{"id":2116,"date":"2021-05-18T22:50:49","date_gmt":"2021-05-18T14:50:49","guid":{"rendered":"http:\/\/works.yundic.com\/kf\/?p=2116"},"modified":"2021-08-18T17:47:40","modified_gmt":"2021-08-18T09:47:40","slug":"%e5%81%9a%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e7%9a%84%e5%87%ba%e5%8f%a3%e4%bc%81%e4%b8%9a%e8%af%b7%e6%b3%a8%e6%84%8f%ef%bc%81%e6%ac%a7%e7%9b%9fmdr%e7%94%9f%e6%95%88%e5%9c%a8%e5%8d%b3%ef%bc%81","status":"publish","type":"post","link":"https:\/\/king-freight.com\/zh_cn\/%e5%81%9a%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e7%9a%84%e5%87%ba%e5%8f%a3%e4%bc%81%e4%b8%9a%e8%af%b7%e6%b3%a8%e6%84%8f%ef%bc%81%e6%ac%a7%e7%9b%9fmdr%e7%94%9f%e6%95%88%e5%9c%a8%e5%8d%b3%ef%bc%81\/","title":{"rendered":"\u505a\u533b\u7597\u5668\u68b0\u7684\u51fa\u53e3\u4f01\u4e1a\u8bf7\u6ce8\u610f\uff01\u6b27\u76df MDR\u751f\u6548\u5728\u5373\uff01"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-2117\" title=\"640-16\" 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srcset=\"https:\/\/king-freight.com\/wp-content\/uploads\/2021\/05\/640-17.png 942w, https:\/\/king-freight.com\/wp-content\/uploads\/2021\/05\/640-17-300x196.png 300w, https:\/\/king-freight.com\/wp-content\/uploads\/2021\/05\/640-17-768x502.png 768w, https:\/\/king-freight.com\/wp-content\/uploads\/2021\/05\/640-17-16x10.png 16w\" sizes=\"auto, (max-width: 942px) 100vw, 942px\" \/><\/p>\n<section>\u603b\u7684\u6765\u8bf4\uff0cMDR\u66f4\u52a0\u5173\u6ce8\u4e34\u5e8a\u6027\u80fd\u3001\u66f4\u597d\u7684\u533b\u7597\u5668\u68b0\u53ef\u8ffd\u6eaf\u6027\u548c\u5bf9\u60a3\u8005\u66f4\u5927\u7684\u900f\u660e\u5ea6\u3002\u8fd9\u610f\u5473\u7740\u5c06\u5bf9\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u533b\u7597\u5668\u68b0\u5b9e\u65bd\u66f4\u4e25\u683c\u7684\u9650\u5236\uff0c\u5bf9\u884c\u4e1a\u4ece\u4e8b\u8005\u63d0\u51fa\u4e86\u66f4\u9ad8\u7684\u8981\u6c42\u3002<br \/>\n\u6839\u636e\u533b\u7597\u79d1\u6280\u54a8\u8be2\u673a\u6784Clifton MedTech Consulting\u7684\u603b\u7ed3\uff0c\u65b0\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4MDR\u7684\u4e3b\u8981\u53d8\u5316\u5305\u62ec\uff1a<\/p>\n<p>\u533b\u7597\u5668\u68b0\u7684\u8303\u56f4\u6269\u5927\uff0c\u5305\u62ec\u67d0\u4e9b\u6ca1\u6709\u533b\u7597\u4f5c\u7528\u7684\u7f8e\u5bb9\u5668\u68b0(\u5982\u7528\u4e8e\u7f8e\u5bb9\u7684\u5f69\u8272\u9690\u5f62\u773c\u955c\uff09\u3002<\/p>\n<p>\u5c06\u8bbe\u7acb\u4e2d\u592e\u7535\u5b50\u8d44\u6599\u5e93\uff08\u79f0\u4e3aEudamed\uff09\u7528\u4e8e\u6536\u96c6\u6240\u6709\u76f8\u5173\u8d44\u8baf\uff0c\u5305\u62ec\u7ecf\u8425\u8005\u3001\u516c\u544a\u673a\u6784\u3001\u5e02\u573a\u76d1\u7763\u8b66\u6212\u3001\u4e34\u5e8a\u8c03\u67e5\u3001\u8bc1\u4e66\u548c\u4ea7\u54c1\u8d44\u8baf\u3002\u6b27\u76df\u6570\u636e\u5e93EUDAMED\u5c06\u5f97\u5230\u6781\u5927\u7684\u6269\u5c55\uff0c\u5e76\u5bf9\u516c\u4f17\u5f00\u653e\u3002\u63d0\u5347\u4ea7\u54c1\u5bf9\u60a3\u8005\u7684\u900f\u660e\u5ea6\u548c\u53ef\u8ffd\u6eaf\u6027\u3002<\/p>\n<p>\u4eca\u540e\u8981\u6c42\u6bcf\u4e2a\u4ea7\u54c1\u5fc5\u987b\u5305\u542b\u4e00\u4e2a\u72ec\u7acb\u7684\u4ea7\u54c1\u8bc6\u522b\u7801\uff08Unique Device Identification\uff0cUDI\uff09,\u52a0\u5f3a\u5176\u5728\u6574\u4e2a\u4f9b\u5e94\u94fe\u7684\u53ef\u8ffd\u6eaf\u6027\u3002<\/p>\n<p>\u533b\u7597\u5668\u68b0\u534f\u8c03\u5c0f\u7ec4\uff08Medical Device Coordination Group\uff0cMDCG\uff09\u6709\u6743\u8981\u6c42\u5bf9\u4ea7\u54c1\u7684\u6027\u80fd\u548c\u5b89\u5168\u6027\u4f5c\u8fdb\u4e00\u6b65\u7684\u79d1\u5b66\u8bc4\u4f30\u3002\u8fd9\u4e2a\u7a0b\u5e8f\u5f88\u53ef\u80fd\u4f1a\u5927\u5927\u5ef6\u957f\u533b\u7597\u5668\u68b0\u7684\u4e0a\u5e02\u8fdb\u7a0b\u3002<\/p>\n<p>\u5bf9\u4e3b\u7ba1\u5f53\u5c40\uff08Competent Authorities\uff09\u53ca\u5176\u76d1\u7ba1\u7684\u516c\u544a\u673a\u6784\u5c06\u91c7\u53d6\u66f4\u52a0\u4e25\u683c\u7684\u89c4\u5b9a\uff0c\u786e\u7acb\u8fd9\u4e9b\u673a\u6784\u7684\u6743\u5229\u548c\u4e49\u52a1\uff0c\u5404\u4e3b\u7ba1\u5f53\u5c40\uff08\u5373\u5404\u6210\u5458\u56fd\u7684\u6cd5\u5b9a\u7ba1\u7406\u673a\u6784\uff09\u8054\u5408\u5ba1\u8ba1\u516c\u544a\u673a\u6784\u662f\u5426\u7b26\u5408\u65b0\u6cd5\u89c4\u7684\u8981\u6c42\u3002<\/p>\n<p>\u5bf9\u4e8e\u690d\u5165\u6027\u5047\u4f53\u7b49\u9ad8\u98ce\u9669\u533b\u7597\u8bbe\u5907\uff0c\u201d\u53ea\u6709\u65b0\u8bbe\u7acb\u7279\u522b\u516c\u544a\u673a\u6784\u201cspecial notified bodies\u201d\u6709\u6743\u6388\u4e88 CE 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