{"id":19169,"date":"2021-10-26T09:12:00","date_gmt":"2021-10-26T07:12:00","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=19169"},"modified":"2021-10-26T08:58:26","modified_gmt":"2021-10-26T06:58:26","slug":"ivdr-emergency-kit","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/services\/ivdr-emergency-kit\/","title":{"rendered":"IVDR Emergency Kit"},"content":{"rendered":"<div style=\"float: left; width: 70%;\">\n<p><img decoding=\"async\" class=\"alignnone wp-image-19942 size-full\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/01\/ivdr-emergency-kit-eng.jpg\" alt=\"ivdr emergency kit eng\" width=\"1200\" height=\"627\" \/><\/p>\n<p><strong>IVDR Emergency Kit:\u00a0t<span class=\"JsGRdQ\">he fastest solution to respond to the main obligations of the IVDR (EU) 2017\/746.<\/span><\/strong><\/p>\n<p>Experts Thema projected a solution to allow\u00a0<span class=\"Y2IQFc\" lang=\"en\">Economic Operators in the IVD sector\u00a0<\/span>to quickly and independently align with the main provisions of the IVDR (EU) 2017\/746, saving time and costs.<\/p>\n<p>IVDR (UE) Emergency Kit is a sort of \u201ctoolbox\u201d in digital format that collects the essential technical tools, the operational base to meet the main IVDR obligations.<\/p>\n<h6><strong>Templates and standard technical Documents available to the customer<\/strong><\/h6>\n<ul>\n<li>standard basic template of the most important documents (QTA; PRRC letter);<\/li>\n<li>technical Documentation template (technical file) with instructions for completion;<\/li>\n<li>fundamental Quality System procedures.<\/li>\n<\/ul>\n<h6><strong>Four IVDR Emergency Kit versions according to specific needs <\/strong><\/h6>\n<ol>\n<li><strong>MANUFACTURER<\/strong> &#8211; IVDR Emergency Kit<\/li>\n<\/ol>\n<ul>\n<li>proxy letter <em>template <\/em>Person Responsible for Regulatory Compliance (PRRC);<\/li>\n<li>technical Documentation <em>template <\/em>(DT IVDR);<\/li>\n<li>post-market Surveillance Procedure (PMS) <em>template<\/em>, Vigilance, Regulatory Authorities (RA) Communications;<\/li>\n<li>template Information Note to Distributor;<\/li>\n<li>Quality Technical Agreement (QTA) Manufacturer\/Distributor EU.<\/li>\n<\/ul>\n<ol start=\"2\">\n<li><strong>AUTHORISED REPRESENTATIVE<\/strong> &#8211; IVDR Emergency Kit<\/li>\n<\/ol>\n<ul>\n<li>proxy letter <em>template <\/em>Person Responsible for Regulatory Compliance PRRC (different from that of the Manufacturer);<\/li>\n<li>post-market Surveillance Procedure (PMS), Vigilance, Regulatory Authorities (RA) Communication\u00a0<em>template<\/em>;<\/li>\n<li>Quality Technical Agreement (QTA) Manufacturer\/Authorised Representative only in English.<\/li>\n<\/ul>\n<ol start=\"3\">\n<li><strong>IMPORTER &#8211; <\/strong>IVDR Emergency Kit<\/li>\n<\/ol>\n<ul>\n<li>Non-Conformity procedures, CAPA, PMS, Regulatory Authorities (RA) and Manufacturer Communication, final MD acceptance check <em>template<\/em>;<\/li>\n<li>importer acceptance check form <em>template.<\/em><\/li>\n<\/ul>\n<ol start=\"4\">\n<li><strong>DISTRIBUTOR\u00a0<\/strong>&#8211; IVDR Emergency Kit<\/li>\n<\/ol>\n<ul>\n<li><em>template <\/em>Non-Conformity procedures, CAPA, Post-Market Surveillance, Regulatory Authorities (RA) and Manufacturer Communications, final Medical Devices Acceptance Checks;<\/li>\n<li><em>template\u00a0<\/em>module Acceptance Controls.<\/li>\n<\/ul>\n<p>The kit is available in Italian and English.<\/p>\n<h6><strong>What are the advantages?<\/strong><\/h6>\n<ul>\n<li><strong>time saving<\/strong>, from a basis developed by Thema experts;<\/li>\n<li><strong>customize, <\/strong>adapting standard contents to your own reality;<\/li>\n<li><strong>save the consultancy costs,<\/strong> if not necessary.<\/li>\n<\/ul>\n<h6><strong>Additional services\u00a0<\/strong><\/h6>\n<p>Do you need qualified support? Do you need clarification? Thema experts remain themselves available for consulting services, even remotely.<\/p>\n<p><strong>Contact us for INFORMATION, COSTS and receive your IVDR Emergency Kit by e-mail!<\/strong><strong><br \/>\n<\/strong>Thema Staff: t. 0542 643496 \/\u00a0<a href=\"mailto:sales@thema-med.com\">sales@thema-med.com\u00a0<\/a><\/p>\n<p><strong><em>Do you want to receive updates on the main regulatory news from around the world?<\/em><\/strong><\/p>\n<p><strong><em>Fill out the form below and receive Thema newsletters.<\/em><\/strong><\/p>\n<\/div>\n<div id=\"serviceslist\" style=\"float: left; width: 27%; margin-left: 1.5%; padding-left: 1.5%; border-left: 1px solid;\">\n<p><a href=\"https:\/\/www.thema-med.com\/en\/services\/ivdr-emergency-kit\/\"><span style=\"color: #0099a8;\">IVDR Emergency Kit<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/services\/new-mdr-emergency-kit\/\">MDR Emergency Kit<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">Strategic Regulatory Consulting<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\">CE Certification Support<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/en\/services\/italian-and-european-ministerial-registrations\/\">Italian and European Ministerial Registrations<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/\">International Registrations outside the EU<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/en\/services\/local-representative\/\">Local Representative <\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/en\/services\/quality-and-international-gmps\/\">Quality and International GMPs<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>IVDR Emergency Kit:\u00a0the fastest solution to respond to the main obligations of the IVDR (EU) 2017\/746. Experts Thema projected a solution  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":9970,"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-19169","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>IVDR Emergency Kit in Vitro Diagnostic Medical Devices\u00a0(IVD)<\/title>\n<meta name=\"description\" content=\"IVDR Emergency Kit: the fastest solution to respond to the mail obligations of the IVDR (EU) 2017\/746. 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