MDR\u533b\u7597\u5668\u68b0\u54a8\u8be2\u662f\u5f53\u524d\u533b\u7597\u5668\u68b0\u884c\u4e1a\u4f01\u4e1a\u9ad8\u5ea6\u5173\u6ce8\u7684\u4e13\u4e1a\u670d\u52a1\u9886\u57df\uff0c\u5b83\u76f4\u63a5\u5173\u7cfb\u5230\u4ea7\u54c1\u5728\u6b27\u6d32\u5e02\u573a\u7684\u5408\u89c4\u51c6\u5165\u4e0e\u5546\u4e1a\u6210\u529f\u3002<\/p>\n<\/p>\n
\u968f\u7740\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR, Regulation (EU) 2017\/745\uff09\u7684\u5168\u9762\u5b9e\u65bd\uff0c\u5176\u5bf9\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\u8981\u6c42\u53d1\u751f\u4e86\u6839\u672c\u6027\u7684\u53d8\u5316\uff0c\u5176\u4e25\u683c\u6027\u548c\u590d\u6742\u6027\u8fdc\u8d85\u4e4b\u524d\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\u3002<\/p>\n<\/p>\n
\u4e00\u3001 \u6df1\u523b\u7406\u89e3\u6b27\u76dfMDR\u6cd5\u89c4\u7684\u6838\u5fc3\u53d8\u5316\u4e0e\u6311\u6218<\/strong><\/p>\n MDR\u6cd5\u89c4\u5e76\u975e\u5bf9MDD\u7684\u7b80\u5355\u5347\u7ea7\uff0c\u800c\u662f\u4e00\u6b21\u5f7b\u5e95\u7684\u9769\u65b0\u3002\u5b83\u6781\u5927\u5730\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\u76f8\u4f3c\u7684\u4ea7\u54c1\uff08\u5982\u7f8e\u5bb9\u9690\u5f62\u773c\u955c\u3001\u62bd\u8102\u8bbe\u5907\u7b49\uff09\u4e5f\u7eb3\u5165\u76d1\u7ba1\u3002<\/p>\n<\/p>\n MDR\u5f3a\u8c03\u4ea7\u54c1\u7684\u5168\u751f\u547d\u5468\u671f\u76d1\u7ba1\uff0c\u4ece\u8bbe\u8ba1\u5f00\u53d1\u3001\u4e34\u5e8a\u8bc4\u4ef7\u3001\u751f\u4ea7\u5236\u9020\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u5230\u6700\u7ec8\u6dd8\u6c70\uff0c\u90fd\u9700\u8981\u5efa\u7acb\u5b8c\u6574\u7684\u53ef\u8ffd\u6eaf\u4f53\u7cfb\u3002\u5176\u5bf9\u4e34\u5e8a\u8bc1\u636e\u7684\u8981\u6c42\u53d8\u5f97\u6781\u4e3a\u4e25\u683c\uff0c\u8981\u6c42\u5236\u9020\u5546\u4e3a\u6240\u6709\u98ce\u9669\u7b49\u7ea7\u7684\u5668\u68b0\u63d0\u4f9b\u5145\u5206\u7684\u4e34\u5e8a\u6570\u636e\u4ee5\u8bc1\u660e\u5176\u5b89\u5168\u6027\u548c\u6027\u80fd\u3002<\/p>\n<\/p>\n \u6b64\u5916\uff0c\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u6d41\u7a0b\u66f4\u52a0\u4e25\u8c28\uff0c\u5ba1\u67e5\u5458\u961f\u4f0d\u4e2d\u52a0\u5165\u4e86\u4e34\u5e8a\u4e13\u5bb6\uff0c\u4f7f\u5f97\u6280\u672f\u6587\u6863\u5ba1\u6838\u548c\u8ba4\u8bc1\u6d41\u7a0b\u8017\u65f6\u66f4\u957f\u3001\u8981\u6c42\u66f4\u9ad8\u3002\u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u72ec\u81ea\u5e94\u5bf9\u8fd9\u4e9b\u9519\u7efc\u590d\u6742\u7684\u65b0\u8981\u6c42\u662f\u4e00\u9879\u8017\u65f6\u8d39\u529b\u4e14\u5145\u6ee1\u98ce\u9669\u7684\u5de8\u5927\u6311\u6218\u3002<\/p>\n<\/p>\n \u4e8c\u3001 MDR\u533b\u7597\u5668\u68b0\u54a8\u8be2\u670d\u52a1\u7684\u6838\u5fc3\u4ef7\u503c\u4e0e\u5185\u5bb9<\/strong><\/p>\n \u4e13\u4e1a\u7684MDR\u533b\u7597\u5668\u68b0\u54a8\u8be2\u670d\u52a1\u65e8\u5728\u4e3a\u5236\u9020\u5546\u63d0\u4f9b\u4e00\u7ad9\u5f0f\u7684\u89e3\u51b3\u65b9\u6848\uff0c\u5e2e\u52a9\u4f01\u4e1a\u9ad8\u6548\u3001\u5408\u89c4\u5730\u5b8c\u6210MDR\u8fc7\u6e21\uff0c\u5e76\u786e\u4fdd\u5176\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6301\u7eed\u7b26\u5408\u65b0\u89c4\u8981\u6c42\u3002<\/p>\n<\/p>\n \u54a8\u8be2\u670d\u52a1\u901a\u5e38\u6db5\u76d6\u4ee5\u4e0b\u51e0\u4e2a\u6838\u5fc3\u6a21\u5757\uff1a\u9996\u5148\u662f\u5dee\u8ddd\u5206\u6790(Gap Analysis)\uff0c\u987e\u95ee\u56e2\u961f\u4f1a\u5168\u9762\u8bc4\u4f30\u4f01\u4e1a\u73b0\u6709\u7684\u6280\u672f\u6587\u6863\u3001\u8d28\u91cf\u4f53\u7cfb\u548c\u6d41\u7a0b\uff0c\u4e0eMDR\u8981\u6c42\u8fdb\u884c\u9010\u6761\u6bd4\u5bf9\uff0c\u8bc6\u522b\u51fa\u5b58\u5728\u7684\u5dee\u8ddd\u548c\u4e0d\u8db3\uff0c\u5e76\u63d0\u4f9b\u8be6\u7ec6\u7684\u6539\u8fdb\u5efa\u8bae\u62a5\u544a\u3002<\/p>\n<\/p>\n \u5176\u6b21\u662f\u6280\u672f\u6587\u6863\u7f16\u5199\u4e0e\u5347\u7ea7\u652f\u6301\uff0cMDR\u5bf9\u6280\u672f\u6587\u6863\u7684\u7ed3\u6784\u3001\u5185\u5bb9\u548c\u6df1\u5ea6\u63d0\u51fa\u4e86\u66f4\u9ad8\u8981\u6c42\uff0c\u54a8\u8be2\u987e\u95ee\u4f1a\u6307\u5bfc\u4f01\u4e1a\u6309\u7167MDR Annex II\u548cIII\u7684\u89c4\u8303\uff0c\u7cfb\u7edf\u6027\u5730\u6574\u7406\u548c\u7f16\u5199\u5305\u62ec\u4ea7\u54c1\u9a8c\u8bc1\u62a5\u544a\u3001\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\uff08CER\uff09\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u8ba1\u5212\uff08PMS\uff09\u3001\u5b9a\u671f\u5b89\u5168\u66f4\u65b0\u62a5\u544a\uff08PSUR\uff09\u7b49\u5173\u952e\u6587\u4ef6\u3002<\/p>\n<\/p>\n \u7b2c\u4e09\u662f\u4e34\u5e8a\u8bc4\u4ef7\u54a8\u8be2\uff0c\u8fd9\u662fMDR\u5408\u89c4\u7684\u91cd\u4e2d\u4e4b\u91cd\u3002\u54a8\u8be2\u670d\u52a1\u673a\u6784\u4f1a\u534f\u52a9\u4f01\u4e1a\u5236\u5b9a\u4e34\u5e8a\u8bc4\u4ef7\u8ba1\u5212\uff0c\u8fdb\u884c\u7cfb\u7edf\u7684\u6587\u732e\u68c0\u7d22\u4e0e\u8bc4\u4f30\uff0c\u5fc5\u8981\u65f6\u89c4\u5212\u5e76\u5b9e\u65bd\u4e34\u5e8a\u7814\u7a76\uff0c\u6700\u7ec8\u64b0\u5199\u7b26\u5408MEDDEV 2.7\/1 rev 4\u548cMDR\u8981\u6c42\u7684\u4e25\u8c28\u7684\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u3002<\/p>\n<\/p>\n \u7b2c\u56db\u662f\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\u5347\u7ea7\u8f85\u5bfc\uff0c\u5e2e\u52a9\u4f01\u4e1a\u4f9d\u636eMDR\u548cISO 13485:2016\u6807\u51c6\u5347\u7ea7\u5176QMS\uff0c\u786e\u4fdd\u5176\u8986\u76d6\u4ece\u6982\u5ff5\u5230\u9000\u5f79\u7684\u5168\u751f\u547d\u5468\u671f\uff0c\u7279\u522b\u662f\u5f3a\u5316\u4e0a\u5e02\u540e\u76d1\u7763\u3001 vigilance\u62a5\u544a\u548c\u7ecf\u6d4e\u8fd0\u8425\u5546\u786e\u8ba4\u7b49\u6d41\u7a0b\u3002<\/p>\n<\/p>\n \u6700\u540e\u662f\u516c\u544a\u673a\u6784\u6c9f\u901a\u4e0e\u5ba1\u6838\u652f\u6301\uff0c\u7ecf\u9a8c\u4e30\u5bcc\u7684\u54a8\u8be2\u987e\u95ee\u53ef\u4ee5\u5145\u5f53\u5236\u9020\u5546\u4e0e\u516c\u544a\u673a\u6784\u4e4b\u95f4\u7684\u6c9f\u901a\u6865\u6881\uff0c\u534f\u52a9\u4f01\u4e1a\u51c6\u5907\u7b26\u5408\u6027\u5ba1\u6838\u7533\u8bf7\uff0c\u5e76\u5728\u73b0\u573a\u5ba1\u6838\u8fc7\u7a0b\u4e2d\u63d0\u4f9b\u4e13\u4e1a\u652f\u6301\uff0c\u786e\u4fdd\u5ba1\u6838\u987a\u5229\u8fdb\u884c\u3002<\/p>\n<\/p>\n \u4e09\u3001 \u5982\u4f55\u9009\u62e9\u4e00\u5bb6\u5408\u9002\u7684MDR\u533b\u7597\u5668\u68b0\u54a8\u8be2\u670d\u52a1\u673a\u6784<\/strong><\/p>\n \u9762\u5bf9\u5e02\u573a\u4e0a\u4f17\u591a\u7684\u54a8\u8be2\u670d\u52a1\u673a\u6784\uff0c\u5236\u9020\u5546\u9700\u8981\u5ba1\u614e\u9009\u62e9\uff0c\u4ee5\u786e\u4fdd\u5408\u4f5c\u7684\u6210\u529f\u3002\u4e00\u4e2a\u4f18\u79c0\u7684\u54a8\u8be2\u5408\u4f5c\u4f19\u4f34\u5e94\u5177\u5907\u4ee5\u4e0b\u7279\u8d28\uff1a\u62e5\u6709\u6df1\u539a\u7684\u6cd5\u89c4\u4e13\u4e1a\u77e5\u8bc6\uff0c\u5176\u987e\u95ee\u56e2\u961f\u5e94\u7cbe\u901aMDR\u6cd5\u89c4\u6587\u672c\u3001\u76f8\u5173\u534f\u8c03\u6807\u51c6\uff08Harmonised Standards\uff09\u4ee5\u53ca\u901a\u7528\u89c4\u8303\uff08Common Specifications\uff09\uff0c\u5e76\u80fd\u51c6\u786e\u89e3\u8bfb\u548c\u5e94\u7528\u3002<\/p>\n<\/p>\n \u5177\u5907\u4e30\u5bcc\u7684\u5b9e\u6218\u7ecf\u9a8c\uff0c\u7406\u60f3\u7684\u670d\u52a1\u5546\u5e94\u62e5\u6709\u5927\u91cf\u6210\u529f\u534f\u52a9\u5404\u7c7b\u533b\u7597\u5668\u68b0\uff08\u5c24\u5176\u662f\u540c\u7b49\u98ce\u9669\u5206\u7c7b\u4ea7\u54c1\uff09\u901a\u8fc7MDR\u8ba4\u8bc1\u7684\u6848\u4f8b\uff0c\u80fd\u591f\u63d0\u4f9b\u5207\u5b9e\u53ef\u884c\u7684\u89e3\u51b3\u65b9\u6848\uff0c\u800c\u975e\u7eb8\u4e0a\u8c08\u5175\u3002<\/p>\n<\/p>\n \u63d0\u4f9b\u672c\u571f\u5316\u7684\u670d\u52a1\u652f\u6301\uff0c\u867d\u7136MDR\u662f\u6b27\u76df\u6cd5\u89c4\uff0c\u4f46\u4e00\u5bb6\u80fd\u591f\u63d0\u4f9b\u4e2d\u6587\u670d\u52a1\u3001\u6df1\u523b\u7406\u89e3\u4e2d\u56fd\u5236\u9020\u5546\u6587\u5316\u548c\u4e1a\u52a1\u4e60\u60ef\u7684\u54a8\u8be2\u516c\u53f8\uff0c\u6c9f\u901a\u6548\u7387\u4f1a\u66f4\u9ad8\uff0c\u5408\u4f5c\u4e5f\u4f1a\u66f4\u52a0\u987a\u7545\u3002<\/p>\n<\/p>\n \u62e5\u6709\u826f\u597d\u7684\u884c\u4e1a\u7f51\u7edc\u8d44\u6e90\uff0c\u4e0e\u591a\u5bb6\u6b27\u76df\u516c\u544a\u673a\u6784\u4fdd\u6301\u826f\u597d\u5408\u4f5c\u5173\u7cfb\u3001\u719f\u6089\u4e0d\u540c\u516c\u544a\u673a\u6784\u5ba1\u6838\u7279\u70b9\u7684\u54a8\u8be2\u516c\u53f8\uff0c\u80fd\u4e3a\u4f01\u4e1a\u63a8\u8350\u66f4\u5408\u9002\u7684\u516c\u544a\u673a\u6784\uff0c\u5e76\u66f4\u6709\u6548\u5730\u63a8\u52a8\u9879\u76ee\u8fdb\u7a0b\u3002<\/p>\n<\/p>\n \u56db\u3001 MDR\u5408\u89c4\u4e4b\u8def\uff1a\u6218\u7565\u89c4\u5212\u4e0e\u957f\u671f\u4ef7\u503c<\/strong><\/p>\n \u5bfb\u6c42MDR\u533b\u7597\u5668\u68b0\u54a8\u8be2\u670d\u52a1\u4e0d\u5e94\u88ab\u89c6\u4e3a\u4e00\u9879\u7b80\u5355\u7684\u6210\u672c\u652f\u51fa\uff0c\u800c\u662f\u4e00\u9879\u5177\u6709\u957f\u671f\u56de\u62a5\u7684\u6218\u7565\u6295\u8d44\u3002\u6210\u529f\u83b7\u5f97MDR\u8ba4\u8bc1\u610f\u5473\u7740\u4ea7\u54c1\u83b7\u5f97\u4e86\u8fdb\u5165\u62e5\u6709\u6570\u4ebf\u4eba\u53e3\u7684\u6b27\u6d32\u5e02\u573a\u7684\u901a\u884c\u8bc1\uff0c\u7ef4\u62a4\u5e76\u63d0\u5347\u4e86\u54c1\u724c\u7684\u5e02\u573a\u58f0\u8a89\u548c\u7ade\u4e89\u529b\u3002<\/p>\n<\/p>\n \u66f4\u91cd\u8981\u7684\u662f\uff0c\u901a\u8fc7\u54a8\u8be2\u670d\u52a1\u7684\u5bfc\u5165\uff0c\u4f01\u4e1a\u80fd\u591f\u7cfb\u7edf\u6027\u5730\u6784\u5efa\u8d77\u4e00\u5957\u7b26\u5408\u56fd\u9645\u6700\u9ad8\u6807\u51c6\u4e4b\u4e00\u7684\u6cd5\u89c4\u6846\u67b6\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3002\u8fd9\u5957\u4f53\u7cfb\u4e0d\u4ec5\u80fd\u5e94\u5bf9\u5f53\u524d\u7684MDR\u8981\u6c42\uff0c\u66f4\u80fd\u4e3a\u4f01\u4e1a\u672a\u6765\u5f00\u53d1\u65b0\u4ea7\u54c1\u3001\u8fdb\u5165\u5168\u7403\u5176\u4ed6\u5e02\u573a\uff08\u5982\u7f8e\u56fd\u3001\u65e5\u672c\u7b49\uff09\u6253\u4e0b\u575a\u5b9e\u7684\u57fa\u7840\uff0c\u63d0\u5347\u4f01\u4e1a\u7684\u6574\u4f53\u8fd0\u8425\u8d28\u91cf\u548c\u98ce\u9669\u7ba1\u7406\u80fd\u529b\u3002<\/p>\n<\/p>\n 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