{"id":9540,"date":"2026-02-25T10:57:53","date_gmt":"2026-02-25T02:57:53","guid":{"rendered":"https:\/\/regask.com\/?p=9540"},"modified":"2026-02-25T10:57:53","modified_gmt":"2026-02-25T02:57:53","slug":"%e8%8b%b1%e5%9b%bd%e8%8d%af%e5%93%81%e5%92%8c%e4%bf%9d%e5%81%a5%e4%ba%a7%e5%93%81%e7%9b%91%e7%ae%a1%e7%bd%b2-mhra-%e6%9b%b4%e6%96%b0%e4%ba%86%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e6%b3%a8%e5%86%8c","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/uk-mhra-updates-medical-device-registration-guidance-with-northern-ireland-changes-eudamed-transition-and-annual-fees\/","title":{"rendered":"\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u7f72 (MHRA) \u66f4\u65b0\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6307\u5357\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2026\u5e742\u670820\u65e5, <\/strong>\u8fd9<strong> \u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u673a\u6784<\/strong> \u82f1\u56fd\u533b\u7597\u5668\u68b0\u6cd5\u89c42002\u53d1\u5e03\u4e86\u5173\u4e8e\u5728\u82f1\u56fd\u548c\u5317\u7231\u5c14\u5170\u6ce8\u518c\u533b\u7597\u5668\u68b0\u4ee5\u6295\u653e\u5e02\u573a\u7684\u6307\u5357\u66f4\u65b0\u3002\u6b64\u6b21\u66f4\u65b0\u9002\u7528\u4e8e\u5728\u82f1\u56fd\u548c\u5317\u7231\u5c14\u5170\u9500\u552e\u533b\u7597\u5668\u68b0\u548c\u4f53\u5916\u8bca\u65ad\u5668\u68b0\u7684\u5236\u9020\u5546\u548c\u6388\u6743\u4ee3\u8868\u3002 <strong>\u5317\u7231\u5c14\u5170\u5e02\u573a\uff0c\u4ee5\u53ca\u5bf9\u5317\u7231\u5c14\u5170\u6ce8\u518c\u9014\u5f84\u3001\u5e74\u5ea6\u6ce8\u518c\u8d39\u7684\u5f71\u54cd\uff0c, <\/strong>\u548c<strong> \u516c\u5f00\u767b\u8bb0\u4fe1\u606f\u900f\u660e\u5ea6\u3002. <\/strong><\/p>\n<div class=\"row\"  id=\"row-1878513586\">\n\n\t<div id=\"col-635974657\" 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-416529833\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-416529833 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-772749427\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-772749427 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u66f4\u65b0\u540e\u7684\u6307\u5357\u9610\u660e\u4e86\u4fee\u8ba2\u5185\u5bb9\u3002 <strong>\u5317\u7231\u5c14\u5170\u6ce8\u518c\u8981\u6c42 <\/strong>\u9886\u5148\u4e8e<strong> 2026\u5e745\u670828\u65e5\u3002.<\/strong> \u81ea\u8be5\u65e5\u8d77\uff0c\u5927\u591a\u6570\u975e\u5b9a\u5236\u533b\u7597\u5668\u68b0\u5fc5\u987b\u5728[\u6b64\u5904\u5e94\u586b\u5199\u6ce8\u518c\u4fe1\u606f]\u6ce8\u518c\u3002 <strong>\u6b27\u6d32\u533b\u7597\u5668\u68b0\u6570\u636e\u5e93<\/strong> \u5728\u8fdb\u5165\u6b27\u76df\u6216\u5317\u7231\u5c14\u5170\u5e02\u573a\u4e4b\u524d\uff0c\u8fd9\u4e9b\u8bbe\u5907\u5c06\u4e0d\u518d\u9700\u8981\u5411\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u7f72 (MHRA) \u6ce8\u518c\uff0c\u5317\u7231\u5c14\u5170\u5e02\u573a\u4e5f\u5c06\u4e0d\u518d\u9700\u8981\u8fd9\u4e9b\u8bbe\u5907\u8fdb\u884c MHRA \u6ce8\u518c\u3002. <strong>\u5b9a\u5236\u8bbe\u5907<\/strong> \u4ecd\u4e0d\u5728 EUDAMED \u7684\u9002\u7528\u8303\u56f4\u5185\uff0c\u5e76\u4e14\u5fc5\u987b\u7ee7\u7eed\u5728\u5317\u7231\u5c14\u5170\u7684 MHRA \u6ce8\u518c\u3002.<\/p>\n<p>\u8be5\u6307\u5357\u4e3a\u5e74\u5ea6\u5de5\u4f5c\u5f15\u5165\u4e86\u4e00\u4e2a\u8be6\u7ec6\u7684\u6846\u67b6\u3002 <strong>MHRA\u6ce8\u518c\u8d39\u5236\u5ea6 <\/strong>\u751f\u6548 <strong>\u81ea2026\u5e744\u67081\u65e5\u8d77\u3002.<\/strong> \u8d39\u7528\u5c06\u6839\u636e\u4ee5\u4e0b\u56e0\u7d20\u8ba1\u7b97\uff1a <strong>\u4e8c\u7ea7\u5168\u7403\u533b\u7597\u5668\u68b0\u547d\u540d\u6cd5 (GMDN)<\/strong> <strong>\u7c7b\u522b<\/strong> \u5df2\u5411\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u7f72 (MHRA) \u6ce8\u518c\uff0c\u8981\u6c42\u5236\u9020\u5546\u5ba1\u67e5\u5176\u8bbe\u5907\u7ec4\u5408\u7684\u7ed3\u6784\uff0c\u4ee5\u4fbf\u8fdb\u884c\u6ce8\u518c\u3002.<\/p>\n<p>\u8fdb\u4e00\u6b65\u8bf4\u660e\u5982\u4e0b\uff1a <strong>\u4f53\u5916\u8bca\u65ad\u8bbe\u5907\uff08IVD\uff09<\/strong> \u6b63\u5728\u7ecf\u5386 <strong>\u7ee9\u6548\u8bc4\u4f30\u7814\u7a76,<\/strong> \u786e\u8ba4\u5fc5\u987b\u5728\u82f1\u56fd\u5f00\u59cb\u5b66\u4e60\u4e4b\u524d\u5b8c\u6210\u6ce8\u518c\u3002\u8be5\u66f4\u65b0\u8fd8\u91cd\u7533\uff1a <strong>\u65b0\u51a0\u75c5\u6bd2\u6297\u539f<\/strong> <strong>\u4ee5\u53ca\u5206\u5b50\uff08PCR\uff09\u68c0\u6d4b\u8bbe\u5907<\/strong> \u5fc5\u987b\u83b7\u5f97 <strong>\u51a0\u72b6\u75c5\u6bd2\u68c0\u6d4b\u8bbe\u5907\u6279\u51c6\uff08CTDA\uff09<\/strong> \u5728 MHRA \u6ce8\u518c\u7533\u8bf7\u88ab\u63a5\u53d7\u4e4b\u524d\uff0c\u5fc5\u987b\u8fdb\u884c\u9a8c\u8bc1\uff0c\u6216\u5217\u5165\u76f8\u5173\u534f\u8bae\u4e2d\u3002.<\/p>\n<p>\u6b64\u5916\uff0c\u8be5\u6307\u5357\u786e\u8ba4\u4e86\u5bf9\u4ee5\u4e0b\u65b9\u9762\u7684\u6539\u8fdb\uff1a<strong> \u516c\u5171\u8bbf\u95ee\u6ce8\u518c\u6570\u636e\u5e93\uff08PARD\uff09\u3002.<\/strong> \u4ece <strong>2026\u5e742\u670823\u65e5\uff0c\u533b\u7597\u5668\u68b0\u54c1\u724c\u6216\u5546\u6807\u540d\u79f0<\/strong> \u5c06\u516c\u5f00\u5c55\u793a\uff0c\u63d0\u9ad8\u6ce8\u518c\u4ea7\u54c1\u7684\u900f\u660e\u5ea6\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-635974657 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1260967603\" 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>\u76d1\u7ba1\u5b9e\u65bd\u65f6\u95f4\u8868<\/h2>\n\t<div id=\"gap-952230072\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-952230072 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<ul>\n<li><strong>2026\u5e742\u670823\u65e5\uff1a<\/strong> \u533b\u7597\u5668\u68b0 <strong>\u54c1\u724c\u548c\u5546\u6807\u540d\u79f0<\/strong> \u5c06\u5f00\u59cb\u663e\u793a\u5728 <strong>\u516c\u5171\u8bbf\u95ee\u6ce8\u518c\u6570\u636e\u5e93\uff08PARD\uff09,<\/strong> \u63d0\u9ad8\u6ce8\u518c\u4ea7\u54c1\u7684\u516c\u4f17\u77e5\u540d\u5ea6\u3002.<\/li>\n<li><strong>2026\u5e744\u67081\u65e5\uff1a\u5e74\u5ea6\u6ce8\u518c\u8d39 <\/strong>\u5bf9\u4e8e\u5df2\u5728\u4ee5\u4e0b\u673a\u6784\u6ce8\u518c\u7684\u533b\u7597\u5668\u68b0<strong> \u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u673a\u6784<\/strong> \u5c06\u751f\u6548\uff0c\u8d39\u7528\u6309\u4ee5\u4e0b\u65b9\u5f0f\u8ba1\u7b97\uff1a <strong>\u5168\u7403\u533b\u7597\u5668\u68b0\u547d\u540d\u6cd5 (GMDN) \u4e8c\u7ea7\u7c7b\u522b\u3002.\u00a0<\/strong><\/li>\n<li><strong>2026\u5e745\u670828\u65e5\uff1aEUDAMED\u6ce8\u518c<\/strong> \u5c06\u6210\u4e3a\u5927\u591a\u6570\u4f01\u4e1a\u7684\u5f3a\u5236\u6027\u8981\u6c42 <strong>\u975e\u5b9a\u5236\u533b\u7597\u5668\u68b0<\/strong> \u5728\u6b27\u76df\u6216\u5317\u7231\u5c14\u5170\u5e02\u573a\u6295\u653e\u4ea7\u54c1\u3002\u81ea\u6b64\u65e5\u671f\u8d77\uff0c, <strong>\u5c06\u4e0d\u518d\u9700\u8981MHRA\u6ce8\u518c\u3002<\/strong> \u9002\u7528\u4e8e\u5317\u7231\u5c14\u5170\u5e02\u573a\u7684\u8fd9\u4e9b\u8bbe\u5907\u3002.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1260967603 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2020083642\" 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-379238909\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-379238909 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6b64\u6b21\u66f4\u65b0\u63d0\u4f9b\u4e86\u66f4\u5927\u7684 <strong>\u76d1\u7ba1\u900f\u660e\u5ea6<\/strong> \u5173\u4e8e\u5317\u7231\u5c14\u5170\u8fc7\u6e21\u540e\u5b89\u6392\uff0c\u4f7f\u82f1\u56fd\u7684\u6d41\u7a0b\u4e0e\u2026\u2026\u4fdd\u6301\u4e00\u81f4 <strong>\u6b27\u76df\u6570\u5b57\u57fa\u7840\u8bbe\u65bd<\/strong> \u901a\u8fc7 EUDAMED\uff0c\u5e76\u5efa\u7acb\u4e00\u4e2a\u7ed3\u6784\u5316\u7684 <strong>\u8d39\u7528\u6846\u67b6<\/strong> \u4e3a\u52a0\u5f3a\u76d1\u7ba1\uff0c\u8fd9\u4e9b\u53d8\u66f4\u65e8\u5728\u63d0\u9ad8\u6548\u7387\u548c\u900f\u660e\u5ea6\uff0c\u540c\u65f6\u5c06\u65b0\u589e\u7684\u884c\u653f\u8d1f\u62c5\u96c6\u4e2d\u5728\u5df2\u786e\u5b9a\u7684\u6ce8\u518c\u548c\u6570\u636e\u7ef4\u62a4\u6d3b\u52a8\u4e0a\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2020083642 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-58478150\" 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-263300287\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-263300287 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8be5\u6307\u5357\u9002\u7528\u4e8e <strong>\u533b\u7597\u5668\u68b0\u548c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u5236\u9020\u5546\u3001\u6388\u6743\u4ee3\u8868, <\/strong>\u548c<strong> \u76d1\u7ba1\u3001\u8d28\u91cf\u548c\u5408\u89c4\u56e2\u961f<\/strong> \u8d1f\u8d23\u82f1\u56fd\u548c\u5317\u7231\u5c14\u5170\u5e02\u573a\u51c6\u5165\uff0c\u4ee5\u53ca <strong>IT\u548c\u6570\u636e\u56e2\u961f<\/strong> \u7ba1\u7406\u76d1\u7ba1\u7533\u62a5\u6587\u4ef6\u548c\u516c\u5f00\u4ea7\u54c1\u4fe1\u606f\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-58478150 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1941049201\" 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-761888626\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-761888626 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5229\u76ca\u76f8\u5173\u65b9\u5e94\u5ba1\u67e5\u5176\u5f53\u524d\u7684MHRA\u6ce8\u518c\u4fe1\u606f\uff0c\u4ee5\u786e\u5b9a\u54ea\u4e9b\u8bbe\u5907\u9700\u8981\u8fdb\u884c\u76f8\u5173\u6ce8\u518c\u3002 <strong>EUDAMED\u6ce8\u518c<\/strong> \u52302026\u5e745\u6708\u5e95\uff0c\u8bc4\u4f30\u5176\u5f71\u54cd <strong>\u5e74\u8d39<\/strong> \u57282026\u5e744\u6708\u4e4b\u524d\uff0c\u5236\u9020\u5546\u5e94\u76f8\u5e94\u5730\u66f4\u65b0\u5185\u90e8\u6d41\u7a0b\u3002\u5411\u5317\u7231\u5c14\u5170\u5e02\u573a\u6295\u653e\u8bbe\u5907\u7684\u5236\u9020\u5546\u4e5f\u5e94\u786e\u8ba4\u8fd9\u4e00\u70b9\u3002 <strong>\u6388\u6743\u4ee3\u8868\u5b89\u6392,<\/strong> \u786e\u4fdd <strong>CTDA\u9a8c\u8bc1<\/strong> \u5728\u9002\u7528\u60c5\u51b5\u4e0b\uff0c\u505a\u597d\u51c6\u5907\uff0c\u63d0\u9ad8\u4ea7\u54c1\u8be6\u60c5\u5728 PARD \u4e0a\u7684\u516c\u5f00\u53ef\u89c1\u5ea6\u3002.<\/p>\n<p>\u968f\u7740\u5404\u7ec4\u7ec7\u8c03\u6574\u4ee5\u9002\u5e94\u82f1\u56fd\u548c\u5317\u7231\u5c14\u5170\u4e0d\u65ad\u53d8\u5316\u7684\u6ce8\u518c\u8981\u6c42\uff0c, <a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u901a\u8fc7\u76d1\u63a7\u5b9e\u65bd\u65f6\u95f4\u8868\u3001\u8ddf\u8e2a\u7279\u5b9a\u53f8\u6cd5\u7ba1\u8f96\u533a\u7684\u4e49\u52a1\u4ee5\u53ca\u7b80\u5316\u6ce8\u518c\u548c\u6570\u636e\u7ba1\u7406\u5de5\u4f5c\u6d41\u7a0b\uff0c\u4e3a\u76d1\u7ba1\u548c\u5408\u89c4\u56e2\u961f\u63d0\u4f9b\u652f\u6301\u3002. <a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u662f\u4e00\u4e2a\u9886\u5148\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u76d1\u7ba1\u60c5\u62a5\u548c\u5de5\u4f5c\u6d41\u7a0b\u7f16\u6392\u5e73\u53f0\uff0c\u5b83\u8d4b\u80fd\u5168\u7403\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u7ec4\u7ec7\uff08\u5305\u62ec\u6d88\u8d39\u54c1\u548c\u751f\u547d\u79d1\u5b66\uff09\uff0c\u4f7f\u5176\u80fd\u591f\u4e3b\u52a8\u5e94\u5bf9\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002. <strong>\u901a\u8fc7\u5c06\u5148\u8fdb\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u4e0e\u4e13\u5bb6\u56e2\u961f\u76f8\u7ed3\u5408\uff0c, <a href=\"http:\/\/regask.com\/zh\/\">RegASK<\/a><\/strong> \u63d0\u4f9b\u53ca\u65f6\u3001\u53ef\u9884\u6d4b\u3001\u53ef\u64cd\u4f5c\u7684\u6d1e\u5bdf\u548c\u7aef\u5230\u7aef\u7684\u81ea\u52a8\u5316\uff0c\u7b80\u5316\u5408\u89c4\u6d41\u7a0b\uff0c\u964d\u4f4e\u98ce\u9669\uff0c\u5e76\u52a0\u901f\u8fdb\u5165 160 \u591a\u4e2a\u56fd\u5bb6\u7684\u5e02\u573a\u3002. <a href=\"http:\/\/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-1941049201 > .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-1549156468\">\n\n\t<div id=\"col-1711665639\" 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-414503975\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-414503975 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u7f72\uff08MHRA\uff09\u5bf9\u5317\u7231\u5c14\u5170\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8fdb\u884c\u4e86\u54ea\u4e9b\u53d8\u66f4\uff1f<\/h4>\n\t<div id=\"gap-1246473376\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1246473376 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4ece 2026 \u5e74 5 \u6708 28 \u65e5\u8d77\uff0c\u5927\u591a\u6570\u975e\u5b9a\u5236\u8bbe\u5907\u5fc5\u987b\u5728 EUDAMED \u6ce8\u518c\u624d\u80fd\u8fdb\u5165\u6b27\u76df\u548c\u5317\u7231\u5c14\u5170\u5e02\u573a\uff0c\u800c\u5317\u7231\u5c14\u5170\u7684\u8fd9\u4e9b\u8bbe\u5907\u5c06\u4e0d\u518d\u9700\u8981 MHRA \u6ce8\u518c\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1711665639 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1159656352\" 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>MHRA\u533b\u7597\u5668\u68b0\u5e74\u5ea6\u6ce8\u518c\u8d39\u4f55\u65f6\u751f\u6548\uff1f<\/h4>\n\t<div id=\"gap-1531420251\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1531420251 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5e74\u5ea6\u6ce8\u518c\u8d39\u81ea 2026 \u5e74 4 \u6708 1 \u65e5\u8d77\u751f\u6548\uff0c\u6309\u5411 MHRA \u6ce8\u518c\u7684 2 \u7ea7 GMDN \u7c7b\u522b\u8ba1\u7b97\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1159656352 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2141052107\" 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>\u5b9a\u5236\u533b\u7597\u5668\u68b0\u662f\u5426\u9700\u8981\u5728 EUDAMED \u6ce8\u518c\uff1f<\/h4>\n\t<div id=\"gap-638462966\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-638462966 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4e0d\u3002\u5b9a\u5236\u8bbe\u5907\u4e0d\u9700\u8981 EUDAMED \u6ce8\u518c\uff0c\u4f46\u5fc5\u987b\u7ee7\u7eed\u5411 MHRA \u6ce8\u518c\u624d\u80fd\u5728\u5317\u7231\u5c14\u5170\u5e02\u573a\u9500\u552e\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2141052107 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1941079251\" 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\u56e2\u961f\u7ba1\u7406\u8fd9\u4e9b MHRA \u6ce8\u518c\u53d8\u66f4\uff1f<\/h4>\n\t<div id=\"gap-2002034920\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2002034920 {\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\u96c6\u4e2d\u5f0f\u76d1\u7ba1\u60c5\u62a5\u548c\u81ea\u52a8\u5316\u5de5\u4f5c\u6d41\u7a0b\uff0c\u5e2e\u52a9\u76d1\u7ba1\u548c\u5408\u89c4\u56e2\u961f\u8ddf\u8e2a\u5373\u5c06\u5230\u6765\u7684\u622a\u6b62\u65e5\u671f\uff0c\u8bc4\u4f30\u65b0\u6536\u8d39\u7ed3\u6784\u7684\u5f71\u54cd\uff0c\u5e76\u7ba1\u7406\u82f1\u56fd\u3001\u5317\u7231\u5c14\u5170\u548c\u6b27\u76df\u7684\u6ce8\u518c\u4e49\u52a1\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1941079251 > .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 20 February 2026, the Medicines &amp; Healthcare products Regulatory Agency published an update to its guidance on registering medical devices for placement on the market in Great Britain and Northern Ireland under the UK Medical Devices Regulations 2002. The update affects manufacturers and authorised representatives placing medical devices and in vitro diagnostic devices on&#8230;<\/p>","protected":false},"author":41,"featured_media":9543,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,39],"tags":[],"class_list":["post-9540","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-medical-devices-insights"],"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>UK MHRA Updates Medical Device Registration Guidance<\/title>\n<meta name=\"description\" content=\"Explore UK MHRA updates on medical device registration guidance and how Northern Ireland changes affect manufacturers.\" \/>\n<meta name=\"robots\" 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