{"id":8386,"date":"2025-11-19T23:35:50","date_gmt":"2025-11-19T23:35:50","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8386"},"modified":"2025-11-19T23:35:50","modified_gmt":"2025-11-19T23:35:50","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%87-6","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/ar\/when-purchasing-a-shockwave-therapy-machine-is-compliance-with-eu-medical-device-regulation-mdr-class-iib-or-iii-mandatory\/","title":{"rendered":"\u0639\u0646\u062f \u0634\u0631\u0627\u0621 \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\u060c \u0647\u0644 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0644\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a (MDR) \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 IIb \u0623\u0648 III \u0625\u0644\u0632\u0627\u0645\u064a\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-premium-digital-illustration-showing-a-modern-sh.jpg\" alt=\"\u062c\u0647\u0627\u0632 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0645\u0639\u0631\u0648\u0636 \u0628\u062c\u0627\u0646\u0628 \u0623\u064a\u0642\u0648\u0646\u0627\u062a \u0627\u0644\u0645\u064a\u0632\u0627\u062a \u0639\u0644\u0649 \u0627\u0644\u0637\u0631\u0627\u0632 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>\u0628\u0635\u0641\u062a\u064a \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629\u060c \u064a\u064f\u0637\u0631\u062d \u0639\u0644\u064a \u0647\u0630\u0627 \u0627\u0644\u0633\u0624\u0627\u0644 \u0641\u064a \u0643\u0644 \u0645\u0646\u0627\u0642\u0635\u0629 \u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u062a\u0642\u0631\u064a\u0628\u064b\u0627: \u201c\u0647\u0644 \u0627\u0644\u0641\u0626\u0629 IIb \u0623\u0648 III \u0625\u0644\u0632\u0627\u0645\u064a\u0629 \u0644\u0623\u0646\u0638\u0645\u0629 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629\u061f\u201d \u0627\u0644\u0625\u062c\u0627\u0628\u0629 \u0627\u0644\u062d\u0642\u064a\u0642\u064a\u0629 \u062a\u0639\u062a\u0645\u062f \u0639\u0644\u0649 \u0627\u0644\u063a\u0631\u0636 \u0627\u0644\u0645\u0642\u0635\u0648\u062f\u060c \u0648\u062a\u0648\u0635\u064a\u0644 \u0627\u0644\u0637\u0627\u0642\u0629\u060c \u0648 <a href=\"https:\/\/www.medical-device-regulation.eu\/2019\/08\/08\/annex-viii\/\">\u0642\u0648\u0627\u0639\u062f \u0627\u0644\u0645\u0644\u062d\u0642 \u0627\u0644\u062b\u0627\u0645\u0646 \u0645\u0646 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDR)<\/a> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup>\u2014 \u0648\u0644\u064a\u0633 \u0639\u0644\u0649 \u062a\u0635\u0646\u064a\u0641 \u0648\u0627\u062d\u062f \u0634\u0627\u0645\u0644.<\/p>\n<p><strong>\u0644\u0627 \u062a\u064f\u0639\u062f \u0627\u0644\u0641\u0626\u0629 IIb \u0623\u0648 III \u0645\u0646 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDR) \u0625\u0644\u0632\u0627\u0645\u064a\u0629 \u062a\u0644\u0642\u0627\u0626\u064a\u064b\u0627 \u0644\u062c\u0645\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. \u062a\u0646\u062f\u0631\u062c \u0645\u0639\u0638\u0645 \u0623\u0646\u0638\u0645\u0629 \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0639\u0644\u0627\u062c\u064a\u0629 \u0636\u0645\u0646 \u0627\u0644\u0641\u0626\u0629 IIa \u0623\u0648 IIb \u0627\u0639\u062a\u0645\u0627\u062f\u064b\u0627 \u0639\u0644\u0649 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0645\u0642\u0635\u0648\u062f\u060c \u0648\u062a\u0648\u0635\u064a\u0644 \u0627\u0644\u0637\u0627\u0642\u0629\u060c \u0648\u0645\u0644\u0641 \u0627\u0644\u0645\u062e\u0627\u0637\u0631. \u0628\u063a\u0636 \u0627\u0644\u0646\u0638\u0631 \u0639\u0646 \u0627\u0644\u0641\u0626\u0629\u060c \u0641\u0625\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDR) \u0648\u0648\u0636\u0639 \u0639\u0644\u0627\u0645\u0629 CE \u0625\u0644\u0632\u0627\u0645\u064a \u0642\u0628\u0644 \u0637\u0631\u062d \u0627\u0644\u0645\u0646\u062a\u062c \u0641\u064a \u0627\u0644\u0633\u0648\u0642 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629.<\/strong><\/p>\n<p>\u062a\u0648\u0636\u062d \u0627\u0644\u0623\u0642\u0633\u0627\u0645 \u0627\u0644\u062a\u0627\u0644\u064a\u0629 \u0645\u0646\u0637\u0642 \u0627\u0644\u062a\u0635\u0646\u064a\u0641\u060c \u0648\u062a\u0648\u0642\u0639\u0627\u062a \u0627\u0644\u0645\u0644\u0641 \u0627\u0644\u0641\u0646\u064a\/\u0639\u0644\u0627\u0645\u0629 CE\u060c \u0648\u0627\u0644\u0639\u0646\u0627\u064a\u0629 \u0627\u0644\u0648\u0627\u062c\u0628\u0629 \u0644\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u060c \u0648\u0643\u064a\u0641 \u064a\u0645\u0643\u0646 \u0644\u0644\u0623\u0646\u0638\u0645\u0629 \u0627\u0644\u0634\u0639\u0627\u0639\u064a\u0629 \u0645\u0642\u0627\u0628\u0644 \u0627\u0644\u0623\u0646\u0638\u0645\u0629 \u0627\u0644\u0645\u0631\u0643\u0632\u0629 \u0623\u0646 \u062a\u0642\u0639 \u0641\u064a \u0641\u0626\u0627\u062a \u0645\u062e\u062a\u0644\u0641\u0629 \u0636\u0645\u0646 \u0627\u0644\u0625\u0637\u0627\u0631 \u0627\u0644\u0623\u0648\u0633\u0639 \u0644\u0640 <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations_en\">\u0627\u0644\u0625\u0637\u0627\u0631 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a \u0644\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 (MDR)<\/a> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup>.<\/p>\n<h2>\u0643\u064a\u0641 \u064a\u062a\u0645 \u062a\u0635\u0646\u064a\u0641 \u0645\u0639\u062f\u0627\u062a \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0636\u0645\u0646 \u0625\u0637\u0627\u0631 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDR)\u061f<\/h2>\n<p>\u064a\u062a\u0645 \u062a\u062d\u062f\u064a\u062f \u0627\u0644\u062a\u0635\u0646\u064a\u0641 \u0628\u0648\u0627\u0633\u0637\u0629 <strong>\u0627\u0644\u063a\u0631\u0636 \u0627\u0644\u0645\u0642\u0635\u0648\u062f<\/strong> \u0648 <strong>\u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0627\u0644\u0643\u0627\u0645\u0646\u0629<\/strong>, \u060c \u0628\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0642\u0648\u0627\u0639\u062f \u0627\u0644\u0645\u0644\u062d\u0642 \u0627\u0644\u062b\u0627\u0645\u0646 \u0645\u0646 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDR) \u0644\u0640 <a href=\"https:\/\/webgate.ec.europa.eu\/udi-helpdesk\/en\/other-relevant-information\/medical-device-classification.html\">\u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0625\u0644\u0649 I\u060c IIa\u060c IIb\u060c \u0648 III<\/a> <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>. \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0647\u064a \u0645\u0639\u062f\u0627\u062a \u0639\u0644\u0627\u062c\u064a\u0629 \u0646\u0634\u0637\u0629 \u063a\u064a\u0631 \u0642\u0627\u0628\u0644\u0629 \u0644\u0644\u0632\u0631\u0639 \u062a\u0642\u0648\u0645 \u0628\u062a\u0648\u0635\u064a\u0644 \u0637\u0627\u0642\u0629 \u0645\u064a\u0643\u0627\u0646\u064a\u0643\u064a\u0629\/\u0635\u0648\u062a\u064a\u0629 \u0639\u0628\u0631 \u0627\u0644\u062c\u0644\u062f \u0625\u0644\u0649 \u0627\u0644\u0623\u0646\u0633\u062c\u0629 \u0627\u0644\u0628\u0634\u0631\u064a\u0629.<\/p>\n<p><strong>\u0628\u0645\u0648\u062c\u0628 \u0627\u0644\u0645\u0644\u062d\u0642 \u0627\u0644\u062b\u0627\u0645\u0646\u060c \u064a\u062a\u0645 \u062a\u0635\u0646\u064a\u0641 ESWT \u0628\u0634\u0643\u0644 \u0639\u0627\u0645 \u0639\u0628\u0631 \u0627\u0644\u0642\u0627\u0639\u062f\u0629 9 (\u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0639\u0644\u0627\u062c\u064a\u0629 \u0627\u0644\u0646\u0634\u0637\u0629 \u0627\u0644\u0645\u062e\u0635\u0635\u0629 \u0644\u0625\u0639\u0637\u0627\u0621 \u0623\u0648 \u062a\u0628\u0627\u062f\u0644 \u0627\u0644\u0637\u0627\u0642\u0629) \u0648\u062a\u062f\u0639\u0645\u0647\u0627 \u0627\u0644\u0642\u0627\u0639\u062f\u0629 11 \u0639\u0646\u062f\u0645\u0627 \u064a\u0642\u0648\u062f \u0627\u0644\u0628\u0631\u0646\u0627\u0645\u062c \u0627\u062f\u0639\u0627\u0621\u0627\u062a \u0627\u0644\u0623\u062f\u0627\u0621. \u0639\u0645\u0644\u064a\u064b\u0627\u060c \u0645\u0639\u0638\u0645 ESWT \u0627\u0644\u0639\u0636\u0644\u064a \u0627\u0644\u0647\u064a\u0643\u0644\u064a \/ \u0627\u0644\u062a\u062c\u0645\u064a\u0644\u064a \u0647\u0648 \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 IIa \u0623\u0648 IIb\u061b \u062a\u0645\u064a\u0644 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0645\u0646 \u062f\u0631\u062c\u0629 \u062a\u0641\u062a\u064a\u062a \u0627\u0644\u062d\u0635\u0648\u0627\u062a \u0625\u0644\u0649 IIb\u060c \u0628\u0645\u0627 \u064a\u062a\u0641\u0642 \u0645\u0639 <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2021-10\/mdcg_2021-24_en_0.pdf\">\u062a\u0648\u062c\u064a\u0647 MDCG 2021-24 \u0628\u0634\u0623\u0646 \u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/a> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup>.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/2a-scene-showing-multiple-clinical-posters-on-a-wal.jpg\" alt=\"\u0645\u0644\u0635\u0642\u0627\u062a \u0627\u0644\u0639\u064a\u0627\u062f\u0629 \u0627\u0644\u062a\u064a \u062a\u0631\u0648\u062c \u0644\u0641\u0648\u0627\u0626\u062f \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0648\u062a\u0637\u0628\u064a\u0642\u0627\u062a \u0627\u0644\u0639\u0644\u0627\u062c (ID#2)\" title=\"\u0641\u0648\u0627\u0626\u062f \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629\" \/><\/p>\n<h3>\u0642\u0631\u0627\u0621\u0629 \u0639\u0645\u0644\u064a\u0629 \u0644\u0644\u0645\u0644\u062d\u0642 \u0627\u0644\u062b\u0627\u0645\u0646 \u0644\u0640 ESWT<\/h3>\n<ul>\n<li><strong>\u0627\u0644\u0642\u0627\u0639\u062f\u0629 9:<\/strong> \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0646\u0634\u0637\u0629 \u0627\u0644\u062a\u064a \u062a\u0648\u0635\u0644 \u0627\u0644\u0637\u0627\u0642\u0629. \u064a\u0632\u062f\u0627\u062f \u0627\u0644\u062e\u0637\u0631 \u0645\u0639 \u062d\u062c\u0645 \u0627\u0644\u0637\u0627\u0642\u0629 \u0648\u0627\u0644\u0639\u0645\u0642 \u0648\u0627\u062d\u062a\u0645\u0627\u0644\u064a\u0629 \u0625\u0635\u0627\u0628\u0629 \u0627\u0644\u0623\u0646\u0633\u062c\u0629.  <\/li>\n<li><strong>\u0627\u0644\u0645\u062f\u0629 \u0648\u0627\u0644\u063a\u0632\u0648:<\/strong> ESWT \u063a\u064a\u0631 \u062c\u0631\u0627\u062d\u064a \u0648\u062a\u0644\u0627\u0645\u0633 \u0639\u0627\u0628\u0631\u060c \u0648\u0644\u0643\u0646 \u0643\u062b\u0627\u0641\u0629 \u0627\u0644\u0637\u0627\u0642\u0629 \u0648\u0627\u0644\u0639\u0636\u0648 \u0627\u0644\u0645\u0633\u062a\u0647\u062f\u0641 \u0645\u0647\u0645\u0627\u0646.  <\/li>\n<li><strong>\u0627\u0644\u063a\u0631\u0636 \u0627\u0644\u0645\u0642\u0635\u0648\u062f:<\/strong> \u062a\u062e\u0641\u064a\u0641 \u0627\u0644\u0623\u0644\u0645\u060c \u0627\u0644\u062a\u0647\u0627\u0628 \u0627\u0644\u0623\u0648\u062a\u0627\u0631\u060c \u0625\u0639\u0627\u062f\u0629 \u062a\u0634\u0643\u064a\u0644 \u0627\u0644\u062c\u0631\u0648\u062d \/ \u0627\u0644\u062c\u0644\u062f\u060c \u0623\u0648 \u062a\u0641\u062a\u064a\u062a \u0627\u0644\u062d\u0635\u0648\u0627\u062a (\u0634\u0628\u064a\u0647 \u0628\u062a\u0641\u062a\u064a\u062a \u0627\u0644\u062d\u0635\u0648\u0627\u062a).  <\/li>\n<\/ul>\n<p>\u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u0641\u0631\u0642 \u0627\u0644\u0646\u0627\u0637\u0642\u0629 \u0628\u0627\u0644\u0635\u064a\u0646\u064a\u0629\u060c <a href=\"https:\/\/www.cn-healthcare.com\/articlewm\/20230721\/content-1581748.html\">\u0646\u0638\u0631\u0629 \u0639\u0627\u0645\u0629 \u0628\u0627\u0644\u0644\u063a\u0629 \u0627\u0644\u0635\u064a\u0646\u064a\u0629 \u0639\u0644\u0649 \u062a\u0635\u0646\u064a\u0641 \u0645\u062e\u0627\u0637\u0631 MDR<\/a> <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup> \u064a\u0645\u0643\u0646 \u0623\u0646 \u062a\u0633\u0627\u0639\u062f \u0641\u064a \u0645\u0648\u0627\u0621\u0645\u0629 \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u062f\u0627\u062e\u0644\u064a\u0629 \u0645\u0639 \u0642\u0648\u0627\u0639\u062f \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a.<\/p>\n<h3>\u0627\u0644\u062c\u062f\u0648\u0644 1 - \u0627\u0644\u0646\u062a\u0627\u0626\u062c \u0627\u0644\u0646\u0645\u0648\u0630\u062c\u064a\u0629 \u0644\u0640 MDR \u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 (\u062a\u0648\u0636\u064a\u062d\u064a\u0629\u060c \u062e\u0627\u0635\u0629 \u0628\u0627\u0644\u062c\u0647\u0627\u0632)<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0645\u0642\u0635\u0648\u062f \/ \u0627\u0644\u062a\u0643\u0646\u0648\u0644\u0648\u062c\u064a\u0627<\/th>\n<th>\u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u0645\u062d\u062a\u0645\u0644\u0629<\/th>\n<th>\u0644\u0645\u0627\u0630\u0627<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u062a\u062e\u0641\u064a\u0641 \u0622\u0644\u0627\u0645 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0648\u0627\u0644\u0647\u064a\u0643\u0644 \u0627\u0644\u0639\u0638\u0645\u064a\u060c \u0627\u0644\u062a\u0647\u0627\u0628 \u0627\u0644\u0623\u0648\u062a\u0627\u0631 (\u0634\u0639\u0627\u0639\u064a \u0623\u0648 \u0645\u0631\u0643\u0632\u061b \u0637\u0627\u0642\u0629 \u063a\u064a\u0631 \u062a\u0641\u062a\u064a\u062a \u0627\u0644\u062d\u0635\u0648\u0627\u062a)<\/td>\n<td>IIa\u2013IIb<\/td>\n<td>\u0637\u0627\u0642\u0629 \u0639\u0644\u0627\u062c\u064a\u0629 \u0646\u0634\u0637\u0629 \u0645\u0639 \u0645\u062e\u0627\u0637\u0631 \u062c\u0647\u0627\u0632\u064a\u0629 \u0645\u062d\u062f\u0648\u062f\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0623\u0645\u0631\u0627\u0636 \u0627\u0644\u062c\u0644\u062f\u064a\u0629 \/ \u0627\u0644\u062a\u062c\u0645\u064a\u0644 (\u0627\u0644\u0633\u064a\u0644\u0648\u0644\u064a\u062a\u060c \u0625\u0639\u0627\u062f\u0629 \u062a\u0634\u0643\u064a\u0644 \u0627\u0644\u0646\u062f\u0628\u0627\u062a)<\/td>\n<td>IIa\u2013IIb<\/td>\n<td>\u0637\u0627\u0642\u0629 \u063a\u064a\u0631 \u062c\u0631\u0627\u062d\u064a\u0629\u061b \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u062a\u0639\u062a\u0645\u062f \u0639\u0644\u0649 \u0627\u0644\u062c\u0631\u0639\u0629\/\u0627\u0644\u0639\u0645\u0642<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u062f\u0639\u0627\u0621\u0627\u062a \u0639\u0644\u0627\u062c \u0627\u0644\u062c\u0631\u0648\u062d \/ \u0627\u0644\u062a\u0626\u0627\u0645 \u0627\u0644\u0639\u0638\u0627\u0645<\/td>\n<td>\u063a\u0627\u0644\u0628\u064b\u0627 IIb<\/td>\n<td>\u0627\u062f\u0639\u0627\u0621\u0627\u062a \u0645\u062e\u0627\u0637\u0631 \u0623\u0639\u0644\u0649\u061b \u062a\u0623\u062b\u064a\u0631 \u0628\u064a\u0648\u0644\u0648\u062c\u064a \u0623\u0639\u0645\u0642<\/td>\n<\/tr>\n<tr>\n<td>\u0637\u0627\u0642\u0629 \u0645\u0631\u0643\u0632\u0629 \u0639\u0627\u0644\u064a\u0629 \u0634\u0628\u064a\u0647\u0629 \u0628\u062a\u0641\u062a\u064a\u062a \u0627\u0644\u062d\u0635\u0648\u0627\u062a \u0644\u062a\u0641\u062a\u064a\u062a \u0627\u0644\u062d\u0635\u0648\u0627\u062a<\/td>\n<td>IIb<\/td>\n<td>\u0625\u0645\u0643\u0627\u0646\u064a\u0629 \u0623\u0643\u0628\u0631 \u0644\u0625\u0635\u0627\u0628\u0629 \u0627\u0644\u0623\u0646\u0633\u062c\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u062e\u0648\u0627\u0631\u0632\u0645\u064a\u0627\u062a \u062c\u0631\u0639\u0627\u062a \u0645\u062f\u0641\u0648\u0639\u0629 \u0628\u0627\u0644\u0628\u0631\u0645\u062c\u064a\u0627\u062a (\u0628\u0631\u0646\u0627\u0645\u062c \u0643\u062c\u0647\u0627\u0632 \u0637\u0628\u064a \u0645\u0633\u062a\u0642\u0644 \u064a\u0624\u062b\u0631 \u0639\u0644\u0649 \u0627\u0644\u0639\u0644\u0627\u062c)<\/td>\n<td>\u062a\u0641\u0627\u0639\u0644 \u0627\u0644\u0642\u0627\u0639\u062f\u0629 11<\/td>\n<td>\u064a\u0645\u0643\u0646 \u0623\u0646 \u064a\u0624\u062f\u064a \u062e\u0637\u0631 \u0627\u0644\u0628\u0631\u0645\u062c\u064a\u0627\u062a \u0625\u0644\u0649 \u0631\u0641\u0639 \u0627\u0644\u0636\u0648\u0627\u0628\u0637\u060c \u0648\u0644\u0627 \u064a\u0632\u0627\u0644 \u064a\u0646\u0637\u0628\u0642 \u0646\u0641\u0633 \u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u062c\u0647\u0627\u0632<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>\u0646\u0642\u0637\u0629 \u0631\u0626\u064a\u0633\u064a\u0629:<\/strong> \u0625\u0646 <strong>\u0627\u0644\u0642\u0627\u0639\u062f\u0629 \u0627\u0644\u0623\u0643\u062b\u0631 \u0635\u0631\u0627\u0645\u0629 \u0627\u0644\u0645\u0637\u0628\u0642\u0629<\/strong> \u062a\u062d\u0643\u0645 \u0641\u064a \u0627\u0644\u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0646\u0647\u0627\u0626\u064a. \u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u062a\u0628\u0631\u064a\u0631 \u0627\u0644\u062a\u0635\u0646\u064a\u0641 \u0628\u0623\u0633\u0627\u0633 \u0631\u0633\u0645\u064a \u0644\u0644\u0645\u0644\u062d\u0642 \u0627\u0644\u062b\u0627\u0645\u0646 \u0641\u064a \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0641\u0646\u064a\u0629\u060c \u0648\u0627\u0644\u0639\u062f\u064a\u062f \u0645\u0646\u0647\u0627 \u064a\u0633\u062a\u062e\u062f\u0645 <a href=\"https:\/\/www.compliancegate.com\/medical-device-classes-european-union\/\">\u0625\u0631\u0634\u0627\u062f\u0627\u062a \u0639\u0645\u0644\u064a\u0629 \u0644\u0641\u0626\u0629 MDR \u0644\u0644\u0645\u0635\u0646\u0639\u064a\u0646 \u0648\u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u064a\u0646 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a<\/a> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup> \u0643\u0646\u0642\u0637\u0629 \u0627\u0646\u0637\u0644\u0627\u0642.<\/p>\n<hr \/>\n<h2>\u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u0645\u0634\u062a\u0631\u064a\u0646 \u0627\u0644\u0630\u064a\u0646 \u064a\u0635\u062f\u0631\u0648\u0646 \u0625\u0644\u0649 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u060c \u0645\u0627 \u0647\u064a \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0648\u0636\u0639 \u0639\u0644\u0627\u0645\u0629 CE\/\u0627\u0644\u0645\u0644\u0641 \u0627\u0644\u0641\u0646\u064a \u0627\u0644\u062a\u064a \u062a\u0646\u0637\u0628\u0642 \u0639\u0644\u0649 \u0647\u0630\u0647 \u0627\u0644\u0641\u0626\u0627\u062a\u061f<\/h2>\n<p>\u064a\u062a\u0637\u0644\u0628 \u0648\u0636\u0639 \u0639\u0644\u0627\u0645\u0629 CE \u0628\u0645\u0648\u062c\u0628 MDR <strong>\u0647\u064a\u0626\u0629 \u0645\u064f\u062e\u0637\u0631 \u0628\u0647\u0627<\/strong> \u0644\u0644\u0641\u0626\u0627\u062a IIa\/IIb\/III. \u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0634\u062a\u0631\u064a\u0646 \u062a\u0648\u0642\u0639 \u062d\u0632\u0645\u0629 \u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0643\u0627\u0645\u0644\u0629 \u0645\u0631\u062a\u0628\u0637\u0629 \u0628\u0627\u0644\u0646\u0645\u0648\u0630\u062c \u0627\u0644\u062f\u0642\u064a\u0642 \u0648\u0627\u0644\u062e\u064a\u0627\u0631\u0627\u062a \u0648\u0627\u0644\u0645\u0644\u062d\u0642\u0627\u062a (\u0645\u062b\u0644 \u0645\u0642\u0627\u0628\u0636 \u0627\u0644\u0623\u064a\u062f\u064a\u060c \u0648\u0627\u0644\u0631\u0624\u0648\u0633\u060c \u0648\u0627\u0644\u0643\u0627\u0628\u0644\u0627\u062a)\u060c \u0645\u0633\u062a\u0646\u064a\u0631\u0629 \u0628\u0640 <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en\">\u0625\u0631\u0634\u0627\u062f\u0627\u062a \u0645\u062f\u0639\u0648\u0645\u0629 \u0645\u0646 MDCG \u0648\u0648\u062b\u0627\u0626\u0642 \u0645\u0641\u064a\u062f\u0629 \u0644\u062a\u0646\u0641\u064a\u0630 MDR<\/a> <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup>.<\/p>\n<p><strong>\u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0623\u062c\u0647\u0632\u0629 ESWT \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 IIa\/IIb\u060c \u062a\u0648\u0642\u0639 \u0634\u0647\u0627\u062f\u0629 EU MDR \u0635\u0627\u0644\u062d\u0629 \u0645\u0646 \u0647\u064a\u0626\u0629 \u0645\u0639\u062a\u0645\u062f\u0629\u060c \u0648\u0625\u0639\u0644\u0627\u0646 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629\u060c \u0648\u0648\u062b\u0627\u0626\u0642 \u0641\u0646\u064a\u0629 \u0643\u0627\u0645\u0644\u0629: \u0642\u0627\u0626\u0645\u0629 \u062a\u062f\u0642\u064a\u0642 GSPR\u060c \u0648\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 (ISO 14971)\u060c \u0648\u062a\u0642\u0631\u064a\u0631 \u0627\u0644\u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u060c \u0648\u062e\u0637\u0629\/\u062a\u0642\u0627\u0631\u064a\u0631 PMCF\u060c \u0648\u062e\u0637\u0629 PMS\u060c \u0648 IFU\/\u0645\u0644\u0635\u0642\u0627\u062a\u060c \u0648\u062a\u0639\u064a\u064a\u0646\u0627\u062a UDI \u0645\u0633\u062c\u0644\u0629 \u0641\u064a EUDAMED.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/3a-high-end-tabletop-scene-displaying-a-complete-md.jpg\" alt=\"\u062c\u0647\u0627\u0632 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0645\u0639 \u0648\u062b\u0627\u0626\u0642 \u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0639\u0644\u0649 \u0637\u0627\u0648\u0644\u0629 (ID#3)\" title=\"\u0627\u0644\u0623\u0648\u0631\u0627\u0642 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629\" \/><\/p>\n<h3>\u0627\u0644\u062c\u062f\u0648\u0644 2 \u2014 \u0639\u0646\u0627\u0635\u0631 \u0645\u0644\u0641 CE \/ \u0627\u0644\u0641\u0646\u064a \u0627\u0644\u062a\u064a \u064a\u062c\u0628 \u0623\u0646 \u064a\u0631\u0627\u0647\u0627 \u0627\u0644\u0645\u0634\u062a\u0631\u0648\u0646 (\u0645\u0643\u062b\u0641\u0629)<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0644\u0628\u0646\u062f<\/th>\n<th>\u0645\u0627 \u0627\u0644\u0630\u064a \u062a\u0628\u062d\u062b \u0639\u0646\u0647<\/th>\n<th>\u0627\u0644\u0645\u0644\u0627\u062d\u0638\u0627\u062a<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>\u0634\u0647\u0627\u062f\u0629 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u0639\u062a\u0645\u062f\u0629 (EU MDR \u0627\u0644\u0645\u0627\u062f\u0629 56)<\/strong><\/td>\n<td>\u0627\u0633\u0645 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u0639\u062a\u0645\u062f\u0629\u060c \u0631\u0642\u0645 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u0639\u062a\u0645\u062f\u0629\u060c \u0646\u0637\u0627\u0642 \u064a\u062f\u0631\u062c \u0646\u0645\u0648\u0630\u062c\u0643 \u0627\u0644\u062f\u0642\u064a\u0642 \u0648\u0645\u0644\u062d\u0642\u0627\u062a\u0647<\/td>\n<td>\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0625\u0635\u062f\u0627\u0631\u060c \u0648\u062a\u0627\u0631\u064a\u062e \u0627\u0644\u0627\u0646\u062a\u0647\u0627\u0621\u060c \u0648\u062a\u063a\u064a\u064a\u0631\u0627\u062a \u0627\u0644\u0634\u0647\u0627\u062f\u0629<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0625\u0639\u0644\u0627\u0646 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629 \u0644\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a<\/strong><\/td>\n<td>\u064a\u0634\u064a\u0631 \u0625\u0644\u0649 MDR\u060c \u0648\u0641\u0626\u0629 \u0627\u0644\u062c\u0647\u0627\u0632\u060c \u0648\u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631 (\u0645\u062b\u0644 EN 60601-1\/-1-2)<\/td>\n<td>\u062a\u0648\u0642\u064a\u0639 \u0642\u0627\u0646\u0648\u0646\u064a \u0648\u062a\u0627\u0631\u064a\u062e \u062d\u0627\u0644\u064a<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0642\u0627\u0626\u0645\u0629 \u062a\u062f\u0642\u064a\u0642 GSPR<\/strong><\/td>\n<td>\u062a\u062a\u0628\u0639 \u0627\u0644\u0645\u0644\u062d\u0642 \u0627\u0644\u0623\u0648\u0644 \u0644\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0648\u0636\u0648\u0627\u0628\u0637 \u0627\u0644\u062a\u0635\u0645\u064a\u0645<\/td>\n<td>\u0625\u0634\u0627\u0631\u0629 \u0645\u0631\u062c\u0639\u064a\u0629 \u0645\u0639 \u0627\u0644\u062a\u0642\u0627\u0631\u064a\u0631<\/td>\n<\/tr>\n<tr>\n<td><strong>\u062a\u0642\u0631\u064a\u0631 \u0627\u0644\u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u0633\u0631\u064a\u0631\u064a (CER)<\/strong><\/td>\n<td>\u0627\u0644\u0623\u062f\u0628\u064a\u0627\u062a \u0648\/\u0623\u0648 \u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0627\u0644\u062a\u064a \u062a\u062f\u0639\u0645 \u0627\u0644\u0645\u0637\u0627\u0644\u0628\u0627\u062a<\/td>\n<td>\u062e\u0637\u0629 PMCF \u0639\u0646\u062f \u0648\u062c\u0648\u062f \u0641\u062c\u0648\u0627\u062a \u0641\u064a \u0627\u0644\u0623\u062f\u0644\u0629<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0645\u0644\u0641 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631<\/strong><\/td>\n<td>\u0639\u0645\u0644\u064a\u0629 ISO 14971\u061b \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0627\u0644\u0645\u0631\u062a\u0628\u0637\u0629 \u0628\u0627\u0644\u062a\u062d\u0642\u0642\/\u0627\u0644\u062a\u0635\u062f\u064a\u0642<\/td>\n<td>\u064a\u0634\u0645\u0644 \u0645\u062e\u0627\u0637\u0631 \u0627\u0644\u0637\u0627\u0642\u0629 \u0648\u0627\u0644\u062c\u0631\u0639\u0629<\/td>\n<\/tr>\n<tr>\n<td><strong>PMS\/PSUR<\/strong><\/td>\n<td>\u062e\u0637\u0629 PMS\u061b PSUR \u0644\u0644\u0625\u064a\u0642\u0627\u0639 IIa\/IIb<\/td>\n<td>\u062d\u0644\u0642\u0629 \u0627\u0644\u062a\u063a\u0630\u064a\u0629 \u0627\u0644\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0645\u064a\u062f\u0627\u0646\u064a\u0629 \u0645\u062d\u062f\u062f\u0629<\/td>\n<\/tr>\n<tr>\n<td><strong>IFU\/\u0648\u0636\u0639 \u0627\u0644\u0639\u0644\u0627\u0645\u0627\u062a\/UDI<\/strong><\/td>\n<td>\u062a\u0639\u064a\u064a\u0646 UDI-DI\u060c \u0627\u0644\u0631\u0645\u0648\u0632\u060c \u0645\u062c\u0645\u0648\u0639\u0629 \u0627\u0644\u0644\u063a\u0627\u062a<\/td>\n<td>EUDAMED SRN \u0644\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629<\/strong><\/td>\n<td>EN 60601-1\u060c EN 60601-1-2\u060c \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u062d\u064a\u0648\u064a (ISO 10993) \u0639\u0646\u062f \u0627\u0644\u0627\u0642\u062a\u0636\u0627\u0621<\/td>\n<td>\u0648\u0636\u0639 \u0639\u0644\u0627\u0645\u0627\u062a EMC \u0644\u0628\u064a\u0626\u0629 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>\u0645\u0633\u0627\u0631 \u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629:<\/strong> \u062a\u0633\u062a\u062e\u062f\u0645 \u0627\u0644\u0641\u0626\u0629 IIa\/IIb \u0639\u0627\u062f\u0629\u064b <strong>\u0627\u0644\u0645\u0644\u062d\u0642 IX (\u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 + \u0648\u062b\u0627\u0626\u0642 \u0641\u0646\u064a\u0629)<\/strong> \u0623\u0648 <strong>\u0627\u0644\u0645\u0644\u062d\u0642 XI<\/strong> \u0627\u0644\u0645\u062a\u063a\u064a\u0631\u0627\u062a\u061b \u064a\u062c\u0628 \u0623\u0646 \u062a\u0630\u0643\u0631 \u0634\u0647\u0627\u062f\u0629 NB \u0627\u0644\u062e\u0627\u0635\u0629 \u0628\u0643 \u0627\u0644\u0645\u0633\u0627\u0631.<\/p>\n<hr \/>\n<h2>\u0645\u0627 \u0647\u064a \u062e\u0637\u0648\u0627\u062a \u0627\u0644\u0639\u0646\u0627\u064a\u0629 \u0627\u0644\u0648\u0627\u062c\u0628\u0629 \u0627\u0644\u062a\u064a \u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u064a\u0646 \u0627\u062a\u062e\u0627\u0630\u0647\u0627 \u0641\u064a\u0645\u0627 \u064a\u062a\u0639\u0644\u0642 \u0628\u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u0645\u0648\u0631\u062f \u0644\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDR)\u061f<\/h2>\n<p>\u064a\u062a\u062d\u0645\u0644 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u0648\u0646 \u0648\u0627\u0644\u0645\u0648\u0632\u0639\u0648\u0646 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0627\u0644\u062a\u0632\u0627\u0645\u0627\u062a \u0642\u0627\u0646\u0648\u0646\u064a\u0629 (\u0627\u0644\u0645\u0627\u062f\u062a\u0627\u0646 13-14 \u0645\u0646 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629). \u0627\u0644\u0639\u0646\u0627\u064a\u0629 \u0627\u0644\u0648\u0627\u062c\u0628\u0629 \u062a\u062d\u0645\u064a \u0627\u0644\u0648\u0635\u0648\u0644 \u0625\u0644\u0649 \u0627\u0644\u0633\u0648\u0642 \u0648\u062a\u0642\u0644\u0644 \u0645\u0646 \u0627\u0644\u0645\u0633\u0624\u0648\u0644\u064a\u0629 \u0628\u0645\u0627 \u064a\u062a\u0645\u0627\u0634\u0649 \u0645\u0639 <a href=\"https:\/\/www.medical-device-regulation.eu\/2019\/07\/08\/mdr-article-13-general-obligations-of-importers\/\">\u0627\u0644\u0645\u0627\u062f\u0629 13 \u0627\u0644\u0627\u0644\u062a\u0632\u0627\u0645\u0627\u062a \u0627\u0644\u0639\u0627\u0645\u0629 \u0644\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u064a\u0646 \u0628\u0645\u0648\u062c\u0628 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/a> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup>.<\/p>\n<p><strong>\u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u064a\u0646 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0623\u0635\u0627\u0644\u0629 \u0634\u0647\u0627\u062f\u0629 NB\u060c \u0648\u0645\u0637\u0627\u0628\u0642\u0629 \u0647\u0648\u064a\u0627\u062a \u0627\u0644\u0646\u0645\u0627\u0630\u062c\u060c \u0648\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 UDI\/\u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a\u060c \u0648\u062a\u0623\u0643\u064a\u062f \u062a\u0641\u0627\u0635\u064a\u0644 \u0627\u0644\u0645\u0634\u063a\u0644 \u0627\u0644\u0627\u0642\u062a\u0635\u0627\u062f\u064a\u060c \u0648\u0627\u0644\u0627\u062d\u062a\u0641\u0627\u0638 \u0628\u0646\u0633\u062e \u0645\u0646 \u0625\u0639\u0644\u0627\u0646 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629 \u0648\u0627\u0644\u0634\u0647\u0627\u062f\u0627\u062a. \u0625\u0646\u0634\u0627\u0621 \u0645\u0633\u0627\u0631 \u064a\u0642\u0638\u0629 \u0644\u0644\u0634\u0643\u0627\u0648\u0649 \u0648\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0645\u064a\u062f\u0627\u0646\u064a\u0629\u060c \u0648\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u062a\u0633\u062c\u064a\u0644\u0627\u062a EUDAMED \u0648\u062a\u0641\u0627\u0635\u064a\u0644 PRRC\u060c \u0628\u0627\u0633\u062a\u062e\u062f\u0627\u0645 <a href=\"https:\/\/casusconsulting.com\/eu-importer-requirements-article-13-the-mdr-ivdr\/\">\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f \u0627\u0644\u062a\u0641\u0635\u064a\u0644\u064a\u0629 \u0648\u0627\u0644\u0623\u0633\u0626\u0644\u0629 \u0627\u0644\u0634\u0627\u0626\u0639\u0629 \u0628\u0645\u0648\u062c\u0628 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\/\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u062a\u0634\u062e\u064a\u0635\u064a\u0629 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a\u0629 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a<\/a> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup> \u0643\u0642\u0627\u0626\u0645\u0629 \u0645\u0631\u062c\u0639\u064a\u0629 \u0639\u0645\u0644\u064a\u0629.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/4a-professional-office-scene-showing-an-eu-importer.jpg\" alt=\"\u0645\u0633\u062a\u0648\u0631\u062f \u064a\u0631\u0627\u062c\u0639 \u0645\u0644\u0641\u0627\u062a \u0627\u0644\u0634\u0647\u0627\u062f\u0627\u062a \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u062a\u062c\u0645\u064a\u0644\u064a\u0629 (ID#4)\" title=\"\u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0634\u0647\u0627\u062f\u0627\u062a\" \/><\/p>\n<h3>\u0627\u0644\u062c\u062f\u0648\u0644 3 - \u0642\u0627\u0626\u0645\u0629 \u0645\u0631\u062c\u0639\u064a\u0629 \u0644\u0644\u0639\u0646\u0627\u064a\u0629 \u0627\u0644\u0648\u0627\u062c\u0628\u0629 \u0644\u0644\u0645\u0633\u062a\u0648\u0631\u062f (\u0646\u0633\u062e\/\u0644\u0635\u0642)<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0644\u062a\u062d\u0643\u0645<\/th>\n<th>\u0643\u064a\u0641\u064a\u0629 \u0627\u0644\u062a\u062d\u0642\u0642<\/th>\n<th>\u0639\u0644\u0627\u0645\u0627\u062a \u062d\u0645\u0631\u0627\u0621<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0635\u0644\u0627\u062d\u064a\u0629 \u0634\u0647\u0627\u062f\u0629 NB<\/td>\n<td>\u062a\u062d\u0642\u0642 \u0645\u0646 \u0631\u0642\u0645 NB\u061b \u0623\u0643\u062f \u0645\u0639 \u0645\u0648\u0642\u0639\/\u0642\u0627\u0639\u062f\u0629 \u0628\u064a\u0627\u0646\u0627\u062a NB<\/td>\n<td>\u0627\u0644\u0634\u0647\u0627\u062f\u0629 \u062a\u0633\u0631\u062f \u0639\u0627\u0626\u0644\u0629 \u0646\u0645\u0627\u0630\u062c \u0645\u062e\u062a\u0644\u0641\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u0625\u0639\u0644\u0627\u0646 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629<\/td>\n<td>\u062a\u062d\u0642\u0642 \u0645\u0646 \u0623\u0631\u0642\u0627\u0645 \u0627\u0644\u0623\u062c\u0632\u0627\u0621 \u0648\u0627\u0644\u062e\u064a\u0627\u0631\u0627\u062a \u0648\u0627\u0644\u0645\u0644\u062d\u0642\u0627\u062a<\/td>\n<td>\u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0645\u0641\u0642\u0648\u062f\u0629 \u0623\u0648 \u0627\u0644\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u062e\u0627\u0637\u0626\u0629 \u0627\u0644\u0645\u0630\u0643\u0648\u0631\u0629<\/td>\n<\/tr>\n<tr>\n<td>UDI \u0648\u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a<\/td>\n<td>\u062a\u062d\u0642\u0642 \u0645\u0646 UDI-DI \u0648 UDI-DI \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u061b \u0627\u0644\u0644\u063a\u0629 \u0627\u0644\u0645\u062d\u062f\u062f\u0629 \u0644\u0644\u062f\u0648\u0644\u0629 \u0627\u0644\u0639\u0636\u0648 \u0627\u0644\u0645\u0633\u062a\u0647\u062f\u0641\u0629<\/td>\n<td>UDI \u063a\u064a\u0631 \u0645\u0637\u0628\u0648\u0639\u061b \u0627\u0633\u0645 \u0627\u0644\u062c\u0647\u0627\u0632 \u063a\u064a\u0631 \u0645\u062a\u0637\u0627\u0628\u0642<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0645\u0634\u063a\u0644\u0648\u0646 \u0627\u0644\u0627\u0642\u062a\u0635\u0627\u062f\u064a\u0648\u0646<\/td>\n<td>\u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629\u060c \u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f\u060c \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f \u0645\u0639\u0631\u0641\u0648\u0646 \u0628\u0639\u0646\u0627\u0648\u064a\u0646\u0647\u0645<\/td>\n<td>\u0645\u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0627\u0644\u0645\u0639\u062a\u0645\u062f \u0645\u0641\u0642\u0648\u062f\u061b \u0639\u0646\u0627\u0648\u064a\u0646 \u0648\u0647\u0645\u064a\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u062a\u0639\u0644\u064a\u0645\u0627\u062a \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0648\u0627\u0644\u0645\u0637\u0627\u0644\u0628\u0627\u062a<\/td>\n<td>\u0627\u0644\u0645\u0637\u0627\u0644\u0628\u0627\u062a \u062a\u062a\u0645\u0627\u0634\u0649 \u0645\u0639 \u0646\u0637\u0627\u0642 \u0634\u0647\u0627\u062f\u0629 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 (CER) \u0648\u0627\u0644\u0634\u0647\u0627\u062f\u0629<\/td>\n<td>\u0627\u0644\u062a\u0633\u0648\u064a\u0642 \u062e\u0627\u0631\u062c \u0627\u0644\u0646\u0637\u0627\u0642\u060c \u0627\u0644\u0645\u0637\u0627\u0644\u0628\u0627\u062a \u0627\u0644\u062c\u0645\u0627\u0644\u064a\u0629 \u063a\u064a\u0631 \u0645\u063a\u0637\u0627\u0629<\/td>\n<\/tr>\n<tr>\n<td>\u0645\u0631\u0627\u0642\u0628\u0629 \u0645\u0627 \u0628\u0639\u062f \u0627\u0644\u062a\u0633\u0648\u064a\u0642 \/ \u0627\u0644\u064a\u0642\u0638\u0629<\/td>\n<td>\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u062a\u0634\u063a\u064a\u0644 \u0627\u0644\u0642\u064a\u0627\u0633\u064a\u0629 \u0644\u0644\u0645\u0648\u0631\u062f \u0644\u0644\u0634\u0643\u0627\u0648\u0649\u060c \u0625\u062f\u0627\u0631\u0629 \u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u0644\u0623\u0639\u0637\u0627\u0644 \u0627\u0644\u062e\u0637\u064a\u0631\u0629 (FSN) \/ \u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u0644\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u062a\u0635\u062d\u064a\u062d\u064a\u0629 \u0648\u0627\u0644\u0648\u0642\u0627\u0626\u064a\u0629 (FSCA)<\/td>\n<td>\u0644\u0627 \u062a\u0648\u062c\u062f \u0639\u0645\u0644\u064a\u0629 \u0645\u0648\u062b\u0642\u0629 \u0623\u0648 \u062c\u0647\u0627\u062a \u0627\u062a\u0635\u0627\u0644<\/td>\n<\/tr>\n<tr>\n<td>EUDAMED \/ SRN<\/td>\n<td>\u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0648\u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f \u0644\u062f\u064a\u0647\u0645\u0627 \u0623\u0631\u0642\u0627\u0645 \u062a\u0633\u062c\u064a\u0644 \u0641\u0631\u064a\u062f\u0629 (SRNs)\u061b \u0625\u062f\u062e\u0627\u0644\u0627\u062a \u0648\u062d\u062f\u0629 UDI \u062d\u0633\u0628 \u0627\u0644\u0627\u0642\u062a\u0636\u0627\u0621<\/td>\n<td>\u0644\u0627 \u064a\u0648\u062c\u062f \u0631\u0642\u0645 \u062a\u0633\u062c\u064a\u0644 \u0641\u0631\u064a\u062f (SRN)\u061b \u201c\u0627\u0644\u062a\u0633\u062c\u064a\u0644 \u0642\u064a\u062f \u0627\u0644\u0627\u0646\u062a\u0638\u0627\u0631\u201d \u0644\u0633\u0646\u0648\u0627\u062a<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u062a\u062d\u0643\u0645 \u0641\u064a \u0627\u0644\u062a\u0643\u0648\u064a\u0646<\/td>\n<td>\u0627\u0644\u062e\u064a\u0627\u0631\u0627\u062a\/\u0627\u0644\u0631\u0624\u0648\u0633\/\u0642\u0637\u0639 \u0627\u0644\u064a\u062f \u0645\u062f\u0631\u062c\u0629 \u0641\u064a \u0627\u0644\u0634\u0647\u0627\u062f\u0629<\/td>\n<td>\u0628\u064a\u0639 \u0645\u062c\u0645\u0648\u0639\u0627\u062a \u063a\u064a\u0631 \u0645\u063a\u0637\u0627\u0629 \u0628\u0627\u0644\u0646\u0637\u0627\u0642<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u0627\u0644\u062d\u0641\u0627\u0638 \u0639\u0644\u0649 \u0623 <strong>\u0627\u062a\u0641\u0627\u0642\u064a\u0629 \u0627\u0644\u0648\u0635\u0648\u0644 \u0625\u0644\u0649 \u0627\u0644\u0645\u0644\u0641 \u0627\u0644\u0641\u0646\u064a<\/strong> \u062d\u062a\u0649 \u062a\u062a\u0645\u0643\u0646 \u0645\u0646 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0623\u062f\u0644\u0629 \u0645\u0633\u062a\u0647\u062f\u0641\u0629 \u0628\u0645\u0648\u062c\u0628 \u0627\u062a\u0641\u0627\u0642\u064a\u0629 \u0639\u062f\u0645 \u0627\u0644\u0625\u0641\u0635\u0627\u062d \u0623\u062b\u0646\u0627\u0621 \u0639\u0645\u0644\u064a\u0627\u062a \u0627\u0644\u062a\u062f\u0642\u064a\u0642 \u0623\u0648 \u0627\u0644\u0645\u0646\u0627\u0642\u0635\u0627\u062a.<\/p>\n<hr \/>\n<h2>\u0647\u0644 \u062a\u0648\u062c\u062f \u0627\u062e\u062a\u0644\u0627\u0641\u0627\u062a \u0641\u064a \u0627\u0644\u062a\u0635\u0646\u064a\u0641\/\u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0628\u064a\u0646 \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0634\u0639\u0627\u0639\u064a\u0629 \u0648\u0627\u0644\u0645\u0631\u0643\u0651\u0632\u0629\u061f<\/h2>\n<p>\u0643\u0644\u0627\u0647\u0645\u0627 <strong>\u0623\u062c\u0647\u0632\u0629 \u0637\u0627\u0642\u0629 \u0646\u0634\u0637\u0629 \u063a\u064a\u0631 \u0642\u0627\u0628\u0644\u0629 \u0644\u0644\u0632\u0631\u0639<\/strong>, \u060c \u0648\u0644\u0643\u0646 \u0627\u0642\u062a\u0631\u0627\u0646 \u0627\u0644\u0637\u0627\u0642\u0629 \u0648\u0627\u0644\u063a\u0631\u0636 \u0627\u0644\u0645\u0642\u0635\u0648\u062f \u064a\u062e\u062a\u0644\u0641\u0627\u0646. \u064a\u0631\u0643\u0632 \u0627\u0644\u0645\u0646\u0638\u0645\u0648\u0646 \u0639\u0644\u0649 <strong>\u0627\u0644\u0645\u062e\u0627\u0637\u0631<\/strong>, \u060c \u0648\u0644\u064a\u0633 \u0627\u0644\u0639\u0644\u0627\u0645\u0627\u062a \u0627\u0644\u062a\u062c\u0627\u0631\u064a\u0629\u061b \u0641\u0647\u0645 \u064a\u0637\u0628\u0642\u0648\u0646 \u0646\u0641\u0633 \u0642\u0648\u0627\u0639\u062f \u0627\u0644\u0645\u0644\u062d\u0642 \u0627\u0644\u062b\u0627\u0645\u0646 \u0627\u0644\u0645\u0644\u062e\u0635\u0629 \u0641\u064a <a href=\"https:\/\/reguverse.com\/documentation\/eu-mdr-indexing\/classification\/\">\u0645\u0644\u0627\u062d\u0638\u0627\u062a \u062a\u0635\u0646\u064a\u0641 ReguVerse MDR<\/a> <sup><a href=\"#footnote-10\" id=\"ref-10\">10<\/a><\/sup>.<\/p>\n<p><strong>\u063a\u0627\u0644\u0628\u064b\u0627 \u0645\u0627 \u062a\u0628\u0631\u0631 \u0627\u0644\u0623\u0646\u0638\u0645\u0629 \u0627\u0644\u0634\u0639\u0627\u0639\u064a\u0629 (\u0645\u0648\u062c\u0627\u062a \u0636\u063a\u0637 \u0623\u0648\u0633\u0639 \u0648\u0633\u0637\u062d\u064a\u0629) \u0627\u0644\u0641\u0626\u0629 IIa \u0644\u0645\u0624\u0634\u0631\u0627\u062a \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0648\u0627\u0644\u0639\u0638\u0627\u0645 \u0648\u0627\u0644\u0647\u064a\u0643\u0644 \u0627\u0644\u0639\u0638\u0645\u064a\u060c \u0628\u064a\u0646\u0645\u0627 \u062a\u0642\u0639 \u0627\u0644\u0623\u0646\u0638\u0645\u0629 \u0627\u0644\u0645\u0631\u0643\u0632\u0629 - \u062e\u0627\u0635\u0629 \u0645\u0639 \u0627\u062f\u0639\u0627\u0621\u0627\u062a \u0623\u0639\u0645\u0642 \u0623\u0648 \u0634\u0628\u064a\u0647\u0629 \u0628\u062a\u0641\u062a\u064a\u062a \u0627\u0644\u062d\u0635\u0648\u0627\u062a - \u0628\u0634\u0643\u0644 \u0623\u0643\u062b\u0631 \u0634\u064a\u0648\u0639\u064b\u0627 \u0641\u064a \u0627\u0644\u0641\u0626\u0629 IIb. \u064a\u0639\u062a\u0645\u062f \u0627\u0644\u062a\u0635\u0646\u064a\u0641 \u0639\u0644\u0649 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0645\u0642\u0635\u0648\u062f\u060c \u0648\u0643\u062b\u0627\u0641\u0629 \u0627\u0644\u0637\u0627\u0642\u0629\u060c \u0648\u0627\u0644\u0639\u0645\u0642\u060c \u0648\u0627\u0644\u0623\u062f\u0644\u0629 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0627\u0644\u062a\u064a \u062a\u062f\u0639\u0645 \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0623\u062f\u0627\u0621.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/5a-close-up-of-a-focused-eswt-device-interface-that.jpg\" alt=\"\u0648\u0627\u062c\u0647\u0629 \u0645\u0642\u0631\u0628\u0629 \u0644\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\u062d\u062f\u064a\u062b \u0641\u064a \u0627\u0644\u0639\u064a\u0627\u062f\u0629 (ID#5)\" title=\"\u0648\u0627\u062c\u0647\u0629 \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629\" \/><\/p>\n<h3>\u0627\u0644\u062c\u062f\u0648\u0644 4 - \u0634\u0639\u0627\u0639\u064a \u0645\u0642\u0627\u0628\u0644 \u0645\u0631\u0643\u0632: \u0627\u0639\u062a\u0628\u0627\u0631\u0627\u062a \u062a\u0646\u0638\u064a\u0645\u064a\u0629 (\u0645\u0639\u0645\u0645\u0629)<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u062c\u0627\u0646\u0628<\/th>\n<th>\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0634\u0639\u0627\u0639\u064a\u0629<\/th>\n<th>\u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0645\u0631\u0643\u0632\u0629<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0645\u0644\u0641 \u0627\u0644\u0637\u0627\u0642\u0629<\/td>\n<td>\u0637\u0627\u0642\u0629 \u0628\u0624\u0631\u064a\u0629 \u0623\u0648\u0633\u0639 \u0648\u0623\u0642\u0644 \u0630\u0631\u0648\u0629<\/td>\n<td>\u0637\u0627\u0642\u0629 \u0628\u0624\u0631\u064a\u0629 \u0623\u0639\u0644\u0649\u060c \u0648\u0635\u0648\u0644 \u0623\u0639\u0645\u0642<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u062f\u0639\u0627\u0621\u0627\u062a \u0646\u0645\u0648\u0630\u062c\u064a\u0629<\/td>\n<td>\u062a\u062e\u0641\u064a\u0641 \u0622\u0644\u0627\u0645 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0648\u0627\u0644\u0639\u0638\u0627\u0645\u060c \u0627\u0644\u062a\u0647\u0627\u0628 \u0627\u0644\u0623\u0648\u062a\u0627\u0631\u060c \u062a\u0646\u0639\u064a\u0645 \u0627\u0644\u0633\u064a\u0644\u0648\u0644\u064a\u062a<\/td>\n<td>\u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0648\u0627\u0644\u0639\u0638\u0627\u0645\u060c \u062a\u062d\u0641\u064a\u0632 \u0627\u0644\u0639\u0638\u0627\u0645\u060c \u0627\u0644\u0623\u0648\u062a\u0627\u0631 \u0627\u0644\u0635\u0639\u0628\u0629\u061b \u0628\u0639\u0636 \u0627\u0644\u0623\u0646\u0638\u0645\u0629 \u0642\u0631\u064a\u0628\u0629 \u0645\u0646 \u0646\u0637\u0627\u0642\u0627\u062a \u062a\u0641\u062a\u064a\u062a \u0627\u0644\u062d\u0635\u0648\u0627\u062a<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u0645\u062d\u062a\u0645\u0644\u0629 (\u062a\u0648\u0636\u064a\u062d\u064a\u0629)<\/td>\n<td>IIa \u2192 IIb (\u0642\u0627\u0626\u0645 \u0639\u0644\u0649 \u0627\u0644\u0645\u062e\u0627\u0637\u0631)<\/td>\n<td>IIb \u0623\u0643\u062b\u0631 \u0634\u064a\u0648\u0639\u064b\u0627<\/td>\n<\/tr>\n<tr>\n<td>\u0639\u0628\u0621 \u0627\u0644\u0623\u062f\u0644\u0629<\/td>\n<td>\u0627\u0644\u0623\u062f\u0628\u064a\u0627\u062a + \u0645\u0639\u0627\u062f\u0644\u0629 \u0627\u0644\u0623\u062f\u0627\u0621<\/td>\n<td>CER \u0623\u0642\u0648\u0649\u060c \u063a\u0627\u0644\u0628\u064b\u0627 \u0645\u0627 \u064a\u064f\u062a\u0648\u0642\u0639 PMCF<\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u062a\u0631\u0643\u064a\u0632 \u0639\u0644\u0649 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631<\/td>\n<td>\u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0643\u0647\u0631\u0648\u0645\u063a\u0646\u0627\u0637\u064a\u0633\u064a\u060c \u0627\u0644\u0623\u062f\u0627\u0621 \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u060c \u0633\u0647\u0648\u0644\u0629 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645<\/td>\n<td>\u0627\u0644\u062a\u062d\u0642\u0642 \u0627\u0644\u0625\u0636\u0627\u0641\u064a \u0645\u0646 \u0627\u0644\u0623\u062f\u0627\u0621 \u0628\u0639\u0645\u0642<\/td>\n<\/tr>\n<tr>\n<td>\u062f\u0642\u0629 \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a<\/td>\n<td>\u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0645\u0647\u0646\u064a\u061b \u062d\u062f\u0648\u062f \u0627\u0644\u0628\u064a\u0626\u0629<\/td>\n<td>\u062a\u062d\u0630\u064a\u0631\u0627\u062a \u0648\u0627\u0636\u062d\u0629 \u0644\u0644\u0623\u0639\u0636\u0627\u0621 \u0627\u0644\u062d\u0633\u0627\u0633\u0629<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>\u062a\u0646\u0628\u064a\u0647:<\/strong> \u0625\u0630\u0627 \u0643\u0627\u0646 \u062c\u0647\u0627\u0632 \u0634\u0639\u0627\u0639\u064a <strong>\u0627\u062f\u0639\u0627\u0621\u0627\u062a \u0627\u0644\u0628\u0631\u0627\u0645\u062c<\/strong> \u0623\u0648 <strong>\u0627\u0644\u062a\u0633\u0648\u064a\u0642<\/strong> \u0627\u0633\u062a\u0646\u062a\u0627\u062c \u062a\u0623\u062b\u064a\u0631\u0627\u062a \u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 \u0623\u0639\u0645\u0642 \u0623\u0648 \u0623\u0647\u062f\u0627\u0641 \u062d\u0648\u0644 \u0627\u0644\u0623\u0639\u0636\u0627\u0621\u060c \u064a\u0645\u0643\u0646 \u062a\u0635\u0639\u064a\u062f \u0627\u0644\u0641\u0626\u0629. <strong>\u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u0646\u0647\u0627\u0626\u064a\u0629 \u062a\u0639\u064a\u0634 \u0641\u064a \u0627\u0644\u063a\u0631\u0636 \u0627\u0644\u0645\u0642\u0635\u0648\u062f<\/strong>.<\/p>\n<hr \/>\n<h2>\u0627\u0644\u062e\u0627\u062a\u0645\u0629<\/h2>\n<p>\u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0627\u0626\u062d\u0629 MDR \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u0625\u0644\u0632\u0627\u0645\u064a\u061b; <strong>\u0627\u0644\u0641\u0626\u0629 IIb \u0623\u0648 III \u0644\u064a\u0633\u062a \u0645\u0637\u0644\u0648\u0628\u0629 \u062a\u0644\u0642\u0627\u0626\u064a\u064b\u0627<\/strong> \u0644\u062c\u0645\u064a\u0639 \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629. \u0645\u0639\u0638\u0645 \u0623\u0646\u0638\u0645\u0629 ESWT \u0647\u064a <strong>\u0627\u0644\u0641\u0626\u0629 IIa \u0623\u0648 IIb<\/strong> \u0627\u0639\u062a\u0645\u0627\u062f\u064b\u0627 \u0639\u0644\u0649 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0645\u0642\u0635\u0648\u062f \u0648\u0645\u0644\u0641 \u0627\u0644\u0637\u0627\u0642\u0629. \u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0634\u062a\u0631\u064a\u0646 \u0627\u0644\u0645\u0637\u0627\u0644\u0628\u0629 \u0628\u0634\u0647\u0627\u062f\u0627\u062a NB\u060c \u0648 DoC\u060c \u0648 UDI\/\u0648\u0636\u0639 \u0627\u0644\u0639\u0644\u0627\u0645\u0627\u062a\u060c \u0648 CER\u060c \u0648\u0645\u0644\u0641\u0627\u062a \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0627\u0644\u062a\u064a <strong>\u062a\u062a\u0637\u0627\u0628\u0642 \u0645\u0639 \u0627\u0644\u0646\u0645\u0648\u0630\u062c \u0648\u0627\u0644\u0627\u062f\u0639\u0627\u0621\u0627\u062a \u0627\u0644\u062f\u0642\u064a\u0642\u0629<\/strong>\u2014 \u0648\u062a\u0623\u0643\u064a\u062f \u0623\u0646 \u0627\u0644\u0645\u0624\u0634\u0631\u0627\u062a \u0627\u0644\u0634\u0639\u0627\u0639\u064a\u0629 \u0623\u0648 \u0627\u0644\u0645\u0631\u0643\u0632\u0629 \u062a\u062a\u0645\u0627\u0634\u0649 \u0645\u0639 \u0627\u0644\u0646\u0637\u0627\u0642 \u0627\u0644\u0645\u0639\u062a\u0645\u062f.<\/p>\n<hr \/>\n<h2>\u0627\u0644\u062d\u0648\u0627\u0634\u064a<\/h2>\n<p><span id=\"footnote-1\">1. \u0646\u0635 \u0645\u0648\u062d\u062f \u063a\u064a\u0631 \u0631\u0633\u0645\u064a \u0644\u0644\u0645\u0644\u062d\u0642 \u0627\u0644\u062b\u0627\u0645\u0646 \u0645\u0646 MDR \u0645\u0639 \u0642\u0648\u0627\u0639\u062f \u0627\u0644\u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0643\u0627\u0645\u0644\u0629. <a href=\"#ref-1\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. \u0646\u0638\u0631\u0629 \u0639\u0627\u0645\u0629 \u0645\u0646 \u0627\u0644\u0645\u0641\u0648\u0636\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u0639\u0644\u0649 \u0627\u0644\u0625\u0637\u0627\u0631 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a \u0627\u0644\u062c\u062f\u064a\u062f MDR\/IVDR. <a href=\"#ref-2\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. \u0645\u0644\u062e\u0635 \u0645\u0643\u062a\u0628 \u0627\u0644\u0645\u0633\u0627\u0639\u062f\u0629 \u0627\u0644\u062e\u0627\u0635 \u0628\u0640 UDI \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0644\u0645\u0628\u0627\u062f\u0626 \u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0641\u064a MDR. <a href=\"#ref-3\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. \u0648\u062b\u064a\u0642\u0629 \u062a\u0648\u062c\u064a\u0647\u064a\u0629 MDCG 2021-24 \u0628\u0634\u0623\u0646 \u062a\u0637\u0628\u064a\u0642 \u0642\u0648\u0627\u0639\u062f \u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0645\u0644\u062d\u0642 \u0627\u0644\u062b\u0627\u0645\u0646 \u0645\u0646 MDR. <a href=\"#ref-4\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. \u0645\u0642\u0627\u0644 \u0635\u064a\u0646\u064a \u064a\u0634\u0631\u062d \u0641\u0626\u0627\u062a \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0648\u0642\u0648\u0627\u0639\u062f \u0627\u0644\u062a\u0635\u0646\u064a\u0641 \u0641\u064a MDR \u0644\u0644\u0645\u0635\u0646\u0639\u064a\u0646. <a href=\"#ref-5\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. \u062f\u0644\u064a\u0644 \u0639\u0645\u0644\u064a \u064a\u0635\u0641 \u0641\u0626\u0627\u062a MDR \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 I\u060c IIa\u060c IIb \u0648 III \u0648\u0645\u0633\u0627\u0631\u0627\u062a \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629. <a href=\"#ref-6\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. \u0641\u0647\u0631\u0633 \u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u062a\u0648\u062c\u064a\u0647 \u0627\u0644\u0645\u062f\u0639\u0648\u0645\u0629 \u0645\u0646 MDCG \u0644\u062f\u0639\u0645 \u062a\u0646\u0641\u064a\u0630 MDR. <a href=\"#ref-7\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. \u0645\u0642\u0627\u0644 \u064a\u0639\u064a\u062f \u0625\u0646\u062a\u0627\u062c \u0627\u0644\u0645\u0627\u062f\u0629 13 \u0645\u0646 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0628\u0634\u0623\u0646 \u0627\u0644\u0627\u0644\u062a\u0632\u0627\u0645\u0627\u062a \u0627\u0644\u0639\u0627\u0645\u0629 \u0644\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u064a\u0646. <a href=\"#ref-8\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. \u0646\u0638\u0631\u0629 \u0639\u0627\u0645\u0629 \u0627\u0633\u062a\u0634\u0627\u0631\u064a\u0629 \u0639\u0644\u0649 \u0627\u0644\u062a\u0632\u0627\u0645\u0627\u062a \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f \u0648\u0627\u0644\u0623\u0633\u0626\u0644\u0629 \u0627\u0644\u0634\u0627\u0626\u0639\u0629 \u0628\u0645\u0648\u062c\u0628 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\/\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u062a\u0634\u062e\u064a\u0635\u064a\u0629 \u0627\u0644\u0645\u062e\u062a\u0628\u0631\u064a\u0629 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a. <a href=\"#ref-9\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. \u0645\u0644\u0627\u062d\u0638\u0627\u062a \u062a\u0648\u0636\u064a\u062d\u064a\u0629 \u0644\u062a\u0639\u0631\u064a\u0641\u0627\u062a \u062a\u0635\u0646\u064a\u0641 \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0628\u0645\u0627 \u0641\u064a \u0630\u0644\u0643 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0639\u0644\u0627\u062c\u064a\u0629 \u0627\u0644\u0646\u0634\u0637\u0629. <a href=\"#ref-10\">\ufe0e<\/a><\/span>  <\/p>","protected":false},"excerpt":{"rendered":"<p>As the manufacturer, I am asked this in nearly every EU tender: \u201cIs Class IIb or III mandatory for shockwave systems?\u201d The real answer depends on intended purpose, energy delivery, and MDR Annex VIII rules 1\u2014not on a single, blanket class. MDR Class IIb or III is not automatically mandatory for all shockwave therapy devices. [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8387,"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-8386","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, is compliance with EU Medical Device Regulation (MDR) Class IIb or III mandatory? - 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-\u0647-6\/\" \/>\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, is compliance with EU Medical Device Regulation (MDR) Class IIb or III mandatory?\" \/>\n<meta property=\"og:description\" content=\"As the manufacturer, I am asked this in nearly every EU tender: \u201cIs Class IIb or III mandatory for shockwave systems?\u201d The real answer depends on intended purpose, energy delivery, and MDR Annex VIII rules 1\u2014not on a single, blanket class. 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