{"id":9490,"date":"2026-02-16T17:21:56","date_gmt":"2026-02-16T09:21:56","guid":{"rendered":"https:\/\/regask.com\/?p=9490"},"modified":"2026-03-03T12:57:36","modified_gmt":"2026-03-03T04:57:36","slug":"%e6%ac%a7%e7%9b%9f%e5%a7%94%e5%91%98%e4%bc%9a%e5%8f%91%e5%b8%83eudmad-2-22-0%e7%89%88%ef%bc%8c%e5%85%b6%e4%b8%ad%e5%8c%85%e5%90%ab%e5%bc%ba%e5%88%b6%e6%80%a7%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/eu-commission-releases-eudamed-version-2-22-0-with-mandatory-medical-device-registration-updates-effective-may-2026\/","title":{"rendered":"\u6b27\u76df\u59d4\u5458\u4f1a\u53d1\u5e03 EUDAMED 2.22.0 \u7248\u672c\uff0c\u65b0\u589e\u5f3a\u5236\u6027\u8981\u6c42\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2026\u5e741\u67085\u65e5<\/strong>\uff0c \u8fd9<strong> \u6b27\u76df\u59d4\u5458\u4f1a<\/strong> \u5ba3\u5e03\u4e86\u8be5\u4ea7\u54c1\u7684\u53d1\u5e03 <strong>EUDAMED \u7248\u672c 2.22.0,<\/strong> \u5f15\u5165\u5f3a\u5236\u6027\u7cfb\u7edf\u66f4\u65b0\u4ee5\u589e\u5f3a <strong>\u533b\u7597\u5668\u68b0\u6ce8\u518c\u548c\u6570\u636e\u7ba1\u7406<\/strong> \u6574\u4e2a\u6b27\u76df\u3002\u6b64\u6b21\u66f4\u65b0\u5f71\u54cd\u8303\u56f4\u5e7f\u6cdb\u3002 <strong>\u5236\u9020\u5546\u3001\u516c\u544a\u673a\u6784\u548c\u5176\u4ed6\u533b\u7597\u5668\u68b0\u5229\u76ca\u76f8\u5173\u8005\uff0c,<\/strong> \u4ece\u2026\u2026\u5f00\u59cb\u5f3a\u5236\u4f7f\u7528\u56db\u4e2a\u6838\u5fc3 EUDAMED \u6a21\u5757 <strong>2026\u5e745\u670828\u65e5\u3002. <\/strong><\/p>\n<div class=\"row\"  id=\"row-627164304\">\n\n\t<div id=\"col-712862807\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-2025727232\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2025727232 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-1189396843\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1189396843 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u53d1\u5e03 <strong>EUDAMED<\/strong> <strong>\u7248\u672c 2.22.0<\/strong> \u589e\u5f3a\u5173\u952e\u6a21\u5757\u7684\u53ef\u8ffd\u6eaf\u6027\u3001\u6570\u636e\u51c6\u786e\u6027\u548c\u53ef\u7528\u6027\uff0c\u5305\u62ec <strong>\u6f14\u5458\u6ce8\u518c\u3001\u8bbe\u5907\u8bc6\u522b\uff08UDI\uff09\u3001\u8bc1\u4e66\u3001,<\/strong> \u548c <strong>\u516c\u5171\u4fe1\u606f\u83b7\u53d6\u3002.\u00a0<\/strong><\/p>\n<p>\u6f14\u5458\u6ce8\u518c, <strong>\u201c\u6700\u540e\u6570\u636e\u786e\u8ba4\u201d\u65e5\u671f<\/strong> \u73b0\u5728\u6309\u7248\u672c\u663e\u793a\uff0c\u63d0\u9ad8\u4e86\u6240\u6709\u6ce8\u518c\u53c2\u4e0e\u8005\u7684\u6570\u636e\u9a8c\u8bc1\u72b6\u6001\u7684\u900f\u660e\u5ea6\u3002.<\/p>\n<p>\u5bf9\u4e8e\u8bbe\u5907\u6ce8\u518c\uff0c, <strong>EMDN \u4ee3\u7801\u7248\u672c\u63a7\u5236<\/strong> \u5df2\u7ecf\u5b9e\u65bd\uff0c\u5e76\u4e14 <strong>\u5df2\u8fc7\u65f6\u7684EMDN\u4ee3\u7801<\/strong> \u5df2\u4ece\u9009\u62e9\u5217\u8868\u4e2d\u5220\u9664\uff0c\u786e\u4fdd\u53ea\u4f7f\u7528\u5f53\u524d\u547d\u540d\u6cd5\u3002.<\/p>\n<p>\u5728\u8bc1\u4e66\u6a21\u5757\u4e2d\uff0c, <strong>\u516c\u544a\u673a\u6784<\/strong> \u73b0\u5728\u5141\u8bb8\u5f15\u7528 <strong>\u672a\u6ce8\u518c\u7684\u6b27\u76df\u5236\u9020\u5546\u6216\u751f\u4ea7\u5546<\/strong> \u5728\u7b7e\u53d1\u88ab\u62d2\u8bc1\u4e66\u6216\u5904\u7406\u76f8\u5173\u7533\u8bf7\u65f6\uff0c\u5305\u62ec <strong>\u65e7\u5f0f\u8bbe\u5907\u3002.\u00a0<\/strong><\/p>\n<p>\u4ece\u6280\u672f\u89d2\u5ea6\u6765\u770b\uff0c, <strong>XSD \u6a21\u5f0f\u7248\u672c 3.0.25<\/strong> \u73b0\u5728\u5bf9\u6240\u6709\u4eba\u6765\u8bf4\u90fd\u662f\u5f3a\u5236\u6027\u7684 <strong>DTX \u670d\u52a1\u8bf7\u6c42\uff0c,<\/strong> \u53cd\u6620\u4e86\u66f4\u65b0\u540e\u7684\u6280\u672f\u6587\u6863\u8981\u6c42\u3002.<\/p>\n<p>\u6279\u91cf\u4e0a\u4f20\u529f\u80fd\u5df2\u5f97\u5230\u589e\u5f3a\uff0c\u5141\u8bb8 <strong>\u90e8\u5206\u6210\u529f\u72b6\u6001,<\/strong> \u7531\u65b0\u652f\u6301<strong> XML\u54cd\u5e94\u7ed3\u6784<\/strong> \u63d0\u4f9b\u5bf9\u8c61\u7ea7\u53cd\u9988\u3002.<\/p>\n<p>\u5728\u516c\u5171\u7f51\u7ad9\u4e0a\uff0c\u53ef\u7528\u6027\u6539\u8fdb\u5305\u62ec <strong>\u6269\u5c55\u7684\u56fd\u5bb6\/\u5730\u533a\u9009\u9879<\/strong> \u548c <strong>\u589e\u5f3a\u578b\u6458\u8981\u62a5\u544a\u7b5b\u9009\u5668,<\/strong> \u6539\u5584\u516c\u4f17\u83b7\u53d6\u533b\u7597\u5668\u68b0\u4fe1\u606f\u7684\u9014\u5f84\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-712862807 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1459630541\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u6267\u6cd5\u65f6\u95f4\u8868<\/h2>\n\t<div id=\"gap-514743135\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-514743135 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5f3a\u5236\u4f7f\u7528 <strong>\u56db\u4e2a\u6838\u5fc3 EUDAMED \u6a21\u5757<\/strong>, \u6f14\u5458\u6ce8\u518c\u3001\u8bbe\u5907\u8bc6\u522b\uff08UDI\uff09\u3001\u8bc1\u4e66\u548c\u516c\u5171\u4fe1\u606f\u8bbf\u95ee\uff0c, <strong>\u5c06\u4e8e2026\u5e745\u670828\u65e5\u751f\u6548\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1459630541 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-395706632\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u751f\u6548\u65e5\u671f<\/h2>\n\t<div id=\"gap-561634967\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-561634967 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5f3a\u5236\u4f7f\u7528 <strong>\u56db\u4e2a\u6838\u5fc3 EUDAMED \u6a21\u5757\uff0c,<\/strong> \u5305\u62ec <strong>\u6f14\u5458\u6ce8\u518c\u3001\u8bbe\u5907\u8bc6\u522b\uff08UDI\uff09\u3001\u8bc1\u4e66\u548c\u516c\u5171\u4fe1\u606f\u8bbf\u95ee\uff0c,<\/strong> \u5bf9\u2026\u2026\u4ea7\u751f\u5f71\u54cd <strong>2026\u5e745\u670828\u65e5\u3002.<\/strong> \u81ea\u5373\u65e5\u8d77\uff0c\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u3001\u516c\u544a\u673a\u6784\u548c\u5176\u4ed6\u76f8\u5173\u5229\u76ca\u6538\u5173\u65b9\u5fc5\u987b\u9075\u5b88\u6839\u636e\u4ee5\u4e0b\u89c4\u5b9a\u5f15\u5165\u7684\u66f4\u65b0\u8981\u6c42\uff1a <strong>EUDAMED \u7248\u672c 2.22.0\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-395706632 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-87265554\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u4e3a\u4ec0\u4e48\u91cd\u8981<\/h2>\n\t<div id=\"gap-1950371836\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1950371836 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8fd9\u4e9b\u66f4\u65b0\u63d0\u4f9b\u4e86\u66f4\u5927\u7684<strong> \u76d1\u7ba1\u653f\u7b56\u7684\u6e05\u6670\u5ea6,<\/strong> \u4f7f EUDAMED \u4e0e <strong>\u6570\u5b57\u6570\u636e\u6cbb\u7406\u671f\u671b,<\/strong> \u5e76\u6539\u8fdb <strong>\u8fd0\u8425\u6548\u7387<\/strong> \u901a\u8fc7\u589e\u5f3a\u53ef\u8ffd\u6eaf\u6027\u548c\u7ed3\u6784\u5316\u6570\u636e\u4ea4\u6362\uff0c\u6b64\u6b21\u66f4\u65b0\u4f18\u5316\u4e86\u5de5\u4f5c\u6d41\u7a0b\u548c\u6280\u672f\u6807\u51c6\uff0c\u65e8\u5728\u652f\u6301\u5408\u89c4\u6027\uff0c\u540c\u65f6\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u53d7\u76d1\u7ba1\u5229\u76ca\u76f8\u5173\u8005\u7684\u4e0d\u5fc5\u8981\u884c\u653f\u8d1f\u62c5\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-87265554 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1419982448\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u8fd9\u9002\u7528\u4e8e\u54ea\u4e9b\u4eba\u7fa4<\/h2>\n\t<div id=\"gap-580278005\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-580278005 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6b64\u66f4\u65b0\u5c24\u5176\u9002\u7528\u4e8e<strong> \u6cd5\u89c4\u4e8b\u52a1\u3001\u8d28\u91cf\u4fdd\u8bc1\u3001IT\u548c\u6570\u636e\u7ba1\u7406\u56e2\u961f,<\/strong> \u548c <strong>\u516c\u544a\u673a\u6784\u8fd0\u8425<\/strong> \u53c2\u4e0e\u6b27\u76df\u533b\u7597\u5668\u68b0\u6ce8\u518c\u3001\u8ba4\u8bc1\u548c\u6301\u7eed\u5408\u89c4\u6027\u76d1\u63a7\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1419982448 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1478034520\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u4e0b\u4e00\u6b65<\/h2>\n\t<div id=\"gap-1974519638\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1974519638 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5229\u76ca\u76f8\u5173\u8005\u5e94\u5ba1\u67e5\u73b0\u6709\u5185\u5bb9 <strong>\u6570\u636e\u5f55\u5165\u548c\u8bbe\u5907\u6ce8\u518c\u6d41\u7a0b<\/strong> \u4e3a\u786e\u4fdd\u4e0e EUDAMED \u7248\u672c 2.22.0 \u4fdd\u6301\u4e00\u81f4\uff0c\u8bc4\u4f30\u7cfb\u7edf\u517c\u5bb9\u6027 <strong>XSD\u6a21\u5f0f\u7248\u672c3.0.25\uff0c,<\/strong> \u5e76\u4e3a\u53d8\u5316\u505a\u597d\u51c6\u5907 <strong>EMDN\u4ee3\u7801\u9009\u62e9\u3001\u786e\u8ba4\u65e5\u671f\u8ddf\u8e2a, <\/strong>\u548c<strong> \u6279\u91cf\u4e0a\u4f20\u54cd\u5e94<\/strong> \u5728 2026 \u5e74 5 \u6708\u5f3a\u5236\u6267\u884c\u65e5\u671f\u4e4b\u524d\u3002.<\/p>\n<p>\u5404\u7ec4\u7ec7\u5728\u8bc4\u4f30\u5176\u662f\u5426\u5df2\u51c6\u5907\u597d\u5f3a\u5236\u4f7f\u7528 EUDAMED \u6a21\u5757\u4ee5\u53ca\u5e94\u5bf9\u4e0d\u65ad\u53d8\u5316\u7684\u6570\u636e\u8981\u6c42\u65f6\uff0c\u53ca\u65e9\u4e86\u89e3\u76d1\u7ba1\u4f53\u7cfb\u7684\u53d8\u5316\u53ef\u4ee5\u663e\u8457\u964d\u4f4e\u5408\u89c4\u98ce\u9669\u3002. <strong><a href=\"https:\/\/regask.com\/zh\/\">RegASK<\/a> \u662f\u4e00\u4e2a\u9886\u5148\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u76d1\u7ba1\u60c5\u62a5\u548c\u5de5\u4f5c\u6d41\u7f16\u6392\u5e73\u53f0<\/strong> \u5b83\u8d4b\u80fd\u5168\u7403\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u7ec4\u7ec7\uff0c\u5305\u62ec\u751f\u547d\u79d1\u5b66\u9886\u57df\uff0c\u4f7f\u5176\u80fd\u591f\u4e3b\u52a8\u5e94\u5bf9\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002\u901a\u8fc7\u5c06\u5148\u8fdb\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u4e0e\u4e13\u5bb6\u56e2\u961f\u76f8\u7ed3\u5408\uff0c, <a href=\"https:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u63d0\u4f9b\u53ca\u65f6\u3001\u53ef\u9884\u6d4b\u3001\u53ef\u64cd\u4f5c\u7684\u89c1\u89e3\u548c\u7aef\u5230\u7aef\u7684\u81ea\u52a8\u5316\uff0c\u5e2e\u52a9\u56e2\u961f\u8ddf\u8e2a EUDAMED \u66f4\u65b0\u3001\u8bc4\u4f30\u5f71\u54cd\u5e76\u7b80\u5316 160 \u591a\u4e2a\u56fd\u5bb6\u7684\u5408\u89c4\u51c6\u5907\u5de5\u4f5c\u3002. <a href=\"https:\/\/regask.com\/zh\/\"><strong>\u4e86\u89e3\u66f4\u591a<\/strong><\/a> \u6216\u8005 <a href=\"https:\/\/regask.com\/zh\/%e9%a2%84%e8%ae%a2%e6%bc%94%e7%a4%ba\/\"><strong>\u7acb\u5373\u9884\u8ba2\u6f14\u793a\u3002\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1478034520 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1933389463\">\n\n\t<div id=\"col-508381923\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>\u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/h3>\n\t<div id=\"gap-3048299\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-3048299 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u4ec0\u4e48\u662f EUDAMED \u7248\u672c 2.22.0\uff1f<\/h4>\n\t<div id=\"gap-874279456\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-874279456 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>EUDAMED \u7248\u672c 2.22.0 \u662f\u4e00\u4e2a\u6b63\u5f0f\u7248\u672c\uff0c\u5b83\u5bf9\u6b27\u76df\u5883\u5185\u7684\u533b\u7597\u5668\u68b0\u6570\u636e\u7ba1\u7406\u3001\u53ef\u8ffd\u6eaf\u6027\u548c\u6280\u672f\u63a5\u53e3\u8fdb\u884c\u4e86\u5f3a\u5236\u6027\u66f4\u65b0\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-508381923 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1885715233\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>EUDAMED\u6838\u5fc3\u6a21\u5757\u4f55\u65f6\u5f00\u59cb\u5f3a\u5236\u4f7f\u7528\uff1f<\/h4>\n\t<div id=\"gap-429909648\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-429909648 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5f3a\u5236\u4f7f\u7528\u56db\u4e2a\u6838\u5fc3 EUDAMED \u6a21\u5757\u7684\u8d77\u59cb\u65e5\u671f\u4e3a <strong>2026\u5e745\u670828\u65e5\u3002.<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1885715233 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1449517707\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u672c\u6b21\u66f4\u65b0\u5bf9 EMDN \u4ee3\u7801\u505a\u4e86\u54ea\u4e9b\u66f4\u6539\uff1f<\/h4>\n\t<div id=\"gap-703940298\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-703940298 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u672c\u6b21\u66f4\u65b0\u5f15\u5165\u4e86 <strong>EMDN \u4ee3\u7801\u7248\u672c\u63a7\u5236<\/strong> \u5e76\u79fb\u9664 <strong>\u8fc7\u65f6\u7684\u4ee3\u7801<\/strong> \u6765\u81ea\u8bbe\u5907\u6ce8\u518c\u9009\u9879\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1449517707 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1347183333\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>RegASK \u5982\u4f55\u5e2e\u52a9\u4f01\u4e1a\u5e94\u5bf9\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u76d1\u7ba1\u53d8\u5316\uff1f<\/h4>\n\t<div id=\"gap-180889753\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-180889753 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u901a\u8fc7\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u76d1\u7ba1\u667a\u80fd\u548c\u4e13\u5bb6\u6307\u5bfc\u7684\u81ea\u52a8\u5316\uff0c\u5e2e\u52a9\u7ec4\u7ec7\u76d1\u63a7\u76d1\u7ba1\u673a\u6784\u7684\u6700\u65b0\u52a8\u6001\uff0c\u8bc4\u4f30\u5408\u89c4\u5f71\u54cd\uff0c\u5e76\u8c03\u6574\u5185\u90e8\u5de5\u4f5c\u6d41\u7a0b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1347183333 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 5 January 2026, the European Commission announced the production release of EUDAMED version 2.22.0, introducing mandatory system updates that enhance medical device registration and data management across the European Union. The update affects manufacturers, Notified Bodies, and other medical device stakeholders, with mandatory use of the four core EUDAMED modules beginning on 28 May&#8230;<\/p>","protected":false},"author":41,"featured_media":9491,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,39,538],"tags":[],"class_list":["post-9490","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-european-union"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU Commission Releases EUDAMED Version 2.22.0 Changes<\/title>\n<meta name=\"description\" content=\"Learn about the EU Commission&#039;s release of EUDAMED version 2.22.0, with updates for mandatory medical device registration effective May 2026.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/zh\/\u6b27\u76df\u59d4\u5458\u4f1a\u53d1\u5e03eudmad-2-22-0\u7248\uff0c\u5176\u4e2d\u5305\u542b\u5f3a\u5236\u6027\u533b\u7597\u5668\u68b0\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU Commission Releases EUDAMED Version 2.22.0 With Mandatory Medical Device Registration Updates Effective May 2026\" \/>\n<meta property=\"og:description\" content=\"Learn about the EU Commission&#039;s release of EUDAMED version 2.22.0, with updates for mandatory medical device registration effective May 2026.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/zh\/\u6b27\u76df\u59d4\u5458\u4f1a\u53d1\u5e03eudmad-2-22-0\u7248\uff0c\u5176\u4e2d\u5305\u542b\u5f3a\u5236\u6027\u533b\u7597\u5668\u68b0\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-16T09:21:56+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-03T04:57:36+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/eu-commission-releases-eudamed-version-2-22-0-mandatory-medical-device-registration-updates-effective-may-2026.png\" \/>\n\t<meta property=\"og:image:width\" content=\"904\" \/>\n\t<meta property=\"og:image:height\" content=\"622\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Shaffa Renaningtyas\" \/>\n<meta name=\"twitter:card\" 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