MDR\u673a\u6784\u4f5c\u4e3a\u533b\u7597\u5668\u68b0\u9886\u57df\u7684\u91cd\u8981\u53c2\u4e0e\u8005\uff0c\u5728\u5168\u7403\u533b\u7597\u76d1\u7ba1\u4f53\u7cfb\u4e2d\u626e\u6f14\u7740\u5173\u952e\u89d2\u8272<\/p>\n<\/p>\n
\u968f\u7740\u533b\u7597\u6280\u672f\u7684\u4e0d\u65ad\u8fdb\u6b65\u548c\u5168\u7403\u5e02\u573a\u7684\u6269\u5927\uff0cMDR\u673a\u6784\u7684\u4f5c\u7528\u65e5\u76ca\u51f8\u663e\uff0c\u4e0d\u4ec5\u786e\u4fdd\u533b\u7597\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u8fd8\u4fc3\u8fdb\u56fd\u9645\u95f4\u7684\u5408\u89c4\u5408\u4f5c<\/p>\n<\/p>\n
1. MDR\u673a\u6784\u7684\u5b9a\u4e49\u4e0e\u80cc\u666f<\/strong><\/p>\n MDR\u673a\u6784\u6307\u7684\u662f\u6839\u636e\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Regulation, MDR\uff09\u8bbe\u7acb\u7684\u8ba4\u8bc1\u548c\u76d1\u7ba1\u5b9e\u4f53\uff0c\u4e3b\u8981\u8d1f\u8d23\u533b\u7597\u5668\u68b0\u7684\u8bc4\u4f30\u3001\u8ba4\u8bc1\u548c\u5e02\u573a\u76d1\u7763<\/p>\n<\/p>\n \u8fd9\u4e9b\u673a\u6784\u901a\u5e38\u7531\u6b27\u76df\u6210\u5458\u56fd\u6388\u6743\uff0c\u5177\u5907\u4e13\u4e1a\u7684\u6280\u672f\u80fd\u529b\u548c\u6cd5\u5f8b\u6743\u5a01\uff0c\u4ee5\u786e\u4fdd\u533b\u7597\u5668\u68b0\u7b26\u5408\u4e25\u683c\u7684\u6b27\u76df\u6807\u51c6<\/p>\n<\/p>\n MDR\u6cd5\u89c4\u4e8e2017\u5e74\u901a\u8fc7\uff0c\u5e76\u4e8e2021\u5e74\u6b63\u5f0f\u5b9e\u65bd\uff0c\u53d6\u4ee3\u4e86\u4e4b\u524d\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\uff0c\u65e8\u5728\u63d0\u9ad8\u900f\u660e\u5ea6\u548c\u60a3\u8005\u5b89\u5168<\/p>\n<\/p>\n \u8fd9\u4e00\u53d8\u9769\u53cd\u6620\u4e86\u5168\u7403\u5bf9\u533b\u7597\u5668\u68b0\u98ce\u9669\u7ba1\u7406\u7684\u91cd\u89c6\uff0cMDR\u673a\u6784\u56e0\u6b64\u6210\u4e3a\u8fde\u63a5\u5236\u9020\u5546\u3001\u76d1\u7ba1\u673a\u6784\u548c\u6d88\u8d39\u8005\u7684\u6865\u6881<\/p>\n<\/p>\n 2. MDR\u673a\u6784\u7684\u6838\u5fc3\u804c\u80fd\u4e0e\u91cd\u8981\u6027<\/strong><\/p>\n MDR\u673a\u6784\u7684\u6838\u5fc3\u804c\u80fd\u5305\u62ec\u5bf9\u533b\u7597\u5668\u68b0\u8fdb\u884c\u6280\u672f\u6587\u6863\u5ba1\u6838\u3001\u4e34\u5e8a\u8bc4\u4f30\u3001\u8d28\u91cf\u4f53\u7cfb\u5ba1\u8ba1\u4ee5\u53ca\u9881\u53d1CE\u8ba4\u8bc1<\/p>\n<\/p>\n \u901a\u8fc7\u8fd9\u4e9b\u6d3b\u52a8\uff0c\u673a\u6784\u786e\u4fdd\u4ea7\u54c1\u5728\u4e0a\u5e02\u524d\u8fbe\u5230\u5b89\u5168\u3001\u6027\u80fd\u548c\u53ef\u9760\u6027\u7684\u8981\u6c42\uff0c\u4ece\u800c\u964d\u4f4e\u533b\u7597\u98ce\u9669\u548c\u4fdd\u62a4\u516c\u4f17\u5065\u5eb7<\/p>\n<\/p>\n \u91cd\u8981\u6027\u4f53\u73b0\u5728\u591a\u4e2a\u65b9\u9762\uff1a\u9996\u5148\uff0cMDR\u673a\u6784\u5e2e\u52a9\u5236\u9020\u5546 navigate \u590d\u6742\u7684\u6cd5\u89c4\u73af\u5883\uff0c\u907f\u514d\u5408\u89c4\u95ee\u9898\u5bfc\u81f4\u7684\u5e02\u573a\u51c6\u5165\u5ef6\u8fdf<\/p>\n<\/p>\n \u5176\u6b21\uff0c\u5b83\u4eec\u589e\u5f3a\u6d88\u8d39\u8005\u4fe1\u4efb\uff0c\u56e0\u4e3a\u7ecf\u8fc7\u8ba4\u8bc1\u7684\u4ea7\u54c1\u88ab\u89c6\u4e3a\u7ecf\u8fc7\u72ec\u7acb\u9a8c\u8bc1\uff0c\u7b26\u5408\u9ad8\u6807\u51c6<\/p>\n<\/p>\n \u6b64\u5916\uff0c\u5728\u5168\u7403\u5316\u7684\u80cc\u666f\u4e0b\uff0cMDR\u673a\u6784\u7684\u8ba4\u8bc1 often \u88ab\u5176\u4ed6\u56fd\u5bb6\u548c\u5730\u533a\u8ba4\u53ef\uff0c\u4fc3\u8fdb\u56fd\u9645\u8d38\u6613<\/p>\n<\/p>\n 3. MDR\u673a\u6784\u7684\u8fd0\u4f5c\u6d41\u7a0b\u4e0e\u6311\u6218<\/strong><\/p>\n MDR\u673a\u6784\u7684\u8fd0\u4f5c\u6d41\u7a0b\u901a\u5e38\u59cb\u4e8e\u5236\u9020\u5546\u7684\u7533\u8bf7\uff0c\u968f\u540e\u673a\u6784\u8fdb\u884c\u521d\u6b65\u8bc4\u4f30\u3001\u73b0\u573a\u5ba1\u8ba1\u548c\u6301\u7eed\u76d1\u7763\uff0c\u4ee5\u786e\u4fdd\u5408\u89c4\u6027<\/p>\n<\/p>\n \u8fd9\u4e2a\u8fc7\u7a0b\u53ef\u80fd\u6d89\u53ca\u591a\u8f6e\u6c9f\u901a\u548c\u4fee\u6539\uff0c\u5c24\u5176\u5bf9\u4e8e\u9ad8\u98ce\u9669\u5668\u68b0\uff0c\u5982\u690d\u5165\u5f0f\u8bbe\u5907\u6216\u8bca\u65ad\u5de5\u5177\uff0c\u8981\u6c42\u66f4\u4e3a\u4e25\u683c<\/p>\n<\/p>\n \u7136\u800c\uff0cMDR\u673a\u6784\u4e5f\u9762\u4e34\u8bf8\u591a\u6311\u6218\uff0c\u5305\u62ec\u8d44\u6e90\u6709\u9650\u3001\u6280\u672f\u590d\u6742\u6027\u589e\u52a0\u4ee5\u53ca\u6cd5\u89c4\u66f4\u65b0\u9891\u7e41<\/p>\n<\/p>\n \u4f8b\u5982\uff0cCOVID-19 \u5927\u6d41\u884c\u671f\u95f4\uff0c\u673a\u6784\u9700\u5feb\u901f\u5904\u7406\u7d27\u6025\u4f7f\u7528\u6388\u6743\uff0c\u540c\u65f6\u7ef4\u6301\u5e38\u89c4\u5ba1\u6838\uff0c\u8fd9\u51f8\u663e\u4e86\u7075\u6d3b\u6027\u548c\u9002\u5e94\u6027\u7684\u9700\u6c42<\/p>\n<\/p>\n \u6b64\u5916\uff0c\u5168\u7403\u5dee\u5f02 in \u76d1\u7ba1\u8981\u6c42\u53ef\u80fd\u5bfc\u81f4\u788e\u7247\u5316\uff0c\u589e\u52a0\u5236\u9020\u5546\u7684\u8d1f\u62c5<\/p>\n<\/p>\n 4. MDR\u673a\u6784\u5728\u5168\u7403\u5e02\u573a\u7684\u5f71\u54cd\u4e0e\u672a\u6765\u8d8b\u52bf<\/strong><\/p>\n MDR\u673a\u6784\u5bf9\u5168\u7403\u5e02\u573a\u7684\u5f71\u54cd\u6df1\u8fdc\uff0c\u5b83\u4eec\u4e0d\u4ec5\u5851\u9020\u4e86\u6b27\u76df\u5185\u90e8\u7684\u5e02\u573a\u89c4\u5219\uff0c\u8fd8\u901a\u8fc7\u4e92\u8ba4\u534f\u8bae\u5f71\u54cd\u5176\u4ed6\u5730\u533a\uff0c\u5982\u7f8e\u56fdFDA\u6216\u4e2d\u56fdNMPA\u7684\u76d1\u7ba1\u5b9e\u8df5<\/p>\n<\/p>\n \u672a\u6765\u8d8b\u52bf\u663e\u793a\uff0cMDR\u673a\u6784\u5c06\u66f4\u52a0\u6ce8\u91cd\u6570\u5b57\u5316\u548c\u4eba\u5de5\u667a\u80fd\u7684\u5e94\u7528\uff0c\u4ee5\u63d0\u5347\u5ba1\u6838\u6548\u7387\u548c\u51c6\u786e\u6027<\/p>\n<\/p>\n \u540c\u65f6\uff0c\u53ef\u6301\u7eed\u6027\u548c\u7f51\u7edc\u5b89\u5168\u5c06\u6210\u4e3a\u65b0\u7684\u7126\u70b9\uff0c\u673a\u6784\u53ef\u80fd\u9700\u8981\u8bc4\u4f30\u533b\u7597\u5668\u68b0\u7684\u73af\u5883\u5f71\u54cd\u548c\u6570\u636e\u4fdd\u62a4\u63aa\u65bd<\/p>\n<\/p>\n \u968f\u7740\u4e2a\u6027\u5316\u533b\u7597\u548c\u8fdc\u7a0b\u76d1\u63a7\u7684\u5174\u8d77\uff0cMDR\u673a\u6784\u4e5f\u5c06 adapt \u5230\u65b0\u5174\u6280\u672f\uff0c\u786e\u4fdd\u521b\u65b0\u4e0d\u4f1a compromise \u5b89\u5168<\/p>\n<\/p>\n \u603b\u4e4b\uff0cMDR\u673a\u6784\u5c06\u7ee7\u7eed evolve\uff0c\u4ee5\u5e94\u5bf9\u4e0d\u65ad\u53d8\u5316\u7684\u533b\u7597 landscape<\/p>\n<\/p>\n 5. \u5982\u4f55\u9009\u62e9\u4e0e\u5408\u4f5cMDR\u673a\u6784<\/strong><\/p>\n \u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u9009\u62e9\u5408\u9002\u7684MDR\u673a\u6784\u81f3\u5173\u91cd\u8981\uff0c\u5e94\u8003\u8651\u673a\u6784\u7684 expertise\u3001\u884c\u4e1a\u58f0\u8a89\u3001\u670d\u52a1\u8303\u56f4\u548c\u54cd\u5e94\u901f\u5ea6<\/p>\n<\/p>\n \u5408\u4f5c\u8fc7\u7a0b\u4e2d\uff0c\u5236\u9020\u5546\u5e94\u63d0\u524d\u51c6\u5907\u8be6\u5c3d\u7684\u6280\u672f\u6587\u6863\uff0c\u5e76\u5efa\u7acb\u5f00\u653e\u6c9f\u901a\uff0c\u4ee5\u987a\u5229\u901a\u8fc7\u8ba4\u8bc1<\/p>\n<\/p>\n \u6b64\u5916\uff0c\u4e86\u89e3\u673a\u6784\u7684\u7279\u5b9a\u8981\u6c42\u548c\u65f6\u95f4\u8868\u53ef\u4ee5\u5e2e\u52a9\u907f\u514d\u5e38\u89c1\u9677\u9631\uff0c\u5982 delays \u6216\u989d\u5916\u6210\u672c<\/p>\n<\/p>\n \u5b9a\u671f\u57f9\u8bad\u548c\u66f4\u65b0 on \u6cd5\u89c4\u53d8\u5316\u4e5f\u662f\u6210\u529f\u5408\u4f5c\u7684\u5173\u952e\uff0c\u786e\u4fdd\u957f\u671f\u5408\u89c4\u548c\u5e02\u573a\u7ade\u4e89\u529b<\/p>\n<\/p>\n \u901a\u8fc7 proactive approach\uff0c\u4f01\u4e1a\u53ef\u4ee5\u6700\u5927\u5316MDR\u673a\u6784\u7684\u4ef7\u503c\uff0c\u5b9e\u73b0\u5168\u7403\u5e02\u573a\u62d3\u5c55<\/p>\n<\/p>\n \u514d\u8d23\u58f0\u660e\uff1a\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<\/p>\n","protected":false},"excerpt":{"rendered":" MDR\u673a\u6784\u4f5c\u4e3a\u533b\u7597\u5668\u68b0\u9886\u57df\u7684\u91cd\u8981\u53c2\u4e0e\u8005\uff0c\u5728\u5168\u7403\u533b\u7597\u76d1\u7ba1\u4f53\u7cfb\u4e2d\u626e\u6f14\u7740\u5173\u952e\u89d2\u8272 \u968f\u7740\u533b\u7597\u6280\u672f\u7684\u4e0d\u65ad\u8fdb\u6b65\u548c\u5168\u7403\u5e02\u573a\u7684 […]<\/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":[290],"class_list":["post-3965","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-mdr"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/3965","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=3965"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/3965\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3965"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3965"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3965"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}