{"id":7799,"date":"2024-01-11T00:38:48","date_gmt":"2024-01-11T00:38:48","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7799"},"modified":"2024-01-12T20:16:11","modified_gmt":"2024-01-12T20:16:11","slug":"ivdd-vs-ivdr-gap-analysis-checklist","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/ivdd-vs-ivdr-gap-analysis-checklist\/","title":{"rendered":"IVDD vs. IVDR Gap Analysis and Checklist for 2017\/746"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7799\" class=\"elementor elementor-7799\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2024\/01\/11\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJanuary 11, 2024\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">IVDD vs. IVDR Gap Analysis and Checklist for 2017\/746<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/04\/Two-people-looking-at-gantt-chart-on-computer-AdobeStock_171797743-_Resized-1104W736H.jpg\" class=\"attachment-full size-full wp-image-1804\" alt=\"Two people looking at gantt chart on computer\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>If you market an IVD in Europe and are just starting to think about doing a thorough gap analysis for the\u00a0<em>In Vitro<\/em> Diagnostic Regulation (IVDR), it&#8217;s definitely not too early to start. An IVDD vs. IVDR gap analysis helps determine where you are now and where you need to be. While the EU IVDR entered into force in May 2017, the final <a href=\"https:\/\/www.orielstat.com\/blog\/eu-ivdr-deadlines\/\">IVDR compliance deadlines<\/a>\u00a0will be here before you know it. This is a longer transition period than for the EU MDR because the preparation phase will take longer for most IVD manufacturers the changes in the IVDR are more significant and impactful than those in the EU MDR.<\/p><h3>\u00a0<\/h3><h3>Where to Begin? Areas to Focus on in Your IVDR Gap Assessment<\/h3><p>Here are some areas that will greatly impact many IVD companies and demand your attention. For easy reference, download this fully linked\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/eu-ivdr-table-of-contents-2017-746\/\">IVDR Table of Contents<\/a>, which also includes the full text of the IVDR.<\/p><p><strong>IVD classification<\/strong>\u00a0Start here. There are new classification groupings (A, B, C, D) and rules that significantly affect many IVDs, notably software, single-use IVDs, companion diagnostics, and genetic tests. (See Article 47 &amp; Annex VIII.)<\/p><p><strong>1 \u2013 More data<\/strong><\/p><p>You will need to carefully evaluate your existing clinical and performance data, as this will be required for Class B, C, and D\u00a0<em>in vitro<\/em>\u00a0diagnostic devices (and Class A as applicable). The IVDR will require you to compile a performance evaluation report (PER see Article 56) for each device, including a scientific validity report, analytical performance report, and clinical performance report. (See Chapter VI &amp; Annexes II, XIII, XIV.)<\/p><p><strong>2 \u2013 Postmarket surveillance<\/strong><\/p><p>There will be a\u00a0<strong><u>lot<\/u><\/strong>\u00a0more focus on vigilance by regulators. You will need to show that you have a continuous process improvement cycle in place that links to your risk management processes. This includes implementation of a postmarket performance follow-up (PMPF) plan. (See Chapter VII &amp; Annex III.)<\/p><p><strong>3 \u2013 Risk management<\/strong><\/p><p>It is no longer acceptable to simply say that you comply with EN ISO 14971. The IVDR compels manufacturers to demonstrate that they are gathering feedback continuously and proactively. Is your risk management process adequate?<\/p><p><strong>4 \u2013 Unique device identification<\/strong><\/p><p>The IVDR will place far more emphasis on supply chain traceability, and thus you will need to implement UDI for your IVDs. If you are already doing this as part of US FDA compliance, you know the process, but the format and mechanics will be different.<\/p><p><strong>5 \u2013 Quality management system<\/strong><\/p><p>If you do not already have EN ISO 13485:2016 certification, there&#8217;s a good chance you will need it unless you only make Class A IVD devices under the IVDR. If you currently comply with US FDA QSR (21 CFR Part 820) your transition will be easier, but don&#8217;t delay Notified Bodies will be in high demand, especially in 2021-2022.<\/p><p>Currently only 10-20% of IVDs are subject to Notified Body scrutiny under the IVDD. That number will jump to 80-90% under the IVDR and swamp [<a href=\"https:\/\/www.orielstat.com\/blog\/number-notified-bodies-pursuing-mdr-ivdr-certification-continues-dwindle\/\">why<\/a>] the limited pool of Notified Bodies authorized to do IVD product reviews.<\/p><h3>\u00a0<\/h3><h3>Creating an EU IVDR Gap Checklist<\/h3><p>With so many compliance tasks to complete, it&#8217;s a good idea to create a checklist that will allow you to track and prioritize them all. When you think about the time to complete these various tasks, remember that you will have competing priorities! Don\u2019t fixate on the IVDR implementation date. Instead, use the anticipated date of your Notified Body audit and work backwards from there. Be conservative! If you think you are going to schedule your Notified Body audit a few months before the implementation date, so do thousands of other IVD companies. Play it safe and schedule your Notified Body audit to occur at least a year before the implementation date for your class of IVDat the latest. Remember that you will be expected to comply with the QMS requirements before the deadline so while you have some extra time to get your technical documentation house in order, get busy on implementing ISO 13485:2016!<\/p><p>Speaking of priorities, if you are not already working with a Notified Body, put that on your to-do list this month. Seriously. In the final year before the IVDR deadlines, there will be an endless queue of panic-stricken IVD manufacturers begging for the attention of a handful of Notified Bodies. Also, keep in mind that not every Notified Body will be designated to handle the full scope of the IVDR. Thus, if you make a range of IVDs, it is possible you may need more than one Notified Body. Be sure to ask about scope when you call Notified Bodies. See\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/eu-notified-bodies-designation-status-mdr-2017-745\/\" target=\"_blank\" rel=\"noopener noreferrer\">this list<\/a>.<\/p><h3>\u00a0<\/h3><h3>Start Now: Strategic Planning<\/h3><ul><li>Which products in your portfolio are sold in the EU\u2019 What is the return on investment?<\/li><li>When do the IVDD-based EC certificates of conformity expire?<\/li><li>What is the state of your technical documentation?<\/li><li>What conformity assessment route (Annex IX, X, XI) will you pursue?<\/li><li>Which devices will have a classification change?<\/li><li>Are you EN ISO 13485:2016 certified?<\/li><li>Has your Notified Body applied for or been designated to perform audits for your type(s) of devices?<\/li><li>What is your role as manufacturer? Do you market any private-label products made by another company?<\/li><li>What resourcing and expertise do you have? Do you need help in training or gap assessment?<\/li><\/ul><h3>\u00a0<\/h3><h3>18+ Months Before Notified Body IVDR Audit<\/h3><ul><li>Create quality plans for the transition based on your device families.<\/li><li>Perform a gap analysis between IVDR requirements and your QMS.<\/li><li>Organize your product SKUs into families to plan your technical documentation strategy.<\/li><li>Create teams for gap fulfillment and work toward milestones.<\/li><\/ul><h3>\u00a0<\/h3><h3>12+ Months Before Notified Body IVDR Audit<\/h3><ul><li>Get certified to EN ISO 13485:2016 (if you aren&#8217;t already).<\/li><li>Gather data needed for performance evaluation reports (PERs).<\/li><li>Keep up to date with current standards and implementing acts.<\/li><li>Conduct awareness training on the IVDR (organization-wide).<\/li><\/ul><h3>\u00a0<\/h3><h3>6-12 Months Before Notified Body IVDR Audit<\/h3><ul><li>Assemble PERs.<\/li><li>Update risk management procedures.<\/li><li>Implement UDI.<\/li><li>Review all labeling.<\/li><li>Update Economic Operator agreements.<\/li><li>Find and appoint an EU Importer and\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/eu-prrc-person-responsible-regulatory-compliance\/\" target=\"_blank\" rel=\"noopener noreferrer\">PRRC<\/a><\/li><li>Perform employee readiness training.<\/li><\/ul><h3>\u00a0<\/h3><h3>1-6 Months Before Notified Body IVDR Audit<\/h3><ul><li>Coach employees for audit readiness.<\/li><li>Perform an internal audit to IVDR requirements.<\/li><li>Assess the completeness of gap closure.<\/li><li>Open CAPAs for remaining gaps.<\/li><li>Prepare for input of data into Eudamed<\/li><\/ul><h3>\u00a0<\/h3><h3>After IVDR Implementation<\/h3><ul><li>Conduct postmarket clinical follow-up.<\/li><li>Start implementing UDI (Class A, B, C).<\/li><li>Continue postmarket surveillance.<\/li><li>Keep up to date with state of the art.<\/li><li>Prepare for surveillance audits.<\/li><li>Conduct ongoing employee training.<\/li><\/ul><h3>\u00a0<\/h3><h3>Monitor the Release of Implementing Acts<\/h3><p>At the time of this writing, a little number of guidance documents related to IVDs have yet been published that clarify important sections of 2017\/746.\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/eu-mdr-ivdr-guidance-documents\/\" target=\"_blank\" rel=\"noopener noreferrer\">See this list<\/a>. For example, the IVDR mandates the compilation of performance evaluation reports (PERs). These are very similar to the clinical evaluation reports (CERs) mandated for medical devices. These implementing acts and guidance documents should be released with plenty of advance notice, but its important that you track these\u00a0<a href=\"https:\/\/ec.europa.eu\/growth\/sectors\/medical-devices\/new-regulations\/guidance_en\" target=\"_blank\" rel=\"noopener noreferrer\">Know More<\/a>\u00a0and\u00a0<a href=\"https:\/\/ec.europa.eu\/growth\/sectors\/medical-devices\/new-regulations\/spread-word_en\" target=\"_blank\" rel=\"noopener noreferrer\">bookmark this section<\/a>\u00a0of the European Commission website.<\/p><h3>\u00a0<\/h3><h3>After You Conduct Your IVDD vs. IVDR Gap Analysis<\/h3><p>This would be an ideal time to sit down with senior management and get them to buy in. Armed with your analysis of all the work that needs to be done, you can make your case for more staff, more consultants, and more internal cooperation that will surely be required to make your IVDD-to-IVDR transition a success. Evaluate current staff capabilities and future needs. Your ideal team should be cross-functional and could include colleagues from Operations, Sales, IT, and Development. Also, given the intense focus of compliance between now and the IVDR deadline, consider outsourcing project management, gap analysis, and EN ISO 13485:2016 implementation as needed.<\/p><p>Of course, this will also be the ideal time to do a rational evaluation of the merits of all products in your portfolio. Given the increased costs of compliance associated with the IVDR, you may decide that some IVDs with slim margins or meager sales might be pulled from the EU market.<\/p><h3>\u00a0<\/h3><h3>The Early Bird Gets the Worm<\/h3><p>Given the anticipated shortages of Notified Body resources and the additional staff and financial burdens you will surely encounter smart RA\/QA managers are getting a jump on the IVDR by doing their IVDR gap analysis now. If you&#8217;re starting to feel a migraine setting in, buy a Costco-sized bottle of ibuprofen because there are no grandfathering provisions.<\/p><h3>\u00a0<\/h3><h2>Want to Learn More?<\/h2><p>We have much more information on the IVDR to share. Read our\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/eu-ivdr-changes-2017-746\/\" target=\"_blank\" rel=\"noopener noreferrer\">super-informative four-part primer<\/a> on the IVDR changes and what you can do to prepare. You&#8217;ll also want to consider our popular <a href=\"https:\/\/www.orielstat.com\/courses\/eu-ivdr-training-2017-746\" target=\"_blank\" rel=\"noopener noreferrer\">European IVDR training<\/a>. This class will walk you through all the changes in the IVDR compared to the IVDD and leave you feeling confident about what you need to do and when. 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Cause Analysis<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-27\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/clinical-evaluation-reports\/\">Clinical Evaluation Reports<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-59\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/combination-products\/\">Combination Products<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-23\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/complaint-handling-postmarket-surveillance\/\">Complaint Handling and PMS<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-33\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/design-control\/\">Design Control<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-34\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/in-vitro-diagnostics-ivdr\/\">EU IVDR (2017\/746)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-16\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/eu-medical-device-regulation\/\">EU MDR (2017\/745)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-14\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/us-fda-qsr\/\">FDA 21 CFR Part 820<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-21\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/510k-submissions\/\">FDA 510(k) Submissions<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-69\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/fda-eua\/\">FDA EUA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-4\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/iso-134852016\/\">ISO 13485 QMS Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-30\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/risk-management-iso14971\/\">ISO 14971 Risk Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-40\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/laboratory-developed-tests-ldt\/\">Lab Developed Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>IVDD vs. IVDR Gap Analysis and Checklist for 2017\/746 If you market an IVD in Europe and are just starting to think about doing a thorough gap analysis for the\u00a0In Vitro Diagnostic Regulation (IVDR), it&#8217;s definitely not too early to start. An IVDD vs. IVDR gap analysis helps determine where you are now and where [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1804,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[34],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/ivdd-vs-ivdr-gap-analysis-checklist\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"IVDD vs. IVDR Gap Analysis and Checklist for 2017\/746 If you market an IVD in Europe and are just starting to think about doing a thorough gap analysis for the\u00a0In Vitro Diagnostic Regulation (IVDR), it&#8217;s definitely not too early to start. An IVDD vs. IVDR gap analysis helps determine where you are now and where [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/ivdd-vs-ivdr-gap-analysis-checklist\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2024-01-11T00:38:48+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-12T20:16:11+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/04\/Two-people-looking-at-gantt-chart-on-computer-AdobeStock_171797743-_Resized-1104W736H.jpg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"1\" \/>\r\n\t<meta property=\"og:image:height\" content=\"1\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\r\n<meta name=\"author\" content=\"usr192162\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"usr192162\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"8 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.orielstat.com\/blog\/ivdd-vs-ivdr-gap-analysis-checklist\/","og_locale":"en_US","og_type":"article","og_description":"IVDD vs. IVDR Gap Analysis and Checklist for 2017\/746 If you market an IVD in Europe and are just starting to think about doing a thorough gap analysis for the\u00a0In Vitro Diagnostic Regulation (IVDR), it&#8217;s definitely not too early to start. 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