{"id":4029,"date":"2025-09-04T13:58:03","date_gmt":"2025-09-04T05:58:03","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=4029"},"modified":"2025-09-04T13:58:03","modified_gmt":"2025-09-04T05:58:03","slug":"mdreu-2017-745","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=4029","title":{"rendered":"mdr(eu 2017\/745)"},"content":{"rendered":"

1. MDR (EU 2017\/745)\uff1a\u5168\u9762\u89e3\u6790\u6b27\u76df\u533b\u7597\u5668\u68b0\u65b0\u6cd5\u89c4<\/strong><\/p>\n

MDR (EU 2017\/745) \u662f\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4 (Medical Device Regulation) \u7684\u7b80\u79f0\uff0c\u8be5\u6cd5\u89c4\u4e8e2017\u5e745\u67085\u65e5\u6b63\u5f0f\u53d1\u5e03\uff0c\u5e76\u53d6\u4ee3\u4e86\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4 (MDD 93\/42\/EEC) \u548c\u6709\u6e90\u690d\u5165\u533b\u7597\u5668\u68b0\u6307\u4ee4 (AIMDD 90\/385\/EEC)\u3002<\/p>\n<\/p>\n

MDR (EU 2017\/745) \u7684\u51fa\u53f0\u80cc\u666f\u6e90\u4e8e\u4e00\u7cfb\u5217\u91cd\u5927\u7684\u533b\u7597\u5668\u68b0\u5b89\u5168\u4e8b\u4ef6\uff0c\u8fd9\u4e9b\u4e8b\u4ef6\u66b4\u9732\u4e86\u65e7\u6307\u4ee4\u4f53\u7cfb\u4e0b\u7684\u76d1\u7ba1\u4e0d\u8db3\u3002<\/p>\n<\/p>\n

\u65b0\u6cd5\u89c4\u65e8\u5728\u5efa\u7acb\u66f4\u900f\u660e\u3001\u66f4\u5b89\u5168\u7684\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u6846\u67b6\uff0c\u786e\u4fdd\u6295\u653e\u6b27\u76df\u5e02\u573a\u7684\u6240\u6709\u533b\u7597\u5668\u68b0\u5177\u6709\u66f4\u9ad8\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\u6807\u51c6\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

2. MDR (EU 2017\/745) \u7684\u6838\u5fc3\u53d8\u5316\u4e0e\u91cd\u8981\u5185\u5bb9<\/strong><\/p>\n

\u4e0e\u4e4b\u524d\u7684\u6307\u4ee4\u76f8\u6bd4\uff0cMDR (EU 2017\/745) \u5f15\u5165\u4e86\u591a\u9879\u6839\u672c\u6027\u7684\u53d8\u9769\uff0c\u8fd9\u4e9b\u53d8\u5316\u5bf9\u5236\u9020\u5546\u3001\u516c\u544a\u673a\u6784\u3001\u5206\u9500\u5546\u4e43\u81f3\u533b\u7597\u4fdd\u5065\u63d0\u4f9b\u5546\u90fd\u4ea7\u751f\u4e86\u6df1\u8fdc\u7684\u5f71\u54cd\u3002<\/p>\n<\/p>\n

2.1. \u6269\u5927\u76d1\u7ba1\u8303\u56f4<\/strong><\/p>\n

MDR (EU 2017\/745) \u663e\u8457\u6269\u5927\u4e86\u5176\u7ba1\u8f96\u8303\u56f4\uff0c\u5c06\u8bb8\u591a\u6b64\u524d\u672a\u660e\u786e\u5f52\u7c7b\u6216\u4e0d\u53d7\u4e25\u683c\u76d1\u7ba1\u7684\u4ea7\u54c1\u7eb3\u5165\u533b\u7597\u5668\u68b0\u8303\u7574\u3002<\/p>\n<\/p>\n

\u4f8b\u5982\uff0c\u67d0\u4e9b\u6ca1\u6709\u533b\u7597\u76ee\u7684\u4f46\u5177\u6709\u7c7b\u4f3c\u529f\u80fd\u7684\u7f8e\u5bb9\u4ea7\u54c1\uff0c\u5982\u7528\u4e8e\u7f8e\u5bb9\u7684\u5f69\u8272\u9690\u5f62\u773c\u955c\u3001\u76ae\u80a4\u586b\u5145\u6750\u6599\u7b49\uff0c\u73b0\u5728\u90fd\u88ab\u660e\u786e\u5212\u5206\u4e3a\u533b\u7597\u5668\u68b0\u5e76\u53d7\u5230MDR\u7684\u76d1\u7ba1\u3002<\/p>\n<\/p>\n

\u6b64\u5916\uff0c\u7528\u4e8e\u6e05\u6d01\u3001\u6d88\u6bd2\u6216\u706d\u83cc\u7684\u5668\u68b0\u4ee5\u53ca\u8f6f\u4ef6\uff08\u5305\u62ec\u7528\u4e8e\u8bca\u65ad\u6216\u6cbb\u7597\u51b3\u7b56\u7684\u72ec\u7acb\u8f6f\u4ef6\uff09\u4e5f\u88ab\u660e\u786e\u7eb3\u5165\u6cd5\u89c4\u76d1\u7ba1\u4e4b\u4e0b\u3002<\/p>\n<\/p>\n

2.2. \u52a0\u5f3a\u4e34\u5e8a\u8bc1\u636e\u8981\u6c42<\/strong><\/p>\n

MDR (EU 2017\/745) \u5bf9\u4e34\u5e8a\u8bc4\u4ef7\u63d0\u51fa\u4e86\u66f4\u4e3a\u4e25\u683c\u548c\u6301\u7eed\u7684\u8981\u6c42\uff0c\u5f3a\u8c03\u4e34\u5e8a\u8bc1\u636e\u662f\u8bc1\u660e\u5668\u68b0\u5b89\u5168\u6027\u548c\u6027\u80fd\u7684\u57fa\u77f3\u3002<\/p>\n<\/p>\n

\u5236\u9020\u5546\u5fc5\u987b\u4e3a\u6240\u6709\u5668\u68b0\uff0c\u5305\u62ec\u9057\u7559\u8bbe\u5907\uff0c\u63d0\u4f9b\u5f3a\u6709\u529b\u7684\u4e34\u5e8a\u6570\u636e\u652f\u6301\uff0c\u8fd9\u4e9b\u6570\u636e\u9700\u8981\u901a\u8fc7\u4e25\u683c\u7684\u4e34\u5e8a\u8bc4\u4ef7\u6765\u83b7\u53d6\uff0c\u5e76\u8d2f\u7a7f\u4ea7\u54c1\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u3002<\/p>\n<\/p>\n

\u6cd5\u89c4\u8981\u6c42\u5b9e\u65bd\u4e0a\u5e02\u540e\u4e34\u5e8a\u8ddf\u8e2a (PMCF) \u4ee5\u6301\u7eed\u6536\u96c6\u548c\u8bc4\u4f30\u4e34\u5e8a\u6570\u636e\uff0c\u786e\u4fdd\u5668\u68b0\u5728\u771f\u5b9e\u4e16\u754c\u4f7f\u7528\u4e2d\u7684\u957f\u671f\u5b89\u5168\u548c\u6027\u80fd\u3002<\/p>\n<\/p>\n

2.3. \u63d0\u9ad8\u900f\u660e\u5ea6\u548c\u53ef\u8ffd\u6eaf\u6027<\/strong><\/p>\n

\u4e3a\u4e86\u589e\u5f3a\u5e02\u573a\u900f\u660e\u5ea6\uff0cMDR (EU 2017\/745) \u5efa\u7acb\u4e86\u6b27\u6d32\u533b\u7597\u5668\u68b0\u6570\u636e\u5e93 (EUDAMED)\uff0c\u8fd9\u662f\u4e00\u4e2a\u7efc\u5408\u6027\u7684\u4fe1\u606f\u6280\u672f\u5e73\u53f0\u3002<\/p>\n<\/p>\n

EUDAMED\u5c06\u6536\u5f55\u6240\u6709\u5728\u6b27\u76df\u5e02\u573a\u4e0a\u6d41\u901a\u7684\u533b\u7597\u5668\u68b0\u4fe1\u606f\uff0c\u5305\u62ec\u5236\u9020\u5546\u548c\u516c\u544a\u673a\u6784\u4fe1\u606f\u3001UDI\u6570\u636e\u3001\u4e34\u5e8a\u8c03\u67e5\u3001\u8b66\u6212\u548c\u4e0a\u5e02\u540e\u76d1\u7763\u4fe1\u606f\u7b49\uff0c\u5e76\u5411\u516c\u4f17\u5f00\u653e\u90e8\u5206\u6570\u636e\u67e5\u8be2\u529f\u80fd\u3002<\/p>\n<\/p>\n

\u540c\u65f6\uff0c\u552f\u4e00\u5668\u68b0\u6807\u8bc6 (UDI) \u7cfb\u7edf\u7684\u5168\u9762\u5b9e\u65bd\u786e\u4fdd\u4e86\u5668\u68b0\u5728\u6574\u4e2a\u4f9b\u5e94\u94fe\u4e2d\u7684\u53ef\u8ffd\u6eaf\u6027\uff0c\u4fbf\u4e8e\u5feb\u901f\u8bc6\u522b\u548c\u53ec\u56de\u95ee\u9898\u4ea7\u54c1\u3002<\/p>\n<\/p>\n

2.4. \u5f3a\u5316\u516c\u544a\u673a\u6784\u5ba1\u6838\u4e0e\u5236\u9020\u5546\u8d23\u4efb<\/strong><\/p>\n

MDR (EU 2017\/745) \u5bf9\u516c\u544a\u673a\u6784\u7684\u8d44\u8d28\u548c\u80fd\u529b\u63d0\u51fa\u4e86\u66f4\u9ad8\u8981\u6c42\uff0c\u5176\u5ba1\u6838\u6d41\u7a0b\u53d8\u5f97\u66f4\u52a0\u4e25\u683c\u548c\u7edf\u4e00\u3002<\/p>\n<\/p>\n

\u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u6cd5\u89c4\u660e\u786e\u4e86\u5176\u4f5c\u4e3a\u5408\u89c4\u7b2c\u4e00\u8d23\u4efb\u4eba\u7684\u5730\u4f4d\uff0c\u8981\u6c42\u4ed6\u4eec\u5efa\u7acb\u66f4\u5b8c\u5584\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3001\u4f9b\u5e94\u94fe\u63a7\u5236\u4ee5\u53ca\u4e0a\u5e02\u540e\u76d1\u7763\u7cfb\u7edf\u3002<\/p>\n<\/p>\n

\u5236\u9020\u5546\u5fc5\u987b\u6307\u5b9a\u4e00\u540d\u4f4d\u4e8e\u6b27\u6d32\u7ecf\u6d4e\u533a\u5185\u7684\u8d1f\u8d23\u4eba (Person Responsible for Regulatory Compliance, PRRC)\uff0c\u4ee5\u786e\u4fdd\u5176\u6301\u7eed\u7b26\u5408MDR\u7684\u5404\u9879\u8981\u6c42\u3002<\/p>\n<\/p>\n

3. MDR (EU 2017\/745) \u7684\u5b9e\u65bd\u65f6\u95f4\u7ebf\u4e0e\u8fc7\u6e21\u671f<\/strong><\/p>\n

MDR (EU 2017\/745) \u539f\u5b9a\u4e8e2020\u5e745\u670826\u65e5\u5f3a\u5236\u5b9e\u65bd\uff0c\u4f46\u7531\u4e8e\u65b0\u51a0\u75ab\u60c5\u7b49\u56e0\u7d20\u7684\u5f71\u54cd\uff0c\u6b27\u76df\u51b3\u5b9a\u63a8\u8fdf\u5176\u5e94\u7528\u65e5\u671f\u3002<\/p>\n<\/p>\n

\u6839\u636e2023\u5e743\u6708\u4fee\u8ba2\u7684\u6761\u4f8b\uff0c\u4e3a\u7f13\u89e3\u533b\u7597\u5668\u68b0\u4f9b\u5e94\u77ed\u7f3a\u98ce\u9669\uff0c\u4e3a\u7279\u5b9a\u5668\u68b0\u63d0\u4f9b\u4e86\u5ef6\u957f\u7684\u8fc7\u6e21\u671f\u3002<\/p>\n<\/p>\n

\u5177\u4f53\u6765\u8bf4\uff0c\u6839\u636e\u5668\u68b0\u7684\u98ce\u9669\u7b49\u7ea7\u548c\u8ba4\u8bc1\u60c5\u51b5\uff0c\u8fc7\u6e21\u671f\u6700\u957f\u53ef\u81f32027\u5e7412\u670831\u65e5\u62162028\u5e7412\u670831\u65e5\uff0c\u4f46\u524d\u63d0\u662f\u5236\u9020\u5546\u9700\u57282024\u5e745\u670826\u65e5\u524d\u4e0e\u516c\u544a\u673a\u6784\u7b7e\u8ba2\u5408\u540c\u5e76\u63d0\u4ea4\u7b26\u5408\u6027\u7533\u8bf7\uff0c\u4e14\u5176\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u9700\u7b26\u5408MDR\u8981\u6c42\u3002<\/p>\n<\/p>\n

4. MDR (EU 2017\/745) \u5bf9\u884c\u4e1a\u7684\u5f71\u54cd\u4e0e\u6311\u6218<\/strong><\/p>\n

MDR (EU 2017\/745) \u7684\u5b9e\u65bd\u5bf9\u6574\u4e2a\u533b\u7597\u5668\u68b0\u884c\u4e1a\u5e26\u6765\u4e86\u524d\u6240\u672a\u6709\u7684\u6311\u6218\uff0c\u540c\u65f6\u4e5f\u63a8\u52a8\u4e86\u884c\u4e1a\u7684\u5347\u7ea7\u4e0e\u9769\u65b0\u3002<\/p>\n<\/p>\n

\u5bf9\u5236\u9020\u5546\u800c\u8a00\uff0c\u5408\u89c4\u6210\u672c\u663e\u8457\u589e\u52a0\uff0c\u4ed6\u4eec\u9700\u8981\u6295\u5165\u5927\u91cf\u8d44\u6e90\u8fdb\u884c\u6280\u672f\u6587\u4ef6\u66f4\u65b0\u3001\u4e34\u5e8a\u6570\u636e\u6536\u96c6\u3001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5347\u7ea7\u4ee5\u53ca\u4eba\u5458\u57f9\u8bad\u3002<\/p>\n<\/p>\n

\u516c\u544a\u673a\u6784\u9762\u4e34\u7740\u5de8\u5927\u7684\u5de5\u4f5c\u538b\u529b\u548c\u80fd\u529b\u5efa\u8bbe\u9700\u6c42\uff0c\u5176\u6570\u91cf\u548c\u5bb9\u91cf\u5728\u6cd5\u89c4\u5b9e\u65bd\u521d\u671f\u4e00\u5ea6\u6210\u4e3a\u74f6\u9888\u3002<\/p>\n<\/p>\n

\u4ece\u957f\u8fdc\u6765\u770b\uff0cMDR (EU 2017\/745) \u901a\u8fc7\u63d0\u5347\u533b\u7597\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u6807\u51c6\uff0c\u589e\u5f3a\u4e86\u516c\u4f17\u5bf9\u533b\u7597\u5668\u68b0\u7684\u4fe1\u4efb\uff0c\u4fc3\u8fdb\u4e86\u521b\u65b0\uff0c\u5e76\u4e3a\u60a3\u8005\u63d0\u4f9b\u4e86\u66f4\u9ad8\u6c34\u5e73\u7684\u4fdd\u62a4\u3002<\/p>\n<\/p>\n

5. \u603b\u7ed3\u4e0e\u5c55\u671b<\/strong><\/p>\n

MDR (EU 2017\/745) \u4ee3\u8868\u4e86\u5168\u7403\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u7684\u6807\u6746\uff0c\u5176\u5168\u9762\u6027\u3001\u4e25\u683c\u6027\u548c\u524d\u77bb\u6027\u4e3a\u5176\u4ed6\u5730\u533a\u7684\u6cd5\u89c4\u5236\u5b9a\u63d0\u4f9b\u4e86\u91cd\u8981\u53c2\u8003\u3002<\/p>\n<\/p>\n

\u5c3d\u7ba1\u5728\u5b9e\u65bd\u8fc7\u7a0b\u4e2d\u9047\u5230\u4e86\u8bf8\u591a\u6311\u6218\uff0c\u4f46\u5176\u6700\u7ec8\u76ee\u6807\u662f\u5efa\u7acb\u4e00\u4e2a\u66f4\u5177\u97e7\u6027\u3001\u900f\u660e\u548c\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u533b\u7597\u5668\u68b0\u751f\u6001\u7cfb\u7edf\u3002<\/p>\n<\/p>\n

\u5bf9\u4e8e\u6240\u6709\u884c\u4e1a\u53c2\u4e0e\u8005\u6765\u8bf4\uff0c\u6df1\u523b\u7406\u89e3\u5e76\u79ef\u6781\u9002\u5e94MDR (EU 2017\/745) \u7684\u8981\u6c42\uff0c\u4e0d\u4ec5\u662f\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u7684\u5f3a\u5236\u6027\u901a\u884c\u8bc1\uff0c\u66f4\u662f\u5b9e\u73b0\u53ef\u6301\u7eed\u53d1\u5c55\u548c\u5168\u7403\u7ade\u4e89\u529b\u7684\u5173\u952e\u6240\u5728\u3002<\/p>\n<\/p>\n

\u514d\u8d23\u58f0\u660e\uff1a\u672c\u6587\u4ec5\u4f9b\u53c2\u8003\uff0c\u672c\u6587\u4f5c\u8005\u53ca\u53d1\u5e03\u5e73\u53f0\u4e0d\u627f\u62c5\u56e0\u53c2\u8003\u672c\u6587\u5185\u5bb9\u800c\u4ea7\u751f\u7684\u4efb\u4f55\u8d23\u4efb\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

1. MDR (EU 2017\/745)\uff1a\u5168\u9762\u89e3\u6790\u6b27\u76df\u533b\u7597\u5668\u68b0\u65b0\u6cd5\u89c4 MDR (EU 2017\/745) \u662f\u6b27 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[353],"class_list":["post-4029","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-mdreu-2017-745"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4029","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4029"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4029\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4029"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4029"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4029"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}