{"id":826,"date":"2026-03-23T02:57:17","date_gmt":"2026-03-23T02:57:17","guid":{"rendered":"https:\/\/adult-diaper.com\/?p=826"},"modified":"2026-03-23T02:59:17","modified_gmt":"2026-03-23T02:59:17","slug":"do-adult-incontinence-products-need-ce-how-requirements-vary-by-market","status":"publish","type":"post","link":"https:\/\/adult-diaper.com\/ja\/do-adult-incontinence-products-need-ce-how-requirements-vary-by-market\/","title":{"rendered":"\u5927\u4eba\u7528\u5931\u7981\u88fd\u54c1\u306bCE\u306f\u5fc5\u8981\u304b\uff1f\u5e02\u5834\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u8981\u4ef6"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u305d\u308c\u306f\u5b8c\u5168\u306b\u4eba\u306b\u3088\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3057\u304b\u3057\u3001\u5927\u4eba\u7528\u5931\u7981\u88fd\u54c1\u306f\u3001\u533b\u7642\u6a5f\u5668\u6cd5\u3001\u8ca9\u58f2\u30af\u30ec\u30fc\u30e0\u3001\u901a\u95a2\u624b\u7d9a\u304d\u3001\u8f38\u5165\u696d\u8005\u306e\u671f\u5f85\u3001\u305d\u3057\u3066\u696d\u754c\u304c\u805e\u3053\u3048\u306a\u3044\u3075\u308a\u3092\u3057\u7d9a\u3051\u3066\u3044\u308b\u9811\u56fa\u306a\u4e8b\u5b9f\u3001\u3064\u307e\u308a\u3001\u540c\u3058\u5438\u53ce\u6027\u88fd\u54c1\u3067\u3082\u3001\u5e02\u5834\u3001\u30e9\u30d9\u30eb\u3001\u4f7f\u7528\u76ee\u7684\u306e\u8a18\u8f09\u304c\u5909\u308f\u308c\u3070\u3001\u6271\u3044\u304c\u5927\u304d\u304f\u5909\u308f\u3063\u3066\u3057\u307e\u3046\u306e\u3060\u3002\u3082\u3046\u3046\u3093\u3056\u308a\u3067\u3059\u304b\uff1f<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EU\u3068\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u3067\u306f\u3001\u6210\u4eba\u7528\u5931\u7981\u88fd\u54c1\u306fMDR 2017\/745\u306b\u57fa\u3065\u304f\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u8a8d\u5b9a\u3055\u308c\u308b\u969b\u306bCE\u30de\u30fc\u30ad\u30f3\u30b0\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u7c73\u56fd\u3067\u306fCE\u306b\u306f\u4f55\u306e\u610f\u5473\u3082\u306a\u304f\u3001\u4ee3\u308f\u308a\u306bFDA\u306e\u6a5f\u5668\u898f\u5247\u304c\u9069\u7528\u3055\u308c\u3001\u82f1\u56fd\u3067\u306fCE\u30de\u30fc\u30ad\u30f3\u30b0\u3055\u308c\u305f\u6a5f\u5668\u306f\u30af\u30e9\u30b9\u3068\u6a5f\u5668\u306e\u7a2e\u985e\u306b\u5fdc\u3058\u3066\u79fb\u884c\u671f\u9593\u4e2d\u3082\u53d7\u3051\u5165\u308c\u3089\u308c\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u3067\u306fTGA\u304c\u5931\u7981\u30d1\u30c3\u30c9\u306fARTG\u306e\u5bfe\u8c61\u304b\u3089\u9664\u5916\u3055\u308c\u308b\u3068\u660e\u8a00\u3057\u3066\u3044\u308b\u3002\u3053\u308c\u306f\u30d6\u30e9\u30f3\u30c7\u30a3\u30f3\u30b0\u306e\u554f\u984c\u3067\u306f\u306a\u3044\u3002\u3053\u308c\u306f\u898f\u5236\u4e0a\u306e\u554f\u984c\u306a\u306e\u3060\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u79c1\u306f\u540c\u3058\u904e\u3061\u3092\u7e70\u308a\u8fd4\u3057\u3066\u3044\u308b\u3002\u4eba\u3005\u306f\u300c\u30d7\u30ec\u30df\u30a2\u30e0\u300d\u3001\u300c\u901a\u6c17\u6027\u300d\u3001\u300c\u63a7\u3048\u3081\u300d\u3068\u3044\u3063\u305f\u3075\u308f\u3075\u308f\u3057\u305f\u8a00\u8449\u306b\u3053\u3060\u308f\u308b\u304c\u3001\u898f\u5236\u5f53\u5c40\u304c\u6c17\u306b\u3057\u3066\u3044\u308b\u306e\u306f\u3001\u305d\u306e\u88fd\u54c1\u304c\u4f55\u306e\u305f\u3081\u306b\u3042\u308b\u306e\u304b\u3001\u8ab0\u306e\u305f\u3081\u306e\u3082\u306e\u306a\u306e\u304b\u3001\u305d\u3057\u3066\u3042\u306a\u305f\u306e\u66f8\u985e\u304c5\u5206\u9593\u306e\u7cbe\u67fb\u306b\u8010\u3048\u3089\u308c\u308b\u304b\u3069\u3046\u304b\u3001\u3068\u3044\u3046\u3053\u3068\u306e\u307b\u3046\u3060\u3068\u3044\u3046\u3053\u3068\u3092\u5fd8\u308c\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u76ee\u6b21<\/h2><nav><ul><li><a href=\"#the-law-follows-the-claim-not-the-absorbency-core\">\u6cd5\u5f8b\u306f\u3001\u5438\u53ce\u6027\u30b3\u30a2\u3067\u306f\u306a\u304f\u3001\u30af\u30ec\u30fc\u30e0\u306b\u5f93\u3046\u3002<\/a><\/li><li><a href=\"#the-market-by-market-reality-most-suppliers-oversimplify\">\u591a\u304f\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u5358\u7d14\u5316\u3057\u3059\u304e\u3066\u3044\u308b\u5e02\u5834\u3054\u3068\u306e\u73fe\u5b9f<\/a><\/li><li><a href=\"#the-2023-2024-precedents-buyers-should-have-paid-attention-to\">\u30d0\u30a4\u30e4\u30fc\u304c\u6ce8\u76ee\u3059\u3079\u304d2023-2024\u5e74\u306e\u524d\u4f8b<\/a><ul><li><a href=\"#brussels-blinked-and-that-was-not-random\">\u30d6\u30ea\u30e5\u30c3\u30bb\u30eb\u306f\u77ac\u304d\u3092\u3057\u305f\u3002<\/a><\/li><li><a href=\"#demand-is-huge-whether-boardrooms-like-the-category-or-not\">\u5f79\u54e1\u5ba4\u304c\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3092\u597d\u3080\u3068\u597d\u307e\u3056\u308b\u3068\u306b\u304b\u304b\u308f\u3089\u305a\u3001\u9700\u8981\u306f\u5927\u304d\u3044\u3002<\/a><\/li><li><a href=\"#one-smart-accessory-can-harden-the-whole-compliance-conversation\">\u30b9\u30de\u30fc\u30c8\u306a\u30a2\u30af\u30bb\u30b5\u30ea\u30fc1\u3064\u3067\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u95a2\u3059\u308b\u4f1a\u8a71\u5168\u4f53\u3092\u56fa\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b<\/a><\/li><\/ul><\/li><li><a href=\"#what-actually-triggers-ce-marking-for-adult-incontinence-products\">\u6210\u4eba\u7528\u5931\u7981\u7528\u54c1\u306eCE\u30de\u30fc\u30ad\u30f3\u30b0\u306e\u30c8\u30ea\u30ac\u30fc\u3068\u306a\u308b\u3082\u306e<\/a><ul><li><a href=\"#intended-purpose-comes-first\">\u76ee\u7684\u512a\u5148<\/a><\/li><li><a href=\"#product-format-matters-less-than-people-think\">\u88fd\u54c1\u306e\u5f62\u5f0f\u306f\u3001\u4eba\u3005\u304c\u8003\u3048\u3066\u3044\u308b\u307b\u3069\u91cd\u8981\u3067\u306f\u306a\u3044<\/a><\/li><li><a href=\"#market-entry-route-changes-the-answer-fast\">\u5e02\u5834\u53c2\u5165\u30eb\u30fc\u30c8\u306f\u7b54\u3048\u3092\u65e9\u304f\u5909\u3048\u308b<\/a><\/li><li><a href=\"#the-documentation-stack-is-where-weak-suppliers-get-exposed\">\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u30fb\u30b9\u30bf\u30c3\u30af\u306f\u3001\u5f31\u3044\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u9732\u5448\u3059\u308b\u5834\u6240\u3067\u3042\u308b\u3002<\/a><\/li><\/ul><\/li><li><a href=\"#faqs\">\u3088\u304f\u3042\u308b\u3054\u8cea\u554f<\/a><ul><li><a href=\"#do-adult-incontinence-products-need-ce-marking-in-europe\">\u5927\u4eba\u7528\u5931\u7981\u88fd\u54c1\u306f\u6b27\u5dde\u3067CE\u30de\u30fc\u30ad\u30f3\u30b0\u304c\u5fc5\u8981\u304b\uff1f<\/a><\/li><li><a href=\"#do-adult-diapers-need-ce-marking-in-the-united-states\">\u5927\u4eba\u7528\u7d19\u304a\u3080\u3064\u306f\u7c73\u56fd\u3067CE\u30de\u30fc\u30ad\u30f3\u30b0\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/a><\/li><li><a href=\"#can-i-sell-a-ce-marked-adult-incontinence-product-in-great-britain-after-brexit\">EU\u96e2\u8131\u5f8c\u3001CE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3057\u305f\u5927\u4eba\u7528\u5931\u7981\u88fd\u54c1\u3092\u82f1\u56fd\u3067\u8ca9\u58f2\u3067\u304d\u307e\u3059\u304b\uff1f<\/a><\/li><li><a href=\"#what-decides-whether-pull-ups-pads-or-underpads-are-medical-devices\">\u61f8\u5782\u4e0b\u7740\u3001\u30d1\u30c3\u30c9\u3001\u30a2\u30f3\u30c0\u30fc\u30d1\u30c3\u30c9\u304c\u533b\u7642\u6a5f\u5668\u3067\u3042\u308b\u304b\u3069\u3046\u304b\u306f\u3001\u4f55\u304c\u6c7a\u3081\u308b\u306e\u3067\u3059\u304b\uff1f<\/a><\/li><li><a href=\"#what-documents-should-an-importer-ask-for-first\">\u8f38\u5165\u696d\u8005\u306f\u307e\u305a\u3069\u306e\u3088\u3046\u306a\u66f8\u985e\u3092\u6c42\u3081\u308b\u3079\u304d\u304b\uff1f<\/a><\/li><\/ul><\/li><li><a href=\"#your-next-move\">\u6b21\u306e\u4e00\u624b<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<div class=\"wp-block-greenshift-blocks-image gspb_image gspb_image-id-gsbp-8a22c60\" id=\"gspb_image-id-gsbp-8a22c60\"><img decoding=\"async\" src=\"https:\/\/adult-diaper.com\/wp-content\/uploads\/2026\/03\/Do-Adult-Incontinence-Products-Need-CE-How-Requirements-Vary-by-Market-2.jpg\" data-src=\"\" alt=\"Do Adult Incontinence Products Need CE How Requirements Vary by Market\" loading=\"lazy\" width=\"750\" height=\"750\"\/><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"the-law-follows-the-claim-not-the-absorbency-core\">\u6cd5\u5f8b\u306f\u3001\u5438\u53ce\u6027\u30b3\u30a2\u3067\u306f\u306a\u304f\u3001\u30af\u30ec\u30fc\u30e0\u306b\u5f93\u3046\u3002<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8a00\u8449\u304c\u5730\u4f4d\u3092\u6c7a\u3081\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u306e\u4e0b\u306b\u3042\u308b\u3002 <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX%3A02017R0745-20230320\" target=\"_blank\" rel=\"noopener\">EU MDR\u30c6\u30ad\u30b9\u30c8<\/a>, \u533b\u7642\u6a5f\u5668\u3068\u306f\u3001\u8a3a\u65ad\u3001\u6cbb\u7642\u3001\u75be\u75c5\u306e\u7de9\u548c\u3001\u50b7\u5bb3\u3084\u969c\u5bb3\u306e\u88dc\u511f\u306a\u3069\u3001\u533b\u7642\u3092\u76ee\u7684\u3068\u3057\u305f\u3082\u306e\u3067\u3042\u308a\u3001\u898f\u5236\u306f\u3001\u88fd\u9020\u8005\u306e\u30e9\u30d9\u30eb\u3001\u4f7f\u7528\u8aac\u660e\u66f8\u3001\u8ca9\u58f2\u4fc3\u9032\u7528\u8cc7\u6599\u3084\u55b6\u696d\u7528\u8cc7\u6599\u306b\u3088\u3063\u3066\u300c\u610f\u56f3\u3055\u308c\u305f\u76ee\u7684\u300d\u3092\u5b9a\u7fa9\u3057\u3066\u3044\u308b\u3002\u3064\u307e\u308a\u3001\u30d1\u30f3\u30d5\u30ec\u30c3\u30c8\u304c\u6cd5\u7684\u306a\u904b\u547d\u3092\u6c7a\u3081\u308b\u3053\u3068\u3082\u3042\u308b\u306e\u3067\u3059\u3002\u8ab0\u304c\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306f\u5225\u5ba4\u3060\u3068\u8a00\u3063\u305f\uff1f<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX%3A02017R0745-20230320\" target=\"_blank\" rel=\"noopener\">\u30e6\u30fc\u30ed\u30ec\u30c3\u30af\u30b9<\/a>)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A 2023 <a href=\"https:\/\/www.frontiersin.org\/journals\/reproductive-health\/articles\/10.3389\/frph.2023.1175627\/full\" target=\"_blank\" rel=\"noopener\">\u6210\u4eba\u7528\u5c3f\u5931\u7981\u88fd\u54c1\u306b\u95a2\u3059\u308bFrontiers\u30ec\u30d3\u30e5\u30fc<\/a> \u5927\u4eba\u7528\u5931\u7981\u7528\u54c1\u306fEU\u3067\u306f\u30af\u30e9\u30b9I\u306e\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u6271\u308f\u308c\u3001\u4e00\u65b9\u3001\u5438\u53ce\u6027AI\u88fd\u54c1\u306f\u30ab\u30ca\u30c0\u3067\u306f\u6210\u5f62\u54c1\u3068\u3057\u3066\u3001\u65e5\u672c\u3067\u306f\u5bb6\u5ead\u7528\u54c1\u3068\u3057\u3066\u6271\u308f\u308c\u3066\u3044\u308b\u3002\u540c\u3058\u30e6\u30fc\u30b6\u30fc\u306e\u554f\u984c\u3002\u540c\u3058\u5438\u53ce\u4f53\u306e\u8ad6\u7406\u3002\u7570\u306a\u308b\u6cd5\u7684\u5305\u88c5\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3060\u304b\u3089\u3053\u305d\u3001\u3053\u306e\u30c8\u30d4\u30c3\u30af\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u5185\u90e8\u30da\u30fc\u30b8\u306e\u6a2a\u306b\u7f6e\u304f\u3079\u304d\u306a\u306e\u3060\u3002 <a href=\"https:\/\/adult-diaper.com\/ja\/studies\/\">\u5927\u4eba\u7528\u7d19\u304a\u3080\u3064\u8a66\u9a13\u5831\u544a\u66f8\u304a\u3088\u3073\u8a3c\u660e\u66f8<\/a>, <a href=\"https:\/\/adult-diaper.com\/ja\/oem-odm-services\/\">\u5927\u4eba\u7528\u5931\u7981\u88fd\u54c1\u306eOEM\/ODM\u30b5\u30fc\u30d3\u30b9<\/a>, \u305d\u3057\u3066 <a href=\"https:\/\/adult-diaper.com\/ja\/incontinence-underwear-manufacturer-guide-for-retail-e-com\/\">\u5c0f\u58f2\u304a\u3088\u3073e\u30b3\u30de\u30fc\u30b9\u5411\u3051\u5931\u7981\u4e0b\u7740\u30e1\u30fc\u30ab\u30fc\u30ac\u30a4\u30c9<\/a>. .\u30d0\u30a4\u30e4\u30fc\u306f\u5f62\u5bb9\u8a5e\u306b\u304a\u91d1\u3092\u6255\u3046\u306e\u3067\u306f\u306a\u3044\u3002\u30d5\u30a1\u30a4\u30eb\u306b\u5bfe\u3057\u3066\u652f\u6255\u3046\u306e\u3060\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"the-market-by-market-reality-most-suppliers-oversimplify\">\u591a\u304f\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u5358\u7d14\u5316\u3057\u3059\u304e\u3066\u3044\u308b\u5e02\u5834\u3054\u3068\u306e\u73fe\u5b9f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u304c\u79c1\u304c\u304a\u898b\u305b\u3067\u304d\u308b\u6700\u3082\u30af\u30ea\u30fc\u30f3\u306a\u30d0\u30fc\u30b8\u30e7\u30f3\u3067\u3059\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u5e02\u5834<\/th><th>CE\u306f\u91cd\u8981\u304b\uff1f<\/th><th>\u901a\u5e38\u9069\u7528\u3055\u308c\u308b\u3082\u306e<\/th><th>\u30d0\u30a4\u30e4\u30fc\u304c\u898b\u9003\u3057\u3066\u3044\u308b\u3082\u306e<\/th><\/tr><\/thead><tbody><tr><td>\u6b27\u5dde\u9023\u5408<\/td><td>\u88fd\u54c1\u304cMDR 2017\/745\u306e\u9069\u7528\u7bc4\u56f2\u306b\u3042\u308b\u533b\u7642\u6a5f\u5668\u3067\u3042\u308b\u5834\u5408\u3001\u53ef<\/td><td>CE\u30de\u30fc\u30af\u3001EU\u9069\u5408\u5ba3\u8a00\u3001\u6280\u8853\u6587\u66f8\u3001\u5e02\u8ca9\u5f8c\u7fa9\u52d9<\/td><td>\u88fd\u54c1\u540d\u306f\u4e8c\u6b21\u7684\u306a\u3082\u306e\u3067\u3042\u308a\u3001\u610f\u56f3\u3055\u308c\u305f\u76ee\u7684\u3068\u30af\u30ec\u30fc\u30e0\u304c\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3059<\/td><\/tr><tr><td>\u30a4\u30ae\u30ea\u30b9<\/td><td>CE\u306f\u79fb\u884c\u671f\u306b\u3082\u5546\u696d\u7684\u306b\u91cd\u8981\u3067\u3042\u308b<\/td><td>\u82f1\u56fd\u306e\u898f\u5247\u304c\u9069\u7528\u3055\u308c\u308b\u304c\u3001\u5206\u985e\u306b\u3088\u3063\u3066\u306fCE\u30de\u30fc\u30af\u4ed8\u304d\u6a5f\u5668\u3082\u4e00\u5b9a\u671f\u9593\u8a8d\u3081\u3089\u308c\u308b<\/td><td>GB\u306f\u6c38\u9060\u306bEU\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u540c\u3058\u3067\u306f\u306a\u3044\u3002<\/td><\/tr><tr><td>\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9<\/td><td>\u306f\u3044<\/td><td>EU\u306eMDR\u898f\u5247\u304c\u9069\u7528\u3055\u308c\u3001CE\u304c\u5fc5\u8981\u3060\u304c\u3001UKNI\u306f\u7279\u5b9a\u306e\u7b2c\u4e09\u8005\u8a55\u4fa1\u306e\u30b1\u30fc\u30b9\u306e\u307f<\/td><td>\u30c1\u30fc\u30e0\u306fNI\u3092GB\u306e\u3088\u3046\u306b\u6271\u3044\u7d9a\u3051\u3066\u304a\u308a\u3001\u305d\u308c\u306f\u4e8b\u52d9\u7684\u306a\u7f60\u3067\u3042\u308b\u3002<\/td><\/tr><tr><td>\u7c73\u56fd<\/td><td>\u3044\u3044\u3048<\/td><td>FDA\u5206\u985e\u3001\u4e8b\u696d\u6240\u767b\u9332\/\u30ea\u30b9\u30c8\u3001\u5931\u7981\u7528\u4fdd\u8b77\u8863\u306e\u30af\u30e9\u30b9I\u6a5f\u5668\u898f\u5247<\/td><td>\u201c510(k)\u514d\u9664 \u201d\u306f \u201c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30d5\u30ea\u30fc \u201d\u3092\u610f\u5473\u3057\u306a\u3044\u201d<\/td><\/tr><tr><td>\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2<\/td><td>\u3044\u3044\u3048<\/td><td>\u5931\u7981\u30d1\u30c3\u30c9\u306fARTG\u306e\u5bfe\u8c61\u304b\u3089\u660e\u78ba\u306b\u9664\u5916\u3055\u308c\u3066\u3044\u308b\u3002<\/td><td>EU\u306e\u30c7\u30d0\u30a4\u30b9\u30fb\u30ed\u30b8\u30c3\u30af\u3092\u3059\u3079\u3066\u306e\u5e02\u5834\u306b\u30b3\u30d4\u30fc\u30fb\u30da\u30fc\u30b9\u30c8\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u306a\u3044\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u30c6\u30fc\u30d6\u30eb\u306f <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX%3A02017R0745-20230320\" target=\"_blank\" rel=\"noopener\">EU MDR<\/a>, <a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\" target=\"_blank\" rel=\"noopener\">MHRA\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>, <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm?ID=EYQ\" target=\"_blank\" rel=\"noopener\">FDA\u306b\u3088\u308b\u5931\u7981\u8863\u985e\u306e\u5206\u985e<\/a>, <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-876\/subpart-F\/section-876\/subpart-F\/section-876.5920\" target=\"_blank\" rel=\"noopener\">21 CFR 876.5920<\/a>, \u305d\u3057\u3066 <a href=\"https:\/\/www.tga.gov.au\/resources\/guidance\/determining-if-your-medical-device-should-be-artg\" target=\"_blank\" rel=\"noopener\">TGA\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>. .\u77ed\u3044\u30d0\u30fc\u30b8\u30e7\u30f3\u306f\u6b8b\u9177\u3060\u304c\u5f79\u306b\u7acb\u3064\uff1a\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u306fEU MDR\u306b\u5f93\u3044\u3001CE\u3092\u8981\u6c42\u3057\u3066\u3044\u308b\u3002\u7c73\u56fd\u306f\u5931\u7981\u7528\u4fdd\u8b77\u8863\u3092\u30af\u30e9\u30b9I\u304a\u3088\u3073510(k)\u514d\u9664\u306b\u5206\u985e\u3057\u3066\u304a\u308a\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306f\u5931\u7981\u30d1\u30c3\u30c9\u3092ARTG\u306e\u5bfe\u8c61\u304b\u3089\u660e\u78ba\u306b\u9664\u5916\u3057\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<div class=\"wp-block-greenshift-blocks-image gspb_image gspb_image-id-gsbp-ca6a822\" id=\"gspb_image-id-gsbp-ca6a822\"><img decoding=\"async\" src=\"https:\/\/adult-diaper.com\/wp-content\/uploads\/2026\/03\/Do-Adult-Incontinence-Products-Need-CE-How-Requirements-Vary-by-Market-3.jpg\" data-src=\"\" alt=\"Do Adult Incontinence Products Need CE How Requirements Vary by Market\" loading=\"lazy\" width=\"750\" height=\"750\"\/><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"the-2023-2024-precedents-buyers-should-have-paid-attention-to\">\u30d0\u30a4\u30e4\u30fc\u304c\u6ce8\u76ee\u3059\u3079\u304d2023-2024\u5e74\u306e\u524d\u4f8b<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"brussels-blinked-and-that-was-not-random\">\u30d6\u30ea\u30e5\u30c3\u30bb\u30eb\u306f\u77ac\u304d\u3092\u3057\u305f\u3002<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u30d6\u30ea\u30e5\u30c3\u30bb\u30eb\u306f\u77ac\u304d\u3092\u3057\u305f\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2023\u5e741\u6708\u306b, <a href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/eu-commission-approves-delay-medical-devices-law-avert-shortages-2023-01-06\/\" target=\"_blank\" rel=\"noopener\">\u30ed\u30a4\u30bf\u30fc\u901a\u4fe1\u304c\u4f1d\u3048\u305f\u3002<\/a> \u6b27\u5dde\u59d4\u54e1\u4f1a\u304c\u3001\u4f9b\u7d66\u4e0d\u8db3\u3092\u56de\u907f\u3059\u308b\u305f\u3081\u306bMDR\u306e\u671f\u9650\u3092\u5ef6\u671f\u3059\u308b\u3053\u3068\u3092\u627f\u8a8d\u3057\u30012024\u5e745\u6708\u306e\u671f\u9650\u3092\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u306b\u5fdc\u3058\u30662027\u5e74\u30842028\u5e74\u306b\u5ef6\u671f\u3057\u305f\u3053\u3068\u3001\u305d\u3057\u3066\u30012024\u5e745\u6708\u306bEU\u7406\u4e8b\u4f1a\u304c\u3001\u4f9b\u7d66\u4e0d\u8db3\u3092\u9632\u6b62\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u63aa\u7f6e\u3092\u6b63\u5f0f\u306b\u63a1\u629e\u3057\u305f\u3002\u3053\u308c\u306f\u4e9b\u7d30\u306a\u624b\u7d9a\u304d\u4e0a\u306e\u9a12\u304e\u3067\u306f\u306a\u3044\u3002\u898f\u5236\u5f53\u5c40\u304c\u3001\u4f9b\u7d66\u306b\u5bfe\u3057\u3066\u5236\u5ea6\u304c\u3042\u307e\u308a\u306b\u3082\u53b3\u3057\u3044\u3082\u306e\u3067\u3042\u3063\u305f\u3053\u3068\u3092\u8a8d\u3081\u305f\u306e\u3060\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"demand-is-huge-whether-boardrooms-like-the-category-or-not\">\u5f79\u54e1\u5ba4\u304c\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3092\u597d\u3080\u3068\u597d\u307e\u3056\u308b\u3068\u306b\u304b\u304b\u308f\u3089\u305a\u3001\u9700\u8981\u306f\u5927\u304d\u3044\u3002<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u5e02\u5834\u306f\u5927\u304d\u3044\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2024\u5e74 <a href=\"https:\/\/www.niddk.nih.gov\/-\/media\/Files\/Strategic-Plans\/urologic\/2024\/UDA-ADR-UI-2024_508.pdf\" target=\"_blank\" rel=\"noopener\">\u7c73\u56fdNIDDK\u6ccc\u5c3f\u5668\u75be\u60a3\u5e74\u6b21\u5831\u544a\u66f8<\/a>, \u5c3f\u5931\u7981\u306f\u5973\u6027\u306e25%\u304b\u308945%\u306b\u8d77\u3053\u308b\u3068\u63a8\u5b9a\u3055\u308c\u3001NHANES\u306b\u57fa\u3065\u304f\u63a8\u5b9a\u3067\u306f49.6%\u306e\u5973\u6027\u304c\u5c3f\u5931\u7981\u3092\u5831\u544a\u3057\u3066\u3044\u308b\u3002\u3053\u308c\u304c\u3001\u5404\u30d6\u30e9\u30f3\u30c9\u304c\u6210\u4eba\u5931\u7981\u3092\u3001\u533f\u540d\u306e\u30d7\u30e9\u30a4\u30d9\u30fc\u30c8\u30fb\u30e9\u30d9\u30eb\u306e\u7bb1\u3067\u3044\u3063\u3071\u3044\u306e\u8107\u306e\u68da\u3068\u3057\u3066\u6271\u3046\u3053\u3068\u306b\u3001\u79c1\u304c\u76ee\u3092\u4e38\u304f\u3059\u308b\u7406\u7531\u306e\u4e00\u3064\u3067\u3042\u308b\u3002\u5927\u4eba\u7528\u5931\u7981\u306f\u3001\u5b9f\u969b\u306e\u533b\u7642\u3084\u8a3a\u7642\u5831\u916c\u306b\u6ce2\u53ca\u3059\u308b\u3001\u5927\u898f\u6a21\u3067\u6301\u7d9a\u7684\u306a\u30b1\u30a2\u30ab\u30c6\u30b4\u30ea\u30fc\u306a\u306e\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"one-smart-accessory-can-harden-the-whole-compliance-conversation\">\u30b9\u30de\u30fc\u30c8\u306a\u30a2\u30af\u30bb\u30b5\u30ea\u30fc1\u3064\u3067\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u95a2\u3059\u308b\u4f1a\u8a71\u5168\u4f53\u3092\u56fa\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a8\u30ec\u30af\u30c8\u30ed\u30cb\u30af\u30b9\u3092\u52a0\u3048\u3001\u71b1\u3092\u52a0\u3048\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6709\u7528\u306a\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3\u306f\u30012023\u5e74\u306e\u5e02\u8ca9\u5f8c\u81e8\u5e8a\u8a66\u9a13\u3067\u3042\u308b\u3002 <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC9895969\/\" target=\"_blank\" rel=\"noopener\">TENA \u30b9\u30de\u30fc\u30c8\u30b1\u30a2 \u30c1\u30a7\u30f3\u30b8\u30a4\u30f3\u30b8\u30b1\u30fc\u30bf\u30fc<\/a>, \u3053\u306e\u88fd\u54c1\u306f\u3001\u4ecb\u8b77\u65bd\u8a2d\u3067\u5438\u53ce\u30d1\u30c3\u30c9\u3068\u3068\u3082\u306b\u4f7f\u7528\u3055\u308c\u308b\u6b27\u5dde\u9023\u5408\uff0f\u30ab\u30ca\u30c0\u30fb\u30af\u30e9\u30b9I\u306e\u533b\u7642\u6a5f\u5668\u30a2\u30af\u30bb\u30b5\u30ea\u30fc\u3067\u3042\u308b\u3068\u8aac\u660e\u3055\u308c\u3066\u3044\u308b\u3002\u30bb\u30f3\u30b7\u30f3\u30b0\u3001\u30c0\u30c3\u30b7\u30e5\u30dc\u30fc\u30c9\u3001\u5909\u66f4\u30bf\u30a4\u30df\u30f3\u30b0\u6c7a\u5b9a\u30b5\u30dd\u30fc\u30c8\u306a\u3069\u3092\u4ed8\u52a0\u3057\u3066\u3057\u307e\u3046\u3068\u3001\u300c\u305f\u3060\u67d4\u3089\u304b\u3044\u5438\u53ce\u6027\u88fd\u54c1\u3092\u58f2\u3063\u3066\u3044\u308b\u3060\u3051\u3067\u3059\u300d\u3068\u3044\u3046\u30bb\u30ea\u30d5\u3092\u771f\u9854\u3067\u64c1\u8b77\u3059\u308b\u306e\u306f\u304b\u306a\u308a\u96e3\u3057\u304f\u306a\u308b\u3068\u3044\u3046\u3053\u3068\u3060\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-actually-triggers-ce-marking-for-adult-incontinence-products\">\u6210\u4eba\u7528\u5931\u7981\u7528\u54c1\u306eCE\u30de\u30fc\u30ad\u30f3\u30b0\u306e\u30c8\u30ea\u30ac\u30fc\u3068\u306a\u308b\u3082\u306e<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"intended-purpose-comes-first\">\u76ee\u7684\u512a\u5148<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u304c\u30d2\u30f3\u30b8\u3060\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5305\u88c5\u3001IFU\u3001\u8ca9\u58f2\u4ee3\u7406\u5e97\u30b7\u30fc\u30c8\u3001\u30a2\u30de\u30be\u30f3\u306e\u30b3\u30d4\u30fc\u3001\u307e\u305f\u306f\u30bb\u30fc\u30eb\u30b9\u30c7\u30c3\u30ad\u306b\u3001\u88fd\u54c1\u304c\u5c3f\u5931\u7981\u306e\u7ba1\u7406\u3001\u75c5\u72b6\u306e\u7de9\u548c\u3001\u307e\u305f\u306f\u969c\u5bb3\u306e\u88dc\u511f\u3092\u610f\u56f3\u3057\u3066\u3044\u308b\u3068\u66f8\u304b\u308c\u3066\u3044\u308b\u5834\u5408\u3001MDR\u306f\u6cd5\u7684\u5730\u4f4d\u3092\u610f\u56f3\u3055\u308c\u305f\u533b\u7642\u76ee\u7684\u304a\u3088\u3073\u30e1\u30fc\u30ab\u30fc\u304c\u63d0\u4f9b\u3059\u308b\u30af\u30ec\u30fc\u30e0\u306b\u7d50\u3073\u3064\u3051\u308b\u305f\u3081\u3001EU\u3067\u306f\u30c7\u30d0\u30a4\u30b9\u306e\u8ad6\u7406\u306b\u307e\u3063\u3057\u3050\u3089\u3067\u3059\u3002\u79c1\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u629c\u304d\u3067\u3001\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u30c1\u30fc\u30e0\u306b\u305d\u306e\u3088\u3046\u306a\u884c\u3092\u66f8\u304b\u305b\u308b\u3053\u3068\u306f\u306a\u3044\u3060\u308d\u3046\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"product-format-matters-less-than-people-think\">\u88fd\u54c1\u306e\u5f62\u5f0f\u306f\u3001\u4eba\u3005\u304c\u8003\u3048\u3066\u3044\u308b\u307b\u3069\u91cd\u8981\u3067\u306f\u306a\u3044<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5927\u4eba\u7528\u304a\u3080\u3064\u306f\u6cd5\u7684\u306a\u30ab\u30c6\u30b4\u30ea\u30fc\u3067\u306f\u306a\u304f\u3001\u5546\u696d\u7684\u306a\u30e9\u30d9\u30eb\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2023\u5e74\u306e\u30d5\u30ed\u30f3\u30c6\u30a3\u30a2\u8ad6\u6587\u306f\u3001EU\u306b\u304a\u3051\u308bAI\u88fd\u54c1\u306f\u30af\u30e9\u30b9I\u533b\u7642\u6a5f\u5668\u3067\u3042\u308a\u3001\u975e\u6ec5\u83cc\u3001\u975e\u6e2c\u5b9a\u30af\u30e9\u30b9I\u88fd\u54c1\u306f\u4e00\u822c\u7684\u306b\u5e02\u8ca9\u524d\u306b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306b\u3088\u308b\u5be9\u67fb\u306f\u5fc5\u8981\u306a\u3044\u304c\u3001\u6280\u8853\u6587\u66f8\u3001\u81e8\u5e8a\u8a55\u4fa1\u3001\u5e02\u8ca9\u5f8c\u306e\u4f5c\u696d\u304c\u5fc5\u8981\u3067\u3042\u308b\u3053\u3068\u3092\u8aac\u660e\u3057\u3066\u3044\u308b\u306e\u3067\u3001\u3053\u3053\u3067\u5f79\u306b\u7acb\u3064\u3002\u3064\u307e\u308a\u3001\u201c\u30aa\u30e0\u30c4 \u201d\u3068\u3044\u3046\u8a00\u8449\u3092 \u201c\u30d7\u30eb\u30a2\u30c3\u30d7 \u201d\u306b\u5909\u3048\u305f\u304b\u3089\u3068\u3044\u3063\u3066\u3001\u9b54\u6cd5\u306e\u3088\u3046\u306b\u30eb\u30fc\u30eb\u30d6\u30c3\u30af\u304c\u5909\u308f\u308b\u308f\u3051\u3067\u306f\u306a\u3044\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"market-entry-route-changes-the-answer-fast\">\u5e02\u5834\u53c2\u5165\u30eb\u30fc\u30c8\u306f\u7b54\u3048\u3092\u65e9\u304f\u5909\u3048\u308b<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">SKU\u3092\u52d5\u304b\u3057\u3001\u7b54\u3048\u3092\u5909\u3048\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EU\u306e\u5834\u5408\u3001\u5bfe\u8c61\u7bc4\u56f2\u306b\u542b\u307e\u308c\u308b\u6a5f\u5668\u306f\u3001\u4e0a\u5e02\u524d\u306bCE\u30de\u30fc\u30af\u3092\u4ed8\u3051\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u30b0\u30ec\u30fc\u30c8\u30d6\u30ea\u30c6\u30f3\u3067\u306f\u3001\u79fb\u884c\u671f\u9593\u4e2d\u3082CE\u30de\u30fc\u30af\u4ed8\u304d\u6a5f\u5668\u304c\u8a8d\u3081\u3089\u308c\u308b\u304c\u3001\u6cd5\u7684\u67a0\u7d44\u307f\u306f\u82f1\u56fd\u56fa\u6709\u306e\u3082\u306e\u3067\u3042\u308b\u3002\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u306b\u3064\u3044\u3066\u306f\u3001EU MDR\u898f\u5247\u304c\u9069\u7528\u3055\u308c\u3001CE\u304c\u5fc5\u8981\u3068\u306a\u308b\u3002\u7c73\u56fd\u3067\u306f\u3001CE\u3067\u306f\u306a\u304f\u300121 CFR 876.5920\u306b\u57fa\u3065\u304fFDA\u306e\u30af\u30e9\u30b9I\u9632\u8b77\u670d\u5206\u985e\u304c\u91cd\u8981\u306a\u53c2\u8003\u8cc7\u6599\u3068\u306a\u308b\u3002\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u3067\u306f\u3001TGA\u304c\u5931\u7981\u30d1\u30c3\u30c9\u3092\u660e\u78ba\u306b\u9664\u5916\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u4e16\u754c\u5171\u901a\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u304c\u3042\u308b\u304b\u306e\u3088\u3046\u306b\u88c5\u3046\u3053\u3068\u306f\u3067\u304d\u306a\u3044\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5185\u90e8\u30ea\u30f3\u30af\u304c\u3044\u3044\u52a0\u6e1b\u3067\u3042\u3063\u3066\u306f\u306a\u3089\u306a\u3044\u7406\u7531\u3082\u305d\u3053\u306b\u3042\u308b\u3002\u3053\u306e\u3088\u3046\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8a18\u4e8b\u306f\u3001\u81ea\u7136\u306b <a href=\"https:\/\/adult-diaper.com\/ja\/briefs-vs-pull-ups-by-channel-pharmacy-institution-ecom\/\">\u30c1\u30e3\u30f3\u30cd\u30eb\u5225\u30d6\u30ea\u30fc\u30d5\u5bfe\u61f8\u5782<\/a>, \u306a\u305c\u306a\u3089\u3001\u30c1\u30e3\u30cd\u30eb\u6226\u7565\u3068\u898f\u5236\u6226\u7565\u306f\u3001\u4eba\u3005\u304c\u8a8d\u3081\u308b\u4ee5\u4e0a\u306b\u983b\u7e41\u306b\u885d\u7a81\u3059\u308b\u304b\u3089\u3060\u3002 <a href=\"https:\/\/adult-diaper.com\/ja\/underpads-manufacturer-guide-disposable-vs-washable\/\">\u30a2\u30f3\u30c0\u30fc\u30d1\u30c3\u30c9 \u30e1\u30fc\u30ab\u30fc\u30ac\u30a4\u30c9<\/a>, \u3068\u3044\u3046\u306e\u3082\u3001\u30a2\u30f3\u30c0\u30fc\u30d1\u30c3\u30c9\u304c\u8ca9\u58f2\u3055\u308c\u308b\u65bd\u8a2d\u3067\u306f\u3001\u66f8\u985e\u4f5c\u6210\u306e\u8981\u8acb\u304c\u65e9\u304f\u304b\u3089\u3042\u308a\u3001\u901a\u5e38\u306f\u3042\u307e\u308a\u5fcd\u8010\u5f37\u304f\u306f\u306a\u3044\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"the-documentation-stack-is-where-weak-suppliers-get-exposed\">\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u30fb\u30b9\u30bf\u30c3\u30af\u306f\u3001\u5f31\u3044\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u9732\u5448\u3059\u308b\u5834\u6240\u3067\u3042\u308b\u3002<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u3082\u3063\u3068\u591a\u304f\u306e\u30d0\u30a4\u30e4\u30fc\u306b\u58f0\u3092\u5927\u306b\u3057\u3066\u8a00\u3063\u3066\u3082\u3089\u3044\u305f\u3044\u53b3\u3057\u3044\u771f\u5b9f\u304c\u3053\u3053\u306b\u3042\u308b\uff1a\u201c\u30b5\u30dd\u30fc\u30c8\u304c\u53d7\u3051\u3089\u308c\u308b \u201d\u3068 \u201c\u30b5\u30dd\u30fc\u30c8\u304c\u53d7\u3051\u3089\u308c\u308b \u201d\u306f\u540c\u3058\u3067\u306f\u306a\u3044\u3002\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3082\u3057\u79c1\u304c\u660e\u65e5\u3001EU\u307e\u305f\u306f\u82f1\u56fd\u306b\u96a3\u63a5\u3059\u308b\u30d3\u30b8\u30cd\u30b9\u306e\u305f\u3081\u306b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u8a8d\u5b9a\u3059\u308b\u306e\u3067\u3042\u308c\u3070\u3001\u76ee\u7684\u5225\u8aac\u660e\u66f8\u3001\u88fd\u54c1\u5206\u985e\u306e\u6839\u62e0\u3001\u30e9\u30d9\u30ea\u30f3\u30b0\u30bb\u30c3\u30c8\u3001\u7533\u544a\u7d4c\u8def\u3001\u5e02\u8ca9\u5f8c\u306e\u82e6\u60c5\u306e\u6d41\u308c\u3001\u30d5\u30a1\u30a4\u30eb\u306e\u6b63\u78ba\u306a\u8cac\u4efb\u4e3b\u4f53\u3092\u5c0b\u306d\u308b\u3060\u308d\u3046\u3002\u7c73\u56fd\u3067\u306f\u3001FDA\u306e\u5206\u985e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306b\u3088\u308c\u3070\u3001\u5931\u7981\u7528\u4fdd\u8b77\u8863\u306f\u30af\u30e9\u30b9I\u3067\u3042\u308a\u3001510(k)\u306f\u514d\u9664\u3055\u308c\u3066\u3044\u308b\u304c\u3001\u30e1\u30fc\u30ab\u30fc\u306b\u306f\u307e\u3060\u7fa9\u52d9\u304c\u3042\u308b\u305f\u3081\u3001\u79c1\u306f\u65bd\u8a2d\u767b\u9332\/\u30ea\u30b9\u30c8\u53c2\u7167\u3082\u30c1\u30a7\u30c3\u30af\u3059\u308b\u3002\u305d\u3053\u3067 <a href=\"https:\/\/adult-diaper.com\/ja\/studies\/\">\u5927\u4eba\u7528\u7d19\u304a\u3080\u3064\u8a66\u9a13\u5831\u544a\u66f8\u304a\u3088\u3073\u8a3c\u660e\u66f8<\/a> \u306a\u305c\u306a\u3089\u3001\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u306f\u5e38\u306b\u30d7\u30ed\u30df\u30b9\u30fb\u30b3\u30d4\u30fc\u306b\u52dd\u308b\u304b\u3089\u3060\u3002.<\/p>\n\n\n\n<div class=\"wp-block-greenshift-blocks-image gspb_image gspb_image-id-gsbp-e98b330\" id=\"gspb_image-id-gsbp-e98b330\"><img decoding=\"async\" src=\"https:\/\/adult-diaper.com\/wp-content\/uploads\/2026\/03\/Do-Adult-Incontinence-Products-Need-CE-How-Requirements-Vary-by-Market-4.jpg\" data-src=\"\" alt=\"Do Adult Incontinence Products Need CE How Requirements Vary by Market\" loading=\"lazy\" width=\"750\" height=\"750\"\/><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"faqs\">\u3088\u304f\u3042\u308b\u3054\u8cea\u554f<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"do-adult-incontinence-products-need-ce-marking-in-europe\">\u5927\u4eba\u7528\u5931\u7981\u88fd\u54c1\u306f\u6b27\u5dde\u3067CE\u30de\u30fc\u30ad\u30f3\u30b0\u304c\u5fc5\u8981\u304b\uff1f<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5927\u4eba\u7528\u5931\u7981\u88fd\u54c1\u304c\u6b27\u5dde\u3067CE\u30de\u30fc\u30ad\u30f3\u30b0\u3092\u5fc5\u8981\u3068\u3059\u308b\u306e\u306f\u3001\u88fd\u9020\u8005\u306e\u610f\u56f3\u3059\u308b\u7528\u9014\u304c\u305d\u306e\u88fd\u54c1\u3092\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066MDR 2017\/745\u306b\u8a72\u5f53\u3059\u308b\u5834\u5408\u3067\u3042\u308a\u3001\u3053\u306e\u5834\u5408\u3001\u305d\u306e\u88fd\u54c1\u304c\u304a\u3080\u3064\u3001\u30d7\u30eb\u30a2\u30c3\u30d7\u3001\u30d1\u30c3\u30c9\u3068\u6c17\u8efd\u306b\u547c\u3070\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3067\u306f\u306a\u304f\u3001\u88fd\u54c1\u306e\u533b\u7642\u4e0a\u306e\u4e3b\u5f35\u3001\u30e9\u30d9\u30eb\u3001\u4f7f\u7528\u8aac\u660e\u66f8\u3001\u8ca9\u58f2\u8cc7\u6599\u306b\u3088\u3063\u3066\u5224\u65ad\u3055\u308c\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u307b\u3068\u3093\u3069\u540c\u3058\u3088\u3046\u306b\u898b\u3048\u308b2\u3064\u306e\u5438\u53ce\u6027\u88fd\u54c1\u304c\u3001\u30af\u30ec\u30fc\u30e0\u304c\u5909\u308f\u308b\u3068\u7570\u306a\u308b\u7fa9\u52d9\u3092\u8ca0\u3046\u3053\u3068\u306b\u306a\u308b\u306e\u306f\u305d\u306e\u305f\u3081\u3060\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"do-adult-diapers-need-ce-marking-in-the-united-states\">\u5927\u4eba\u7528\u7d19\u304a\u3080\u3064\u306f\u7c73\u56fd\u3067CE\u30de\u30fc\u30ad\u30f3\u30b0\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u7c73\u56fd\u3067\u306f\u3001\u5931\u7981\u7528\u4fdd\u8b77\u8863\u306f\u30af\u30e9\u30b9I\u6a5f\u5668\u3068\u3057\u3066FDA\u898f\u523621 CFR 876.5920\u306b\u8a72\u5f53\u3057\u3001FDA\u306b\u3088\u3063\u3066510(k)-exempt\u3068\u3057\u3066\u30ea\u30b9\u30c8\u30a2\u30c3\u30d7\u3055\u308c\u3066\u3044\u308b\u305f\u3081\u3001\u767b\u9332\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u7fa9\u52d9\u306f\u4f9d\u7136\u3068\u3057\u3066\u6b8b\u3063\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3060\u304b\u3089\u3001\u201cFDA\u514d\u9664 \u201d\u3060\u304b\u3089\u3068\u3044\u3063\u3066\u3001\u898f\u5f8b\u30bc\u30ed\u3067\u51fa\u8377\u3067\u304d\u308b\u308f\u3051\u3067\u306f\u306a\u3044\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"can-i-sell-a-ce-marked-adult-incontinence-product-in-great-britain-after-brexit\">EU\u96e2\u8131\u5f8c\u3001CE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3057\u305f\u5927\u4eba\u7528\u5931\u7981\u88fd\u54c1\u3092\u82f1\u56fd\u3067\u8ca9\u58f2\u3067\u304d\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p 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