{"id":3897,"date":"2025-12-23T12:42:01","date_gmt":"2025-12-23T11:42:01","guid":{"rendered":"https:\/\/www.cqssalud.com\/cqs-expands-its-role-as-an-eu-reference-laboratory-in-two-categories-of-in-vitro-diagnostic-devices-parasitic-infections-and-blood-groups\/"},"modified":"2025-12-23T12:46:22","modified_gmt":"2025-12-23T11:46:22","slug":"cqs-expands-its-role-as-an-eu-reference-laboratory-in-two-categories-of-in-vitro-diagnostic-devices-parasitic-infections-and-blood-groups","status":"publish","type":"post","link":"https:\/\/www.cqssalud.com\/en\/cqs-expands-its-role-as-an-eu-reference-laboratory-in-two-categories-of-in-vitro-diagnostic-devices-parasitic-infections-and-blood-groups\/","title":{"rendered":"CQS expands its role as an EU reference laboratory in two categories of in vitro diagnostic devices: parasitic infections and blood groups"},"content":{"rendered":"<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>The laboratory has been designated to verify in vitro diagnostic medical devices<\/b><b><i>in vitro<\/i><\/b><b> (IVDs) intended for the detection or quantification of markers of parasitic infection, as well as those intended for the detection of blood group markers.<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>This designation reinforces CQS&#8217;s role as a European Union Reference Laboratory (EURL) with verification and advisory functions.<\/b><\/li>\n<\/ul>\n<p><b>Madrid, XX December 2025. <\/b><span style=\"font-weight: 400;\"> Consulting Chemical Healthcare (CQS) has been designated by the European Commission as a13&gt; as a reference laboratory for the European Union&#8217;s European Union (EURL) in two new categories of medical devices for in vitro diagnosis <\/span><i><span style=\"font-weight: 400;\">in vitro<\/span><\/i><span style=\"font-weight: 400;\"> or <\/span><b>IVDS <\/b><span style=\"font-weight: 400;\">of class D. Specifically, the private laboratory CQS has been designated to verify products. a43&gt; has been designated to verify sanitary products intended for a49&gt; the detection or quantification of <\/span><b>markers of parasitic infection parasitic infection and of markers of blood groups sangu\u00edneos<\/b><span style=\"font-weight: 400;\">, according to as set out in the <\/span><a href=\"https:\/\/www.boe.es\/buscar\/doc.php?id=DOUE-L-2025-81956\"><span style=\"font-weight: 400;\">Regulation of Implementation (EU) 2025\/2526, approved on last 16 of December<\/span><\/a><span style=\"font-weight: 400;\">. <\/span> <\/p>\n<p><span style=\"font-weight: 400;\">This extension of scope reinforces CQS&#8217;s role as an EURL under Regulation (EU) 2017\/746 (IVDR), consolidating its position as an independent scientific entity of European relevance. CQS was already designated at the end of 2023 as an EU reference laboratory in the categories of detection or quantification of markers of  <\/span><b>herpesvirus infection and bacterial infections<\/b><span style=\"font-weight: 400;\">. The incorporation of these two new areas represents a coherent and progressive expansion of its scope, in line with the confidence placed in it by the Spanish and European authorities in its ability to perform these functions in an environment of enhanced supervision.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The designation recognises not only the laboratory&#8217;s technical competence, but also its organisational strength, the robustness of its quality systems and its ability to operate under high standards of independence, traceability and regulatory compliance, key elements in the new European model for the control of higher-risk in vitro diagnostic devices. This designation process by the European Commission has been supported and pre-nominated by the Spanish Agency for Medicines and Health Products (AEMPS). <\/span><\/p>\n<p><i><span style=\"font-weight: 400;\">&#8220;These new designations are not only scientific and technical recognition, but also an additional responsibility,&#8221;<\/span><\/i><span style=\"font-weight: 400;\"> says Dr. Juan Jos\u00e9 \u00c1lvarez Mill\u00e1n, CEO of CQS. <\/span><i><span style=\"font-weight: 400;\">&#8220;The European Commission thoroughly evaluates aspects such as staff experience, procedures, quality systems, material resources and compliance with applicable standards. We take on this new challenge with a clear commitment to the independence, scientific rigour and operational excellence required by the IVDR,&#8221;<\/span><\/i><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In practice, this designation implies that CQS will assume key functions related to the verification of the performance of the with the verification of the performance of Class D devices, the verification of the compliance with common specifications, the performance of tests on batches and the specialised and technical support provided by notified bodies and a31&gt; both to notified bodies and to regulatory authorities, thus strengthening the European system for the evaluation and control of IVDS a44&gt; IVDSs with the greatest clinical impact.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The new regulation of the European Union on medical devices for in vitro diagnostic purposes <\/span><i><span style=\"font-weight: 400;\">in vitro<\/span><\/i><span style=\"font-weight: 400;\"> seeks to increase the safety, transparency and reliability of medical devices used in daily clinical practice. In this regard, CQS is part of a network of EURLs that cooperate and coordinate to standardise testing methods, verification processes and practices across all Member States, thereby strengthening public health protection throughout the European Union.  <\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The laboratory has been designated to verify in vitro diagnostic medical devicesin vitro (IVDs) intended for the detection or quantification of markers of parasitic infection, as well as those intended for the detection of blood group markers. This designation reinforces CQS&#8217;s role as a European Union Reference Laboratory (EURL) with verification and advisory functions. Madrid, [&#8230;]\n","protected":false},"author":1,"featured_media":3895,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[46],"tags":[],"class_list":["post-3897","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cqs-en"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/posts\/3897","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/comments?post=3897"}],"version-history":[{"count":1,"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/posts\/3897\/revisions"}],"predecessor-version":[{"id":3898,"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/posts\/3897\/revisions\/3898"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/media\/3895"}],"wp:attachment":[{"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/media?parent=3897"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/categories?post=3897"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/tags?post=3897"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}