{"id":6649,"date":"2024-05-29T10:41:54","date_gmt":"2024-05-29T02:41:54","guid":{"rendered":"https:\/\/greenoo.tw\/?p=6649"},"modified":"2026-02-02T09:32:35","modified_gmt":"2026-02-02T01:32:35","slug":"eu-ce-doc-declaration-template-guide-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/en\/eu-ce-doc-declaration-template-guide-2026\/","title":{"rendered":"\u6b50\u76df CE \u8a8d\u8b49 DoC \u8072\u660e\u6a21\u677f\u5b8c\u6574\u6307\u5357|\u53f0\u7063\u696d\u8005 2026 \u6700\u65b0\u8981\u6c42"},"content":{"rendered":"<h2><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-20214\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-declaration-template-guide-feature-2026.png\" alt=\"\u6b50\u76df CE \u8a8d\u8b49 DoC \u8072\u660e\u6a21\u677f\u5b8c\u6574\u6307\u5357\u5c01\u9762,\u986f\u793a CE \u6a19\u8a8c\u8207\u5b98\u65b9\u6587\u4ef6\u5716\u793a\" width=\"2560\" height=\"1352\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-declaration-template-guide-feature-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-declaration-template-guide-feature-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-declaration-template-guide-feature-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-declaration-template-guide-feature-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-declaration-template-guide-feature-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/h2>\n<h2>\u4ec0\u9ebc\u662f\u6b50\u76df CE \u8a8d\u8b49 DoC \u8072\u660e?\u70ba\u4f55\u53f0\u7063\u696d\u8005\u5fc5\u9808\u6e96\u5099?<\/h2>\n<p>\u6b50\u76df CE \u8a8d\u8b49 DoC(Declaration of Conformity,\u7b26\u5408\u6027\u8072\u660e)\u662f\u88fd\u9020\u5546\u5411\u6b50\u76df\u5e02\u5834\u8b49\u660e\u7522\u54c1\u7b26\u5408\u76f8\u95dc\u6cd5\u898f\u8981\u6c42\u7684\u6b63\u5f0f\u6587\u4ef6\u3002\u6839\u64da\u6b50\u76df MDR \u7b2c 19 \u689d(\u7db2\u5740:<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj)%E8%88%87\" target=\"_blank\" rel=\"noopener\">https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj)\u8207<\/a> GPSR \u7b2c 8 \u689d(\u7db2\u5740:<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2023\/988\/oj),%E6%89%80%E6%9C%89%E5%8A%A0%E8%B2%BC\" target=\"_blank\" rel=\"noopener\">https:\/\/eur-lex.europa.eu\/eli\/reg\/2023\/988\/oj),\u6240\u6709\u52a0\u8cbc<\/a> CE \u6a19\u8a8c\u7684\u7522\u54c1\u5fc5\u9808\u9644\u6709\u7b26\u5408\u6027\u8072\u660e,\u5426\u5247\u7121\u6cd5\u5408\u6cd5\u9032\u5165\u6b50\u76df\u5e02\u5834\u3002<\/p>\n<p>\u5c0d\u53f0\u7063\u696d\u8005\u800c\u8a00,DoC \u8072\u660e\u4e0d\u50c5\u662f\u6cd5\u898f\u8981\u6c42,\u66f4\u662f\u6d77\u95dc\u6e05\u95dc\u3001\u5e02\u5834\u76e3\u7763\u6aa2\u67e5\u3001\u5ba2\u6236\u9a57\u5ee0\u6642\u7684\u6838\u5fc3\u6587\u4ef6\u3002\u82e5\u5167\u5bb9\u4e0d\u5b8c\u6574\u6216\u683c\u5f0f\u932f\u8aa4,\u53ef\u80fd\u5c0e\u81f4:<\/p>\n<ul>\n<li><strong>Customs detention<\/strong>:\u7121\u6cd5\u8b49\u660e\u7522\u54c1\u7b26\u5408\u6b50\u76df\u6cd5\u898f<\/li>\n<li><strong>\u5e02\u5834\u76e3\u7763\u7f70\u6b3e<\/strong>:\u6700\u9ad8\u53ef\u9054\u7522\u54c1\u71df\u696d\u984d\u7684 4%<\/li>\n<li><strong>\u5ba2\u6236\u62d2\u6536<\/strong>:\u6b50\u76df\u8cb7\u5bb6\u8981\u6c42\u63d0\u4f9b\u6b63\u78ba DoC \u6587\u4ef6<\/li>\n<\/ul>\n<p>\u56e0\u6b64,\u638c\u63e1\u6b63\u78ba\u7684 DoC \u8072\u660e\u6a21\u677f\u8207\u64b0\u5beb\u8981\u6c42,\u662f\u53f0\u7063\u696d\u8005\u51fa\u53e3\u6b50\u76df\u7684\u5fc5\u5099\u80fd\u529b\u3002<\/p>\n<hr \/>\n<h2>DoC \u8072\u660e\u7684\u6cd5\u898f\u57fa\u790e\u8207\u9069\u7528\u7bc4\u570d<\/h2>\n<p>\u6b50\u76df\u5c0d\u4e0d\u540c\u7522\u54c1\u985e\u5225\u6709\u4e0d\u540c\u7684\u7b26\u5408\u6027\u8072\u660e\u8981\u6c42,\u4e3b\u8981\u6db5\u84cb\u4ee5\u4e0b\u6cd5\u898f:<\/p>\n<h3>\u91ab\u7642\u5668\u6750(MDR\/IVDR)<\/h3>\n<p>\u4f9d\u64da MDR \u9644\u4ef6 IV(\u7db2\u5740:<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj)%E8%88%87\" target=\"_blank\" rel=\"noopener\">https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj)\u8207<\/a> IVDR \u9644\u4ef6 III,\u91ab\u7642\u5668\u6750\u7684 DoC \u5fc5\u9808\u5305\u542b\u88fd\u9020\u5546\u8cc7\u8a0a\u3001\u6388\u6b0a\u4ee3\u7406\u4eba\u8cc7\u8a0a\u3001\u516c\u544a\u6a5f\u69cb\u8a8d\u8b49\u7de8\u865f(\u82e5\u9069\u7528)\u3001\u7b26\u5408\u6a19\u6e96\u6e05\u55ae\u7b49\u3002<\/p>\n<h3>\u4e00\u822c\u6d88\u8cbb\u54c1(GPSR)<\/h3>\n<p>\u4f9d\u64da GPSR \u7b2c 8 \u689d(\u7db2\u5740:<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2023\/988\/oj),%E8%87%AA\" target=\"_blank\" rel=\"noopener\">https:\/\/eur-lex.europa.eu\/eli\/reg\/2023\/988\/oj),\u81ea<\/a> 2024 \u5e74 12 \u6708\u8d77,\u4e00\u822c\u6d88\u8cbb\u54c1(\u73a9\u5177\u3001\u96fb\u5b50\u7522\u54c1\u3001\u5bb6\u5c45\u7528\u54c1)\u5fc5\u9808\u63d0\u4f9b\u6280\u8853\u6587\u4ef6\u8207\u7b26\u5408\u6027\u8072\u660e,\u8b49\u660e\u7b26\u5408\u7522\u54c1\u5b89\u5168\u8981\u6c42\u3002<\/p>\n<h3>\u5176\u4ed6 CE \u8a8d\u8b49\u7522\u54c1<\/h3>\n<p>\u5305\u542b LVD(\u4f4e\u96fb\u58d3\u6307\u4ee4)\u3001EMC(\u96fb\u78c1\u76f8\u5bb9\u6307\u4ee4)\u3001RoHS(\u6709\u5bb3\u7269\u8cea\u9650\u5236\u6307\u4ee4)\u3001WEEE(\u96fb\u5b50\u96fb\u5668\u5ee2\u68c4\u7269\u6307\u4ee4)\u7b49,\u7686\u9700\u6e96\u5099\u5c0d\u61c9\u7684 DoC \u8072\u660e\u3002<\/p>\n<p>\u82e5\u5c1a\u672a\u5efa\u7acb\u5c0d\u5168\u7403\u6388\u6b0a\u4ee3\u7406\u4eba\u5236\u5ea6\u7684\u6574\u9ad4\u7406\u89e3,\u5efa\u8b70\u5148\u5f9e\u5b8c\u6574\u7e3d\u89bd\u5165\u624b,\u6709\u52a9\u65bc\u5f8c\u7e8c\u5224\u65b7\u4e0d\u540c\u570b\u5bb6\u6cd5\u898f\u8207\u57f7\u884c\u5dee\u7570\u3002<\/p>\n<p>\ud83d\udc49 \u5ef6\u4f38\u95b1\u8b80:\u5168\u7403\u6388\u6b0a\u4ee3\u7406\u4eba\u5b8c\u6574\u6307\u5357|\u53f0\u7063\u696d\u8005\u51fa\u53e3\u5fc5\u8b80(2026 \u6700\u65b0)<br \/>\n(\u6587\u7ae0\u7db2\u5740:<a href=\"https:\/\/greenoo.tw\/en\/global-authorized-representative\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/global-authorized-representative\/<\/a>)<\/p>\n<hr \/>\n<h2>DoC \u8072\u660e\u6a21\u677f\u5fc5\u5099 8 \u5927\u8981\u7d20<\/h2>\n<p>\u6839\u64da\u6b50\u76df\u5b98\u65b9\u8981\u6c42(\u7db2\u5740:<a href=\"https:\/\/ec.europa.eu\/growth\/single-market\/ce-marking_en),%E6%89%80%E6%9C%89\" target=\"_blank\" rel=\"noopener\">https:\/\/ec.europa.eu\/growth\/single-market\/ce-marking_en),\u6240\u6709<\/a> DoC \u8072\u660e\u5fc5\u9808\u5305\u542b\u4ee5\u4e0b 8 \u9805\u6838\u5fc3\u8cc7\u8a0a:<\/p>\n<h3>1. \u88fd\u9020\u5546\u5b8c\u6574\u8cc7\u8a0a<\/h3>\n<ul>\n<li>\u516c\u53f8\u6cd5\u5b9a\u540d\u7a31(\u4e2d\u82f1\u6587\u7686\u53ef,\u9700\u8207\u5546\u696d\u767b\u8a18\u4e00\u81f4)<\/li>\n<li>\u8a3b\u518a\u5730\u5740(\u5b8c\u6574\u8857\u9053\u5730\u5740,\u4e0d\u53ef\u50c5\u63d0\u4f9b\u90f5\u653f\u4fe1\u7bb1)<\/li>\n<li>Contact Phone &amp; Email<\/li>\n<\/ul>\n<h3>2. \u6388\u6b0a\u4ee3\u7406\u4eba\u8cc7\u8a0a(\u82e5\u9069\u7528)<\/h3>\n<p>\u82e5\u88fd\u9020\u5546\u672a\u5728\u6b50\u76df\u8a2d\u7acb\u8a3b\u518a\u5730,\u5fc5\u9808\u5217\u51fa\u6388\u6b0a\u4ee3\u7406\u4eba(Authorized Representative)\u6216\u7522\u54c1\u5b89\u5168\u4ee3\u8868(Product Safety Representative)\u7684\u5b8c\u6574\u8cc7\u8a0a,\u5305\u542b\u516c\u53f8\u540d\u7a31\u3001\u6b50\u76df\u8a3b\u518a\u5730\u5740\u3001\u806f\u7d61\u65b9\u5f0f\u3002<\/p>\n<h3>3. \u7522\u54c1\u8b58\u5225\u8cc7\u8a0a<\/h3>\n<ul>\n<li>\u7522\u54c1\u540d\u7a31(\u5546\u54c1\u540d\u3001\u578b\u865f\u3001\u6279\u865f)<\/li>\n<li>\u7522\u54c1\u5716\u7247\u6216\u8a73\u7d30\u63cf\u8ff0<\/li>\n<li>GTIN \u6216 UDI \u7de8\u78bc(\u91ab\u7642\u5668\u6750\u5fc5\u9808)<\/li>\n<\/ul>\n<h3>4. \u9069\u7528\u6cd5\u898f\u6e05\u55ae<\/h3>\n<p>\u660e\u78ba\u5217\u51fa\u7522\u54c1\u7b26\u5408\u7684\u6240\u6709\u6b50\u76df\u6cd5\u898f\u8207\u6307\u4ee4,\u4f8b\u5982:<\/p>\n<ul>\n<li>MDR 2017\/745(\u91ab\u7642\u5668\u6750)<\/li>\n<li>GPSR 2023\/988(\u4e00\u822c\u7522\u54c1\u5b89\u5168)<\/li>\n<li>EMC Directive 2014\/30\/EU(\u96fb\u78c1\u76f8\u5bb9)<\/li>\n<\/ul>\n<h3>5. \u7b26\u5408\u6a19\u6e96\u6e05\u55ae<\/h3>\n<p>\u5217\u51fa\u7522\u54c1\u4f9d\u5faa\u7684\u6b50\u76df\u5354\u8abf\u6a19\u6e96(Harmonized Standards),\u4f8b\u5982:<\/p>\n<ul>\n<li>EN 60601-1:2006+A1:2013(\u91ab\u7642\u5668\u6750\u96fb\u6c23\u5b89\u5168)<\/li>\n<li>EN 71-1:2014(\u73a9\u5177\u5b89\u5168)<\/li>\n<\/ul>\n<h3>6. \u516c\u544a\u6a5f\u69cb\u8cc7\u8a0a(\u82e5\u9069\u7528)<\/h3>\n<p>\u82e5\u7522\u54c1\u9700\u7d93\u516c\u544a\u6a5f\u69cb(Notified Body)\u8a8d\u8b49,\u5fc5\u9808\u5217\u51fa:<\/p>\n<ul>\n<li>\u516c\u544a\u6a5f\u69cb\u540d\u7a31\u8207\u8b58\u5225\u7de8\u865f<\/li>\n<li>\u8a8d\u8b49\u7de8\u865f(Certificate Number)<\/li>\n<\/ul>\n<h3>7. \u7c3d\u7f72\u8cc7\u8a0a<\/h3>\n<ul>\n<li>\u7c3d\u7f72\u5730\u9ede\u8207\u65e5\u671f<\/li>\n<li>\u7c3d\u7f72\u4eba\u59d3\u540d\u8207\u8077\u4f4d(\u9700\u70ba\u516c\u53f8\u6cd5\u5b9a\u4ee3\u8868\u4eba\u6216\u6388\u6b0a\u7c3d\u7f72\u4eba)<\/li>\n<li>\u89aa\u7b46\u7c3d\u540d(\u6578\u4f4d\u7c3d\u7ae0\u9700\u7b26\u5408 eIDAS \u898f\u7bc4)<\/li>\n<\/ul>\n<h3>8. \u6280\u8853\u6587\u4ef6\u5b58\u653e\u8cc7\u8a0a<\/h3>\n<p>\u8aaa\u660e\u6280\u8853\u6587\u4ef6(Technical Documentation)\u7684\u5b58\u653e\u5730\u9ede\u8207\u4fdd\u5b58\u671f\u9650(\u4e00\u822c\u70ba\u7522\u54c1\u4e0a\u5e02\u5f8c 10 \u5e74)\u3002<\/p>\n<hr \/>\n<h3>\u5716 2:DoC \u8072\u660e 8 \u5927\u5fc5\u5099\u8981\u7d20\u6aa2\u6838\u8868<\/h3>\n<p>&nbsp;<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-20215\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-essential-elements-checklist-2026.png\" alt=\"DoC \u8072\u660e 8 \u5927\u5fc5\u5099\u8981\u7d20\u6aa2\u6838\u8868,\u5217\u51fa\u88fd\u9020\u5546\u8cc7\u8a0a\u3001\u6388\u6b0a\u4ee3\u7406\u4eba\u3001\u7522\u54c1\u8b58\u5225\u3001\u9069\u7528\u6cd5\u898f\u7b49\u6838\u5fc3\u689d\u6b3e\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-essential-elements-checklist-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-essential-elements-checklist-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-essential-elements-checklist-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-essential-elements-checklist-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-essential-elements-checklist-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/p>\n<hr \/>\n<h2>\u4e0d\u540c\u7522\u54c1\u985e\u5225\u7684 DoC \u8072\u660e\u5dee\u7570<\/h2>\n<h3>\u91ab\u7642\u5668\u6750(MDR\/IVDR)<\/h3>\n<p>\u91ab\u7642\u5668\u6750\u7684 DoC \u8072\u660e\u5fc5\u9808\u5305\u542b UDI(\u552f\u4e00\u5668\u6750\u8b58\u5225\u78bc)\u3001EUDAMED \u8a3b\u518a\u7de8\u865f\u3001\u516c\u544a\u6a5f\u69cb\u8a8d\u8b49\u8cc7\u8a0a(Class IIa \u4ee5\u4e0a)\u3002<\/p>\n<h3>\u4e00\u822c\u6d88\u8cbb\u54c1(GPSR)<\/h3>\n<p>\u4e00\u822c\u6d88\u8cbb\u54c1\u7684 DoC \u8072\u660e\u9700\u660e\u78ba\u5217\u51fa\u7522\u54c1\u5b89\u5168\u4ee3\u8868(Product Safety Representative)\u8cc7\u8a0a,\u4e26\u8aaa\u660e\u7522\u54c1\u7b26\u5408 GPSR \u7684\u98a8\u96aa\u8a55\u4f30\u8981\u6c42\u3002<\/p>\n<h3>\u96fb\u5b50\u96fb\u5668\u7522\u54c1(LVD\/EMC\/RoHS)<\/h3>\n<p>\u96fb\u5b50\u96fb\u5668\u7522\u54c1\u901a\u5e38\u9700\u540c\u6642\u7b26\u5408\u591a\u9805\u6307\u4ee4,DoC \u8072\u660e\u5fc5\u9808\u5206\u5225\u5217\u51fa\u5404\u6307\u4ee4\u7684\u7b26\u5408\u6027\u8aaa\u660e\u8207\u6e2c\u8a66\u6a19\u6e96\u3002<\/p>\n<div class=\"MarkdownTable_tableContainer__2k5Kh\" tabindex=\"0\" role=\"region\">\n<table>\n<thead>\n<tr>\n<th>Product Category<\/th>\n<th>\u5fc5\u9808\u5305\u542b\u7684\u7279\u6b8a\u689d\u6b3e<\/th>\n<th>\u9069\u7528\u6cd5\u898f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u91ab\u7642\u5668\u6750<\/td>\n<td>UDI\u3001EUDAMED \u7de8\u865f\u3001\u516c\u544a\u6a5f\u69cb\u8cc7\u8a0a<\/td>\n<td>MDR\/IVDR<\/td>\n<\/tr>\n<tr>\n<td>\u4e00\u822c\u6d88\u8cbb\u54c1<\/td>\n<td>\u7522\u54c1\u5b89\u5168\u4ee3\u8868\u8cc7\u8a0a<\/td>\n<td>GPSR<\/td>\n<\/tr>\n<tr>\n<td>Electronic Appliances<\/td>\n<td>\u591a\u6307\u4ee4\u7b26\u5408\u6027\u8072\u660e<\/td>\n<td>LVD\/EMC\/RoHS<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<hr \/>\n<h2>DoC \u8072\u660e\u5e38\u898b\u932f\u8aa4\u8207\u907f\u5751\u6307\u5357<\/h2>\n<h3>\u932f\u8aa4 1:\u6388\u6b0a\u4ee3\u7406\u4eba\u8cc7\u8a0a\u932f\u8aa4\u6216\u7f3a\u6f0f<\/h3>\n<p>\u8a31\u591a\u53f0\u7063\u696d\u8005\u50c5\u5217\u51fa\u88fd\u9020\u5546\u8cc7\u8a0a,\u5ffd\u7565\u6b50\u76df\u6388\u6b0a\u4ee3\u7406\u4eba\u8cc7\u8a0a,\u5c0e\u81f4\u6d77\u95dc\u7121\u6cd5\u806f\u7e6b\u7576\u5730\u4ee3\u8868\u3002<\/p>\n<p><strong>Solutions<\/strong>:\u82e5\u5c1a\u672a\u6307\u5b9a\u6388\u6b0a\u4ee3\u7406\u4eba,\u5fc5\u9808\u5728\u7522\u54c1\u4e0a\u5e02\u524d\u5b8c\u6210\u6307\u5b9a\u3002<\/p>\n<h3>\u932f\u8aa4 2:\u7b26\u5408\u6a19\u6e96\u7248\u672c\u904e\u671f<\/h3>\n<p>\u5217\u51fa\u7684 EN \u6a19\u6e96\u7248\u672c\u5df2\u88ab\u65b0\u7248\u672c\u53d6\u4ee3,\u5c0e\u81f4\u7b26\u5408\u6027\u8072\u660e\u7121\u6548\u3002<\/p>\n<p><strong>Solutions<\/strong>:\u5b9a\u671f\u67e5\u8a62\u6b50\u76df\u5b98\u65b9\u516c\u544a\u6a5f\u69cb\u8cc7\u6599\u5eab(\u7db2\u5740:<a href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/),%E7%A2%BA%E8%AA%8D%E6%9C%80%E6%96%B0%E6%A8%99%E6%BA%96%E7%89%88%E6%9C%AC%E3%80%82\" target=\"_blank\" rel=\"noopener\">https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/),\u78ba\u8a8d\u6700\u65b0\u6a19\u6e96\u7248\u672c\u3002<\/a><\/p>\n<h3>\u932f\u8aa4 3:\u7c3d\u7f72\u4eba\u7121\u6388\u6b0a<\/h3>\n<p>DoC \u8072\u660e\u7531\u975e\u6cd5\u5b9a\u4ee3\u8868\u4eba\u7c3d\u7f72,\u4e14\u672a\u63d0\u4f9b\u6388\u6b0a\u66f8\u3002<\/p>\n<p><strong>Solutions<\/strong>:\u7c3d\u7f72\u524d\u9700\u53d6\u5f97\u516c\u53f8\u5167\u90e8\u6388\u6b0a\u6587\u4ef6,\u4e26\u4fdd\u7559\u6388\u6b0a\u7d00\u9304\u3002<\/p>\n<hr \/>\n<h3>\u5716 3:DoC \u8072\u660e\u5e38\u898b\u932f\u8aa4\u8207\u6b63\u78ba\u7bc4\u4f8b\u5c0d\u7167<\/h3>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-20216\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-common-mistakes-correct-examples-2026.png\" alt=\"DoC \u8072\u660e\u5e38\u898b\u932f\u8aa4\u8207\u6b63\u78ba\u7bc4\u4f8b\u5c0d\u7167\u5716,\u986f\u793a\u6388\u6b0a\u4ee3\u7406\u4eba\u3001\u6a19\u6e96\u7248\u672c\u3001\u7c3d\u7f72\u4eba\u7b49\u95dc\u9375\u932f\u8aa4\u8207\u6b63\u78ba\u5beb\u6cd5\" width=\"2560\" height=\"1429\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-common-mistakes-correct-examples-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-common-mistakes-correct-examples-2026-768x429.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-common-mistakes-correct-examples-2026-1536x857.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-common-mistakes-correct-examples-2026-2048x1143.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/eu-ce-doc-common-mistakes-correct-examples-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/p>\n<hr \/>\n<h2>DoC \u8072\u660e\u7684\u88fd\u4f5c\u8207\u7ba1\u7406\u6d41\u7a0b<\/h2>\n<h3>\u6b65\u9a5f 1:\u78ba\u8a8d\u7522\u54c1\u9069\u7528\u6cd5\u898f<\/h3>\n<p>\u67e5\u8a62\u7522\u54c1\u985e\u5225\u5c0d\u61c9\u7684\u6b50\u76df\u6cd5\u898f(MDR\/GPSR\/LVD\/EMC \u7b49),\u78ba\u8a8d\u9700\u5217\u5165\u7684\u6cd5\u898f\u6e05\u55ae\u3002<\/p>\n<h3>\u6b65\u9a5f 2:\u53d6\u5f97\u7b26\u5408\u6027\u6e2c\u8a66\u5831\u544a<\/h3>\n<p>\u59d4\u8a17\u6b50\u76df\u8a8d\u53ef\u7684\u6e2c\u8a66\u5be6\u9a57\u5ba4\u9032\u884c\u7522\u54c1\u6e2c\u8a66,\u53d6\u5f97\u7b26\u5408 EN \u6a19\u6e96\u7684\u6e2c\u8a66\u5831\u544a\u3002<\/p>\n<h3>\u6b65\u9a5f 3:\u6e96\u5099\u6280\u8853\u6587\u4ef6<\/h3>\n<p>\u6574\u7406\u7522\u54c1\u8a2d\u8a08\u6587\u4ef6\u3001\u98a8\u96aa\u8a55\u4f30\u5831\u544a\u3001\u6e2c\u8a66\u5831\u544a,\u5efa\u7acb\u5b8c\u6574\u7684\u6280\u8853\u6587\u4ef6\u6a94\u6848\u3002<\/p>\n<h3>\u6b65\u9a5f 4:\u64b0\u5beb DoC \u8072\u660e<\/h3>\n<p>\u4f9d\u64da\u4e0a\u8ff0 8 \u5927\u8981\u7d20,\u9010\u9805\u586b\u5beb DoC \u8072\u660e\u5167\u5bb9,\u78ba\u4fdd\u8cc7\u8a0a\u5b8c\u6574\u4e14\u6b63\u78ba\u3002<\/p>\n<h3>\u6b65\u9a5f 5:\u6cd5\u5b9a\u4ee3\u8868\u7c3d\u7f72<\/h3>\n<p>\u7531\u516c\u53f8\u6cd5\u5b9a\u4ee3\u8868\u4eba\u6216\u6388\u6b0a\u7c3d\u7f72\u4eba\u7c3d\u7f72 DoC \u8072\u660e,\u4e26\u8a3b\u660e\u7c3d\u7f72\u65e5\u671f\u8207\u5730\u9ede\u3002<\/p>\n<h3>\u6b65\u9a5f 6:\u4fdd\u5b58\u8207\u66f4\u65b0<\/h3>\n<p>DoC \u8072\u660e\u9700\u8207\u6280\u8853\u6587\u4ef6\u4e00\u4f75\u4fdd\u5b58\u81f3\u5c11 10 \u5e74,\u4e26\u5728\u7522\u54c1\u8a2d\u8a08\u6216\u6cd5\u898f\u8b8a\u66f4\u6642\u53ca\u6642\u66f4\u65b0\u3002<\/p>\n<p>\u82e5\u9032\u4e00\u6b65\u95dc\u5fc3\u6b50\u76df\u6388\u6b0a\u4ee3\u7406\u4eba\u7684\u6307\u5b9a\u6d41\u7a0b\u8207 MDR\/IVDR \u6cd5\u898f\u8981\u6c42,\u53ef\u53c3\u8003\u4ee5\u4e0b\u8aaa\u660e\u9801\u9762,\u4ee5\u91d0\u6e05\u5be6\u52d9\u4e0a\u7684\u5224\u65b7\u91cd\u9ede\u3002<\/p>\n<p>\ud83d\udc49 \u5ef6\u4f38\u95b1\u8b80:\u6b50\u76df\u6388\u6b0a\u4ee3\u7406\u4eba\u5b8c\u6574\u6307\u5357|MDR\/IVDR \u6cd5\u898f\u8981\u6c42\u8207\u6307\u5b9a\u6d41\u7a0b(2026)<br \/>\n(\u6587\u7ae0\u7db2\u5740:<a href=\"https:\/\/greenoo.tw\/en\/global-authorized-representative-eu-authorized-representative-guide\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/global-authorized-representative-eu-authorized-representative-guide\/<\/a>)<\/p>\n<hr \/>\n<h2>Conclusion<\/h2>\n<p>\u638c\u63e1\u6b63\u78ba\u7684 DoC \u8072\u660e\u6a21\u677f\u8207\u64b0\u5beb\u8981\u6c42,\u662f\u53f0\u7063\u696d\u8005\u51fa\u53e3\u6b50\u76df\u5e02\u5834\u7684\u57fa\u790e\u80fd\u529b\u3002\u95dc\u9375\u91cd\u9ede\u5305\u62ec:<\/p>\n<ul>\n<li>DoC \u8072\u660e\u662f CE \u8a8d\u8b49\u7684\u6cd5\u5b9a\u6587\u4ef6,\u5fc5\u9808\u5305\u542b 8 \u5927\u6838\u5fc3\u8981\u7d20<\/li>\n<li>\u4e0d\u540c\u7522\u54c1\u985e\u5225(\u91ab\u6750\u3001\u6d88\u8cbb\u54c1\u3001\u96fb\u5b50\u96fb\u5668)\u6709\u4e0d\u540c\u7684\u7279\u6b8a\u8981\u6c42<\/li>\n<li>\u5e38\u898b\u932f\u8aa4\u5305\u542b\u6388\u6b0a\u4ee3\u7406\u4eba\u8cc7\u8a0a\u7f3a\u6f0f\u3001\u6a19\u6e96\u7248\u672c\u904e\u671f\u3001\u7c3d\u7f72\u4eba\u7121\u6388\u6b0a<\/li>\n<li>DoC \u8072\u660e\u9700\u8207\u6280\u8853\u6587\u4ef6\u4e00\u4f75\u4fdd\u5b58 10 \u5e74,\u4e26\u5728\u6cd5\u898f\u8b8a\u66f4\u6642\u53ca\u6642\u66f4\u65b0<\/li>\n<li>\u5efa\u8b70\u59d4\u8a17\u5c08\u696d\u9867\u554f\u5354\u52a9\u6aa2\u8996,\u78ba\u4fdd\u7b26\u5408\u6700\u65b0\u6cd5\u898f\u8981\u6c42<\/li>\n<\/ul>\n<p>\u82e5\u5c0d\u6b50\u76df CE \u8a8d\u8b49 DoC \u8072\u660e\u4ecd\u6709\u7591\u554f,\u6b61\u8fce\u53c3\u8003\u7da0\u5708\u5708\u5b98\u7db2(\u7db2\u5740:<a href=\"https:\/\/greenoo.tw)%E7%9A%84%E5%B0%88%E6%A5%AD%E9%A1%A7%E5%95%8F%E6%9C%8D%E5%8B%99%E3%80%82\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw)\u7684\u5c08\u696d\u9867\u554f\u670d\u52d9\u3002<\/a><\/p>\n<hr \/>\n<h2>\u53c3\u8003\u8cc7\u6599<\/h2>\n<p>\u672c\u6587\u5167\u5bb9\u57fa\u65bc\u4ee5\u4e0b\u5b98\u65b9\u8cc7\u6599\u64b0\u5beb(\u622a\u81f3 2026 \u5e74 1 \u6708):<\/p>\n<ol>\n<li>European Parliament and Council. &#8220;Regulation (EU) 2017\/745 on Medical Devices (MDR).&#8221; Official Journal of the European Union, \u7db2\u5740:<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\" target=\"_blank\" rel=\"noopener\">https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj<\/a><\/li>\n<li>European Parliament and Council. &#8220;Regulation (EU) 2023\/988 on General Product Safety (GPSR).&#8221; Official Journal of the European Union, \u7db2\u5740:<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2023\/988\/oj\" target=\"_blank\" rel=\"noopener\">https:\/\/eur-lex.europa.eu\/eli\/reg\/2023\/988\/oj<\/a><\/li>\n<li>European Commission. &#8220;CE Marking.&#8221; European Commission &#8211; Growth, \u7db2\u5740:<a href=\"https:\/\/ec.europa.eu\/growth\/single-market\/ce-marking_en\" target=\"_blank\" rel=\"noopener\">https:\/\/ec.europa.eu\/growth\/single-market\/ce-marking_en<\/a><\/li>\n<li>European Commission. &#8220;NANDO (New Approach Notified and Designated Organisations).&#8221; \u7db2\u5740:<a href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/\" target=\"_blank\" rel=\"noopener\">https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/<\/a><\/li>\n<\/ol>\n<p>\u8a3b:\u5404\u570b\u6cd5\u898f\u53ef\u80fd\u66f4\u65b0,\u5efa\u8b70\u67e5\u95b1\u6700\u65b0\u5b98\u65b9\u6587\u4ef6\u6216\u8aee\u8a62\u5c08\u696d\u9867\u554f\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>\u4ec0\u9ebc\u662f\u6b50\u76df CE \u8a8d\u8b49 DoC \u8072\u660e?\u70ba\u4f55\u53f0\u7063\u696d\u8005\u5fc5\u9808\u6e96\u5099? \u6b50\u76df CE \u8a8d\u8b49 DoC(Declaration [&hellip;]<\/p>","protected":false},"author":11,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[42,1],"tags":[],"class_list":["post-6649","post","type-post","status-publish","format-standard","hentry","category-42","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/6649"}],"collection":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/comments?post=6649"}],"version-history":[{"count":3,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/6649\/revisions"}],"predecessor-version":[{"id":20218,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/6649\/revisions\/20218"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/media?parent=6649"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/categories?post=6649"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/tags?post=6649"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}