{"id":13832,"date":"2020-03-17T20:34:20","date_gmt":"2020-03-17T19:34:20","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=13832"},"modified":"2023-01-31T14:36:07","modified_gmt":"2023-01-31T13:36:07","slug":"the-mdr-emergency-kit-is-arriving-the-fastest-solution-for-economic-operators-of-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/03\/17\/the-mdr-emergency-kit-is-arriving-the-fastest-solution-for-economic-operators-of-medical-devices\/","title":{"rendered":"The MDR EMERGENCY KIT is coming: the fastest solution for Economic Operators of medical devices."},"content":{"rendered":"\r\n<p><strong>Manufacturers, Authorised Representatives, Importers, and Distributors<\/strong>of medical devices may not have yet fulfilled the obligations required by the <strong>MDR (EU) 2017\/745<\/strong> for Economic Operators.<\/p>\r\n\r\n\r\n\r\n<p>It could be hard to keep the appointments with your Consultant because of the<strong> limits due to COVID-19<\/strong>.<\/p>\r\n\r\n\r\n\r\n<p>For this reason, Thema experts suggest a rapid and effective last minute solution: <strong>MDR Emergency Kit, <\/strong>a kind of \u201cS.O.S toolbox\u201d in digital format, to solve the problem the fastest way possible.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-14009\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/03\/MDR-Emergency-Kit-EN-1024x535.png\" alt=\"\" \/><\/figure>\r\n\r\n\r\n\r\n<p>Each Kit contains <strong>template and Technical documentation, Quality System documentation, letters of delegation and Quality Technical Agreements<\/strong>, that is, essential information and concrete answers to the main doubts about the MDR\u00a0requirements.<\/p>\r\n\r\n\r\n\r\n<p><strong>By April 2, 2020 <\/strong>four different MDR Emergency Kit versions will be available. These versions have been thought for: \u00a0<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>Manufacturer <\/strong>(template letter of delegation of the Person Responsible for the compliance with the regulation, template Technical Documentation, Post-Market Surveillance procedures, Surveillance, Communications to the Regulatory Authorities, template information Note to the Dealer, Quality Technical Agreement Manufacturer\/ Dealer).\u00a0<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>Authorised Representative<\/strong> (template letter of delegationof the Person Responsible for the compliance with the regulation, Post-Market Surveillance procedures, Surveillance, Communications to the Regulatory Authorities, Quality Technical Agreement Manufacturer\/ Dealer).<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>Importer<\/strong> (procedures for Non-Compliance, CAPA, Post-Market Surveillance, Communications to the Regulatory Authorities and to the Manufacturer, Controls in acceptance of finished devices, Controls in Acceptance module).<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>Distributors <\/strong>(procedures for Non-Compliance, CAPA, Post-Market Surveillance, Communications to the Regulatory Authorities and to the Manufacturer, Controls in acceptance of finished devices, Controls in Acceptance module).<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>The Kits provide all the <strong>essential instruments to operate correctly<\/strong> in compliance with new obligations for Economic Operators.<\/p>\r\n\r\n\r\n\r\n<p>This service allows to<strong> save time and costs<\/strong>, without risking being caught unprepared at the next application date of MDR. \u00a0<\/p>\r\n\r\n\r\n\r\n<p>In case of need for further <strong>Thema qualified support<\/strong>, our experts are available for additional and customized consulting services.<\/p>\r\n\r\n\r\n\r\n<p><strong>It\u2019s already possible to book the MDR Emergency Kit. Contact us for more details and prices! <\/strong><\/p>\r\n\r\n\r\n\r\n<p>Phone 0542 643496 \/ <strong> <a href=\"sales@thema-med.com\">sales@thema-group.it<\/a><\/strong><\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Manufacturers, Authorised Representatives, Importers, and Distributorsof medical devices may not have yet fulfilled the obligations required by the MDR (EU) 2017\/745  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-13832","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO 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