\u6b27\u76df\u533b\u7597\u5668\u68b0\u67e5\u8be2\u662f\u533b\u7597\u5668\u68b0\u884c\u4e1a\u4ece\u4e1a\u8005\u3001\u76d1\u7ba1\u673a\u6784\u4ee5\u53ca\u76f8\u5173\u5229\u76ca\u65b9\u7ecf\u5e38\u9700\u8981\u8fdb\u884c\u7684\u5173\u952e\u64cd\u4f5c\u3002<\/p>\n
\u5b83\u6307\u7684\u662f\u901a\u8fc7\u6b27\u76df\u5b98\u65b9\u6216\u6388\u6743\u7684\u6570\u636e\u5e93\u4e0e\u5e73\u53f0\uff0c\u68c0\u7d22\u548c\u6838\u5b9e\u533b\u7597\u5668\u68b0\u7684\u6ce8\u518c\u3001\u8ba4\u8bc1\u3001\u7b26\u5408\u6027\u58f0\u660e\u4ee5\u53ca\u5236\u9020\u5546\u4fe1\u606f\u7b49\u4e00\u7cfb\u5217\u91cd\u8981\u6570\u636e\u7684\u8fc7\u7a0b\u3002<\/p>\n<\/p>\n
\u5bf9\u4e8e\u5e0c\u671b\u5c06\u4ea7\u54c1\u6295\u653e\u81f3\u6b27\u6d32\u5e02\u573a\u7684\u5236\u9020\u5546\u3001\u8d1f\u8d23\u91c7\u8d2d\u7684\u533b\u9662\u7ba1\u7406\u4eba\u5458\u3001\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u7684\u79d1\u7814\u4eba\u5458\uff0c\u4e43\u81f3\u5173\u6ce8\u81ea\u8eab\u6240\u7528\u533b\u7597\u8bbe\u5907\u5b89\u5168\u6027\u7684\u60a3\u8005\u800c\u8a00\uff0c\u638c\u63e1\u5982\u4f55\u8fdb\u884c\u6709\u6548\u7684\u6b27\u76df\u533b\u7597\u5668\u68b0\u67e5\u8be2\u90fd\u662f\u4e00\u9879\u81f3\u5173\u91cd\u8981\u7684\u6280\u80fd\u3002<\/p>\n
\u672c\u6587\u5c06\u7cfb\u7edf\u6027\u5730\u4ecb\u7ecd\u6b27\u76df\u533b\u7597\u5668\u68b0\u67e5\u8be2\u7684\u6838\u5fc3\u5e73\u53f0\u3001\u67e5\u8be2\u65b9\u6cd5\u3001\u5173\u952e\u4fe1\u606f\u89e3\u8bfb\u4ee5\u53ca\u5176\u91cd\u8981\u6027\uff0c\u4e3a\u60a8\u63d0\u4f9b\u4e00\u4efd\u5b9e\u7528\u7684\u64cd\u4f5c\u6307\u5357\u3002<\/p>\n<\/p>\n
\u4e00\u3001 \u6b27\u76df\u533b\u7597\u5668\u68b0\u67e5\u8be2\u7684\u6838\u5fc3\uff1aEUDAMED\u6570\u636e\u5e93<\/strong><\/p>\n \u8fdb\u884c\u6b27\u76df\u533b\u7597\u5668\u68b0\u67e5\u8be2\uff0c\u9996\u8981\u7684\u5b98\u65b9\u5e73\u53f0\u662f\u6b27\u76df\u533b\u7597\u5668\u68b0\u6570\u636e\u5e93\uff08EUDAMED\uff09\u3002<\/p>\n EUDAMED\u662f\u6b27\u76df\u6839\u636e\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff09\u548c\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08IVDR\uff09\u5efa\u7acb\u7684\u4e00\u4e2a\u7efc\u5408\u6027\u4fe1\u606f\u6280\u672f\u7cfb\u7edf\uff0c\u65e8\u5728\u589e\u5f3a\u900f\u660e\u5ea6\uff0c\u534f\u8c03\u5e02\u573a\u76d1\u7763\uff0c\u5e76\u4e3a\u516c\u4f17\u63d0\u4f9b\u4fe1\u606f\u3002<\/p>\n<\/p>\n EUDAMED\u7684\u8bbe\u8ba1\u76ee\u6807\u662f\u6210\u4e3a\u6240\u6709\u6b27\u76df\u533b\u7597\u5668\u68b0\u76f8\u5173\u4fe1\u606f\u7684\u4e2d\u592e\u5b58\u50a8\u5e93\u3002<\/p>\n \u5176\u529f\u80fd\u6a21\u5757\u6db5\u76d6\u4e86\u5668\u68b0\u7684\u552f\u4e00\u6807\u8bc6\uff08UDI\uff09\u3001\u5668\u68b0\u6ce8\u518c\u3001\u8ba4\u8bc1\u548c\u7b26\u5408\u6027\u58f0\u660e\u3001\u5236\u9020\u5546\u4e0e\u6388\u6743\u4ee3\u8868\u4fe1\u606f\u3001\u4e34\u5e8a\u7814\u7a76\u3001\u8b66\u6212\u548c\u4e0a\u5e02\u540e\u76d1\u7763\u4ee5\u53ca\u5e02\u573a\u76d1\u7763\u7b49\u3002<\/p>\n<\/p>\n \u76ee\u524d\uff0cEUDAMED\u6b63\u5904\u4e8e\u5206\u9636\u6bb5\u4e0a\u7ebf\u8fc7\u7a0b\u4e2d\u3002<\/p>\n \u867d\u7136\u5176\u5168\u90e8\u529f\u80fd\u5c1a\u672a\u5b8c\u5168\u5f00\u653e\uff0c\u4f46\u5176\u4e2d\u7684\u201c\u5668\u68b0\u6ce8\u518c\u201d\u6a21\u5757\uff08Actor Registration and Device Registration\uff09\u548c\u90e8\u5206\u516c\u5171\u95e8\u6237\u7f51\u7ad9\u5df2\u7ecf\u6295\u5165\u4f7f\u7528\uff0c\u5141\u8bb8\u7528\u6237\u8fdb\u884c\u57fa\u7840\u7684\u6b27\u76df\u533b\u7597\u5668\u68b0\u67e5\u8be2\u3002<\/p>\n<\/p>\n \u4e8c\u3001 \u5982\u4f55\u8fdb\u884c\u6b27\u76df\u533b\u7597\u5668\u68b0\u67e5\u8be2\uff1a\u5206\u6b65\u6307\u5357<\/strong><\/p>\n \u8981\u8fdb\u884c\u4e00\u6b21\u6210\u529f\u7684\u6b27\u76df\u533b\u7597\u5668\u68b0\u67e5\u8be2\uff0c\u60a8\u53ef\u4ee5\u9075\u5faa\u4ee5\u4e0b\u6b65\u9aa4\uff0c\u8bbf\u95eeEUDAMED\u7684\u516c\u5171\u754c\u9762\u3002<\/p>\n<\/p>\n 1. \u8bbf\u95ee\u5b98\u65b9\u95e8\u6237<\/strong><\/p>\n \u9996\u5148\uff0c\u8bf7\u786e\u4fdd\u60a8\u8bbf\u95ee\u7684\u662fEUDAMED\u7684\u5b98\u65b9\u7f51\u7ad9\uff08\u4f8b\u5982\uff1aec.europa.eu\/tools\/eudamed\uff09\uff0c\u4ee5\u907f\u514d\u8bbf\u95ee\u5230\u9519\u8bef\u6216\u975e\u5b98\u65b9\u7684\u4fe1\u606f\u6e90\u3002<\/p>\n \u5728\u7f51\u7ad9\u9996\u9875\uff0c\u60a8\u53ef\u4ee5\u627e\u5230\u201cPublic\u201d\u6216\u201cPublic Site\u201d\u7684\u5165\u53e3\uff0c\u70b9\u51fb\u8fdb\u5165\u516c\u5171\u67e5\u8be2\u9875\u9762\u3002<\/p>\n<\/p>\n 2. \u7406\u89e3\u67e5\u8be2\u9009\u9879<\/strong><\/p>\n \u5728\u516c\u5171\u67e5\u8be2\u9875\u9762\uff0c\u60a8\u901a\u5e38\u4f1a\u770b\u5230\u591a\u79cd\u67e5\u8be2\u9009\u9879\uff0c\u4e3b\u8981\u5305\u62ec\u6309\u5668\u68b0\u57fa\u672c\u4fe1\u606f\u67e5\u8be2\u548c\u6309\u7ecf\u6d4e\u8fd0\u8425\u8005\u4fe1\u606f\u67e5\u8be2\u3002<\/p>\n \u5668\u68b0\u57fa\u672c\u4fe1\u606f\u67e5\u8be2\u53ef\u80fd\u5305\u62ec\u5668\u68b0\u540d\u79f0\u3001\u578b\u53f7\u3001UDI-DI\uff08\u8bbe\u5907\u6807\u8bc6\u7b26\uff09\u3001\u5668\u68b0\u7c7b\u522b\u7b49\u3002<\/p>\n \u7ecf\u6d4e\u8fd0\u8425\u8005\u4fe1\u606f\u67e5\u8be2\u5219\u5305\u62ec\u5236\u9020\u5546\u540d\u79f0\u3001\u6388\u6743\u4ee3\u8868\u540d\u79f0\u53ca\u5176SRN\uff08\u5355\u4e00\u6ce8\u518c\u53f7\u7801\uff09\u3002<\/p>\n<\/p>\n 3. \u6267\u884c\u67e5\u8be2\u5e76\u7b5b\u9009\u7ed3\u679c<\/strong><\/p>\n \u8f93\u5165\u60a8\u5df2\u77e5\u7684\u4e00\u4e2a\u6216\u591a\u4e2a\u5173\u952e\u8bcd\u8fdb\u884c\u641c\u7d22\u3002<\/p>\n \u7531\u4e8e\u6570\u636e\u5e93\u4fe1\u606f\u5e9e\u5927\uff0c\u5efa\u8bae\u60a8\u5c3d\u91cf\u4f7f\u7528\u6700\u5177\u4f53\u7684\u4fe1\u606f\uff08\u5982SRN\u6216UDI-DI\uff09\u4ee5\u83b7\u5f97\u6700\u7cbe\u786e\u7684\u7ed3\u679c\u3002<\/p>\n \u7cfb\u7edf\u4f1a\u8fd4\u56de\u4e00\u4e2a\u7ed3\u679c\u5217\u8868\uff0c\u60a8\u53ef\u4ee5\u70b9\u51fb\u5355\u4e2a\u7ed3\u679c\u4ee5\u67e5\u770b\u66f4\u8be6\u7ec6\u7684\u4fe1\u606f\u3002<\/p>\n<\/p>\n 4. \u89e3\u8bfb\u67e5\u8be2\u7ed3\u679c<\/strong><\/p>\n \u67e5\u8be2\u7ed3\u679c\u9875\u9762\u4f1a\u5c55\u793a\u8be5\u533b\u7597\u5668\u68b0\u7684\u6838\u5fc3\u4fe1\u606f\u3002<\/p>\n \u60a8\u9700\u8981\u91cd\u70b9\u5173\u6ce8\u4ee5\u4e0b\u51e0\u70b9\uff1a\u5668\u68b0\u7684\u57fa\u672c\u63cf\u8ff0\u548c\u578b\u53f7\u3001\u5176\u98ce\u9669\u5206\u7c7b\uff08I\u7c7b\uff0c IIa, IIb, III\u7c7b\uff09\u3001\u6307\u5b9a\u7684\u516c\u544a\u673a\u6784\u540d\u79f0\u53ca\u5176\u7f16\u53f7\u3001\u8bc1\u4e66\u72b6\u6001\uff08\u6709\u6548\u3001\u6682\u505c\u3001\u64a4\u9500\u7b49\uff09\u3001\u4ee5\u53ca\u5236\u9020\u5546\u548c\u6388\u6743\u4ee3\u8868\u7684\u8be6\u7ec6\u8054\u7cfb\u4fe1\u606f\u3002<\/p>\n \u8fd9\u4e9b\u4fe1\u606f\u662f\u9a8c\u8bc1\u4ea7\u54c1\u5408\u89c4\u6027\u548c\u5408\u6cd5\u6027\u7684\u5173\u952e\u3002<\/p>\n<\/p>\n \u4e09\u3001 \u6b27\u76df\u533b\u7597\u5668\u68b0\u67e5\u8be2\u7684\u5173\u952e\u4fe1\u606f\u89e3\u8bfb<\/strong><\/p>\n \u4ec5\u4ec5\u627e\u5230\u4fe1\u606f\u8fd8\u4e0d\u591f\uff0c\u6b63\u786e\u89e3\u8bfb\u4fe1\u606f\u540c\u6837\u91cd\u8981\u3002<\/p>\n \u4ee5\u4e0b\u662f\u51e0\u4e2a\u5173\u952e\u70b9\u7684\u89e3\u8bfb\u8bf4\u660e\u3002<\/p>\n<\/p>\n 1. \u552f\u4e00\u8bbe\u5907\u6807\u8bc6\u7b26\uff08UDI\uff09<\/strong><\/p>\n UDI\u662f\u533b\u7597\u5668\u68b0\u7684\u552f\u4e00\u201c\u8eab\u4efd\u8bc1\u201d\uff0c\u7531UDI-DI\uff08\u8bbe\u5907\u6807\u8bc6\u7b26\uff09\u548cUDI-PI\uff08\u751f\u4ea7\u6807\u8bc6\u7b26\uff09\u7ec4\u6210\u3002<\/p>\n UDI-DI\u662f\u7279\u5b9a\u4e8e\u5236\u9020\u5546\u548c\u5668\u68b0\u578b\u53f7\u7684\u56fa\u5b9a\u7f16\u7801\uff0c\u800cUDI-PI\u5219\u5305\u542b\u6279\u53f7\u3001\u5e8f\u5217\u53f7\u3001\u751f\u4ea7\u65e5\u671f\u548c\u6709\u6548\u671f\u7b49\u4fe1\u606f\u3002<\/p>\n \u5728\u6b27\u76df\u533b\u7597\u5668\u68b0\u67e5\u8be2\u4e2d\uff0cUDI-DI\u662f\u7cbe\u51c6\u5b9a\u4f4d\u7279\u5b9a\u578b\u53f7\u5668\u68b0\u7684\u6700\u53ef\u9760\u65b9\u5f0f\u3002<\/p>\n<\/p>\n 2. \u516c\u544a\u673a\u6784\uff08Notified Body\uff09<\/strong><\/p>\n \u516c\u544a\u673a\u6784\u662f\u7ecf\u6b27\u76df\u5b98\u65b9\u6307\u5b9a\u3001\u8d1f\u8d23\u8bc4\u4f30\u9664I\u7c7b\u65e0\u83cc\/\u6d4b\u91cf\/\u53ef\u91cd\u590d\u624b\u672f\u5668\u68b0\u4ee5\u5916\u7684\u5927\u90e8\u5206\u533b\u7597\u5668\u68b0\u662f\u5426\u7b26\u5408MDR\/IVDR\u8981\u6c42\u7684\u72ec\u7acb\u7ec4\u7ec7\u3002<\/p>\n \u67e5\u8be2\u7ed3\u679c\u4e2d\u663e\u793a\u7684\u516c\u544a\u673a\u6784\u540d\u79f0\u548c\u7f16\u53f7\u662f\u786e\u8ba4\u8be5\u5668\u68b0\u5df2\u901a\u8fc7\u7b2c\u4e09\u65b9\u7b26\u5408\u6027\u8bc4\u4f30\u7684\u91cd\u8981\u8bc1\u636e\u3002<\/p>\n \u52a1\u5fc5\u6838\u5b9e\u8be5\u516c\u544a\u673a\u6784\u662f\u5426\u4ecd\u5728\u6b27\u76df\u7684\u5b98\u65b9\u540d\u5355\u4e0a\u4e14\u8d44\u8d28\u6709\u6548\u3002<\/p>\n<\/p>\n 3. \u8bc1\u4e66\u72b6\u6001\uff08Certificate Status\uff09<\/strong><\/p>\n \u8bc1\u4e66\u72b6\u6001\u76f4\u63a5\u53cd\u6620\u4e86\u8be5\u5668\u68b0\u5f53\u524d\u5728\u6b27\u76df\u5e02\u573a\u7684\u5408\u6cd5\u4e0a\u5e02\u8d44\u683c\u3002<\/p>\n \u201c\u6709\u6548\u201d\u72b6\u6001\u8868\u793a\u8bc1\u4e66\u6b63\u5e38\uff1b\u201c\u6682\u505c\u201d\u8868\u793a\u6682\u65f6\u65e0\u6548\uff0c\u5668\u68b0\u53ef\u80fd\u65e0\u6cd5\u9500\u552e\u6216\u4f7f\u7528\uff1b\u201c\u64a4\u9500\u201d\u5219\u8868\u793a\u8bc1\u4e66\u5df2\u88ab\u6c38\u4e45\u53d6\u6d88\u3002<\/p>\n \u67e5\u8be2\u65f6\u52a1\u5fc5\u786e\u8ba4\u72b6\u6001\u4e3a\u201c\u6709\u6548\u201d\u3002<\/p>\n<\/p>\n \u56db\u3001 \u6b27\u76df\u533b\u7597\u5668\u68b0\u67e5\u8be2\u7684\u91cd\u8981\u6027\u4e0e\u5e94\u7528\u573a\u666f<\/strong><\/p>\n \u6b27\u76df\u533b\u7597\u5668\u68b0\u67e5\u8be2\u7edd\u975e\u4e00\u4e2a\u7b80\u5355\u7684\u6d41\u7a0b\uff0c\u5b83\u5728\u591a\u4e2a\u573a\u666f\u4e0b\u53d1\u6325\u7740\u81f3\u5173\u91cd\u8981\u7684\u4f5c\u7528\u3002<\/p>\n<\/p>\n 1. \u5e02\u573a\u51c6\u5165\u4e0e\u5408\u89c4\u6027\u9a8c\u8bc1<\/strong><\/p>\n \u5bf9\u4e8e\u5236\u9020\u5546\u548c\u51fa\u53e3\u5546\uff0c\u67e5\u8be2\u662f\u9a8c\u8bc1\u81ea\u8eab\u4ea7\u54c1\u6216\u7ade\u4e89\u5bf9\u624b\u4ea7\u54c1\u662f\u5426\u5df2\u83b7\u5f97\u5408\u6cd5CE\u8ba4\u8bc1\u3001\u7b26\u5408\u6b27\u76df\u6cd5\u89c4\u8981\u6c42\u7684\u7b2c\u4e00\u6b65\u3002<\/p>\n \u8fd9\u662f\u4ea7\u54c1\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u7684\u5fc5\u8981\u524d\u63d0\u3002<\/p>\n<\/p>\n 2. \u91c7\u8d2d\u51b3\u7b56\u4e0e\u4f9b\u5e94\u94fe\u7ba1\u7406<\/strong><\/p>\n \u533b\u9662\u3001\u8bca\u6240\u7b49\u91c7\u8d2d\u65b9\u5728\u8d2d\u4e70\u533b\u7597\u5668\u68b0\u524d\uff0c\u53ef\u4ee5\u901a\u8fc7\u67e5\u8be2\u6765\u6838\u5b9e\u4f9b\u5e94\u5546\u8d44\u8d28\u7684\u771f\u4f2a\u548c\u4ea7\u54c1\u7684\u5408\u89c4\u72b6\u6001\uff0c\u786e\u4fdd\u91c7\u8d2d\u7684\u8bbe\u5907\u5b89\u5168\u53ef\u9760\uff0c\u907f\u514d\u8d2d\u5165\u4e0d\u5408\u89c4\u4ea7\u54c1\u5e26\u6765\u7684\u6cd5\u5f8b\u548c\u533b\u7597\u98ce\u9669\u3002<\/p>\n<\/p>\n 3. \u5e02\u573a\u76d1\u7763\u4e0e\u8b66\u6212<\/strong><\/p>\n \u5404\u56fd\u76d1\u7ba1\u673a\u6784\u5229\u7528EUDAMED\u8fdb\u884c\u5e02\u573a\u76d1\u7763\uff0c\u8ddf\u8e2a\u5668\u68b0\u7684\u4e0a\u5e02\u540e\u8868\u73b0\uff0c\u7ba1\u7406\u8b66\u6212\u62a5\u544a\uff08\u5982\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\uff09\uff0c\u5e76\u80fd\u8fc5\u901f\u8ffd\u6eaf\u95ee\u9898\u5668\u68b0\uff0c\u91c7\u53d6\u7ea0\u6b63\u63aa\u65bd\uff08\u5982\u53ec\u56de\uff09\uff0c\u4ece\u800c\u4fdd\u62a4\u516c\u4f17\u5065\u5eb7\u3002<\/p>\n<\/p>\n 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