\u533b\u7597\u5668\u68b0\u6b27\u76df\u8ba4\u8bc1MDR\u662f\u5f53\u524d\u5168\u7403\u533b\u7597\u5668\u68b0\u884c\u4e1a\u5173\u6ce8\u7684\u70ed\u70b9\u8bdd\u9898\uff0c\u5b83\u4ee3\u8868\u7740\u6b27\u76df\u5bf9\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u6846\u67b6\u7684\u91cd\u5927\u53d8\u9769\u3002<\/p>\n<\/p>\n
\u81ea2021\u5e745\u670826\u65e5\u5168\u9762\u5b9e\u65bd\u4ee5\u6765\uff0c\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR, Regulation (EU) 2017\/745\uff09\u5df2\u6b63\u5f0f\u53d6\u4ee3\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\u3002<\/p>\n
\u8fd9\u4e00\u8f6c\u53d8\u4e0d\u4ec5\u4ec5\u662f\u540d\u79f0\u4e0a\u7684\u6539\u53d8\uff0c\u66f4\u662f\u76d1\u7ba1\u7406\u5ff5\u3001\u6d41\u7a0b\u548c\u8981\u6c42\u7684\u5168\u9762\u5347\u7ea7\uff0c\u65e8\u5728\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\u53ca\u5176\u4ed6\u76f8\u5173\u4eba\u5458\u7684\u5065\u5eb7\u3002<\/p>\n<\/p>\n
\u5bf9\u4e8e\u4efb\u4f55\u5e0c\u671b\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u7684\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u800c\u8a00\uff0c\u6df1\u523b\u7406\u89e3\u5e76\u6210\u529f\u901a\u8fc7MDR\u8ba4\u8bc1\u5df2\u6210\u4e3a\u4e00\u9879\u4e0d\u53ef\u6216\u7f3a\u4e14\u6781\u5177\u6311\u6218\u6027\u7684\u4efb\u52a1\u3002<\/p>\n<\/p>\n
\u4e00\u3001\u6b27\u76dfMDR\u8ba4\u8bc1\u6982\u8ff0\uff1a\u4eceMDD\u5230MDR\u7684\u6839\u672c\u6027\u53d8\u9769<\/strong><\/p>\n \u6b27\u76dfMDR\u8ba4\u8bc1\u7684\u6838\u5fc3\u5728\u4e8e\u5efa\u7acb\u4e86\u4e00\u4e2a\u66f4\u4e25\u683c\u3001\u66f4\u900f\u660e\u548c\u66f4\u5177\u8ffd\u6eaf\u6027\u7684\u76d1\u7ba1\u4f53\u7cfb\u3002<\/p>\n \u4e0e\u4e4b\u524d\u7684MDD\u6307\u4ee4\u76f8\u6bd4\uff0cMDR\u6cd5\u89c4\u7684\u9002\u7528\u8303\u56f4\u66f4\u5e7f\uff0c\u5bf9\u4e34\u5e8a\u8bc1\u636e\u7684\u8981\u6c42\u66f4\u4e3a\u4e25\u82db\uff0c\u5e76\u663e\u8457\u52a0\u5f3a\u4e86\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u529b\u5ea6\u4ee5\u53ca\u4e3b\u7ba1\u5f53\u5c40\u7684\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u8d23\u4efb\u3002<\/p>\n \u5b83\u5f3a\u8c03\u4ea7\u54c1\u7684\u5168\u751f\u547d\u5468\u671f\u76d1\u7ba1\uff0c\u4ece\u8bbe\u8ba1\u3001\u751f\u4ea7\u5230\u4e0a\u5e02\u540e\u76d1\u6d4b\u3001\u8b66\u6212\u548c\u62a5\u5e9f\uff0c\u90fd\u9700\u8981\u5236\u9020\u5546\u63d0\u4f9b\u5145\u5206\u7684\u8bc1\u660e\u6587\u4ef6\u3002<\/p>\n \u6b64\u5916\uff0cMDR\u5bf9\u552f\u4e00\u8bbe\u5907\u6807\u8bc6\uff08UDI\uff09\u3001\u7ecf\u6d4e\u8fd0\u8425\u5546\u8d23\u4efb\u4ee5\u53ca\u60a3\u8005\u690d\u5165\u5361\u4fe1\u606f\u7b49\u65b9\u9762\u90fd\u63d0\u51fa\u4e86\u5168\u65b0\u4e14\u5177\u4f53\u7684\u8981\u6c42\u3002<\/p>\n<\/p>\n \u4e8c\u3001MDR\u8ba4\u8bc1\u7684\u5173\u952e\u6d41\u7a0b\u4e0e\u6838\u5fc3\u8981\u6c42<\/strong><\/p>\n \u6210\u529f\u83b7\u5f97\u533b\u7597\u5668\u68b0\u6b27\u76df\u8ba4\u8bc1MDR\u662f\u4e00\u4e2a\u7cfb\u7edf\u6027\u7684\u5de5\u7a0b\uff0c\u6d89\u53ca\u591a\u4e2a\u5173\u952e\u73af\u8282\u3002<\/p>\n<\/p>\n 1. \u5668\u68b0\u5206\u7c7b\u4e0e\u7b26\u5408\u6027\u8def\u5f84\u9009\u62e9<\/strong><\/p>\n \u5236\u9020\u5546\u9996\u5148\u9700\u8981\u4f9d\u636eMDR\u9644\u5f55VIII\u7684\u89c4\u5219\uff0c\u51c6\u786e\u786e\u5b9a\u5176\u5668\u68b0\u7684\u98ce\u9669\u7b49\u7ea7\uff08I\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u6216III\u7c7b\uff09\u3002<\/p>\n \u5206\u7c7b\u7ed3\u679c\u76f4\u63a5\u51b3\u5b9a\u4e86\u7b26\u5408\u6027\u8bc4\u4f30\u7684\u8def\u5f84\uff0c\u4f8b\u5982\uff0c\u9664\u4e86\u65e0\u83cc\u6216\u5177\u6709\u6d4b\u91cf\u529f\u80fd\u7684I\u7c7b\u5668\u68b0\uff0c\u5927\u90e8\u5206I\u7c7b\u5668\u68b0\u53ef\u4ee5\u8fdb\u884c\u81ea\u6211\u7b26\u5408\u6027\u58f0\u660e\uff0c\u800c\u66f4\u9ad8\u98ce\u9669\u7b49\u7ea7\u7684\u5668\u68b0\u5219\u5fc5\u987b\u7ecf\u8fc7\u516c\u544a\u673a\u6784\u7684\u4e25\u683c\u8bc4\u5ba1\u3002<\/p>\n<\/p>\n 2. \u6280\u672f\u6587\u4ef6\u51c6\u5907<\/strong><\/p>\n \u6280\u672f\u6587\u4ef6\u662fMDR\u8ba4\u8bc1\u7533\u8bf7\u7684\u6838\u5fc3\uff0c\u5176\u6df1\u5ea6\u548c\u5e7f\u5ea6\u8fdc\u8d85MDD\u65f6\u671f\u7684\u8981\u6c42\u3002<\/p>\n \u5b83\u5fc5\u987b\u63d0\u4f9b\u8bc1\u660e\u5668\u68b0\u7b26\u5408\u901a\u7528\u5b89\u5168\u4e0e\u6027\u80fd\u8981\u6c42\uff08GSPR\uff09\u7684\u5168\u90e8\u8bc1\u636e\uff0c\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\u5668\u68b0\u63cf\u8ff0\u4e0e\u89c4\u683c\u3001\u6807\u7b7e\u4e0e\u4f7f\u7528\u8bf4\u660e\u3001\u8bbe\u8ba1\u5236\u9020\u4fe1\u606f\u3001\u901a\u7528\u5b89\u5168\u4e0e\u6027\u80fd\u8981\u6c42 checklist\u3001\u98ce\u9669\u6536\u76ca\u5206\u6790\u3001\u4e34\u5e8a\u524d\u4e0e\u4e34\u5e8a\u8bc4\u4ef7\u8d44\u6599\u4ee5\u53ca\u4e0a\u5e02\u540e\u76d1\u7763\u8ba1\u5212\u7b49\u3002<\/p>\n \u5176\u4e2d\uff0c\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\uff08CER\uff09\u53ca\u5176\u6301\u7eed\u7684\u66f4\u65b0\u9700\u8981\u57fa\u4e8e\u5145\u8db3\u7684\u4e34\u5e8a\u8bc1\u636e\uff0c\u8bc1\u660e\u5668\u68b0\u5728\u5176\u9884\u671f\u7528\u9014\u4e0b\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\u3002<\/p>\n<\/p>\n 3. \u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\uff08QMS\uff09<\/strong><\/p>\n \u5236\u9020\u5546\u5fc5\u987b\u5efa\u7acb\u5e76\u5b9e\u65bd\u7b26\u5408MDR\u6cd5\u89c4\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\uff0c\u901a\u5e38\u9700\u8981\u4f9d\u636eISO 13485\u6807\u51c6\u8fdb\u884c\u6784\u5efa\uff0c\u5e76\u63a5\u53d7\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u3002<\/p>\n QMS\u9700\u8986\u76d6\u6240\u6709\u4e0e\u5668\u68b0\u5b89\u5168\u76f8\u5173\u7684\u8fc7\u7a0b\uff0c\u5305\u62ec\u98ce\u9669\u7ba1\u7406\u3001\u4e34\u5e8a\u8bc4\u4ef7\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u3001\u4f9b\u5e94\u5546\u63a7\u5236\u7b49\u3002<\/p>\n<\/p>\n 4. \u9009\u62e9\u5e76\u63a5\u53d7\u516c\u544a\u673a\u6784\u5ba1\u6838<\/strong><\/p>\n \u5bf9\u4e8e\u9700\u8981\u516c\u544a\u673a\u6784\u4ecb\u5165\u7684\u5668\u68b0\uff0c\u5236\u9020\u5546\u5fc5\u987b\u9009\u62e9\u4e00\u5bb6\u7ecf\u6b27\u76df\u59d4\u5458\u4f1a\u6307\u5b9a\u4e14\u5177\u6709\u76f8\u5e94\u4ea7\u54c1\u8303\u56f4\u8d44\u8d28\u7684\u516c\u544a\u673a\u6784\u3002<\/p>\n \u516c\u544a\u673a\u6784\u5c06\u8fdb\u884c\u4e25\u683c\u7684\u6587\u4ef6\u8bc4\u5ba1\u548c\u73b0\u573a\u5ba1\u6838\uff0c\u4ee5\u5168\u9762\u8bc4\u4f30\u6280\u672f\u6587\u4ef6\u3001QMS\u4ee5\u53ca\u5668\u68b0\u662f\u5426\u7b26\u5408MDR\u8981\u6c42\u3002<\/p>\n \u5ba1\u6838\u901a\u8fc7\u540e\uff0c\u5236\u9020\u5546\u5c06\u83b7\u5f97MDR\u8bc1\u4e66\u3002<\/p>\n<\/p>\n 5. \u6307\u5b9a\u6b27\u76df\u6388\u6743\u4ee3\u8868\uff08EU Authorized Representative\uff09<\/strong><\/p>\n \u5bf9\u4e8e\u4f4d\u4e8e\u6b27\u76df\u4ee5\u5916\u7684\u5236\u9020\u5546\uff08\u5982\u4e2d\u56fd\u5236\u9020\u5546\uff09\uff0c\u6cd5\u5f8b\u5f3a\u5236\u8981\u6c42\u5fc5\u987b\u6307\u5b9a\u4e00\u4e2a\u4f4d\u4e8e\u6b27\u76df\u5883\u5185\u7684\u6388\u6743\u4ee3\u8868\u3002<\/p>\n \u8be5\u4ee3\u8868\u5c06\u627f\u62c5\u7279\u5b9a\u7684\u6cd5\u5f8b\u8d23\u4efb\uff0c\u4f5c\u4e3a\u5236\u9020\u5546\u5728\u6b27\u76df\u7684\u8054\u7edc\u70b9\uff0c\u8d1f\u8d23\u4e0e\u76d1\u7ba1\u673a\u6784\u6c9f\u901a\uff0c\u5e76\u786e\u4fdd\u6280\u672f\u6587\u4ef6\u7b49\u8d44\u6599\u53ef\u4f9b\u4e3b\u7ba1\u5f53\u5c40\u968f\u65f6\u67e5\u9605\u3002<\/p>\n<\/p>\n 6. \u4ea7\u54c1\u6ce8\u518c\u4e0eUDI\u5206\u914d<\/strong><\/p>\n \u83b7\u5f97CE\u8bc1\u4e66\u540e\uff0c\u5236\u9020\u5546\u9700\u901a\u8fc7\u6b27\u76df\u7684\u7535\u5b50\u7cfb\u7edf\uff08EUDAMED\uff09\u5b8c\u6210\u5668\u68b0\u6ce8\u518c\uff0c\u4e3a\u5176\u5206\u914d\u5e76\u6807\u6ce8\u552f\u4e00\u8bbe\u5907\u6807\u8bc6\uff08UDI\uff09\u3002<\/p>\n UDI\u7cfb\u7edf\u6781\u5927\u5730\u589e\u5f3a\u4e86\u4ea7\u54c1\u7684\u53ef\u8ffd\u6eaf\u6027\uff0c\u4fbf\u4e8e\u5e02\u573a\u76d1\u63a7\u548c\u95ee\u9898\u4ea7\u54c1\u7684\u53ec\u56de\u3002<\/p>\n<\/p>\n \u4e09\u3001\u5236\u9020\u5546\u9762\u4e34\u7684\u4e3b\u8981\u6311\u6218\u4e0e\u5e94\u5bf9\u7b56\u7565<\/strong><\/p>\n \u5411MDR\u8fc7\u6e21\u7684\u8fc7\u7a0b\u5bf9\u5236\u9020\u5546\u800c\u8a00\u5145\u6ee1\u4e86\u6311\u6218\u3002<\/p>\n \u9996\u5148\uff0c\u662f\u4e34\u5e8a\u8bc1\u636e\u8981\u6c42\u7684\u663e\u8457\u63d0\u9ad8\u3002<\/p>\n \u8bb8\u591a\u4f9d\u636eMDD\u8ba4\u8bc1\u7684\u73b0\u6709\u4ea7\u54c1\u53ef\u80fd\u7f3a\u4e4f\u8db3\u591f\u7684\u4e34\u5e8a\u6570\u636e\u6765\u6ee1\u8db3MDR\u66f4\u4e3a\u4e25\u683c\u7684\u6807\u51c6\uff0c\u8fd9\u5c31\u9700\u8981\u5236\u9020\u5546\u8fdb\u884c\u989d\u5916\u7684\u4e34\u5e8a\u7814\u7a76\u6216\u7cfb\u7edf\u6027\u7684\u6587\u732e\u56de\u987e\uff0c\u6210\u672c\u548c\u65f6\u95f4\u6295\u5165\u5de8\u5927\u3002<\/p>\n \u5176\u6b21\uff0c\u516c\u544a\u673a\u6784\u8d44\u6e90\u7d27\u5f20\uff0c\u5ba1\u6838\u6392\u961f\u65f6\u95f4\u957f\uff0c\u8fdb\u4e00\u6b65\u5ef6\u957f\u4e86\u8ba4\u8bc1\u5468\u671f\u3002<\/p>\n 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