{"id":515,"date":"2022-01-28T12:44:50","date_gmt":"2022-01-28T18:44:50","guid":{"rendered":"https:\/\/casusconsulting.com\/?page_id=515"},"modified":"2024-04-05T16:47:18","modified_gmt":"2024-04-05T21:47:18","slug":"ivdr-ce-marking","status":"publish","type":"page","link":"https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/","title":{"rendered":"IVDR CE Marking"},"content":{"rendered":"\n<div class=\"wp-block-themepunch-revslider revslider\" data-modal=\"false\" data-slidertitle=\"IVDR CE Marking Page - B+W\" style=\"\">\n\t\t\t<!-- START IVDR CE Marking Page  B+W REVOLUTION SLIDER 6.7.1 --><p class=\"rs-p-wp-fix\"><\/p>\n\t\t\t<rs-module-wrap id=\"rev_slider_165_1_wrapper\" data-source=\"gallery\" style=\"visibility:hidden;background:transparent;padding:0;margin:0px auto;margin-top:0;margin-bottom:0;\">\n\t\t\t\t<rs-module id=\"rev_slider_165_1\" style=\"\" data-version=\"6.7.1\">\n\t\t\t\t\t<rs-slides style=\"overflow: hidden; position: 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data-initiallyhideonmobile=\"false\"\n                    data-initiallyshow=\"true\"><div class=\"ub_table-of-contents-header-container\"><div class=\"ub_table-of-contents-header\">\n                    <div class=\"ub_table-of-contents-title\">Table of Contents<\/div><\/div><\/div><div class=\"ub_table-of-contents-extra-container\"><div class=\"ub_table-of-contents-container ub_table-of-contents-1-column \"><ul><li><a href=https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#0-general-overview-steps-to-ce-mark-ivds->General Overview: Steps to CE Mark IVDs<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#2-in-vitro-diagnostic-regulation-ivdr-2017746->In Vitro Diagnostic Regulation (IVDR) 2017\/746<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#5-classifying-ivds->Classifying IVDs<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#6-ivdr-compliance-key-elements->IVDR Compliance: Key Elements<\/a><ul><li><a href=https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#8-technical-documentation-file-ivdr-annex-ii->Technical Documentation File (IVDR Annex II)<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#12-post-market-surveillance-ivdr-annex-iii->Post-Market Surveillance (IVDR Annex III)<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#17-performance-evaluation-ivdr-annex-xiii->Performance Evaluation (IVDR Annex XIII)<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#18-quality-management-system-qms->Quality Management System (QMS)<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#19-other-requirements->Other Requirements<\/a><\/li><\/ul><\/li><li><a href=https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#24-additional-resources->Additional Resources<\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-4896ede3e187d54bbfa849819c5d44cc\" id=\"0-general-overview-steps-to-ce-mark-ivds-\"><strong>General Overview: Steps to CE Mark IVDs<\/strong><\/h2>\n\n\n\n<p>In order to sell your in vitro diagnostic (IVD) medical device in Europe, it must first be CE Marked to the IVD Regulation (IVDR). CE Marking is Europe\u2019s version of marketing approval. <\/p>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-9e68f25176459193ec032d3f150b739d\" id=\"1-click-through-the-below-steps-to-see-the-high-level-process-to-ce-mark-ivds-\"><strong>Click through the below steps to see the high-level process to CE Mark IVDs:<\/strong><\/h4>\n\n\n\n<div style=\"height:5px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n\n\n\n\t\t\t<!-- Cool Timeline PRO V4.6.2 -->\r\n\t\t\t<div class=\"ctl-wrapper\">\r\n\t\t\t\t\t\t\t\t<div id=\"cool_timeline_1\" class=\"cool-timeline-wrapper ctl-horizontal ctl-horizontal-wrapper ctl-horizontal-timeline ctl-design-2\" data-items=\"3\" data-start-on=\"0\" data-autoplay=\"false\" data-autoplay-speed=\"10\" data-load=\"\" data-nav=\"hide\" data-line-filling=\"false\" data-nav-pos=\"right\">\r\n\t\t\t\t\t<div class=\"ctl-wrapper-inside\">\r\n\t\t\t\t\t\t\t\t\t\t\t\t<div id=\"ctl-slider-container\" class=\"ctl-slider-container swiper-container ctl-line-filler swiper-container-horizontal\">\r\n\t\t\t\t\t\t\t<!-- Timeline Container -->\r\n\t\t\t\t\t\t\t<div class=\"ctl-slider-wrapper ctl-timeline-container swiper-wrapper\">\r\n\t\t\t\t\t\t\t\t<!-- Timeline Content --><div  id=\"ctl-story-9928\" class=\"ctl-story ctl-story-dot-icon swiper-slide odd ctl-no-media\"  data-story-index=\"1\"><!-- Story Labels --><div class=\"ctl-labels\"><div class=\"ctl-label-big\">STEP 1<\/div><div class=\"ctl-label-small\"><\/div><\/div><!-- Story IconDot --><div class=\"ctl-icondot\"><\/div> <!-- Story Arrow --><div class=\"ctl-arrow\"><\/div>\r\n\t\t\t<!-- Story Content --><div class=\"ctl-content\"><!-- Story Title --><div class=\"ctl-title story-9928\"><a target=\"_self\" title=\"Classify your IVD\" href=\"https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#5-classifying-ivds-\" class=\"story-link\">Classify your IVD<\/a><\/div><!-- Story Description --><div class=\"ctl-description\"><span style=\"color: #000000;\">Devices are classified according to a set of risk-based &#8216;rules&#8217; under IVDR Annex VIII: Class A, B, C and D<\/span>\r\n\r\n&nbsp;\r\n<ul>\r\n \t<li><span style=\"color: #000000;\">If the IVD is Class A sterile, Class B, Class C or Class D, it will require a formal CE Certificate issued by a European Notified Body.<\/span><\/li>\r\n \t<li><span style=\"color: #000000;\">If the device is Class A non-sterile, the manufacturer will &#8216;self-certify&#8217; the IVD.<\/span><\/li>\r\n<\/ul><\/div><\/div><\/div><!-- Timeline Content --><div  id=\"ctl-story-9893\" class=\"ctl-story ctl-story-dot-icon swiper-slide even ctl-no-media\"  data-story-index=\"2\"><!-- Story Labels --><div class=\"ctl-labels\"><div class=\"ctl-label-big\">STEP 2<\/div><div class=\"ctl-label-small\"><\/div><\/div><!-- Story IconDot --><div class=\"ctl-icondot\"><\/div> <!-- Story Arrow --><div class=\"ctl-arrow\"><\/div>\r\n\t\t\t<!-- Story Content --><div class=\"ctl-content\"><!-- Story Title --><div class=\"ctl-title story-9893\"><a target=\"_self\" title=\"Technical Documentation File\" href=\"https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#7-technical-documentation-file-ivdr-annex-ii-\" class=\"story-link\">Technical Documentation File<\/a><\/div><!-- Story Description --><div class=\"ctl-description\"><p><span style=\"color: #000000;\">Draft a Technical Documentation File (TDF). <\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #000000;\">A TDF is made up of the following elements:<\/span><\/p>\n<p>&nbsp;<\/p>\n<ol>\n<li><span style=\"color: #000000;\">Main Body that describes the device and verifies how the device has met the all the applicable general safety and performance requirements<\/span><\/li>\n<li><span style=\"color: #000000;\">Performance Evaluation (procedure, plan and report)<\/span><\/li>\n<li><span style=\"color: #000000;\">Risk assessment conducted for the device<\/span><\/li>\n<li><span style=\"color: #000000;\">Post-market surveillance system<\/span><\/li>\n<\/ol>\n<\/div><\/div><\/div><!-- Timeline Content --><div  id=\"ctl-story-9898\" class=\"ctl-story ctl-story-dot-icon swiper-slide odd ctl-no-media\"  data-story-index=\"3\"><!-- Story Labels --><div class=\"ctl-labels\"><div class=\"ctl-label-big\">STEP 3<\/div><div class=\"ctl-label-small\"><\/div><\/div><!-- Story IconDot --><div class=\"ctl-icondot\"><\/div> <!-- Story Arrow --><div class=\"ctl-arrow\"><\/div>\r\n\t\t\t<!-- Story Content --><div class=\"ctl-content\"><!-- Story Title --><div class=\"ctl-title story-9898\"><a target=\"_self\" title=\"Quality Management System\" href=\"https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#17-quality-management-system-qms-\" class=\"story-link\">Quality Management System<\/a><\/div><!-- Story Description --><div class=\"ctl-description\"><p><span style=\"color: #000000;\">All manufacturers must implement a quality management system (QMS). <\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #000000;\">Generally, manufacturers implement to EN ISO 13485. It is a standard that was developed specifically for medical devices and has been harmonized in Europe, i.e., it generally meets the QMS requirements of the IVDR.\u00a0\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li><span style=\"color: #000000;\">Class A non-sterile manufacturers: QMS may be less robust than higher-risk devices but must at least meet the minimum requirements under IVDR Article 10(8). Further, the QMS does not have to be audited by a third party.<\/span><\/li>\n<li><span style=\"color: #000000;\">All other manufacturers: implement a QMS and undergo review by a Notified Body.<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div><!-- Timeline Content --><div  id=\"ctl-story-9895\" class=\"ctl-story ctl-story-dot-icon swiper-slide even ctl-no-media\"  data-story-index=\"4\"><!-- Story Labels --><div class=\"ctl-labels\"><div class=\"ctl-label-big\">STEP 4<\/div><div class=\"ctl-label-small\"><\/div><\/div><!-- Story IconDot --><div class=\"ctl-icondot\"><\/div> <!-- Story Arrow --><div class=\"ctl-arrow\"><\/div>\r\n\t\t\t<!-- Story Content --><div class=\"ctl-content\"><!-- Story Title --><div class=\"ctl-title story-9895\"><a target=\"_self\" title=\"Unique Device Identifier\" href=\"https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#20-udi-system-\" class=\"story-link\">Unique Device Identifier<\/a><\/div><!-- Story Description --><div class=\"ctl-description\"><p><span style=\"color: #000000;\">Implement Unique Device Identifier (UDI) system. <\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #000000;\">If you already have a UDI system in place for another market (e.g., US FDA), then this is generally sufficient for Europe. The main differences are:<\/span><\/p>\n<p>&nbsp;<\/p>\n<ol>\n<li><span style=\"color: #000000;\">The EU Commission only recognizes the following UDI issuing agencies: GS1, HIBCC, ICCBBA and IFA GmbH.<\/span><\/li>\n<li><span style=\"color: #000000;\">The MDR\/IVDR introduces a new concept: the Basic UDI-DI. This is unique to Europe, and must be established as part of the UDI system.<\/span><\/li>\n<\/ol>\n<\/div><\/div><\/div><!-- Timeline Content --><div  id=\"ctl-story-9901\" class=\"ctl-story ctl-story-dot-icon swiper-slide odd ctl-no-media\"  data-story-index=\"5\"><!-- Story Labels --><div class=\"ctl-labels\"><div class=\"ctl-label-big\">STEP 5<\/div><div class=\"ctl-label-small\"><\/div><\/div><!-- Story IconDot --><div class=\"ctl-icondot\"><\/div> <!-- Story Arrow --><div class=\"ctl-arrow\"><\/div>\r\n\t\t\t<!-- Story Content --><div class=\"ctl-content\"><!-- Story Title --><div class=\"ctl-title story-9901\"><a target=\"_self\" title=\"EU Authorized Representative\" href=\"https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#19-european-authorized-representative-\" class=\"story-link\">EU Authorized Representative<\/a><\/div><!-- Story Description --><div class=\"ctl-description\"><p><span style=\"color: #000000;\">Non-European manufacturers must appoint a European Authorized Representative (EU AR).<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #000000;\">The EU AR is the point of contact between you and the EU national competent authorities. <\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #000000;\">They are identified on your device labeling, Declaration of Conformity, and Notified Body issued CE Certificate (if applicable).<\/span><\/p>\n<\/div><\/div><\/div><!-- Timeline Content --><div  id=\"ctl-story-9902\" class=\"ctl-story ctl-story-dot-icon swiper-slide even ctl-no-media\"  data-story-index=\"6\"><!-- Story Labels --><div class=\"ctl-labels\"><div class=\"ctl-label-big\">STEP 6<\/div><div class=\"ctl-label-small\"><\/div><\/div><!-- Story IconDot --><div class=\"ctl-icondot\"><\/div> <!-- Story Arrow --><div class=\"ctl-arrow\"><\/div>\r\n\t\t\t<!-- Story Content --><div class=\"ctl-content\"><!-- Story Title --><div class=\"ctl-title story-9902\"><a target=\"_self\" title=\"CE Mark the Device\" href=\"https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#7-notified-bodies-\" class=\"story-link\">CE Mark the Device<\/a><\/div><!-- Story Description --><div class=\"ctl-description\"><p><span style=\"color: #000000;\">Once the all the previous items are in place:<\/span><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li><span style=\"color: #000000;\">Class A sterile, Class B, Class C, or Class D devices must engage a Notified Body to CE Mark the device. The Notified Body will conduct an audit, and upon successful completion, issue a CE certificate. The Notified Body\u2019s 4-digit number will be placed adjacent to the CE symbol.<\/span><\/li>\n<li><span style=\"color: #000000;\">Class A non-sterile devices do\u00a0<em>not<\/em> require Notified Body review. Instead, the manufacturer will \u2018self-affix\u2019 the CE symbol to the device labeling.<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div><!-- Timeline Content --><div  id=\"ctl-story-9903\" class=\"ctl-story ctl-story-dot-icon swiper-slide odd ctl-no-media\"  data-story-index=\"7\"><!-- Story Labels --><div class=\"ctl-labels\"><div class=\"ctl-label-big\">STEP 7<\/div><div class=\"ctl-label-small\"><\/div><\/div><!-- Story IconDot --><div class=\"ctl-icondot\"><\/div> <!-- Story Arrow --><div class=\"ctl-arrow\"><\/div>\r\n\t\t\t<!-- Story Content --><div class=\"ctl-content\"><!-- Story Title --><div class=\"ctl-title story-9903\"><a target=\"_blank\" title=\"Declaration of Conformity\" href=\"https:\/\/casusconsulting.com\/declaration-of-conformity-eu-switzerland-uk\/\" class=\"story-link\">Declaration of Conformity<\/a><\/div><!-- Story Description --><div class=\"ctl-description\"><p><span style=\"color: #000000;\">Manufacturer must sign a Declaration of Conformity (DoC).<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #000000;\">The DoC is a legally binding document, in which the manufacturer asserts that they have met the minimum requirements of the IVDR.\u00a0<\/span><\/p>\n<\/div><\/div><\/div><!-- Timeline Content --><div  id=\"ctl-story-9904\" class=\"ctl-story ctl-story-dot-icon swiper-slide even ctl-no-media\"  data-story-index=\"8\"><!-- Story Labels --><div class=\"ctl-labels\"><div class=\"ctl-label-big\">STEP 8<\/div><div class=\"ctl-label-small\"><\/div><\/div><!-- Story IconDot --><div class=\"ctl-icondot\"><\/div> <!-- Story Arrow --><div class=\"ctl-arrow\"><\/div>\r\n\t\t\t<!-- Story Content --><div class=\"ctl-content\"><!-- Story Title --><div class=\"ctl-title story-9904\"><a target=\"_self\" title=\"Device Registration\" href=\"https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#21-device-registration-eudamed-\" class=\"story-link\">Device Registration<\/a><\/div><!-- Story Description --><div class=\"ctl-description\"><p><span style=\"color: #000000;\">IVDs must be registered in Europe. <\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #000000;\">If the manufacturer is established in Europe, they will register with their local Competent Authority. If they are not, then the EU Authorized Representative will register the foreign manufacturer&#8217;s device with their local Competent Authority.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #000000;\">NOTE: EUDAMED, the European databased on medical devices, will allow all manufacturers to register their devices independently. However, EUDAMED has been delayed.\u00a0<\/span><\/p>\n<\/div><\/div><\/div><!-- Timeline Content --><div  id=\"ctl-story-9908\" class=\"ctl-story ctl-story-dot-icon swiper-slide odd ctl-no-media\"  data-story-index=\"9\"><!-- Story Labels --><div class=\"ctl-labels\"><div class=\"ctl-label-big\">STEP 9<\/div><div class=\"ctl-label-small\"><\/div><\/div><!-- Story IconDot --><div class=\"ctl-icondot\"><\/div> <!-- Story Arrow --><div class=\"ctl-arrow\"><\/div>\r\n\t\t\t<!-- Story Content --><div class=\"ctl-content\"><!-- Story Title --><div class=\"ctl-title story-9908\"><a target=\"_self\" title=\"Begin Marketing in Europe\" href=\"https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/#22-vigilance-\" class=\"story-link\">Begin Marketing in Europe<\/a><\/div><!-- Story Description --><div class=\"ctl-description\"><p><span style=\"color: #000000;\">You may now begin marketing in Europe.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #000000;\">You must maintain CE marking for as long as the device continues to be marketed. This includes compliance with vigilance requirements: reporting serious incidents and field safety corrective actions, e.g., recalls.\u00a0<\/span><\/p>\n<\/div><\/div><\/div>\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t<span class=\"swiper-notification\" aria-live=\"assertive\" aria-atomic=\"true\"><\/span>\r\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t<\/div>\r\n\t\t\t\t\t<!-- Swiper Next button -->\r\n\t\t\t\t\t<div class=\"ctl-button-prev swiper-button-disabled\" tabindex=\"0\" role=\"button\" aria-label=\"Previous slide\" aria-disabled=\"true\">\r\n\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1em\" viewBox=\"0 0 320 512\">\r\n\t\t\t\t<path d=\"M34.52 239.03L228.87 44.69c9.37-9.37 24.57-9.37 33.94 0l22.67 22.67c9.36 9.36 9.37 24.52.04 33.9L131.49 256l154.02 154.75c9.34 9.38 9.32 24.54-.04 33.9l-22.67 22.67c-9.37 9.37-24.57 9.37-33.94 0L34.52 272.97c-9.37-9.37-9.37-24.57 0-33.94z\"\/>\r\n\t\t\t\t<\/svg>\t\t\t\t\t<\/div>\r\n\t\t\t\t\t<!-- Swiper Previous Button -->\r\n\t\t\t\t\t<div class=\"ctl-button-next\" tabindex=\"0\" role=\"button\" aria-label=\"Next slide\" aria-disabled=\"false\">\r\n\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1em\" viewBox=\"0 0 320 512\">\r\n\t\t\t\t<path d=\"M285.476 272.971L91.132 467.314c-9.373 9.373-24.569 9.373-33.941 0l-22.667-22.667c-9.357-9.357-9.375-24.522-.04-33.901L188.505 256 34.484 101.255c-9.335-9.379-9.317-24.544.04-33.901l22.667-22.667c9.373-9.373 24.569-9.373 33.941 0L285.475 239.03c9.373 9.372 9.373 24.568.001 33.941z\"\/>\r\n\t\t\t\t<\/svg>\t\t\t\t\t<\/div>\r\n\t\t\t\t\t<!-- Swiper Horizontal line -->\r\n\t\t\t\t\t<div class=\"ctl-h-line\"><\/div>\r\n\t\t\t\t\t\t\t\t\t\t\t<style id=\"cool_timeline_1-styles\" type=\"text\/css\">\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t.ctl-wrapper :where(#ctl-year-slide-9928,#ctl-story-9928.ctl-story){--ctw-second-story-color :#000000;--ctw-first-story-color:#000000;}\t\t\t\t\t\t<\/style>\r\n\t\t\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t<\/div>\r\n\t\t\t\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-6115de7dc945408ccb3d0cf66ac0080b\" id=\"2-in-vitro-diagnostic-regulation-ivdr-2017746-\"><strong>In Vitro Diagnostic Regulation (IVDR) 2017\/746<\/strong><\/h2>\n\n\n\n<p>The In Vitro Diagnostic medical devices Regulation (IVDR) is the current IVD legislation. Prior to that, IVDs were governed by the In Vitro Diagnostic Medical Device Directive (IVDD) 98\/79\/EC. <\/p>\n\n\n\n<p>On 26 May 2022, the IVDR superseded the IVDD. This means that all IVDs newly being placed onto the European market after 26 May 2022, must comply with the IVDR.<\/p>\n\n\n\n<p>The IVDR is much more robust legislation, up-classifying most IVDs on the European market. <\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-2ded02b89384cd409b990636d672ac00\" id=\"3-ivddivdr-progressive-rollout-dates-\"><strong>IVDD\/IVDR Progressive Rollout Dates<\/strong><\/h4>\n\n\n\n<p>The IVDR granted a transition period for most devices that held valid IVDD CE Marking on 26 May 2022. Those are called &#8220;legacy&#8221; devices and they have the following timeframes to comply with the IVDR.<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-black-color has-text-color has-link-color\"><thead><tr><th>Eventual IVDR Classification<\/th><th>Compliance Deadline (&#8220;IVDR Progressive Rollout&#8221;)<\/th><\/tr><\/thead><tbody><tr><td>Class A non-sterile<\/td><td>26 May 2022 &#8211; No transition period granted; must comply immediately<\/td><\/tr><tr><td>Class A sterile<\/td><td>26 May 2027 &#8211; An additional five years granted<\/td><\/tr><tr><td>Class B<\/td><td>26 May 2027 &#8211; An additional five years granted<\/td><\/tr><tr><td>Class C<\/td><td>26 May 2026 &#8211; An additional four years granted<\/td><\/tr><tr><td>Class D<\/td><td>26 May 2025 &#8211; An additional three years granted<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The above transition period was granted for devices that require Notified Body certification under the IVDR. This was necessary, due to 1) the lack of Notified Bodies accredited to the IVDR at the time the IVDR was to come into force and 2) the extensive number of IVDs that were upclassed (now requiring Notified Body certification) under the IVDR. <\/p>\n\n\n\n<p>Further, some elements of the IVDR were applied to all IVDs on 26 May 2022, its date of application (DoA), irrespective of the transition timelines. For example, the IVDR&#8217;s vigilance, post-market surveillance and market surveillance requirements will apply to every IVD on the market, even those that are IVDD CE marked as <span class=\"tooltip tooltip-txt\" data-tooltip=\"Legacy devices are those that have valid CE marking under the old Directives and are allowed to continue to be placed on the EU market for a set period of time after the new Regulations come into force, due to the transition period allowance.\" data-position=\"top\">&#8216;legacy&#8217;<\/span>\n devices under the above transition period.<\/p>\n\n\n\n<p>For more information, please read: <strong><a href=\"https:\/\/casusconsulting.com\/what-are-legacy-devices\/\" data-type=\"link\" data-id=\"https:\/\/casusconsulting.com\/what-are-legacy-devices\/\" target=\"_blank\" rel=\"noreferrer noopener\">What are Legacy Devices?<\/a><\/strong><\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile\" style=\"grid-template-columns:40% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Email-Casus-Consulting-1024x576.jpg\" alt=\"\" class=\"wp-image-9748 size-full\" srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Email-Casus-Consulting-1024x576.jpg 1024w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Email-Casus-Consulting-300x169.jpg 300w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Email-Casus-Consulting-768x432.jpg 768w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Email-Casus-Consulting-1536x864.jpg 1536w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Email-Casus-Consulting-2048x1152.jpg 2048w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Email-Casus-Consulting-260x146.jpg 260w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Email-Casus-Consulting-50x28.jpg 50w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Email-Casus-Consulting-133x75.jpg 133w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Email-Casus-Consulting-960x540.jpg 960w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Email-Casus-Consulting-1200x675.jpg 1200w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<h1 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-f7c67099c13c807c75f9f68187d848c9\" id=\"4-need-help-\"><strong>Need Help?<\/strong><\/h1>\n\n\n\n<p>Whether you need a quote or just want to discuss the best options for your business, we will help guide you.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-background wp-element-button\" href=\"mailto:contact@casusconsulting.com\" style=\"background-color:#b31c1c\">Email us<\/a><\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:18px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-31c94a7d4bbb66cbd42eced43d7a5767\" id=\"5-classifying-ivds-\"><strong>Classifying IVDs<\/strong><\/h2>\n\n\n\n<p>IVDs are classified according to risk level, with Class A being the lowest risk and Class D being the highest risk. Manufacturers should refer to IVDR, Annex VIII for the full set of classification rules. <\/p>\n\n\n\n<p>Included in the table below are some examples for reference.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th>Class<\/th><th>Examples<\/th><\/tr><\/thead><tbody><tr><td>Class A (sterile \/non-sterile) <\/td><td> &#8211; General reagents (not assay specific) used with a Class A instrument, e.g. general sequencing consumable reagents used with a sequencer.<br> &#8211; Specimen containers or evacuated or non-evacuated tubes, empty or prefilled with a fixative solution or other general reagent to preserve the condition, stimulation, transport, storage and collection of biological specimens (e.g. cells, tissues specimens, urine, faeces) for the purpose of in vitro diagnostic examinations.<\/td><\/tr><tr><td>Class B <\/td><td> &#8211; Urine dipstick to determine urinary tract infection at point of care.<br> &#8211; Rapid tests for the detection of Group A Strep, Respiratory Syncytial Virus, and Influenza virus(es).<br> &#8211; Antibody tests for HAV, dengue, chikungunya and West Nile virus.<br> &#8211; Control materials used to verify the migration of immunochromatographic assays.<\/td><\/tr><tr><td>Class C <\/td><td> &#8211; Medical device software for high-resolution analysis of HLA sequencing data, for transplantation purposes.<br> &#8211; Devices intended for detecting the presence of, or exposure to, a sexually transmitted agent, e.g., Chlamydia trachomatis, Human papilloma virus (HPV).<br> &#8211; Blood glucose reagents \/ strips for patient monitoring.<br> &#8211; Mobile cardiac marker monitoring test for acute presenting patients: Troponin I, Troponin T, CKMB (when intended to be used for monitoring cardiac muscle injury).<\/td><\/tr><tr><td>Class D <\/td><td> &#8211; Tests for Hepatitis B, C, D.<br> &#8211; Tests for Human Immunodeficiency Virus (HIV) 1 and 2.<br> &#8211; Tests for SARS CoV and SARS-CoV-2.<br> &#8211; Tests for Haemorrhagic fever viruses, e.g. Ebola, Marburg, Lassa, Crimean-Congo Haemorrhagic fever.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<div style=\"height:5px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Refer to <strong><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-02\/md_mdcg_2020_guidance_classification_ivd-md_en.pdf\" data-type=\"link\" data-id=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-02\/md_mdcg_2020_guidance_classification_ivd-md_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">MDCG Guidance Document 2020-16 rev.2<\/a><\/strong> for more explanation (and examples) regarding IVD device classification. <\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-21f8201b074960441b0f662789a935bb\" id=\"6-ivdr-compliance-key-elements-\"><strong>IVDR Compliance: Key Elements<\/strong><\/h2>\n\n\n\n<p>Prior to CE Marking an IVD, manufacturers must compile technical and performance documentation to demonstrate compliance with the IVDR.<\/p>\n\n\n\n<p>All IVDs, irrespective of classification and risk level, require the following elements from the IVDR:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ol>\n<li>IVDR, Annex II \u2013 Technical Documentation File (TDF), which includes information related to product design and manufacturing, product verification and validation, and risk analysis and management<\/li>\n\n\n\n<li>IVDR, Annex III \u2013 Post-Market Surveillance (PMS) appendix<\/li>\n\n\n\n<li>IVDR, Annex XIII \u2013 Performance Evaluation Report (PER)<\/li>\n<\/ol>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p>Not all the requirements outlined in each section above may apply to your device. Manufacturers should determine which sections within each Annex (TDF\/PMS\/PER) are applicable for their device. Where a section is deemed not applicable, manufacturers should document a rationale as to why this has been excluded from the Technical Documentation File (TDF) and\/or Performance Evaluation Report (PER).<\/p>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-03723a7e8c26433e7400de4ba11f8aba\" id=\"7-notified-bodies-\"><strong>Notified Bodies<\/strong><\/h4>\n\n\n\n<p>Further, unless the device is the very lowest risk class, it must undergo a conformity assessment review by a Notified Body. Notified Bodies are organizations accredited and supervised by the European National&nbsp;Competent Authorities,&nbsp;and their role is to evaluate if products have met the minimum safety and efficacy requirements. The Notified Body issues \u201cCE Mark Approval\u201d for the device by issuing a CE certificate<\/p>\n\n\n\n<p>Casus Consulting can help you understand how the IVDR applies to your device, and the required information to be included in each file. We can also provide support in conducting a gap analysis of your <span class=\"tooltip tooltip-txt\" data-tooltip=\"Legacy devices are those that have valid CE marking under the old Directives and are allowed to continue to be placed on the EU market for a set period of time after the new Regulations come into force, due to the transition period allowance.\" data-position=\"top\">&#8216;legacy&#8217;<\/span>\n device technical files and upgrading them to the IVDR.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-08633b4a085984e7278eaa6a994bebc7\" id=\"8-technical-documentation-file-ivdr-annex-ii-\"><strong>Technical Documentation File<\/strong> <strong>(IVDR Annex II)<\/strong><\/h3>\n\n\n\n<p>Manufacturers should consider the technical file as a whole when drafting, rather than looking at the sections as standalone items. For example, the General Safety and Performance Requirements (GSPRs) include information from the Risk Management section, and elements of the Risk Management section need to be considered for the Post-market Surveillance plan.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-91daaf2f1f28f124f6f76f17c8329143\" id=\"9-technical-documentation-file-main-body-\"><strong>Technical Documentation File (Main Body)<\/strong><\/h4>\n\n\n\n<p>The main body of an IVDR complaint TDF should include key details and documentation related to the device, including the description, labeling\/IFUs, design and manufacturing information, product verification and validation (i.e., data to prove the safety and efficacy of the device).<\/p>\n\n\n\n<p>Two key components that manufacturers need to develop for the IVDR TDF are the General Safety and Performance Requirements and Risk Management section.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-23453637fb37f9d23fef0bdcf9a22824\" id=\"10-general-safety-amp-performance-requirements-gsprs-\"><strong>General Safety &amp; Performance Requirements (GSPRs)<\/strong><\/h4>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-2 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li>The GSPRs detail the specific criteria manufacturers must meet to establish minimum safety and efficacy requirements for their device, e.g., requirements for performance, risk management, design, etc.<\/li>\n\n\n\n<li>The GSPRs, located in Annex I of the IVDR, are similar to the Essential Requirements Checklist (ERC), located in Annex I of the IVDD.<\/li>\n\n\n\n<li>European Harmonized Standards should be utilized, where available. The reason is that use of harmonized standards \u2018presumes compliance\u2019 to the applicable requirement.<\/li>\n\n\n\n<li>Where the EU Commission has released Common Specifications for specific product types, they should be applied to the device unless the manufacturer \u201ccan duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent hereto\u201d.<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p>Resource: <strong><a href=\"https:\/\/casusconsulting.com\/list-mdr-ivdr-harmonized-standards-common-specifications\/\" data-type=\"link\" data-id=\"https:\/\/casusconsulting.com\/list-mdr-ivdr-harmonized-standards-common-specifications\/\" target=\"_blank\" rel=\"noreferrer noopener\">List of Harmonized Standards &amp; Common Specifications<\/a><\/strong><\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-f4e0aeb47db0b2a6055e3cbd9f4282ec\" id=\"11-risk-analysis-amp-management-\"><strong>Risk Analysis &amp; Management<\/strong><\/h4>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-3 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li>Manufacturers must assess possible risks related to their device and rate the probability of occurrence against the severity of harm if it does occur.&nbsp;Manufacturers should detail the procedures in place to mitigate the risk or actions to take if it occurs.&nbsp;An approach some companies follow is to incorporate a Failure Mode and Effects Analysis (FMEA) template as part of their overall risk management system.<\/li>\n\n\n\n<li>EN ISO 14971:2019, for medical device risk management, is harmonized standard under the EU IVDR.<\/li>\n\n\n\n<li>Annex I, section 3 of the IVDR includes specific criteria that manufacturers must meet when implementing their risk management system. This section states that risk management is \u201c<em>a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating<\/em>\u201d.<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"ub_call_to_action wp-block-ub-call-to-action-block\"  id=\"ub_call_to_action_d44e2fb0-06f7-406e-b748-b725670762b7\">\n                <div class=\"ub_call_to_action_headline\">\n                    <p class=\"ub_call_to_action_headline_text\"><strong>EU Guide: Post-Market Surveillance<\/strong><\/p><\/div>\n                <div class=\"ub_call_to_action_content\">\n                    <p class=\"ub_cta_content_text\">Learn the difference between market surveillance &amp; post-market surveillance. Plus how PMS Plans and Reports, PMCF\/PMPF, Trend Reporting and Vigilance all intertwine.<\/p><\/div>\n                <div class=\"ub_call_to_action_button\">\n                    <a href=\"https:\/\/casusconsulting.com\/mdr-ivdr-post-market-surveillance\/\" target=\"_blank\" rel=\"noopener noreferrer\"\n                        class=\"ub_cta_button\">\n                        <p class=\"ub_cta_button_text\">Click Here<\/p><\/a><\/div><\/div>\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-2b601deab1516d0527e06eb1c8d4e434\" id=\"12-post-market-surveillance-ivdr-annex-iii-\"><strong>Post-Market Surveillance (IVDR Annex III)<\/strong><\/h3>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-e374532b7550795b80ba864a278e349b\" id=\"13-post-market-surveillance-plan-\"><strong>Post-Market Surveillance Plan<\/strong><\/h4>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-4 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li>The Post Market Surveillance (PMS) section of the TDF details the manufacturer\u2019s plan to collect and assess post-market data. The PMS Plan should include information from serious incidents, complaints, public information on other similar medical devices, and more (refer to IVDR Annex III, Section 1(a)).<\/li>\n\n\n\n<li>The PMS Plan must also establish how the manufacturer will use the data collected to take action when needed. Actions may include making updates to device documentation, such as the PER, improving the risk management and\/or taking preventative or corrective action.<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-bba624768c8c85f39b8aa7072d8a2a43\" id=\"14-post-market-performance-follow-up-pmpf-plan-\"><strong>Post-Market Performance Follow-up (PMPF) Plan<\/strong><\/h4>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-5 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li>The Post-Market Performance Follow-up (PMPF) plan is a subset of your PMS Plan and is very much intertwined with your risk management and performance evaluation. The PMPF plan is intended to help identify previously unknown risks and to confirm the device\u2019s safety and performance.<\/li>\n\n\n\n<li>A PMPF Plan can include a PMPF study when warranted. However, other methods can also be used to address gaps in your pre-clinical data and to demonstrate a continued positive benefit-risk ratio, when appropriate. Examples include feedback via patient or physician surveys and screening of scientific literature.<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-7a0e6498394213e107a23ec2e7efc470\" id=\"15-post-market-surveillance-report-pmsr-\"><strong>Post-Market Surveillance Report (PMSR)<\/strong><\/h4>\n\n\n\n<p>Manufacturers of Class A and B devices must prepare a post-market surveillance report (PMSR) based on data collected once the product is on the market. The PMSR is generated through review and analysis of the gathered PMS data and should also include any preventative or corrective actions taken.<\/p>\n\n\n\n<p>The IVDR states the PMSR should be updated \u2018when necessary\u2019 and made available to the notified body and competent authorities \u2018upon request\u2019.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-21b844e17af0d09b0dfe6e336a5af60c\" id=\"16-periodic-safety-update-report-psur-\"><strong>Periodic Safety Update Report (PSUR)<\/strong><\/h4>\n\n\n\n<p>Manufacturers of Class C and D devices are required to prepare a Periodic Safety Update Report (PSUR) for each device.<\/p>\n\n\n\n<p>The PSUR is a living record in which the manufacturer systematically assesses their PMS data to ensure the device continues to be safe and effective and to provide an accurate picture of the products&#8217; performance post-market. This includes any preventative or corrective actions taken and volume of sales.<\/p>\n\n\n\n<p>The PSUR must be updated at least annually. A Class C manufacturers must make the PSUR available to its notified body, upon request. Manufacturers of Class D IVDs must provide the updated PSURs to their notified body and the PSUR will further be accessible to all national competent authorities and the EU Commission.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-93c27e95ca902753e21c9ce80c1f00f3\" id=\"17-performance-evaluation-ivdr-annex-xiii-\"><strong>Performance Evaluation (IVDR Annex XIII)<\/strong><\/h3>\n\n\n\n<p>The Performance Evaluation Report (PER) is a crucial element of the technical file, and includes the following information:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-6 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li>basic device information,<\/li>\n\n\n\n<li>Performance Evaluation Plan (PEP),<\/li>\n\n\n\n<li>common specifications and harmonized standards,<\/li>\n\n\n\n<li>a literature review,<\/li>\n\n\n\n<li>data from a performance study (if required),<\/li>\n\n\n\n<li>Post-Market Surveillance (PMS) data,<\/li>\n\n\n\n<li>Post-Market Performance Follow-Up (PMPF) data,<\/li>\n\n\n\n<li>a plan for continual updates to this section, and<\/li>\n\n\n\n<li>other relevant device documentation, such as the IFU.<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p>The PER is intended to be a \u2018living\u2019 document and should be continually updated. Specifically, the regulation states that the \u201c<em>clinical evidence and its assessment in the performance evaluation report shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer&#8217;s PMPF plan&#8230;and the post-market surveillance plan&#8230;<\/em>\u201d.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-02d4814f8fc72eb644980cb6d31009c3\" id=\"18-quality-management-system-qms-\"><strong>Quality Management System (QMS)<\/strong><\/h3>\n\n\n\n<p>All manufacturers must implement a quality management system (QMS). <\/p>\n\n\n\n<p>Class A non-sterile manufacturers may develop a QMS that is less robust than higher risk device manufacturers. However, at a minimum it must meet the requirements outlined under the IVDR, Article 10(8). Further, the QMS does not have to be assessed by a third party. <\/p>\n\n\n\n<p>All other manufacturers must implement a QMS and undergo Notified Body review as outlined in Annex IX, X, XI, as applicable. <\/p>\n\n\n\n<p>ISO 13485 is the international standard on medical device quality management systems. It has been harmonized in Europe under the MDR and IVDR (EN ISO 13485:2016). <\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-8564075dc5c5070fe3d52517384eeca1\" id=\"19-other-requirements-\"><strong>Other Requirements<\/strong><\/h3>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-dfa68a7a1a5222ba05e4dacb4c2b2f30\" id=\"20-european-authorized-representative-\"><strong>European Authorized Representative<\/strong><\/h4>\n\n\n\n<p>All non-European manufacturers must appoint a <strong><a href=\"https:\/\/casusconsulting.com\/services\/europe\/authorized-representative\/\" data-type=\"link\" data-id=\"https:\/\/casusconsulting.com\/services\/europe\/authorized-representative\/\" target=\"_blank\" rel=\"noreferrer noopener\">European Authorized Representative<\/a><\/strong> (AR). They are also referred to as an EC Rep. <\/p>\n\n\n\n<p>The EU AR is the point of contact between you and the EU national competent authorities, and is identified on your device labeling, Declaration of Conformity, and Notified Body issued CE Certificate (if applicable). <\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-1f615dbdc4b76abbbacff1adf158ebc5\" id=\"21-udi-system-\"><strong>UDI System<\/strong><\/h4>\n\n\n\n<p>Manufacturers must implement a Unique Device Identification (UDI) system for its devices. The UDI system is generally similar to the US FDA&#8217;s UDI system. Some differences exist, however, such as:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li>The EU Commission only recognizes the following UDI issuing agencies: GS1, HIBCC, ICCBBA and IFA GmbH.<\/li>\n\n\n\n<li>The MDR\/IVDR introduces a new concept: the <strong><a href=\"https:\/\/casusconsulting.com\/basic-udi-di\/\" data-type=\"link\" data-id=\"https:\/\/casusconsulting.com\/basic-udi-di\/\" target=\"_blank\" rel=\"noreferrer noopener\">Basic UDI-DI<\/a><\/strong>. This is unique to Europe, and must be established as part of the UDI system.<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-554e6973b6e09392566d39ae4973125c\" id=\"22-device-registration-eudamed-\"><strong>Device Registration &#8211; EUDAMED<\/strong><\/h4>\n\n\n\n<p><strong><a href=\"https:\/\/casusconsulting.com\/eudamed_basics\/\" data-type=\"link\" data-id=\"https:\/\/casusconsulting.com\/eudamed_basics\/\" target=\"_blank\" rel=\"noreferrer noopener\">EUDAMED<\/a><\/strong> is the European databank on medical devices. It&#8217;s the central system for device data management, including housing all manufacturers, importers, authorized representatives, devices on European market, vigilance, clinical investigations, performance evaluations, and more. <\/p>\n\n\n\n<p>After a manufacturer has CE Marked their device, they must register themselves, and the device in EUDAMED. If the manufacturer is not located in Europe, then it must first link itself to its EU Authorized Representative, in order to complete the registration. <\/p>\n\n\n\n<p>Currently, EUDAMED is voluntary. It has been postponed, and is still under development.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-0ef986c9af755edae73d3498898a5945\" id=\"23-vigilance-\"><strong>Vigilance<\/strong><\/h4>\n\n\n\n<p>Manufacturers must <strong><a href=\"https:\/\/casusconsulting.com\/eu-vigilance-requirements\/\" data-type=\"link\" data-id=\"https:\/\/casusconsulting.com\/eu-vigilance-requirements\/\" target=\"_blank\" rel=\"noreferrer noopener\">report vigilance<\/a><\/strong> (serious incidents and Field Safety Corrective Actions (FSCAs)) to the applicable European Competent Authorities. To ensure this requirement is met, manufacturers should develop a vigilance procedure that describes how to identify if an incident is reportable; and, if it is deemed reportable, the timeframes and method to do so. <\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-815942d85224158d2408633335aa2490\" id=\"24-additional-resources-\"><strong>Additional Resources<\/strong><\/h2>\n\n\n\n<p>Please see below for additional materials on how to comply with European requirements.<\/p>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-themepunch-revslider revslider\" data-modal=\"false\" data-slidertitle=\"Additional Resources - Europe\" style=\"\">\n\t\t\t<!-- START Additional Resources  Europe REVOLUTION SLIDER 6.7.1 --><p 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5;\"><!--\n\n\t\t\t\t\t\t\t\t--><rs-row\n\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-419-layer-5\" \n\t\t\t\t\t\t\t\t\tdata-type=\"row\"\n\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\tdata-dim=\"minh:300px,220px,auto,auto;\"\n\t\t\t\t\t\t\t\t\tdata-basealign=\"slide\"\n\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\tdata-margin=\"t:150,150,70,70;b:150;\"\n\t\t\t\t\t\t\t\t\tdata-padding=\"r:65,75,50,50;l:65,75,50,50;\"\n\t\t\t\t\t\t\t\t\tdata-frame_1=\"sR:10;\"\n\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8690;sA:9000;\"\n\t\t\t\t\t\t\t\t\tstyle=\"z-index:5;\"\n\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-419-layer-6\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:0,100px,0,0;yo:0,100px,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/03\/shutterstock_668595718-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-419-layer-16\" \n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-color=\"#c5a477\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:5px,5px,0,0;yo:5px,5px,0,0;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:15;l:15;ls:2px;fw:600;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:0,0,150,150;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:40;r:20;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:8;font-family:'Poppins';display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t> \n\t\t\t\t\t\t\t\t\t\t<\/rs-layer><!--\n\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-419-layer-3\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/services\/europe\/steps-to-market\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:7;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Europe Market Overview \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-419-layer-7\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:278px,347px,0,0;yo:0,0,321px,321px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:9;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/09\/Europe-Steps-to-Market_Medical-Devices-and-IVDs-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-419-layer-15\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/services\/europe\/authorized-representative\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:10;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>EU Authorized Representative \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-419-layer-8\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:556px,694px,694px,694px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:12;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/05\/iStock-696570136-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-419-layer-19\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/services\/europe\/mdr-ce-marking\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:5px,0,0,0;yo:5px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:19,25,25,25;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:13;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>MDR CE Marking Overview \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-419-layer-13\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:15;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/05\/iStock-1295309857-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-419-layer-17\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:19,25,25,25;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:16;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>IVDR CE Marking Overview \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\t\t\t\t\t\t\t\t--><\/rs-row><!--\n\t\t\t\t\t\t\t--><\/rs-zone><!--\n-->\t\t\t\t\t<\/rs-slide>\n\t\t\t\t\t\t<rs-slide style=\"position: absolute;\" data-key=\"rs-420\" data-title=\"Slide\" data-anim=\"ms:600;\" data-in=\"o:0;\" data-out=\"a:false;\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"\/\/casusconsulting.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/dummy.png\" alt=\"Slide\" title=\"Begin Marketing in Europe\" class=\"rev-slidebg tp-rs-img rs-lazyload\" data-lazyload=\"\/\/casusconsulting.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/transparent.png\" data-bg=\"c:#eeeeee;\" data-parallax=\"off\" data-no-retina>\n<!--\t\t\t\t\t\t--><rs-zone id=\"rrzt_420\" class=\"rev_row_zone_top\" style=\"z-index: 5;\"><!--\n\n\t\t\t\t\t\t\t\t--><rs-row\n\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-420-layer-5\" \n\t\t\t\t\t\t\t\t\tdata-type=\"row\"\n\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\tdata-dim=\"minh:300px,220px,auto,auto;\"\n\t\t\t\t\t\t\t\t\tdata-basealign=\"slide\"\n\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\tdata-margin=\"t:150,150,70,70;b:150;\"\n\t\t\t\t\t\t\t\t\tdata-padding=\"r:65,75,50,50;l:65,75,50,50;\"\n\t\t\t\t\t\t\t\t\tdata-frame_1=\"sR:10;\"\n\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8690;sA:9000;\"\n\t\t\t\t\t\t\t\t\tstyle=\"z-index:5;\"\n\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-420-layer-6\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:0,100px,0,0;yo:0,100px,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/06\/EU-MDR-Classification-Tool-Medical-Devices-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-420-layer-3\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/mdr-classification-tool\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:7;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>MDR Classification Tool \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-420-layer-7\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:278px,347px,0,0;yo:0,0,321px,321px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:9;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/shutterstock_2197042063-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-420-layer-15\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/eu-language-translation-requirements\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:10;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>EU Language Requirements \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-420-layer-8\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:556px,694px,694px,694px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:12;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/06\/EU-Medical-Device-and-IVD-Registration-Requirements-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-420-layer-19\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/eu-registration-requirements\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:5px,0,0,0;yo:5px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:13;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>EU Registration Requirements \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-420-layer-13\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:15;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/04\/MDR-Transition-Guide-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-420-layer-17\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/mdr-transition-extension-guide\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:16;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>MDR Transition Extension Guide \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\t\t\t\t\t\t\t\t--><\/rs-row><!--\n\t\t\t\t\t\t\t--><\/rs-zone><!--\n-->\t\t\t\t\t<\/rs-slide>\n\t\t\t\t\t\t<rs-slide style=\"position: absolute;\" data-key=\"rs-421\" data-title=\"Slide\" data-anim=\"ms:600;\" data-in=\"o:0;\" data-out=\"a:false;\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"\/\/casusconsulting.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/dummy.png\" alt=\"Slide\" title=\"Begin Marketing in Europe\" class=\"rev-slidebg tp-rs-img rs-lazyload\" data-lazyload=\"\/\/casusconsulting.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/transparent.png\" data-bg=\"c:#eeeeee;\" data-parallax=\"off\" data-no-retina>\n<!--\t\t\t\t\t\t--><rs-zone id=\"rrzt_421\" class=\"rev_row_zone_top\" style=\"z-index: 5;\"><!--\n\n\t\t\t\t\t\t\t\t--><rs-row\n\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-421-layer-5\" \n\t\t\t\t\t\t\t\t\tdata-type=\"row\"\n\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\tdata-dim=\"minh:300px,220px,auto,auto;\"\n\t\t\t\t\t\t\t\t\tdata-basealign=\"slide\"\n\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\tdata-margin=\"t:150,150,70,70;b:150;\"\n\t\t\t\t\t\t\t\t\tdata-padding=\"r:65,75,50,50;l:65,75,50,50;\"\n\t\t\t\t\t\t\t\t\tdata-frame_1=\"sR:10;\"\n\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8690;sA:9000;\"\n\t\t\t\t\t\t\t\t\tstyle=\"z-index:5;\"\n\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-421-layer-6\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:0,100px,0,0;yo:0,100px,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2022\/07\/shutterstock_1809555460-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-421-layer-3\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/eu-importer-requirements-article-13-the-mdr-ivdr\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:7;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>EU Importer Requirements \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-421-layer-7\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:278px,347px,0,0;yo:0,0,321px,321px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:9;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2022\/11\/shutterstock_258687632-scaled.jpg') no-repeat left center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-421-layer-15\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/gmdn-emdn-and-cnd\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:10;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Guide: GMDN, EMDN & CND codes \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-421-layer-8\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:556px,694px,694px,694px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:12;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/06\/shutterstock_2146808379-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-421-layer-19\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/systems-procedure-packs-and-kits-requirements\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:5px,0,0,0;yo:5px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:13;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Guide: Systems\/Procedure Packs \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-421-layer-13\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:15;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2022\/07\/shutterstock_665882575-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-195-slide-421-layer-17\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/registering-devices-in-eudamed\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:16;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Registering Devices in EUDAMED \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\t\t\t\t\t\t\t\t--><\/rs-row><!--\n\t\t\t\t\t\t\t--><\/rs-zone><!--\n-->\t\t\t\t\t<\/rs-slide>\n\t\t\t\t\t<\/rs-slides>\n\t\t\t\t\t<rs-static-layers class=\"rs-stl-visible\"><!--\n\n\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\tid=\"slider-195-slide-187-layer-1\" \n\t\t\t\t\t\t\t\tclass=\"rs-layer-static\"\n\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\tdata-xy=\"x:c;xo:10px,0,0,0;yo:0,130px,55px,55px;\"\n\t\t\t\t\t\t\t\tdata-text=\"s:15,15,12,12;l:38,38,28,28;ls:2px;fw:500,600,600,600;a:inherit;\"\n\t\t\t\t\t\t\t\tdata-basealign=\"slide\"\n\t\t\t\t\t\t\t\tdata-rsp_o=\"off\"\n\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\tdata-onslides=\"s:1;\"\n\t\t\t\t\t\t\t\tdata-margin=\"t:60,0,0,0;\"\n\t\t\t\t\t\t\t\tdata-padding=\"t:2;r:40,40,30,30;l:42,42,32,32;\"\n\t\t\t\t\t\t\t\tdata-frame_0=\"o:1;\"\n\t\t\t\t\t\t\t\tdata-frame_0_sfx=\"se:blocktoright;\"\n\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.inOut;sp:50;\"\n\t\t\t\t\t\t\t\tdata-frame_1_sfx=\"se:blocktoright;\"\n\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8250;\"\n\t\t\t\t\t\t\t\tstyle=\"z-index:5;background-color:#000000;font-family:'Poppins';text-transform:uppercase;\"\n\t\t\t\t\t\t\t>Europe Resource Center \n\t\t\t\t\t\t\t<\/rs-layer><!--\n\t\t\t\t\t--><\/rs-static-layers>\n\t\t\t\t<\/rs-module>\n\t\t\t\t<script>\n\t\t\t\t\tsetREVStartSize({c: 'archives',rl:[1240,1024,778,480],el:[600,300,960,720],gw:[1240,1024,778,480],gh:[400,300,960,720],type:'carousel',justify:'',layout:'fullwidth',mh:\"0\"});if (window.RS_MODULES!==undefined && window.RS_MODULES.modules!==undefined && window.RS_MODULES.modules[\"archives\"]!==undefined) {window.RS_MODULES.modules[\"archives\"].once = false;window.revapi195 = undefined;if (window.RS_MODULES.checkMinimal!==undefined) window.RS_MODULES.checkMinimal()}\n\t\t\t\t<\/script>\n\t\t\t<\/rs-module-wrap>\n\t\t\t<!-- END REVOLUTION SLIDER -->\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The IVDR date of application was 26 May 2022. Find out the transition periods, how to classify your IVD, and how to CE mark under the IVDR.<\/p>\n","protected":false},"author":2,"featured_media":9869,"parent":507,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ub_ctt_via":"","footnotes":""},"featured_image_src":"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/shutterstock_2270998021-scaled.jpg","_links":{"self":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/515"}],"collection":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/comments?post=515"}],"version-history":[{"count":119,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/515\/revisions"}],"predecessor-version":[{"id":11643,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/515\/revisions\/11643"}],"up":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/507"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media\/9869"}],"wp:attachment":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media?parent=515"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}