{"id":8444,"date":"2025-11-25T23:43:20","date_gmt":"2025-11-25T23:43:20","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8444"},"modified":"2025-11-25T23:43:20","modified_gmt":"2025-11-25T23:43:20","slug":"%d8%b9%d9%86%d8%af-%d8%b4%d8%b1%d8%a7%d8%a1-%d8%ac%d9%87%d8%a7%d8%b2-%d8%b9%d9%84%d8%a7%d8%ac-%d8%a8%d8%a7%d9%84%d9%85%d9%88%d8%ac%d8%a7%d8%aa-%d8%a7%d9%84%d8%b5%d8%af%d9%85%d9%8a%d8%a9%d8%8c-%d9%87","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/ar\/when-purchasing-a-shockwave-therapy-machine-must-the-supplier-have-a-european-authorised-representative-ec-rep\/","title":{"rendered":"\u0639\u0646\u062f \u0634\u0631\u0627\u0621 \u062c\u0647\u0627\u0632 \u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629\u060c \u0647\u0644 \u064a\u062c\u0628 \u0623\u0646 \u064a\u0643\u0648\u0646 \u0644\u062f\u0649 \u0627\u0644\u0645\u0648\u0631\u062f \u0645\u0645\u062b\u0644 \u0645\u0639\u062a\u0645\u062f \u0641\u064a \u0623\u0648\u0631\u0648\u0628\u0627 (EC REP)\u061f"},"content":{"rendered":"<p style=\"float: right; margin-left: 15px; margin-bottom: 15px;\">\n  <img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/1a-modern-high-end-medical-device-showroom-where-a.jpg\" alt=\"\u062c\u0647\u0627\u0632 \u0637\u0628\u064a \u0645\u062a\u0648\u0627\u0641\u0642 \u0645\u0639 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 (EU MDR) \u0645\u0639\u0631\u0648\u0636 \u0641\u064a \u062c\u0646\u0627\u062d \u0645\u0639\u0631\u0636 \u062a\u0646\u0638\u064a\u0645\u064a \u0623\u0648\u0631\u0648\u0628\u064a (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>\u0628\u0627\u0644\u0639\u0645\u0644 \u0639\u0646 \u0643\u062b\u0628 \u0645\u0639 \u0627\u0644\u0645\u0648\u0632\u0639\u064a\u0646 \u0627\u0644\u0630\u064a\u0646 \u064a\u0634\u062a\u0631\u0648\u0646 \u0627\u0644\u0645\u0639\u062f\u0627\u062a \u0627\u0644\u0637\u0628\u064a\u0629 \u0645\u0646\u0627\u060c \u063a\u0627\u0644\u0628\u064b\u0627 \u0645\u0627 \u0623\u0644\u0627\u062d\u0638 \u0627\u0631\u062a\u0628\u0627\u0643\u064b\u0627 \u062d\u0648\u0644 \u0645\u0627 \u0625\u0630\u0627 \u0643\u0627\u0646 \u064a\u062c\u0628 \u0639\u0644\u0649 \u0643\u0644 \u0645\u0648\u0631\u062f \u063a\u064a\u0631 \u062a\u0627\u0628\u0639 \u0644\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u062a\u0639\u064a\u064a\u0646 \u0645\u0645\u062b\u0644 \u0645\u0639\u062a\u0645\u062f \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0642\u0628\u0644 \u0628\u064a\u0639 \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0641\u064a \u0623\u0648\u0631\u0648\u0628\u0627.<\/p>\n<p><strong>\u0646\u0639\u0645\u060c \u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0648\u0631\u062f\u064a\u0646 \u063a\u064a\u0631 \u0627\u0644\u062a\u0627\u0628\u0639\u064a\u0646 \u0644\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0623\u0646 \u064a\u0643\u0648\u0646 \u0644\u062f\u064a\u0647\u0645 \u0645\u0645\u062b\u0644 \u0645\u0639\u062a\u0645\u062f \u0641\u064a \u0623\u0648\u0631\u0648\u0628\u0627 (EC REP) \u0639\u0646\u062f \u0637\u0631\u062d \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0641\u064a \u0633\u0648\u0642 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0644\u0623\u0646 \u0647\u0630\u0647 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0647\u064a \u0645\u0639\u062f\u0627\u062a \u0637\u0628\u064a\u0629 \u062a\u062e\u0636\u0639 \u0644\u0644\u0627\u0626\u062d\u0629 MDR \u0627\u0644\u0645\u0627\u062f\u0629 11\u060c \u0648\u0627\u0644\u062a\u064a \u062a\u062a\u0637\u0644\u0628 \u0645\u0645\u062b\u0644\u0627\u064b \u0645\u0639\u064a\u0646\u0627\u064b \u0645\u0642\u0631\u0647 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0644\u0636\u0645\u0627\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u0642\u0627\u0646\u0648\u0646\u064a \u0648\u0627\u0644\u0625\u0634\u0631\u0627\u0641 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a.<\/strong><\/p>\n<p>\u0641\u0647\u0645 \u0647\u0630\u0627 \u0627\u0644\u0645\u062a\u0637\u0644\u0628 \u064a\u0633\u0627\u0639\u062f \u0627\u0644\u0645\u0634\u062a\u0631\u064a\u0646 \u0639\u0644\u0649 \u062a\u062c\u0646\u0628 \u062a\u0623\u062e\u064a\u0631\u0627\u062a \u0627\u0644\u062c\u0645\u0627\u0631\u0643\u060c \u0648\u0627\u0644\u0627\u0646\u062a\u0647\u0627\u0643\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629\u060c \u0648\u062e\u0637\u0631 \u062a\u0644\u0642\u064a \u0623\u062c\u0647\u0632\u0629 \u063a\u064a\u0631 \u0645\u062a\u0648\u0627\u0641\u0642\u0629.<\/p>\n<hr \/>\n<h2>\u0645\u0627 \u0647\u0648 \u062f\u0648\u0631 \u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f \u0644\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u061f<\/h2>\n<p>\u0645\u0646 \u0627\u0644\u062c\u0627\u0646\u0628 \u0627\u0644\u062a\u0634\u063a\u064a\u0644\u064a \u0644\u0644\u062a\u0635\u0646\u064a\u0639\u060c \u0646\u0639\u0645\u0644 \u0645\u0639 \u0645\u0645\u062b\u0644\u064a\u0646 \u0645\u0639\u062a\u0645\u062f\u064a\u0646 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0628\u0627\u0646\u062a\u0638\u0627\u0645\u060c \u0644\u0630\u0644\u0643 \u0646\u0631\u0649 \u0645\u062f\u0649 \u0623\u0647\u0645\u064a\u062a\u0647\u0645 \u0644\u0636\u0645\u0627\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u0633\u0644\u0633 \u0644\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (\u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a) 2017\/745.<\/p>\n<p><strong>\u064a\u0639\u0645\u0644 \u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f \u0646\u064a\u0627\u0628\u0629 \u0639\u0646 \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u062e\u0627\u0631\u062c \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0644\u0636\u0645\u0627\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0627\u0626\u062d\u0629 MDR\u060c \u0648\u0627\u0644\u0627\u062d\u062a\u0641\u0627\u0638 \u0628\u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0641\u0646\u064a\u0629\u060c \u0648\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0627\u062a\u0635\u0627\u0644 \u0645\u0639 \u0627\u0644\u0633\u0644\u0637\u0627\u062a \u0627\u0644\u0648\u0637\u0646\u064a\u0629\u060c \u0648\u0627\u0644\u0627\u062d\u062a\u0641\u0627\u0638 \u0628\u0633\u062c\u0644\u0627\u062a \u0645\u0627 \u0628\u0639\u062f \u0627\u0644\u062a\u0633\u0648\u064a\u0642\u060c \u0648\u062f\u0639\u0645 \u0627\u0644\u0625\u0628\u0644\u0627\u063a \u0639\u0646 \u0627\u0644\u064a\u0642\u0638\u0629 \u0644\u0644\u062d\u0648\u0627\u062f\u062b \u0623\u0648 \u0627\u0644\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u062a\u0635\u062d\u064a\u062d\u064a\u0629.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/2a-conceptual-yet-realistic-scene-showing-a-shipmen.jpg\" alt=\"\u0645\u0645\u0631 \u062a\u0641\u062a\u064a\u0634 \u062c\u0645\u0631\u0643\u064a \u0645\u0639 \u0644\u0627\u0641\u062a\u0627\u062a \u062a\u0648\u0636\u062d \u062a\u062e\u0644\u064a\u0635 \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0648\u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0627\u0633\u062a\u064a\u0631\u0627\u062f (ID#2)\" title=\"\u0641\u062d\u0635 \u0627\u0644\u062c\u0645\u0627\u0631\u0643 \u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\" \/><\/p>\n<p>\u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0644\u064a\u0633 \u0645\u062c\u0631\u062f \u0635\u0646\u062f\u0648\u0642 \u0628\u0631\u064a\u062f \u0623\u0648 \u0634\u062e\u0635 \u0627\u062a\u0635\u0627\u0644. \u0644\u062f\u064a\u0647\u0645 \u0645\u0633\u0624\u0648\u0644\u064a\u0629 \u0642\u0627\u0646\u0648\u0646\u064a\u0629 - \u0648\u0623\u062d\u064a\u0627\u0646\u064b\u0627 \u0645\u0633\u0624\u0648\u0644\u064a\u0629 \u0645\u0634\u062a\u0631\u0643\u0629 - \u0645\u0639 \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629.<\/p>\n<p>\u0644\u0641\u0647\u0645 \u0633\u0628\u0628 \u0648\u062c\u0648\u062f \u0647\u0630\u0627 \u0627\u0644\u062f\u0648\u0631\u060c \u064a\u0642\u0648\u0645 \u0627\u0644\u0639\u062f\u064a\u062f \u0645\u0646 \u0627\u0644\u0645\u0635\u0646\u0639\u064a\u0646 \u0628\u0645\u0631\u0627\u062c\u0639\u0629 <strong><a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\">\u0625\u0637\u0627\u0631 \u0639\u0645\u0644 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a<\/a><\/strong> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup> \u0627\u0644\u0630\u064a \u064a\u062d\u062f\u062f \u0645\u0633\u0624\u0648\u0644\u064a\u0627\u062a \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u062e\u0627\u0631\u062c \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0627\u0644\u0639\u0627\u0645\u0644\u0629 \u0641\u064a \u0623\u0648\u0631\u0648\u0628\u0627.<\/p>\n<h3>\u0627\u0644\u0645\u0633\u0624\u0648\u0644\u064a\u0627\u062a \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629 \u0644\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f<\/h3>\n<ol>\n<li>\n<p><strong>\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0641\u0646\u064a\u0629<\/strong><br \/>\n\u064a\u062a\u0645\u0627\u0634\u0649 \u0647\u0630\u0627 \u0645\u0639 \u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0645\u0648\u0636\u062d\u0629 \u0641\u064a <strong><a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\">\u0642\u0648\u0627\u0639\u062f \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0641\u0646\u064a\u0629 \u0644\u0644\u0645\u0644\u062d\u0642\u064a\u0646 \u0627\u0644\u062b\u0627\u0646\u064a \u0648\u0627\u0644\u062b\u0627\u0644\u062b \u0645\u0646 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDR)<\/a><\/strong> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup>.<\/p>\n<\/li>\n<li>\n<p><strong>\u0627\u0644\u062d\u0641\u0627\u0638 \u0639\u0644\u0649 \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629<\/strong><br \/>\n\u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f \u0644\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a (EC REP) \u062a\u062e\u0632\u064a\u0646 \u0627\u0644\u0645\u0644\u0641\u0627\u062a \u0627\u0644\u0641\u0646\u064a\u0629 \u0644\u0645\u062f\u0629 10 \u0633\u0646\u0648\u0627\u062a \u0639\u0644\u0649 \u0627\u0644\u0623\u0642\u0644 \u0628\u0639\u062f \u062f\u062e\u0648\u0644 \u0622\u062e\u0631 \u062c\u0647\u0627\u0632 \u0625\u0644\u0649 \u0627\u0644\u0633\u0648\u0642.<\/p>\n<\/li>\n<li>\n<p><strong>\u0627\u0644\u062a\u0639\u0627\u0648\u0646 \u0645\u0639 \u0627\u0644\u0633\u0644\u0637\u0627\u062a<\/strong><br \/>\n\u062a\u062a\u0628\u0639 \u0627\u0644\u062a\u0632\u0627\u0645\u0627\u062a\u0647\u0645 \u0627\u0644\u0647\u064a\u0643\u0644 \u0627\u0644\u0630\u064a \u062d\u062f\u062f\u062a\u0647 <strong><a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations_en\">\u0627\u0644\u0631\u0642\u0627\u0628\u0629 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0644\u0644\u0633\u0644\u0637\u0629 \u0627\u0644\u0645\u062e\u062a\u0635\u0629 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a<\/a><\/strong> <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>.<\/p>\n<\/li>\n<li>\n<p><strong>\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u064a\u0642\u0638\u0629<\/strong><br \/>\n\u062a\u062a\u0639\u0644\u0642 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u064a\u0642\u0638\u0629 \u0628\u0640 <strong><a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\">\u0627\u0644\u0645\u0648\u0627\u062f 87-90 \u0645\u0646 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDR) \u0628\u0634\u0623\u0646 \u0627\u0644\u0625\u0628\u0644\u0627\u063a \u0639\u0646 \u0627\u0644\u062d\u0648\u0627\u062f\u062b<\/a><\/strong> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup>.<\/p>\n<\/li>\n<\/ol>\n<h3>\u062c\u062f\u0648\u0644 \u0646\u0638\u0631\u0629 \u0639\u0627\u0645\u0629 \u0639\u0644\u0649 \u0627\u0644\u0645\u0633\u0624\u0648\u0644\u064a\u0627\u062a<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0644\u0645\u0633\u0624\u0648\u0644\u064a\u0629<\/th>\n<th>\u0627\u0644\u0648\u0635\u0641<\/th>\n<th>\u0645\u0633\u062a\u0648\u0649 \u0627\u0644\u0623\u0647\u0645\u064a\u0629<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644<\/td>\n<td>\u064a\u0636\u0645\u0646 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629 \u0644\u0639\u0644\u0627\u0645\u0629 CE \u0642\u0628\u0644 \u0627\u0644\u0628\u064a\u0639<\/td>\n<td>\u0639\u0627\u0644\u064a\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0627\u062d\u062a\u0641\u0627\u0638 \u0628\u0627\u0644\u0648\u062b\u0627\u0626\u0642<\/td>\n<td>\u062a\u062d\u062a\u0641\u0638 \u0628\u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0641\u0646\u064a\u0629 \u0644\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629<\/td>\n<td>\u0639\u0627\u0644\u064a\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u062a\u0648\u0627\u0635\u0644 \u0645\u0639 \u0627\u0644\u062c\u0647\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629<\/td>\n<td>\u0646\u0642\u0637\u0629 \u0627\u0644\u0627\u062a\u0635\u0627\u0644 \u0627\u0644\u0623\u0648\u0644\u0649 \u062f\u0627\u062e\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a<\/td>\n<td>\u0639\u0627\u0644\u064a\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u062f\u0639\u0645 \u0627\u0644\u064a\u0642\u0638\u0629<\/td>\n<td>\u062a\u062a\u0639\u0627\u0645\u0644 \u0645\u0639 \u0627\u0644\u0625\u0628\u0644\u0627\u063a \u0639\u0646 \u0627\u0644\u062d\u0648\u0627\u062f\u062b \u0648\u062a\u0646\u0633\u064a\u0642 FSCA<\/td>\n<td>\u0645\u062a\u0648\u0633\u0637<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a<\/td>\n<td>\u064a\u0624\u0643\u062f \u0623\u0646 \u062a\u0641\u0627\u0635\u064a\u0644 \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0645\u0637\u0628\u0648\u0639\u0629 \u0628\u0634\u0643\u0644 \u0635\u062d\u064a\u062d<\/td>\n<td>\u0639\u0627\u0644\u064a\u0629<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u0628\u062f\u0648\u0646 \u0645\u0645\u062b\u0644 \u0645\u0639\u062a\u0645\u062f\u060c \u0644\u0627 \u064a\u0645\u0643\u0646 \u0648\u0636\u0639 \u062c\u0647\u0627\u0632 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0645\u0635\u0646\u0639 \u062e\u0627\u0631\u062c \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0628\u0634\u0643\u0644 \u0642\u0627\u0646\u0648\u0646\u064a \u0641\u064a \u0633\u0648\u0642 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a.<\/p>\n<hr \/>\n<h2>\u0643\u064a\u0641 \u064a\u0624\u062b\u0631 \u0648\u062c\u0648\u062f \u0645\u0645\u062b\u0644 \u0645\u0639\u062a\u0645\u062f \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0639\u0644\u0649 \u0639\u0644\u0627\u0645\u0629 CE \u0648\u062a\u062e\u0644\u064a\u0635 \u0627\u0644\u0627\u0633\u062a\u064a\u0631\u0627\u062f\u061f<\/h2>\n<p>\u0645\u0646 \u0633\u064a\u0631 \u0639\u0645\u0644 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u062f\u064a\u0646\u0627\u060c \u0646\u0631\u0649 \u0623\u0646 \u0648\u062c\u0648\u062f \u0645\u0645\u062b\u0644 \u0645\u0639\u062a\u0645\u062f \u0644\u064a\u0633 \u0627\u062e\u062a\u064a\u0627\u0631\u064a\u064b\u0627 - \u0641\u0647\u0648 \u064a\u0624\u062b\u0631 \u0628\u0634\u0643\u0644 \u0645\u0628\u0627\u0634\u0631 \u0639\u0644\u0649 \u0635\u0644\u0627\u062d\u064a\u0629 \u0639\u0644\u0627\u0645\u0629 CE \u0648\u0642\u0628\u0648\u0644 \u0627\u0644\u062c\u0645\u0627\u0631\u0643 \u0639\u0644\u0649 \u062d\u062f\u0648\u062f \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a.<\/p>\n<p>\u064a\u0644\u0639\u0628 \u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f \u062f\u0648\u0631\u064b\u0627 \u0631\u0626\u064a\u0633\u064a\u064b\u0627 \u0641\u064a \u0631\u0628\u0637 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0628\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0639\u0644\u0627\u0645\u0629 CE\u060c \u0648\u0627\u0644\u062a\u064a \u062a\u0646\u062f\u0631\u062c \u062a\u062d\u062a <strong><a href=\"https:\/\/single-market-economy.ec.europa.eu\/single-market\/product-compliance\/ce-marking_en\">\u0642\u0648\u0627\u0639\u062f \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0639\u0644\u0627\u0645\u0629 CE \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0644\u0644\u0645\u0646\u062a\u062c\u0627\u062a<\/a><\/strong> <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup>.<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/3an-interior-view-of-a-customs-office-where-officer.jpg\" alt=\"\u0636\u0628\u0627\u0637 \u064a\u0631\u0627\u062c\u0639\u0648\u0646 \u0625\u0639\u0644\u0627\u0646 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629 \u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0639\u0644\u0649 \u0634\u0627\u0634\u0627\u062a \u0627\u0644\u0643\u0645\u0628\u064a\u0648\u062a\u0631 \u0641\u064a \u0645\u0643\u062a\u0628 \u0627\u0644\u062a\u0641\u062a\u064a\u0634 (ID#3)\" title=\"\u0645\u0643\u062a\u0628 \u062a\u0641\u062a\u064a\u0634 \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\" \/><\/p>\n<h3>\u0644\u0645\u0627\u0630\u0627 \u064a\u0631\u062a\u0628\u0637 \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0628\u0639\u0644\u0627\u0645\u0629 CE<\/h3>\n<p>\u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f \u0627\u0644\u062a\u0648\u0642\u064a\u0639 \u0639\u0644\u0649 \u0625\u0639\u0644\u0627\u0646 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629 \u0648\u0641\u0642\u064b\u0627 \u0644\u0640 <strong><a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\">\u0642\u0648\u0627\u0639\u062f \u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629 \u0627\u0644\u0645\u0631\u0641\u0642\u0629 \u0628\u0627\u0644\u0645\u0644\u0627\u062d\u0642 V \u0645\u0646 MDR<\/a><\/strong> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup>, \u060c \u0645\u0645\u0627 \u064a\u062c\u0639\u0644\u0647 \u0645\u0633\u0624\u0648\u0644\u0627\u064b \u0642\u0627\u0646\u0648\u0646\u064a\u064b\u0627.<\/p>\n<h3>\u0627\u0644\u062a\u0623\u062b\u064a\u0631 \u0639\u0644\u0649 \u0627\u0644\u062a\u062e\u0644\u064a\u0635 \u0627\u0644\u062c\u0645\u0631\u0643\u064a<\/h3>\n<p>\u062a\u062a\u062d\u0642\u0642 \u0627\u0644\u062c\u0645\u0627\u0631\u0643 \u0628\u0634\u0643\u0644 \u0645\u062a\u0643\u0631\u0631 \u0645\u0645\u0627 \u0625\u0630\u0627 \u0643\u0627\u0646 \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0645\u0633\u062c\u0644\u0627\u064b \u0641\u064a <strong><a href=\"https:\/\/health.ec.europa.eu\/eudamed-actors_en\">\u0648\u062d\u062f\u0629 \u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u062c\u0647\u0627\u062a \u0627\u0644\u0641\u0627\u0639\u0644\u0629 \u0641\u064a EUDAMED<\/a><\/strong> <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup>, \u060c \u0645\u0645\u0627 \u064a\u0633\u0627\u0639\u062f \u0639\u0644\u0649 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0647\u0648\u064a\u0629 \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0648\u062a\u0641\u0648\u064a\u0636\u0647\u0627.<\/p>\n<h3>\u0639\u0644\u0627\u0645\u0629 CE \u0648\u062c\u062f\u0648\u0644 \u0627\u0644\u062c\u0645\u0627\u0631\u0643<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0644\u0645\u0643\u0648\u0646 \u0627\u0644\u0630\u064a \u062a\u0645 \u0641\u062d\u0635\u0647 \u0628\u0648\u0627\u0633\u0637\u0629 \u0627\u0644\u062c\u0645\u0627\u0631\u0643<\/th>\n<th>\u0627\u0644\u0645\u062a\u0637\u0644\u0628<\/th>\n<th>\u0645\u0631\u062a\u0628\u0637 \u0628\u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u061f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0639\u0644\u0627\u0645\u0629 CE<\/td>\n<td>\u064a\u062c\u0628 \u0623\u0646 \u064a\u062a\u0628\u0639 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0645\u0644\u062d\u0642 \u0627\u0644\u062e\u0627\u0645\u0633 \u0645\u0646 MDR<\/td>\n<td>\u0646\u0639\u0645<\/td>\n<\/tr>\n<tr>\n<td>\u062a\u0648\u0642\u064a\u0639 \u0625\u0639\u0644\u0627\u0646 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629<\/td>\n<td>\u064a\u062c\u0628 \u0639\u0644\u0649 \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0627\u0644\u062a\u0648\u0642\u064a\u0639 \u0646\u064a\u0627\u0628\u0629 \u0639\u0646 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u062e\u0627\u0631\u062c \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a<\/td>\n<td>\u0646\u0639\u0645<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a<\/td>\n<td>\u064a\u062c\u0628 \u0623\u0646 \u062a\u0638\u0647\u0631 \u062a\u0641\u0627\u0635\u064a\u0644 \u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f<\/td>\n<td>\u0646\u0639\u0645<\/td>\n<\/tr>\n<tr>\n<td>\u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0645\u0646\u062a\u062c<\/td>\n<td>\u0627\u0644\u0641\u0626\u0629 IIa\/IIb \u0644\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629<\/td>\n<td>\u0628\u0634\u0643\u0644 \u063a\u064a\u0631 \u0645\u0628\u0627\u0634\u0631<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>What questions should buyers ask about a supplier&#8217;s EU representation?<\/h2>\n<p>\u064a\u0641\u062a\u0631\u0636 \u0627\u0644\u0639\u062f\u064a\u062f \u0645\u0646 \u0627\u0644\u0645\u0634\u062a\u0631\u064a\u0646 \u0623\u0646 \u0627\u0644\u0645\u0648\u0631\u062f \u0644\u062f\u064a\u0647 \u0628\u0627\u0644\u0641\u0639\u0644 \u0645\u0645\u062b\u0644 \u0645\u0641\u0648\u0636\u060c \u0648\u0644\u0643\u0646 \u0647\u0630\u0627 \u0644\u064a\u0633 \u0635\u062d\u064a\u062d\u064b\u0627 \u062f\u0627\u0626\u0645\u064b\u0627. \u0637\u0631\u062d \u0627\u0644\u0623\u0633\u0626\u0644\u0629 \u0627\u0644\u0635\u062d\u064a\u062d\u0629 \u064a\u062d\u0645\u064a \u0639\u0645\u0644\u0643 \u0645\u0646 \u0645\u062e\u0627\u0637\u0631 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644.<\/p>\n<p>\u063a\u0627\u0644\u0628\u064b\u0627 \u0645\u0627 \u064a\u0639\u062a\u0645\u062f \u0627\u0644\u0645\u0634\u062a\u0631\u0648\u0646 \u0639\u0644\u0649 <strong><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2021-07\/mdcg_2021-13_en_0.pdf\">\u062a\u0648\u062c\u064a\u0647\u0627\u062a MDCG 2021-13 \u0628\u0634\u0623\u0646 \u0645\u0633\u0624\u0648\u0644\u064a\u0627\u062a \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 - \u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0641\u0648\u0636<\/a><\/strong> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup> \u0644\u062a\u0642\u064a\u064a\u0645 \u0645\u0627 \u0625\u0630\u0627 \u0643\u0627\u0646\u062a \u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0645\u0648\u0631\u062f \u062a\u0644\u0628\u064a \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644.<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/4a-professional-buyer-s-office-where-a-procurement-.jpg\" alt=\"\u0631\u062c\u0644 \u0623\u0639\u0645\u0627\u0644 \u064a\u0643\u0645\u0644 \u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0639\u0646\u0627\u064a\u0629 \u0627\u0644\u0648\u0627\u062c\u0628\u0629 \u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0628\u062c\u0627\u0646\u0628 \u0645\u0639\u062f\u0627\u062a \u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0641\u064a \u0627\u0644\u0645\u0643\u062a\u0628 (ID#4)\" title=\"\u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0639\u0646\u0627\u064a\u0629 \u0627\u0644\u0648\u0627\u062c\u0628\u0629\" \/><\/p>\n<h3>\u0623\u0633\u0626\u0644\u0629 \u0631\u0626\u064a\u0633\u064a\u0629 \u0644\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644<\/h3>\n<ol>\n<li>\u0645\u0646 \u0647\u0648 \u0645\u0645\u062b\u0644\u0643 \u0627\u0644\u0645\u0641\u0648\u0636\u061f  <\/li>\n<li>\u0647\u0644 \u064a\u0645\u0643\u0646\u0643 \u062a\u0642\u062f\u064a\u0645 \u0627\u062a\u0641\u0627\u0642\u064a\u0629 \u062a\u0641\u0648\u064a\u0636 EC REP\u061f  <\/li>\n<li>\u0647\u0644 EC REP \u0645\u0637\u0628\u0648\u0639 \u0639\u0644\u0649 \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a\u061f  <\/li>\n<li>\u0647\u0644 EC REP \u0645\u0633\u062c\u0644 \u0641\u064a EUDAMED\u061f  <\/li>\n<li>\u0647\u0644 \u064a\u062f\u0639\u0645 EC REP \u0627\u0644\u0645\u0631\u0627\u0642\u0628\u0629 \u0628\u0639\u062f \u0627\u0644\u062a\u0633\u0648\u064a\u0642\u061f<\/li>\n<\/ol>\n<h3>\u062c\u062f\u0648\u0644 \u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u062a\u062d\u0642\u0642 \u0644\u0644\u0645\u0634\u062a\u0631\u064a<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0644\u0645\u0648\u0636\u0648\u0639 \u0644\u0644\u062a\u062d\u0642\u0642<\/th>\n<th>\u0623\u0633\u0626\u0644\u0629 \u0644\u0637\u0631\u062d\u0647\u0627<\/th>\n<th>\u0645\u0627 \u064a\u0624\u0643\u062f\u0647<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0627\u0644\u0647\u0648\u064a\u0629<\/td>\n<td>\u201c\u0645\u0646 \u0647\u0648 EC REP \u0627\u0644\u062e\u0627\u0635 \u0628\u0643\u061f\u201d<\/td>\n<td>\u062a\u0645\u062b\u064a\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0627\u0644\u0623\u0635\u064a\u0644<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u062a\u0648\u062b\u064a\u0642<\/td>\n<td>\u201c\u0647\u0644 \u064a\u0645\u0643\u0646\u0643 \u062a\u0642\u062f\u064a\u0645 \u062a\u0641\u0648\u064a\u0636\u0643 \u0648\u0648\u062b\u064a\u0642\u0629 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629\u061f\u201d<\/td>\n<td>\u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u0642\u0627\u0646\u0648\u0646\u064a<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a<\/td>\n<td>\u201c\u0627\u0639\u0631\u0636 \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u0627\u0644\u062a\u064a \u062a\u062d\u062a\u0648\u064a \u0639\u0644\u0649 \u0645\u0639\u0644\u0648\u0645\u0627\u062a \u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a.\u201d<\/td>\n<td>\u062c\u0627\u0647\u0632\u064a\u0629 \u0627\u0644\u0645\u0646\u062a\u062c<\/td>\n<\/tr>\n<tr>\n<td>EUDAMED<\/td>\n<td>\u201c\u0647\u0644 \u0647\u0645 \u0645\u0633\u062c\u0644\u0648\u0646 \u0641\u064a EUDAMED\u061f\u201d<\/td>\n<td>\u0627\u0644\u0634\u0641\u0627\u0641\u064a\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u064a\u0642\u0638\u0629<\/td>\n<td>\u201c\u0647\u0644 \u064a\u062f\u0639\u0645\u0648\u0646 \u0627\u0644\u0625\u0628\u0644\u0627\u063a \u0639\u0646 \u0627\u0644\u062d\u0648\u0627\u062f\u062b\u061f\u201d<\/td>\n<td>\u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0633\u0644\u0627\u0645\u0629<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u0647\u0644 \u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0625\u0644\u0632\u0627\u0645\u064a \u062f\u0627\u0626\u0645\u064b\u0627 \u0644\u0644\u0645\u0635\u0646\u0639\u064a\u0646 \u062e\u0627\u0631\u062c \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u061f<\/h2>\n<p>\u0641\u064a \u0627\u0644\u0645\u0646\u0627\u0642\u0634\u0627\u062a \u0645\u0639 \u0627\u0644\u0645\u0634\u062a\u0631\u064a\u0646 \u0627\u0644\u062f\u0648\u0644\u064a\u064a\u0646\u060c \u063a\u0627\u0644\u0628\u064b\u0627 \u0645\u0627 \u0646\u0648\u0636\u062d \u0645\u062a\u0649 \u064a\u0643\u0648\u0646 \u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f \u0645\u0637\u0644\u0648\u0628\u064b\u0627 \u0648\u0645\u062a\u0649 \u0644\u0627 \u064a\u0643\u0648\u0646 \u0643\u0630\u0644\u0643.<\/p>\n<p>\u064a\u0623\u062a\u064a \u0641\u0647\u0645 \u0642\u0648\u0627\u0639\u062f \u0627\u0644\u062a\u0646\u0633\u064a\u0628 \u0645\u0646 \u0645\u0648\u0627\u0631\u062f \u0645\u062b\u0644 <strong><a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/placing-medical-devices-market_en\">\u062a\u0648\u062c\u064a\u0647\u0627\u062a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0628\u0634\u0623\u0646 \u0637\u0631\u062d \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0641\u064a \u0627\u0644\u0633\u0648\u0642<\/a><\/strong> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup>, \u060c \u0648\u0627\u0644\u062a\u064a \u062a\u0648\u0636\u062d \u0645\u062a\u0649 \u064a\u0645\u0643\u0646 \u0644\u0643\u064a\u0627\u0646 \u0642\u0627\u0646\u0648\u0646\u064a \u062f\u0627\u062e\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0623\u0646 \u064a\u0639\u0645\u0644 \u0643\u062c\u0647\u0629 \u062a\u0635\u0646\u064a\u0639 \u0645\u0633\u0624\u0648\u0644\u0629.<\/p>\n<p><img decoding=\"async\" src=\"&quot;https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/5a-desk-level-scene-showing-a-shockwave-device-its.jpg\" alt=\"\u0647\u0644 \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0625\u0644\u0632\u0627\u0645\u064a\u061f\" title=\"\u062a\u0648\u0642\u064a\u0639 \u0625\u0639\u0644\u0627\u0646 CE\" \/><\/p>\n<h3>\u0645\u062a\u0649 \u064a\u0643\u0648\u0646 \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0645\u0637\u0644\u0648\u0628\u064b\u0627<\/h3>\n<ul>\n<li>\u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u062a\u0642\u0639 \u062e\u0627\u0631\u062c \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a  <\/li>\n<li>\u0627\u0644\u0645\u0646\u062a\u062c \u0645\u0635\u0646\u0641 \u0643\u062c\u0647\u0627\u0632 \u0637\u0628\u064a  <\/li>\n<li>\u0633\u064a\u062a\u0645 \u062a\u0633\u0648\u064a\u0642 \u0627\u0644\u062c\u0647\u0627\u0632 \u0623\u0648 \u062a\u0648\u0632\u064a\u0639\u0647 \u062f\u0627\u062e\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a  <\/li>\n<\/ul>\n<h3>\u0645\u062a\u0649 \u0644\u0627 \u064a\u0643\u0648\u0646 \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0645\u0637\u0644\u0648\u0628\u064b\u0627<\/h3>\n<ul>\n<li>\u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0644\u062f\u064a\u0647\u0627 \u0643\u064a\u0627\u0646 \u0642\u0627\u0646\u0648\u0646\u064a \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a  <\/li>\n<li>\u0627\u0644\u0645\u0646\u062a\u062c \u0644\u064a\u0633 \u062c\u0647\u0627\u0632\u064b\u0627 \u0637\u0628\u064a\u064b\u0627  <\/li>\n<li>\u0648\u0627\u0631\u062f\u0627\u062a \u0634\u062e\u0635\u064a\u0629 \u063a\u064a\u0631 \u062a\u062c\u0627\u0631\u064a\u0629  <\/li>\n<\/ul>\n<h3>\u062c\u062f\u0648\u0644 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0644\u0633\u064a\u0646\u0627\u0631\u064a\u0648<\/th>\n<th>\u0647\u0644 \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0645\u0637\u0644\u0648\u0628\u061f<\/th>\n<th>\u0627\u0644\u0633\u0628\u0628<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0634\u0631\u0643\u0629 \u0645\u0635\u0646\u0639\u0629 \u062e\u0627\u0631\u062c \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u062a\u0628\u064a\u0639 \u0644\u0645\u0648\u0632\u0639\u064a\u0646 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a<\/td>\n<td>\u0646\u0639\u0645<\/td>\n<td>\u0645\u062a\u0637\u0644\u0628 \u0627\u0644\u0645\u0627\u062f\u0629 11 \u0645\u0646 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDR)<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0630\u0627\u062a \u0627\u0644\u0643\u064a\u0627\u0646 \u0627\u0644\u0642\u0627\u0646\u0648\u0646\u064a \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a<\/td>\n<td>\u0644\u0627 \u064a\u0648\u062c\u062f<\/td>\n<td>\u0627\u0644\u0643\u064a\u0627\u0646 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u064a\u062a\u062d\u0645\u0644 \u0627\u0644\u0645\u0633\u0624\u0648\u0644\u064a\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u0634\u0631\u0643\u0629 \u0645\u0635\u0646\u0639\u0629 \u0645\u062d\u0644\u064a\u0629 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a<\/td>\n<td>\u0644\u0627 \u064a\u0648\u062c\u062f<\/td>\n<td>\u0636\u0645\u0646 \u0627\u0644\u0646\u0638\u0627\u0645 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a \u0644\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0628\u0627\u0644\u0641\u0639\u0644<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u0627\u0644\u062e\u0627\u062a\u0645\u0629<\/h2>\n<p>\u064a\u062c\u0628 \u0623\u0646 \u064a\u0643\u0648\u0646 \u0644\u062f\u0649 \u062c\u0647\u0627\u0632 \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0645\u0635\u0646\u0639 \u062e\u0627\u0631\u062c \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0645\u0645\u062b\u0644 \u0645\u0639\u062a\u0645\u062f \u0644\u062a\u0644\u0628\u064a\u0629 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDR)\u060c \u0648\u0636\u0645\u0627\u0646 \u0639\u0644\u0627\u0645\u0629 CE \u0635\u0627\u0644\u062d\u0629\u060c \u0648\u062f\u0639\u0645 \u0627\u0644\u0627\u062a\u0635\u0627\u0644 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u060c \u0648\u062a\u0645\u0643\u064a\u0646 \u0627\u0644\u062a\u062e\u0644\u064a\u0635 \u0627\u0644\u062c\u0645\u0631\u0643\u064a \u0627\u0644\u0633\u0644\u0633 \u0644\u0644\u0627\u0633\u062a\u064a\u0631\u0627\u062f\u060c \u0645\u0645\u0627 \u064a\u062c\u0639\u0644 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a (EC REP) \u0636\u0631\u0648\u0631\u064a\u064b\u0627 \u0644\u0623\u064a \u0645\u0634\u062a\u0631\u064d \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a.<\/p>\n<hr \/>\n<h2>\u0627\u0644\u062d\u0648\u0627\u0634\u064a<\/h2>\n<p><span id=\"footnote-1\">1. \u0645\u0631\u062c\u0639 \u0625\u0637\u0627\u0631 \u0639\u0645\u0644 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (EUR-Lex). <a href=\"#ref-1\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. \u0642\u0648\u0627\u0639\u062f \u0627\u0644\u062a\u0648\u062b\u064a\u0642 \u0627\u0644\u0641\u0646\u064a \u0641\u064a \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629. <a href=\"#ref-2\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. \u062a\u0648\u062c\u064a\u0647\u0627\u062a \u0627\u0644\u0633\u0644\u0637\u0629 \u0627\u0644\u0645\u062e\u062a\u0635\u0629 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a. <a href=\"#ref-3\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u064a\u0642\u0638\u0629 \u0641\u064a \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629. <a href=\"#ref-4\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. \u0646\u0638\u0631\u0629 \u0639\u0627\u0645\u0629 \u0639\u0644\u0649 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0639\u0644\u0627\u0645\u0629 CE. <a href=\"#ref-5\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. \u0642\u0648\u0627\u0639\u062f \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0645\u0644\u062d\u0642 \u0627\u0644\u062e\u0627\u0645\u0633 \u0645\u0646 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629. <a href=\"#ref-6\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. \u0648\u062d\u062f\u0629 \u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u062c\u0647\u0627\u062a \u0627\u0644\u0641\u0627\u0639\u0644\u0629 \u0641\u064a EUDAMED. <a href=\"#ref-7\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. \u062a\u0648\u062c\u064a\u0647\u0627\u062a MDCG \u0628\u0634\u0623\u0646 \u0645\u0633\u0624\u0648\u0644\u064a\u0627\u062a \u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a. <a href=\"#ref-8\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. \u062a\u0648\u062c\u064a\u0647\u0627\u062a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0628\u0634\u0623\u0646 \u0637\u0631\u062d \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0641\u064a \u0627\u0644\u0633\u0648\u0642. <a href=\"#ref-9\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. \u0645\u0648\u0627\u0631\u062f \u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0641\u064a \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629. <a href=\"#ref-10\">\ufe0e<\/a><\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Working closely with distributors who source medical equipment from us, I often notice confusion about whether every non-EU supplier must appoint an EU Authorised Representative before selling shockwave therapy devices in Europe. Yes, non-EU suppliers must have a European Authorised Representative (EC REP) when placing shockwave therapy machines on the EU market because these devices [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8445,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"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":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","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-opacity":"","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-opacity":"","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-opacity":"","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-opacity":"","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-opacity":"","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-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[60],"tags":[],"class_list":["post-8444","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-shockwave-therapy-machine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>When purchasing a Shockwave Therapy Machine, must the supplier have a European authorised representative (EC REP)? - KMSLaser<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kmslaser.com\/ar\/\u0639\u0646\u062f-\u0634\u0631\u0627\u0621-\u062c\u0647\u0627\u0632-\u0639\u0644\u0627\u062c-\u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a-\u0627\u0644\u0635\u062f\u0645\u064a\u0629\u060c-\u0647\/\" \/>\n<meta property=\"og:locale\" content=\"ar_AR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"When purchasing a Shockwave Therapy Machine, must the supplier have a European authorised representative (EC REP)?\" \/>\n<meta property=\"og:description\" content=\"Working closely with distributors who source medical equipment from us, I often notice confusion about whether every non-EU supplier must appoint an EU Authorised Representative before selling shockwave therapy devices in Europe. 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