{"id":7241,"date":"2023-10-15T00:21:09","date_gmt":"2023-10-15T00:21:09","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7241"},"modified":"2024-01-11T16:37:22","modified_gmt":"2024-01-11T16:37:22","slug":"ivdr-ldt-faq","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/ivdr-ldt-faq\/","title":{"rendered":"EU IVDR Compliance for In-House Lab Developed IVD Tests"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7241\" class=\"elementor elementor-7241\" 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-1b0c5cde elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b0c5cde\" 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-6dd05cd3\" data-id=\"6dd05cd3\" 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-7ca59751 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7ca59751\" 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-6ea4084d\" data-id=\"6ea4084d\" 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-3fab5c3f elementor-widget elementor-widget-post-info\" data-id=\"3fab5c3f\" 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\/2023\/10\/15\/\">\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\tOctober 15, 2023\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-5f16c1c2 elementor-widget elementor-widget-heading\" data-id=\"5f16c1c2\" 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\">EU IVDR Compliance for In-House Lab Developed IVD Tests <\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f7ff590 elementor-widget elementor-widget-image\" data-id=\"1f7ff590\" 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\/02\/blood-sample-tubes-IVD-tests.jpeg\" class=\"attachment-full size-full wp-image-1454\" alt=\"In Vit\" 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-1005398 elementor-widget elementor-widget-text-editor\" data-id=\"1005398\" 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>When it comes to compliance with European regulations, manufacturers of in-house lab-developed tests have had it pretty good\u2026along with most other IVD manufacturers. While the EU\u00a0<em>I<\/em>n Vitro\u00a0Diagnostic Directive (IVDD 98\/79\/EC) exempted makers of so-called in-house tests (aka LDT), the new\u00a0In Vitro\u00a0Diagnostic Regulation does not carve out many exemptions for these tests. Still, without a single utterance of LDT in the entire IVDR, and no guidance documents published as of October 2023 many manufacturers are scratching their collective heads about what will be required and what to do next.<\/p><p>First, let us clarify what we mean by the generic term \u201clab-developed tests.\u201d Although this specific term is not really used in the EU as it is in the US, there are two distinct types of in-house tests.<\/p><p><strong>1 \u2013 Tests developed by and conducted at a\u00a0<em>health institution<\/em>\u00a0(for example, a biopsy tissue sample).<\/strong>\u00a0A health institution is an organization whose primary purpose is the care or treatment of patients or the promotion of public health, and while the institution is placing an IVD \u201cinto service,\u201d it is not placing the IVD \u201con the (EU) market.\u201d IVDR Article 5 describes the specific requirements for these health institutions.<\/p><p><strong>2 \u2013\u00a0<em>Testing services<\/em>\u00a0where a sample is sent to a lab and a result is sent back (for example, a commercial genetic test using a saliva sample).<\/strong>\u00a0Testing services are covered under IVDR Article 6 regarding Distance Sales and are treated the same as if the IVD was sold commercially (placed on the market).<\/p><p>This article focuses on testing services and Article 6. Some key points to understand:<\/p><ul><li>So-called LDTs are not defined nor mentioned in the IVDR, but they are covered by it.<\/li><li>In order to be exempt from CE Marking, an in-house IVD must have no equivalent CE Marked IVD on the market.<\/li><li>The same classification system applied to IVDs applies to LDTs \/ in-house IVDs.<\/li><li>Compliance is not dependent on where the test is conducted.<\/li><li>At minimum, all tests must comply with the General Safety and Performance Requirements in Annex I of the IVDR.<\/li><li>Risk classification for an LDT \/ in-house IVD should follow the IVDR classification rules found in IVDR Article 47 and Annex VIII.<\/li><li>ISO 15189 will work for a health institution, but for testing services, ISO 13485 certification may be necessary.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1af7ef elementor-widget elementor-widget-heading\" data-id=\"a1af7ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">IVDR Compliance for Commercial IVD Testing Services<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb40341 elementor-widget elementor-widget-text-editor\" data-id=\"cb40341\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Shown below is a quick reference table of compliance applicable for in-house tests where a sample is collected within the EU, then sent back to a lab inside or outside the EU.<\/p><p>\u00a0<\/p><table width=\"112%\"><tbody><tr><td width=\"341\"><p><strong>Areas to Review<\/strong><\/p><\/td><td width=\"359\"><p><strong>Required?<\/strong><\/p><\/td><\/tr><tr><td width=\"341\"><p><strong>General Safety and Performance Requirements<\/strong><\/p><\/td><td width=\"359\"><p>Required, see Annex I<\/p><\/td><\/tr><tr><td width=\"341\"><p><strong>CE Marking of Test<\/strong><\/p><\/td><td width=\"359\"><p>Required, regardless of where actual testing is done<\/p><\/td><\/tr><tr><td width=\"341\"><p><strong>IVDR Classification of Specimen Receptacles<\/strong><\/p><\/td><td width=\"359\"><p>Class A<\/p><\/td><\/tr><tr><td width=\"341\"><p><strong>IVDR Classification of Tests<\/strong><\/p><\/td><td width=\"359\"><p>Class B, C, or D<\/p><\/td><\/tr><tr><td width=\"341\"><p><strong>Performance Evaluation<\/strong><\/p><\/td><td width=\"359\"><p>Required, see Article 56 and Annex XIII<\/p><\/td><\/tr><tr><td width=\"341\"><p><strong>Postmarket Surveillance (PMS)<\/strong><\/p><\/td><td width=\"359\"><p>Required, see Articles 78-79 and Annex III<\/p><\/td><\/tr><tr><td width=\"341\"><p><strong>Corrective and Preventive Action (CAPA)<\/strong><\/p><\/td><td width=\"359\"><p>Required under Annex I<\/p><\/td><\/tr><tr><td width=\"341\"><p><strong>Quality Management System Compliance<\/strong><\/p><\/td><td width=\"359\"><p>ISO 13485 is essential<\/p><\/td><\/tr><tr><td width=\"341\"><p><strong>Exemption for Research Use Only (RUO) Products<\/strong><\/p><\/td><td width=\"359\"><p>Must have no medical purpose<\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d78be8 elementor-widget elementor-widget-heading\" data-id=\"6d78be8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Are there any guidance documents to help understand IVDR requirements for IVD tests?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed9a568 elementor-widget elementor-widget-text-editor\" data-id=\"ed9a568\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>As of October 2023, there are no published guidance documents from the IMDRF related to compliance for these types of tests. This may change soon, and we recommend you monitor the\u00a0<a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec12\">European Commission page showing all current and planned EU MDR and IVDR guidance<\/a>.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f58d85 elementor-widget elementor-widget-heading\" data-id=\"1f58d85\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">We ship CE Marked specimen receptacles to Europe but do the actual testing outside Europe. Do we really need to comply with the IVDR?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8a15706 elementor-widget elementor-widget-text-editor\" data-id=\"8a15706\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Yes. Even though specimen receptacles are considered Class A devices under the IVDR and can be self-certified, your test itself is no longer exempt and must follow IVDR classification guidelines found in Annex VIII, Article 47, and\u00a0<a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_sector\/docs\/md_mdcg_2020_guidance_classification_ivd-md_en.pdf\">this guidance document<\/a>. Also, it no longer matters where the actual test is conducted if your specimens are taken from European patients. Article 6 \u2013 Distance Sales specifically describes the need for compliance for testing services.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4491cb0 elementor-widget elementor-widget-heading\" data-id=\"4491cb0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Is our IVD considered Research Use Only (RUO) and thus exempt from the IVDR?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-665032a elementor-widget elementor-widget-text-editor\" data-id=\"665032a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Unlikely. MEDDEV 2.14\/2 clearly defines Research Use Only (RUO) products, and to qualify under that definition, the test must have no intended medical purpose.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-adf488d elementor-widget elementor-widget-heading\" data-id=\"adf488d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">We have ISO 15189 certification. Do we really need to get ISO 13485 certification too?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d34923e elementor-widget elementor-widget-text-editor\" data-id=\"d34923e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>If your IVD is Class B, C, or D, probably yes. The primary reason is that ISO 15189 certification focuses on the requirements for using in-house tests, whereas ISO 13485 adds requirements for manufacturing. As such, ISO 15189 does not cover all of the requirements of the IVDR. To be sure, consult with your Notified Body.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c822fb5 elementor-widget elementor-widget-heading\" data-id=\"c822fb5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Want to Learn More?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b959ace elementor-widget elementor-widget-text-editor\" data-id=\"b959ace\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>If you need to get up to speed quickly on the IVDR, we have just the program for you. 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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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-0cb1859 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0cb1859\" 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-54408df\" data-id=\"54408df\" 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<div class=\"elementor-element elementor-element-efec1d2 elementor-widget elementor-widget-image\" data-id=\"efec1d2\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor\/assets\/images\/placeholder.png\" title=\"\" alt=\"\" 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\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>EU IVDR Compliance for In-House Lab Developed IVD Tests When it comes to compliance with European regulations, manufacturers of in-house lab-developed tests have had it pretty good\u2026along with most other IVD manufacturers. While the EU\u00a0In Vitro\u00a0Diagnostic Directive (IVDD 98\/79\/EC) exempted makers of so-called in-house tests (aka LDT), the new\u00a0In Vitro\u00a0Diagnostic Regulation does not carve out [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1454,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[34,40],"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=\"description\" content=\"https:\/\/www.orielstat.com\/blog\/ivdr-ldt-faq\/Read about EU IVDR (In Vitro Diagnostic Regulation) compliance for makers of laboratory-developed tests (LDT) and in-house IVD Tests (IH-IVDs).\" \/>\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\/ivdr-ldt-faq\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"https:\/\/www.orielstat.com\/blog\/ivdr-ldt-faq\/Read about EU IVDR (In Vitro Diagnostic Regulation) compliance for makers of laboratory-developed tests (LDT) and in-house IVD Tests (IH-IVDs).\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/ivdr-ldt-faq\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - 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