSPR\uff09\u3002<\/p>\n

\u6280\u672f\u6587\u4ef6\u9700\u8981\u5305\u542b\u533b\u7597\u5668\u68b0\u7684\u8be6\u7ec6\u63cf\u8ff0\u4e0e\u89c4\u683c\uff0c\u5305\u62ec\u6240\u6709\u53d8\u578b\u548c\u9644\u4ef6\uff0c\u4ee5\u53ca\u5176\u9884\u671f\u7528\u9014\u7684\u660e\u786e\u754c\u5b9a\u3002<\/p>\n

\u5236\u9020\u5546\u5fc5\u987b\u63d0\u4f9b\u5305\u62ec\u8bbe\u8ba1\u3001\u5236\u9020\u8fc7\u7a0b\u3001\u9a8c\u8bc1\u548c\u786e\u8ba4\u5728\u5185\u7684\u5b8c\u6574\u4fe1\u606f\uff0c\u5e76\u8bc1\u660e\u5df2\u5efa\u7acb\u4e86\u6709\u6548\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3002<\/p>\n

\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u662f\u6280\u672f\u6587\u4ef6\u7684\u91cd\u4e2d\u4e4b\u91cd\uff0c\u9700\u8981\u6839\u636eMDR Annex XIV Part A\u548cMEDDEV 2.7\/1 rev.4\u6307\u5357\u8fdb\u884c\u7cfb\u7edf\u89c4\u5212\u3001\u5b9e\u65bd\u548c\u8bc4\u4f30\u3002<\/p>\n

\u5bf9\u4e8eIII\u7c7b\u548c\u53ef\u690d\u5165\u533b\u7597\u5668\u68b0\uff0c\u901a\u5e38\u9700\u8981\u63d0\u4f9b\u4e34\u5e8a\u8c03\u67e5\u6570\u636e\u4ee5\u8bc1\u660e\u5176\u5b89\u5168\u6027\u548c\u6027\u80fd\uff0c\u9664\u975e\u6709\u5145\u5206\u7406\u7531\u8bc1\u660e\u53ef\u4ee5\u5f15\u7528\u73b0\u6709\u4e34\u5e8a\u6570\u636e\u3002<\/p>\n

\u6b64\u5916\uff0c\u6280\u672f\u6587\u4ef6\u8fd8\u9700\u5305\u542b\u4ea7\u54c1\u6807\u7b7e\u3001\u4f7f\u7528\u8bf4\u660e\uff08IFU\uff09\u3001\u98ce\u9669\u7ba1\u7406\u548c\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u8ba1\u5212\u7b49\u5173\u952e\u4fe1\u606f\u3002<\/p>\n<\/p>\n

\u56db\u3001\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\uff08QMS\uff09\u7684\u5efa\u7acb\u4e0e\u8ba4\u8bc1\u6761\u4ef6<\/strong><\/p>\n

\u5236\u9020\u5546\u5fc5\u987b\u5efa\u7acb\u5e76\u6301\u7eed\u5b9e\u65bd\u7b26\u5408MDR Article 10(9)\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\uff0c\u8be5\u4f53\u7cfb\u5e94\u8986\u76d6\u533b\u7597\u5668\u68b0\u751f\u547d\u5468\u671f\u7684\u6240\u6709\u9636\u6bb5\uff0c\u4ece\u6982\u5ff5\u548c\u8bbe\u8ba1\u5230\u751f\u4ea7\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u548c\u6700\u7ec8\u505c\u7528\u3002<\/p>\n

QMS\u7684\u5173\u952e\u8981\u7d20\u5305\u62ec\u6218\u7565\u751f\u4ea7\u76d1\u63a7\u3001\u4ea7\u54c1\u89c4\u5212\u3001\u8bbe\u8ba1\u3001\u91c7\u8d2d\u3001\u5236\u9020\u3001\u4ea7\u54c1\u9a8c\u8bc1\u3001\u5b89\u88c5\u3001\u670d\u52a1\u3001\u6700\u7ec8\u68c0\u9a8c\u4ee5\u53ca\u5b58\u50a8\u548c\u5206\u9500\u7b49\u8fc7\u7a0b\u63a7\u5236\u3002<\/p>\n

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\u5bf9\u4e8e\u9664I\u7c7b\u65e0\u83cc\u3001\u6d4b\u91cf\u6216\u53ef\u91cd\u590d\u4f7f\u7528\u624b\u672f\u5668\u68b0\u4ee5\u5916\u7684\u6240\u6709\u533b\u7597\u5668\u68b0\uff0c\u5236\u9020\u5546\u7684QMS\u9700\u8981\u63a5\u53d7\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u5e76\u83b7\u5f97\u8ba4\u8bc1\uff0c\u8fd9\u662f\u7533\u8bf7MDR\u7b26\u5408\u6027\u8bc4\u4f30\u7684\u5148\u51b3\u6761\u4ef6\u3002<\/p>\n<\/p>\n

\u4e94\u3001\u6307\u5b9a\u6b27\u76df\u6388\u6743\u4ee3\u8868\uff08EC Rep\uff09\u7684\u6761\u4ef6<\/strong><\/p>\n

\u5bf9\u4e8e\u4f4d\u4e8e\u6b27\u76df\u4ee5\u5916\u7684\u5236\u9020\u5546\uff0cMDR\u5f3a\u5236\u8981\u6c42\u6307\u5b9a\u4e00\u4e2a\u5728\u6b27\u76df\u5883\u5185\u8bbe\u7acb\u7684\u6388\u6743\u4ee3\u8868\uff0c\u8be5\u4ee3\u8868\u7531\u5236\u9020\u5546\u4e66\u9762\u6388\u6743\uff0c\u4ee3\u8868\u5236\u9020\u5546\u5c65\u884cMDR\u89c4\u5b9a\u7684\u7279\u5b9a\u4e49\u52a1\u3002<\/p>\n

\u6b27\u76df\u6388\u6743\u4ee3\u8868\u5fc5\u987b\u5bf9\u5236\u9020\u5546\u7684\u6280\u672f\u6587\u4ef6\u3001\u7b26\u5408\u6027\u58f0\u660e\u4ee5\u53ca\u552e\u540e\u76d1\u7763\u4f53\u7cfb\u8fdb\u884c\u9a8c\u8bc1\u5e76\u4fdd\u6709\u526f\u672c\uff0c\u4ee5\u5907\u6210\u5458\u56fd\u4e3b\u7ba1\u5f53\u5c40\u68c0\u67e5\u3002<\/p>\n

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p>\u8be5\u58f0\u660e\u5fc5\u987b\u6839\u636eMDR Annex IV\u7684\u8981\u6c42\u7cbe\u5fc3\u7f16\u5199\uff0c\u5185\u5bb9\u5e94\u5305\u62ec\u5236\u9020\u5546\u4fe1\u606f\u3001\u533b\u7597\u5668\u68b0\u57fa\u672c\u4fe1\u606f\u3001\u6240\u9075\u5faa\u7684\u6cd5\u89c4\u4ee5\u53ca\u6240\u5e94\u7528\u7684\u7b26\u5408\u6027\u8bc4\u4f30\u7a0b\u5e8f\u7b49\u3002<\/p>\n

\u7b26\u5408\u6027\u58f0\u660e\u5fc5\u987b\u4e0e\u6280\u672f\u6587\u4ef6\u4e00\u540c\u4fdd\u5b58\uff0c\u5e76\u5728\u4e3b\u7ba1\u5f53\u5c40\u8981\u6c42\u65f6\u80fd\u591f\u7acb\u5373\u63d0\u4f9b\uff0c\u5b83\u662f\u5728\u4ea7\u54c1\u4e0a\u52a0\u8d34CE\u6807\u5fd7\u7684\u6700\u7ec8\u6b65\u9aa4\u548c\u76f4\u63a5\u4f9d\u636e\u3002<\/p>\n<\/p>\n

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MDR\u6781\u5927\u5730\u5f3a\u5316\u4e86\u4e0a\u5e02\u540e\u76d1\u7763\u7684\u8981\u6c42\uff0c\u5236\u9020\u5546\u5fc5\u987b\u79ef\u6781\u3001\u7cfb\u7edf\u5730\u6536\u96c6\u5e76\u5206\u6790\u5176\u4ea7\u54c1\u6295\u653e\u5e02\u573a\u540e\u5173\u4e8e\u4f53\u9a8c\u548c\u8d28\u91cf\u7684\u6570\u636e\u3002<\/p>\n

\u5236\u9020\u5546\u9700\u8981\u5efa\u7acb\u5e76\u7ef4\u62a4\u4e00\u4e2a\u4e0a\u5e02\u540e\u76d1\u7763\u4f53\u7cfb\uff0c\u8be5\u4f53\u7cfb\u662f\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u4e00\u4e2a\u7ec4\u6210\u90e8\u5206\uff0c\u65e8\u5728\u8bc6\u522b\u662f\u5426\u9700\u8981\u7acb\u5373\u91c7\u53d6\u9884\u9632\u548c\u7ea0\u6b63\u63aa\u65bd\u3002<\/p>\n

p>\u5bf9\u4e8eIIa\u3001IIb\u548cIII\u7c7b\u5668\u68b0\uff0c\u5236\u9020\u5546\u5fc5\u987b\u7f16\u5199\u4e0a\u5e02\u540e\u76d1\u7763\u62a5\u544a\uff0c\u4ee5\u603b\u7ed3PMS\u6536\u96c6\u7684\u6570\u636e\u548c\u5206\u6790\u7ed3\u679c\u3002<\/p>\n

\u6b64\u5916\uff0c\u5236\u9020\u5546\u8fd8\u5fc5\u987b\u5efa\u7acb\u8b66\u6212\u7cfb\u7edf\uff0c\u53ca\u65f6\u5411\u4e3b\u7ba1\u5f53\u5c40\u62a5\u544a\u4e25\u91cd\u4e8b\u6545\u548c\u73b0\u573a\u5b89\u5168\u7ea0\u6b63\u63aa\u65bd\uff08FSCA\uff09\u3002<\/p>\n

p>\u5bf9\u4e8eIIb\u7c7b\u548cIII\u7c7b\u5668\u68b0\uff0c\u5236\u9020\u5546\u8fd8\u9700\u5b9a\u671f\u7f16\u5199\u5e76\u66f4\u65b0\u5b9a\u671f\u5b89\u5168\u66f4\u65b0\u62a5\u544a\uff08PSUR\uff09\uff0c\u8fd9\u4efd\u62a5\u544a\u9700\u603b\u7ed3\u5668\u68b0\u7684\u6536\u76ca-\u98ce\u9669\u786e\u5b9a\u3001PMSP\u7684\u4e3b\u8981\u53d1\u73b0\u4ee5\u53ca\u8b66\u6212\u6570\u636e\u7684\u5206\u6790\u7ed3\u679c\uff0c\u5bf9\u4e8eIII\u7c7b\u5668\u68b0\u548c\u53ef\u690d\u5165\u5668\u68b0\uff0cPSUR\u9700\u8981\u6bcf\u5e74\u66f4\u65b0\u5e76\u63d0\u4ea4\u7ed9\u516c\u544a\u673a\u6784\u3002<\/p>\n<\/p>\n

\u516b\u3001\u7533\u8bf7MDR\u7684\u6d41\u7a0b\u6982\u8ff0<\/strong><\/p>\n

\u7533\u8bf7MDR\u7b26\u5408\u6027\u8bc4\u4f30\u7684\u6574\u4f53\u6d41\u7a0b\u59cb\u4e8e\u5668\u68b0\u5206\u7c7b\uff0c\u5236\u9020\u5546\u9996\u5148\u9700\u6839\u636e\u9644\u5f55VIII\u7684\u89c4\u5219\u786e\u5b9a\u5176\u5668\u68b0\u7684\u98ce\u9669\u7b49\u7ea7\u3002<\/p>\n

p>\u968f\u540e\uff0c\u5236\u9020\u5546\u9700\u51c6\u5907\u8be6\u5c3d\u7684\u6280\u672f\u6587\u4ef6\u548c\u5efa\u7acb\u7b26\u5408\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u5bf9\u4e8e\u9700\u8981\u516c\u544a\u673a\u6784\u4ecb\u5165\u7684\u5668\u68b0\uff0c\u5236\u9020\u5546\u9700\u5411\u5177\u6709\u76f8\u5e94\u8d44\u8d28\u7684\u516c\u544a\u673a\u6784\u63d0\u51fa\u7533\u8bf7\u3002<\/p>\n

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