MDR\u8ba4\u8bc1\u673a\u6784\u6709\u54ea\u4e9b\uff1f\u8fd9\u662f\u8bb8\u591a\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u548c\u51fa\u53e3\u5546\u5728\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u65f6\u9996\u5148\u9700\u8981\u9762\u5bf9\u7684\u95ee\u9898\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\u9009\u62e9\u4e00\u5bb6\u5408\u9002\u7684\u516c\u544a\u673a\u6784\uff08Notified Body\uff09\u8fdb\u884c\u4ea7\u54c1\u8ba4\u8bc1\u53d8\u5f97\u81f3\u5173\u91cd\u8981\u3002<\/p>\n<\/p>\n
\u4e00\u3001MDR\u8ba4\u8bc1\u673a\u6784\u6982\u8ff0\uff1a\u4ec0\u4e48\u662f\u516c\u544a\u673a\u6784\uff1f<\/strong><\/p>\n \u516c\u544a\u673a\u6784\uff08Notified Body\uff09\u662f\u7ecf\u6b27\u76df\u6210\u5458\u56fd\u653f\u5e9c\u6307\u5b9a\uff0c\u5e76\u4f9d\u636e\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff09\u6216\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08IVDR\uff09\u5bf9\u533b\u7597\u5668\u68b0\u8fdb\u884c\u7b26\u5408\u6027\u8bc4\u4f30\u7684\u72ec\u7acb\u673a\u6784\u3002<\/p>\n<\/p>\n \u5b83\u4eec\u7684\u4e3b\u8981\u804c\u8d23\u662f\u8bc4\u4f30\u533b\u7597\u5668\u68b0\u662f\u5426\u7b26\u5408MDR\u89c4\u5b9a\u7684\u57fa\u672c\u5b89\u5168\u548c\u6027\u80fd\u8981\u6c42\uff0c\u5e76\u5bf9\u7b26\u5408\u8981\u6c42\u7684\u4ea7\u54c1\u9881\u53d1CE\u8ba4\u8bc1\u8bc1\u4e66\uff0c\u8fd9\u662f\u4ea7\u54c1\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u7684\u201c\u901a\u884c\u8bc1\u201d\u3002<\/p>\n<\/p>\n \u4e0e\u4e4b\u524d\u7684MDD\u6307\u4ee4\u76f8\u6bd4\uff0cMDR\u6cd5\u89c4\u5bf9\u516c\u544a\u673a\u6784\u7684\u76d1\u7ba1\u548c\u8981\u6c42\u66f4\u4e3a\u4e25\u683c\uff0c\u5176\u5ba1\u6838\u6d41\u7a0b\u4e5f\u66f4\u590d\u6742\u548c\u5168\u9762\u3002<\/p>\n<\/p>\n \u4e8c\u3001\u4e3b\u8981\u7684MDR\u8ba4\u8bc1\u673a\u6784\uff08\u516c\u544a\u673a\u6784\uff09\u540d\u5355<\/strong><\/p>\n \u622a\u81f3\u76ee\u524d\uff0c\u5df2\u6709\u4e8c\u5341\u591a\u5bb6\u516c\u544a\u673a\u6784\u88ab\u6b63\u5f0f\u6307\u5b9a\u5177\u5907MDR\u5ba1\u6838\u8d44\u8d28\u3002<\/p>\n<\/p>\n \u4ee5\u4e0b\u5217\u4e3e\u4e00\u4e9b\u5728\u5168\u7403\u8303\u56f4\u5185\u8f83\u4e3a\u77e5\u540d\u548c\u6d3b\u8dc3\u7684MDR\u8ba4\u8bc1\u673a\u6784\uff08\u8bf7\u6ce8\u610f\uff0c\u540d\u5355\u52a8\u6001\u66f4\u65b0\uff0c\u8bf7\u4ee5\u6b27\u76df\u5b98\u65b9NANDO\u6570\u636e\u5e93\u4e3a\u51c6\uff09\uff1a<\/p>\n<\/p>\n 1. T\u00dcV\u5357\u5fb7\u610f\u5fd7\u96c6\u56e2\uff08T\u00dcV S\u00dcD\uff09\uff1a\u5168\u7403\u9886\u5148\u7684\u6280\u672f\u670d\u52a1\u516c\u53f8\uff0c\u5176\u516c\u544a\u673a\u6784\u4ee3\u53f7\u4e3a0123\u3002<\/p>\n<\/p>\n 2. \u5fb7\u56fd\u83b1\u8335T\u00dcV\uff08T\u00dcV Rheinland\uff09\uff1a\u53e6\u4e00\u5bb6\u5fb7\u56fd\u5de8\u5934\uff0c\u516c\u544a\u673a\u6784\u4ee3\u53f7\u4e3a0197\uff0c\u5728\u533b\u7597\u5668\u68b0\u8ba4\u8bc1\u9886\u57df\u62e5\u6709\u4e30\u5bcc\u7ecf\u9a8c\u3002<\/p>\n<\/p>\n 3. \u82f1\u56fd\u6807\u51c6\u534f\u4f1a\uff08BSI Group\uff09\uff1a\u5168\u7403\u6700\u65e9\u7684\u516c\u544a\u673a\u6784\u4e4b\u4e00\uff0c\u516c\u544a\u673a\u6784\u4ee3\u53f7\u4e3a0086\uff0c\u5c3d\u7ba1\u82f1\u56fd\u5df2\u8131\u6b27\uff0c\u4f46\u5176MDR\u8d44\u8d28\u4ecd\u9002\u7528\u4e8e\u6b27\u76df\u5e02\u573a\u3002<\/p>\n<\/p>\n 4. \u5fb7\u51ef\u8ba4\u8bc1\uff08DEKRA\uff09\uff1a\u516c\u544a\u673a\u6784\u4ee3\u53f7\u4e3a0158\uff0c\u4e1a\u52a1\u8303\u56f4\u5e7f\u6cdb\uff0c\u8fd1\u5e74\u6765\u5728\u533b\u7597\u5668\u68b0\u8ba4\u8bc1\u9886\u57df\u79ef\u6781\u62d3\u5c55\u3002<\/p>\n<\/p>\n 5. \u610f\u5927\u5229\u8ba4\u8bc1\u673a\u6784\uff08IMQ\uff09\uff1a\u516c\u544a\u673a\u6784\u4ee3\u53f7\u4e3a0476\uff0c\u662f\u610f\u5927\u5229\u91cd\u8981\u7684\u8ba4\u8bc1\u670d\u52a1\u63d0\u4f9b\u5546\u3002<\/p>\n<\/p>\n 6. \u6cd5\u56fd\u5fc5\u7ef4\u56fd\u9645\u68c0\u9a8c\u96c6\u56e2\uff08Bureau Veritas\uff09\uff1a\u516c\u544a\u673a\u6784\u4ee3\u53f7\u4e3a0459\uff0c\u63d0\u4f9b\u6d4b\u8bd5\u3001\u68c0\u9a8c\u548c\u8ba4\u8bc1\u670d\u52a1\u3002<\/p>\n<\/p>\n 7. \u745e\u58ebSGS\u96c6\u56e2\uff1a\u516c\u544a\u673a\u6784\u4ee3\u53f7\u4e3a0120\uff0c\u662f\u5168\u7403\u9886\u5148\u7684\u68c0\u9a8c\u3001\u9274\u5b9a\u3001\u6d4b\u8bd5\u548c\u8ba4\u8bc1\u673a\u6784\u3002<\/p>\n<\/p>\n 8. \u5fb7\u56fdDekra\uff1a\u516c\u544a\u673a\u6784\u4ee3\u53f7\u4e3a0158\uff0c\u662f\u6b27\u6d32\u6700\u5927\u7684\u673a\u52a8\u8f66\u68c0\u9a8c\u673a\u6784\uff0c\u4e5f\u63d0\u4f9b\u4ea7\u54c1\u8ba4\u8bc1\u670d\u52a1\u3002<\/p>\n<\/p>\n 9. \u7231\u5c14\u5170NSAI\uff1a\u516c\u544a\u673a\u6784\u4ee3\u53f7\u4e3a2318\uff0c\u662f\u7231\u5c14\u5170\u7684\u56fd\u5bb6\u6807\u51c6\u6743\u5a01\u673a\u6784\u3002<\/p>\n<\/p>\n 10. \u8377\u5170DARE!! Services B.V.\uff1a\u516c\u544a\u673a\u6784\u4ee3\u53f7\u4e3a2546\u3002<\/p>\n<\/p>\n \u8bf7\u6ce8\u610f\uff0c\u6b64\u540d\u5355\u4ec5\u4e3a\u90e8\u5206\u793a\u4f8b\uff0c\u5e76\u975e\u5168\u90e8\u3002\u5236\u9020\u5546\u5728\u9009\u62e9\u65f6\uff0c\u5fc5\u987b\u67e5\u8be2\u6b27\u76df\u5b98\u65b9\u53d1\u5e03\u7684NANDO\uff08\u65b0\u65b9\u6cd5\u6307\u4ee4\u516c\u544a\u673a\u6784\u548c\u6307\u5b9a\u673a\u6784\uff09\u6570\u636e\u5e93\uff0c\u4ee5\u83b7\u53d6\u6700\u65b0\u3001\u6700\u5b8c\u6574\u4e14\u5177\u5907\u76f8\u5e94\u4ea7\u54c1\u8303\u56f4\u8d44\u8d28\u7684\u673a\u6784\u540d\u5355\u3002<\/p>\n<\/p>\n \u4e09\u3001\u5982\u4f55\u9009\u62e9\u9002\u5408\u7684MDR\u8ba4\u8bc1\u673a\u6784\uff1f<\/strong><\/p>\n \u9009\u62e9\u54ea\u5bb6MDR\u8ba4\u8bc1\u673a\u6784\u5e76\u975e\u7b80\u5355\u5730\u770b\u540d\u6c14\u5927\u5c0f\uff0c\u800c\u662f\u4e00\u4e2a\u9700\u8981\u7efc\u5408\u8003\u91cf\u7684\u6218\u7565\u51b3\u7b56\u3002<\/p>\n<\/p>\n \u9996\u5148\uff0c\u4f01\u4e1a\u5fc5\u987b\u786e\u8ba4\u8be5\u516c\u544a\u673a\u6784\u662f\u5426\u5df2\u88ab\u6b27\u76df\u59d4\u5458\u4f1a\u6b63\u5f0f\u6307\u5b9a\uff0c\u5e76\u4e14\u5176\u6388\u6743\u8303\u56f4\uff08Scope\uff09\u662f\u5426\u8986\u76d6\u4e86\u60a8\u7684\u4ea7\u54c1\u7c7b\u578b\u3002<\/p>\n<\/p>\n MDR\u6cd5\u89c4\u4e0b\uff0c\u516c\u544a\u673a\u6784\u7684\u8d44\u8d28\u662f\u5206\u8303\u56f4\u7684\uff0c\u5e76\u975e\u6240\u6709\u673a\u6784\u90fd\u80fd\u8ba4\u8bc1\u6240\u6709\u7c7b\u578b\u7684\u533b\u7597\u5668\u68b0\u3002<\/p>\n<\/p>\n \u5176\u6b21\uff0c\u9700\u8981\u8003\u8651\u673a\u6784\u7684\u884c\u4e1a\u7ecf\u9a8c\u548c\u4e13\u4e1a\u77e5\u8bc6\u3002\u4e13\u6ce8\u4e8e\u60a8\u4ea7\u54c1\u6240\u5c5e\u9886\u57df\uff08\u5982\u5fc3\u8840\u7ba1\u3001\u9aa8\u79d1\u3001\u6709\u6e90\u690d\u5165\u7269\u7b49\uff09\u7684\u673a\u6784\uff0c\u901a\u5e38\u80fd\u63d0\u4f9b\u66f4\u4e13\u4e1a\u3001\u9ad8\u6548\u7684\u5ba1\u6838\u670d\u52a1\u3002<\/p>\n<\/p>\n \u7b2c\u4e09\uff0c\u8bc4\u4f30\u673a\u6784\u7684\u670d\u52a1\u8d28\u91cf\u3001\u6c9f\u901a\u6548\u7387\u3001\u9879\u76ee\u5468\u671f\u548c\u8d39\u7528\u3002\u4e0d\u540c\u673a\u6784\u7684\u62a5\u4ef7\u548c\u5ba1\u6838\u65f6\u95f4\u53ef\u80fd\u5b58\u5728\u663e\u8457\u5dee\u5f02\u3002<\/p>\n<\/p>\n \u7b2c\u56db\uff0c\u8003\u8651\u673a\u6784\u7684\u56fd\u9645\u8ba4\u53ef\u5ea6\u548c\u58f0\u8a89\u3002\u4e00\u5bb6\u58f0\u8a89\u5353\u8457\u7684\u516c\u544a\u673a\u6784\u9881\u53d1\u7684\u8bc1\u4e66\uff0c\u53ef\u80fd\u66f4\u53d7\u5e02\u573a\u3001\u76d1\u7ba1\u673a\u6784\u548c\u5ba2\u6237\u7684\u4fe1\u4efb\u3002<\/p>\n<\/p>\n \u6700\u540e\uff0c\u8fd8\u9700\u8003\u8651\u5730\u7f18\u548c\u8bed\u8a00\u56e0\u7d20\u3002\u9009\u62e9\u4e0e\u60a8\u516c\u53f8\u5730\u7406\u4f4d\u7f6e\u76f8\u8fd1\u3001\u6c9f\u901a\u8bed\u8a00\u65e0\u969c\u788d\u7684\u673a\u6784\uff0c\u6709\u52a9\u4e8e\u51cf\u5c11\u6c9f\u901a\u6210\u672c\uff0c\u63d0\u9ad8\u5ba1\u6838\u6548\u7387\u3002<\/p>\n<\/p>\n \u56db\u3001MDR\u8ba4\u8bc1\u7684\u6700\u65b0\u52a8\u6001\u4e0e\u6311\u6218<\/strong><\/p>\n MDR\u8fc7\u6e21\u671f\u867d\u7136\u5df2\u7ecf\u8fc7\u5ef6\u957f\uff0c\u4f46\u5236\u9020\u4e1a\u754c\u4ecd\u7136\u9762\u4e34\u7740\u516c\u544a\u673a\u6784\u4ea7\u80fd\u4e0d\u8db3\u3001\u5ba1\u6838\u6392\u961f\u65f6\u95f4\u957f\u3001\u5ba1\u6838\u8981\u6c42\u4e25\u82db\u7b49\u5de8\u5927\u6311\u6218\u3002<\/p>\n<\/p>\n \u8bb8\u591a\u516c\u544a\u673a\u6784\u5df2\u7ecf\u6ee1\u8d1f\u8377\u8fd0\u8f6c\uff0c\u63a5\u53d7\u65b0\u5ba2\u6237\u7684\u610f\u613f\u548c\u80fd\u529b\u6709\u9650\u3002\u56e0\u6b64\uff0c\u5236\u9020\u5546\u5e94\u5c3d\u65e9\u542f\u52a8MDR\u5408\u89c4\u9879\u76ee\uff0c\u5e76\u5c3d\u5feb\u4e0e\u5fc3\u4eea\u7684\u516c\u544a\u673a\u6784\u63a5\u6d3d\uff0c\u9501\u5b9a\u5ba1\u6838\u8d44\u6e90\u3002<\/p>\n<\/p>\n \u6b64\u5916\uff0c\u6b27\u76df\u5b98\u65b9\u4e5f\u5728\u6301\u7eed\u6307\u5b9a\u65b0\u7684\u516c\u544a\u673a\u6784\uff0c\u4ee5\u7f13\u89e3\u5e02\u573a\u538b\u529b\u3002\u4f01\u4e1a\u5e94\u4fdd\u6301\u5bf9NANDO\u6570\u636e\u5e93\u7684\u5173\u6ce8\uff0c\u4e86\u89e3\u6700\u65b0\u6307\u5b9a\u7684\u673a\u6784\uff0c\u8fd9\u6216\u8bb8\u80fd\u63d0\u4f9b\u65b0\u7684\u9009\u62e9\u3002<\/p>\n<\/p>\n \u4e94\u3001MDR\u8ba4\u8bc1\u6d41\u7a0b\u7b80\u4ecb<\/strong><\/p>\n \u4e0e\u516c\u544a\u673a\u6784\u5408\u4f5c\u7684MDR\u8ba4\u8bc1\u6d41\u7a0b\u901a\u5e38\u5305\u62ec\u51e0\u4e2a\u5173\u952e\u9636\u6bb5\u3002<\/p>\n<\/p>\n \u9996\u5148\u662f\u51c6\u5907\u9636\u6bb5\uff0c\u4f01\u4e1a\u9700\u8981\u5efa\u7acb\u7b26\u5408MDR\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\uff0c\u5e76\u51c6\u5907\u8be6\u5c3d\u7684\u6280\u672f\u6587\u6863\uff08Technical Documentation\uff09\u3002<\/p>\n<\/p>\n 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