{"id":6191,"date":"2025-11-04T13:48:08","date_gmt":"2025-11-04T13:48:08","guid":{"rendered":"https:\/\/www.almacgroup.com\/diagnostics\/?page_id=6191"},"modified":"2025-11-14T11:32:01","modified_gmt":"2025-11-14T11:32:01","slug":"eu-ivdr-support-health-institution","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/diagnostics\/eu-ivdr-support-health-institution\/","title":{"rendered":"EU IVDR Support &amp; Health Institution"},"content":{"rendered":"\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<p><!-- wp:paragraph {\"align\":\"left\"} --><\/p>\n<h3><strong>Almac as a Health Institution &#8211; <span data-teams=\"true\">Your faster route to EU trial enrolment<\/span><\/strong><\/h3>\n<p>The UK Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that Almac Diagnostic Services UK laboratory in Craigavon, Northern Ireland, meets the definition of a Health Institution provided all IVDR Article 5(5) requirements are met:<\/p>\n<p><em>Screening services for pharma-sponsored medicinal product clinical trials to determine eligibility for trial enrolment or patient stratification once enrolled on the trial, i.e. IVDs function in an interventional capacity. Samples are collected from clinical trial sites worldwide and shipped to Almac, therefore the IVD is used in the same institution (Almac\u2019s clinical laboratory) in which it is made (although results are distributed worldwide). These IVDs meet all GSPR requirements set out in IVDR Annex I and meet all Article 5(5) requirements. It is not intended that the IVD will generate clinical performance data for submission to regulatory authorities, it will solely be used within the clinical trial.<\/em><\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<p><!-- wp:paragraph {\"align\":\"left\"} --><\/p>\n<h3><strong>The IVDR Challenge<\/strong><\/h3>\n<p>Depending on the intended use of the IVD within the trial, IVDR requires Clinical Performance Study (CPS) applications to be submitted to the Competent Authority (CA) of each country in which there is a clinical trial site. The increased administrative burden and long CA and ethical committee review times can lead to delays in trial initiation and increased costs.<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<p><!-- wp:paragraph {\"align\":\"left\"} --><\/p>\n<h3><strong>Benefits for Pharma &amp; Biotech Companies of utilising Almac as a Health Institution<\/strong><\/h3>\n<p>Utilising Almac as a Health Institution means a faster and cheaper route to EU trial enrolment for your biomarker led clinical trial programmes.<br \/>\nSome of Almac\u2019s own existing IVDs, and IVDs created for pharma clinical trial sponsors, may be able to be used as in-house devices within Almac as a \u2018Health Institution\u2019. For these IVDs, Almac must meet all requirements set out in IVDR Article 5(5).<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<p><!-- wp:paragraph {\"align\":\"left\"} --><br \/>\n<strong><u>For Pharma Sponsors of Clinical Trials there would be no need for IVD:<\/u><\/strong><\/p>\n<ul>\n<li>Marketing approval<\/li>\n<\/ul>\n<p><strong>or<\/strong><\/p>\n<ul>\n<li>Clinical Performance Study (CPS) approval<\/li>\n<\/ul>\n<p><strong><u>Benefits<\/u><\/strong><br \/>\n<br \/>\n<strong>Time:<\/strong> <strong>Faster Route for EU Clinical Trials Participant Enrolment<\/strong><br \/>\n<strong>Money:<\/strong>\u00a0 <strong>Cost reduction for Trials without need to pay for CPS applications to multiple Competent Authorities<\/strong><\/p>\n<p>Our Almac Diagnostic Services UK laboratory provides genomic &amp; anatomic pathology services and is fully compliant with the criteria defined in IVDR Article 5(5) including a robust quality management system, ISO 15189 accreditation, device review and device declaration procedures inclusive of ensuring IVDR Annex I general safety and performance requirements (GSPRs) are met.<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<div class=\"u-flex u-block@m\">\n<div class=\"u-align-center u-p-a2 u-bg-light-grey u-m-r1 u-m-b1\" style=\"max-width: 400px;\">\n<h3><\/h3>\n<h3><strong><span style=\"color: #0064a8;\">Find out how we meet IVDR Article 5 (5) Requirements<\/span><\/strong><\/h3>\n<p><strong>The following document outlines in more detail how Almac Diagnostic Services meets all the requirements of IVDR Article 5.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p class=\"u-m-t2\"><a class=\"c-btn&quot;\" href=\"\/wp-content\/uploads\/sites\/3\/2025\/11\/DX_Health-Institution-Status_PDF-1-1.pdf\">Download article<\/a><\/p>\n<\/div>\n<div class=\"u-align-center u-p-a2 u-bg-light-grey u-m-r1 u-m-b1\" style=\"max-width: 400px;\"><a href=\"\/wp-content\/uploads\/sites\/3\/2025\/11\/DX_Health-Institution-Status_PDF-1-1.pdf\"><img decoding=\"async\" class=\"alignnone size-medium lazyload\" data-src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/11\/IVDR_UpdatedCover.png\" alt=\"\" width=\"214\" height=\"300\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 214px; --smush-placeholder-aspect-ratio: 214\/300;\" \/><noscript><img decoding=\"async\" class=\"alignnone size-medium\" src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/11\/IVDR_UpdatedCover.png\" alt=\"\" width=\"214\" height=\"300\" \/><\/noscript><\/a><\/div>\n<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<h3><strong>Interested in Partnering with Almac as a Health Institution?<\/strong><\/h3>\n<p>&nbsp;<\/p>\n<p style=\"line-height: 16.5pt; margin: 0cm 0cm 12.0pt 0cm;\">Get in touch today to start a discussion around your EU Clinical Trial requirements.<\/p>\n<p><a class=\"c-btn c-btn-secondary c-btn--red\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/contact-us\">Contact Our Regulatory Experts<\/a><\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<h3><strong>IVDR \u2013 Background<\/strong><\/h3>\n<p class=\"has-text-align-left\">Medical technologies are tightly regulated in the European Union.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph {\"align\":\"left\"} --><\/p>\n<p class=\"has-text-align-left\">Previously, under <strong>IVDD guidelines<\/strong> \u2013 Roughly <strong><em>only 20% of devices were certified by a notified body<\/em><\/strong> with a CE mark on market. Now, under the new <strong>IVDR regulation<\/strong> \u2013 <strong><em>This number increases dramatically and more than 80% of all new devices will need certification by a notified body<\/em><\/strong> to obtain a CE Mark and be placed on market.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph {\"align\":\"left\"} --><\/p>\n<p class=\"has-text-align-left\"><strong>Before an IVD (in-Vitro Diagnostic) can be legally placed on the EU market, a manufacturer must comply with the requirements of all applicable EU legislation and affix a CE mark to their device.<\/strong><\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<p><img decoding=\"async\" class=\"alignleft wp-image-4702 lazyload\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/IVDR-Timeline-for-Transition-update-e1706606388716.png\" alt=\"\" width=\"820\" height=\"340\" data-srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/IVDR-Timeline-for-Transition-update-e1706606388716.png 653w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/IVDR-Timeline-for-Transition-update-e1706606388716-300x125.png 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/IVDR-Timeline-for-Transition-update-e1706606388716-480x199.png 480w\" data-sizes=\"(max-width: 820px) 100vw, 820px\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 820px; --smush-placeholder-aspect-ratio: 820\/340;\" \/><noscript><img decoding=\"async\" class=\"alignleft wp-image-4702\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/IVDR-Timeline-for-Transition-update-e1706606388716.png\" alt=\"\" width=\"820\" height=\"340\" srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/IVDR-Timeline-for-Transition-update-e1706606388716.png 653w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/IVDR-Timeline-for-Transition-update-e1706606388716-300x125.png 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/IVDR-Timeline-for-Transition-update-e1706606388716-480x199.png 480w\" sizes=\"(max-width: 820px) 100vw, 820px\" \/><\/noscript><\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<p><!-- wp:paragraph {\"align\":\"left\"} --><\/p>\n<h3><strong>IVDR \u2013 Impact for Biopharma Companies &amp; Clinical Trials<\/strong><\/h3>\n<p>Recently issued EU guidance on the interface between the Clinical Trial Regulation (CTR) and IVDR places increased responsibility with pharma sponsors for the oversight, safety and performance of tests selected for use within drug clinical trials by the trial sponsors.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>This guidance obligates the sponsor of drug clinical trials to obtain a statement of compliance to IVDR\u2019s general safety and performance requirements (GSPR) from manufacturers of IVDs for use within clinical trials.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>Additionally for unapproved tests utilised in an interventional manner (e.g. where treatment arm is being determined by the test) or as performance devices where the device is under investigation, the IVD manufacturer will be required to obtain clinical performance study (CPS) regulatory approval for use of their test from each EU Competent Authority in which the clinical trial is active.<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<p><!-- wp:paragraph {\"align\":\"left\"} --><\/p>\n<h3><strong>Almac IVDR Support for Biopharma Companies<\/strong><\/h3>\n<p>Almac Diagnostic Services can support Biotech and Pharma companies with up-to-date guidance and support for your biomarker programmes around IVDR and compliance with the new regulations for Europe.<\/p>\n<ul>\n<li><strong>Almac is well positioned to meet the requirements of IVDR to provide services that allow the development, validation and delivery of clinical trial assays for analysis of specimens from EU clinical trial sites.<\/strong><\/li>\n<li><strong>Almac can ensure that pharma clinical trial sponsors meet their obligations under CTR<\/strong>.<\/li>\n<li><strong>Almac can ensure that not only EU requirements are met, but additionally for our Biopharma partners global trials, that all other regulatory requirements are aligned optimally for smooth IVD approval in each region. <\/strong><\/li>\n<\/ul>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<p><!-- wp:paragraph {\"align\":\"left\"} --><\/p>\n<h3><strong>Almac IVDR Preparedness<\/strong><\/h3>\n<ul>\n<li>Almac has reviewed the appropriate IVDR Regulation.<\/li>\n<li>Almac has updated our procedures and documents as part of our QMS to ensure compliance, including PMS (Post Marketing Surveys) &amp; reporting, GSPRs (General Safety &amp; Performance Requirements) and Scientific Validity.<\/li>\n<li>Almac has already transitioned some CE Marked assays from IVDD to IVDR to allow use within clinical trials within the transition period by our Biopharma clients.<\/li>\n<li>Almac is currently in the process of submitting Clinical Protocol Study (CPS) applications (on behalf of major Pharma &amp; Biotech partners) for current assays to enable use of data for registrational trial purposes including:\n<ul>\n<li>Spain<\/li>\n<li>Portugal<\/li>\n<li>Germany<\/li>\n<li>Turkey<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<!-- Half image, half text -->\n<section class=\"u-bg-white t-theme-component-overwrite\" id=\"halfMediaTextBlock\">\n    <div class=\"c-half-media-text \">\n        <div class=\"o-wrapper\">\n                                                        <article class=\"o-grid u-bg-white\">\n                            <div class=\"u-width-half u-width-7\/12@l u-width-full@m c-half-media__repeat-text none u-bg-white\">\n                                                                    <h2 class=\"u-m-b3\">Almac&#8217;s Unique Geographical Location &#038; IVDR Benefits<\/h2>\n                                                                <p>Northern Ireland is the only part of U.K. to have a land border with the EU. <strong>Almac Diagnostic Services, is in the unique global position of being based in Northern Ireland, which, due to the Windsor Agreement, has unfettered access to both the EU and UK Markets.<\/strong><\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>The UK Government has guaranteed unfettered access for Northern Ireland\u2019s businesses to the rest of the UK internal market. For medical devices, this means that any CE marked device held by a Northern Ireland business is valid for the whole of the UK market provided it falls within the definition of a <em>qualifying \u201cNorthern Ireland good\u201d.<\/em> Therefore, CE marked devices that can be placed on the Northern Ireland market and are qualifying Northern Ireland goods, can also be placed on the UK market and will not need to undergo any further registration in Great Britain.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p><strong>This places Almac in an extremely advantageous position for assay development and deployment in clinical trials, saving time, costs &amp; additional regulatory hurdles along the approval process for assays approved from our Craigavon laboratory.<\/strong><\/p>\n                                                            <\/div>\n                            <div class=\"u-width-half u-width-5\/12@l u-width-full@m u-flex c-half-media__repeat-image\">\n                                                                    <img decoding=\"async\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/Almac-Unique-Geographical-Location-IVDR-Benefits.png\" alt=\"Almac's Unique Geographical Location &#038; IVDR Benefits\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" class=\"lazyload\" style=\"--smush-placeholder-width: 388px; --smush-placeholder-aspect-ratio: 388\/316;\"><noscript><img decoding=\"async\" class=\"\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/Almac-Unique-Geographical-Location-IVDR-Benefits.png\" alt=\"Almac's Unique Geographical Location &#038; IVDR Benefits\"><\/noscript>\n                                                            <\/div>\n                        <\/article>\n                                        <\/div>\n    <\/div>\n<\/section>\n\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"u-bg-light-grey t-theme-component-overwrite\" id=\"halfMediaHalfTextNewBlock\">\n    <div class=\"o-wrapper\">\n        <div class=\"o-grid\">\n            <div class=\"o-grid__item u-width-full\">\n                \n\n                    <!--If media is image, show it left, content right -->\n                    \n                        <div class=\"u-flex u-width-full u-m-y6 u-flex-direction-column@s u-flex-justify-start\">\n\n                            <div class=\"u-width-half u-width-full@m\">\n                                                                    <h2 class=\"u-m-b2 u-m-b2 u-c-text\">Almac Diagnostic Services <br> Blog  \u2013 \u2018Almac Voice\u2019 <\/h2>\n                                \n                                <div class=\"u-c-text\"><p>Read our latest blog on \u201cPotential impact of IVDR on diagnostic testing in Europe \u2013 What are the implications for the pharmaceutical industry?\u201d<\/p>\n<p>Written by Joe Clune, CDx commercialisation consultant and Stewart McWilliams, \u00a0VP of Quality and Regulatory Affairs at Almac Diagnostic Services, the blog covers the following key topics:<\/p>\n<ul>\n<li><strong>Introduction to IVDR<\/strong><\/li>\n<li><strong>IVDR \u2013 What\u2019s New? <\/strong><\/li>\n<li><strong>Challenges in the implementation of IVDR<\/strong><\/li>\n<li><strong>Background \u2013 Companion Diagnostics<\/strong><\/li>\n<li><strong>The evolving landscape of approved tests vs LDTs<\/strong><\/li>\n<li><strong>Will Europe still have LDTs with IVDR?<\/strong><\/li>\n<li><strong>What does Pharma need to do?<\/strong><\/li>\n<\/ul>\n<\/div>\n\n                                                                                                            <a class=\"c-btn u-m-t2 u-c-text\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/Almac-Dx-IVDR-Blog-FINAL-Jan-2024.pdf\">Download<\/a>\n                                                                    \n                            <\/div>\n\n                            <div class=\"u-width-half u-width-full@m\">\n                                <div class=\"u-width-half u-block u-center u-width-3\/4@m u-width-full@s u-m-t2@s\">\n                                                                                                                        <img decoding=\"async\" class=\"u-width-full lazyload\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/Almac-Voice-IVDR-Blog.png\" alt=\"\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 493px; --smush-placeholder-aspect-ratio: 493\/700;\" \/><noscript><img decoding=\"async\" class=\"u-width-full\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/Almac-Voice-IVDR-Blog.png\" alt=\"\"\/><\/noscript>\n\n                                            <div class=\"u-bg-white u-p3 u-a-center\">\n\n                                                <h3 class=\"u-text-20 u-c-text\"><\/h3>\n\n                                                                                                    <a class=\"c-btn c-btn c-btn2 u-m-t2 u-c-text\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/01\/Almac-Dx-IVDR-Blog-FINAL-Jan-2024.pdf\">Download<\/a>\n                                                \n                                            <\/div>\n                                                                                                            <\/div>\n                            <\/div>\n                        <\/div>\n\n                    \n                            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<h2>Almac Webinar &#8211; Available on demand<\/h2>\n<p>In this Almac webinar, hosted by X Talks, the expert speakers focus on their experience with IVDR and describe strategies for solving the specific challenges faced during the IVDR submission process for clinical trial assays being utilised as CDx, allowing global trials to commence and complete in a timely manner.<\/p>\n<p>Download this webinar today where experts will share their experience with EU IVDR and provide insights into solving challenges faced during the EU IVDR submission process.<\/p>\n<p><strong>Presenters: <\/strong><\/p>\n<p>Dr. Stewart McWilliams, Global VP Quality and Regulatory Affairs, Almac Diagnostic\u00a0Services<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-4955 lazyload\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/03\/stewart-mcwilliams.png\" alt=\"\" width=\"103\" height=\"103\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 103px; --smush-placeholder-aspect-ratio: 103\/103;\" \/><noscript><img decoding=\"async\" class=\"alignnone size-full wp-image-4955\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/03\/stewart-mcwilliams.png\" alt=\"\" width=\"103\" height=\"103\" \/><\/noscript><\/p>\n<p>Charlene Robb, IVD Regulatory Affairs Team Leader, Almac Diagnostic Services<\/p>\n<p><img decoding=\"async\" class=\"alignleft wp-image-5141 lazyload\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/04\/Charlene-Robb-300x300.png\" alt=\"\" width=\"106\" height=\"106\" data-srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/04\/Charlene-Robb-300x300.png 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/04\/Charlene-Robb-150x150.png 150w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/04\/Charlene-Robb-320x320.png 320w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/04\/Charlene-Robb.png 500w\" data-sizes=\"(max-width: 106px) 100vw, 106px\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 106px; --smush-placeholder-aspect-ratio: 106\/106;\" \/><noscript><img decoding=\"async\" class=\"alignleft wp-image-5141\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/04\/Charlene-Robb-300x300.png\" alt=\"\" width=\"106\" height=\"106\" srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/04\/Charlene-Robb-300x300.png 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/04\/Charlene-Robb-150x150.png 150w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/04\/Charlene-Robb-320x320.png 320w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/04\/Charlene-Robb.png 500w\" sizes=\"(max-width: 106px) 100vw, 106px\" \/><\/noscript><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><a class=\"c-btn c-btn-primary c-btn--red\" style=\"color: white !important;\" href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/overcoming-eu-ivdr-challenges-when-using-clinical-trial-assays-to-accelerate-global-cdx-trials\/\">Download<\/a><\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<!-- Half image, half text -->\n<section class=\"u-bg-light-grey t-theme-component-overwrite\" id=\"halfMediaTextBlock\">\n    <div class=\"c-half-media-text \">\n        <div class=\"o-wrapper\">\n                                                        <article class=\"o-grid u-bg-light-grey\">\n                            <div class=\"u-width-half u-width-7\/12@l u-width-full@m c-half-media__repeat-text none u-bg-light-grey\">\n                                                                    <h2 class=\"u-m-b3\">Contact us<\/h2>\n                                                                <p style=\"line-height: 16.5pt; margin: 0cm 0cm 12.0pt 0cm;\">Looking for an informal conversation on how Almac Diagnostic Services might help with your IVDR requirements?<\/p>\n<p style=\"line-height: 16.5pt; margin: 0cm 0cm 12.0pt 0cm;\">\nGet in touch and one of our experts will follow up with you.<\/p>\n                                                                    <a class=\"c-btn c-btn-primary c-btn--red u-m-t2 u-m-t0@m\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/contact-us\/\">Contact us<\/a>\n                                                            <\/div>\n                            <div class=\"u-width-half u-width-5\/12@l u-width-full@m u-flex c-half-media__repeat-image\">\n                                                                    <img decoding=\"async\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2023\/02\/dx-contact-us-e1675778827484.png\" alt=\"Contact us\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" class=\"lazyload\" style=\"--smush-placeholder-width: 337px; --smush-placeholder-aspect-ratio: 337\/179;\"><noscript><img decoding=\"async\" class=\"\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2023\/02\/dx-contact-us-e1675778827484.png\" alt=\"Contact us\"><\/noscript>\n                                                            <\/div>\n                        <\/article>\n                                        <\/div>\n    <\/div>\n<\/section>\n\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1870,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-6191","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.3.1 (Yoast SEO v26.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU IVDR Support &amp; 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