{"id":14174,"date":"2020-08-18T11:33:15","date_gmt":"2020-08-18T09:33:15","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=14174"},"modified":"2022-07-27T09:21:48","modified_gmt":"2022-07-27T07:21:48","slug":"new-mdr-emergency-kit-economic-operators-medical-devices","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/new-mdr-emergency-kit-economic-operators-medical-devices\/","title":{"rendered":"MDR Emergency Kit 1"},"content":{"rendered":"\r\n<p><strong>MDR Emergency Kit: the fastest solution for Economic Operators of Medical Devices<\/strong><\/p>\r\n\r\n\r\n\r\n<p>Have you thought about how to apply the MDR (EU) 2017\/745? The limitations caused by the COVID-19 emergency do not allow you to keep all your appointments with your counsellor? Do you want to save time and costs?<\/p>\r\n\r\n\r\n\r\n<div class=\"wp-block-image\">\r\n<figure class=\"aligncenter\"><img decoding=\"async\" class=\"wp-image-14559\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/05\/MDR-Emergency-Kit-eng-1024x535.png\" alt=\"\" \/><\/figure>\r\n<\/div>\r\n\r\n\r\n\r\n<p>Thema experts propose a fast and effective solution: MDR Emergency Kit, a sort of \u201cS.O.S. toolbox\u201d in digital format to adapt quickly to the restrictive provisions of the MDR (EU) 2017\/745.<\/p>\r\n\r\n\r\n\r\n<p class=\"has-text-color has-background has-medium-font-size\" style=\"background-color: #0099a8; color: #ffffff; text-align: center;\"><strong>Templates and standard technical documents available to the customer <\/strong><\/p>\r\n\r\n<ul>\r\n<li>Standard basic template of the most important documents (QTA; PRRC letter);<\/li>\r\n<li>Technical Documentation template (technical file) with instructions for completion;<\/li>\r\n<li>Basic Quality System procedures;<\/li>\r\n<\/ul>\r\n\r\n<p class=\"has-text-color has-background has-medium-font-size\" style=\"background-color: #0099a8; color: #ffffff; text-align: center;\"><strong>Four MDR Emergency Kit versions according to specific needs <\/strong><\/p>\r\n\r\n\r\n\r\n<p>1. <strong>MANUFACTURER<\/strong>&#8211; MDR Emergency Kit<\/p>\r\n\r\n<ul>\r\n<li><em>Template <\/em>delegation letter Person Responsible for Regulatory Compliance (PRRC);<\/li>\r\n<li><em>Template <\/em>Technical Documentation (TD MDR);<\/li>\r\n<li><em>Template <\/em>Post-Market Surveillance (PMS) Procedures, Vigilance, RA Communications;<\/li>\r\n<li><em>Template<\/em> Information Note to Distributor;<\/li>\r\n<li>Quality Technical Agreement (QTA) Manufacturer\/Distributor EU.<\/li>\r\n<\/ul>\r\n\r\n<p>2. <strong>AUTHORISED REPRESENTATIVE<\/strong>&#8211; MDR Emergency Kit<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><em>Template <\/em>delegation letter Person Responsible for Regulatory Compliance PRRC (different from that of the Manufacturer);<\/li>\r\n<li>Post-Market Surveillance (PMS) procedures, Vigilance, Regulatory Authorities (RA) Communication <em>template;<\/em><\/li>\r\n<li>Quality Technical Agreement (QTA) Manufacturer\/Authorised Representative only in English.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>3. <strong>IMPORTER<\/strong> &#8211; MDR Emergency Kit<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><em>Template\u00a0<\/em>Non-Conformity procedures, CAPA, PMS, RA Communication, final MD acceptance Controls;<\/li>\r\n<li><em>Template <\/em>Acceptance Controls form.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>4. <strong>DISTRIBUTOR<\/strong> &#8211; MDR Emergency Kit<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><em>Template <\/em>Non-Conformity procedures, CAPA, Post-Market Surveillance, Regulatory Authorities (RA) and Manufacturer Communications, final Medical Devices Acceptance Controls;<\/li>\r\n<li><em>Template <\/em>Acceptance Controls form.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>The kit is available in Italian and English.<\/p>\r\n\r\n\r\n\r\n<p class=\"has-text-color has-background has-medium-font-size\" style=\"background-color: #0099a8; color: #ffffff; text-align: center;\"><strong>Advantages <\/strong><\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>time saving<\/strong>, from a basis developed by Thema experts;<\/li>\r\n<li><strong>customize, <\/strong>adapting standard content to your own reality;<\/li>\r\n<li><strong>saving consultancy costs, <\/strong>if not necessary.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p class=\"has-text-color has-background has-medium-font-size\" style=\"background-color: #0099a8; color: #ffffff; text-align: center;\"><strong>Additional service<\/strong><\/p>\r\n\r\n\r\n\r\n<p>Do you need qualified support? Do you need clarification? Thema experts remain themselves available for consulting services, even remotely.<\/p>\r\n\r\n\r\n\r\n<p class=\"has-text-color has-background has-very-dark-gray-color\" style=\"background-color: #ffbd4a;\"><strong>Contact us and receive your MDR Emergency Kit by e-mail!<br \/><\/strong>Thema Staff: t. 0542 643496 \/ <a href=\"mailto:sales@thema-med.com\">sales@thema-med.com<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>MDR Emergency Kit: the fastest solution for Economic Operators of Medical Devices Have you thought about how to apply the MDR  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7097,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-14174","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>NEW: MDR Emergency Kit - The fastest solution for Economic Operators of medical devices<\/title>\n<meta name=\"description\" content=\"Haven\u2019t you taken care about MDR (UE) 2017\/745 yet? 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