{"id":3063,"date":"2024-09-27T10:27:23","date_gmt":"2024-09-27T08:27:23","guid":{"rendered":"https:\/\/www.cqssalud.com\/eu-reference-laboratories\/"},"modified":"2026-01-19T14:10:12","modified_gmt":"2026-01-19T13:10:12","slug":"eurl","status":"publish","type":"page","link":"https:\/\/www.cqssalud.com\/en\/eurl\/","title":{"rendered":"EU Reference Laboratories"},"content":{"rendered":"\t<section class=\"section\" id=\"section_1355660147\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-1651430236\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-2010682049\" class=\"text-box banner-layer x0 md-x0 lg-x0 y95 md-y95 lg-y95 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n\t<div id=\"text-2560135555\" class=\"text\">\n\t\t\n<h3 class=\"uppercase\" style=\"text-align: left;\"><b>EU REFERENCE LABORATORIES (EURL-IVD)<\/b><\/h3>\n\t\t\n<style>\n#text-2560135555 {\n  font-size: 2rem;\n}\n<\/style>\n\t<\/div>\n\t\n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-2010682049 {\n  width: 60%;\n}\n#text-box-2010682049 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-1651430236 {\n  padding-top: 300px;\n}\n#banner-1651430236 .bg.bg-loaded {\n  background-image: url(https:\/\/www.cqssalud.com\/wp-content\/uploads\/2024\/05\/cqs_salud-laboratorio-15-en-tamano-grande.jpeg);\n}\n#banner-1651430236 .bg {\n  background-position: 0% 51%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1355660147 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n<\/style>\n\t<\/section>\n\t\n\t<section class=\"section\" id=\"section_1525255433\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\"  id=\"row-447773063\">\n\n\t<div id=\"col-2038050595\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t<div class=\"is-border\"\n\t\tstyle=\"border-width:0px 5px 0px 0px;\">\n\t<\/div>\n\t\t\t\n\t<div id=\"gap-502546186\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-502546186 {\n  padding-top: 18px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>The European Commission has designated 5 laboratories to become EU Reference Laboratories (EURLs) for high-risk in vitro diagnostic (IVD) medical devices in accordance with Article 100 of Regulation (EU) 2017\/746<\/h2>\n<div class=\"is-divider divider clearfix\" style=\"max-width:400px;\"><\/div>\n<div class=\"row\"  id=\"row-144839536\">\n\n\t<div id=\"col-1383447751\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-834796313\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-834796313 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_607046927\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"382\" height=\"398\" src=\"https:\/\/www.cqssalud.com\/wp-content\/uploads\/2024\/05\/eurl-ivd.png\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.cqssalud.com\/wp-content\/uploads\/2024\/05\/eurl-ivd.png 382w, https:\/\/www.cqssalud.com\/wp-content\/uploads\/2024\/05\/eurl-ivd-288x300.png 288w\" sizes=\"auto, (max-width: 382px) 100vw, 382px\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_607046927 {\n  width: 72%;\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1759477486\" class=\"col medium-3 small-12 large-3\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1360300446\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1360300446 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_450002455\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"867\" height=\"878\" src=\"https:\/\/www.cqssalud.com\/wp-content\/uploads\/2024\/09\/EN_fundedbyEU_VERTICAL_RGB_POS.png.webp\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.cqssalud.com\/wp-content\/uploads\/2024\/09\/EN_fundedbyEU_VERTICAL_RGB_POS.png.webp 867w, https:\/\/www.cqssalud.com\/wp-content\/uploads\/2024\/09\/EN_fundedbyEU_VERTICAL_RGB_POS.png-296x300.webp 296w, https:\/\/www.cqssalud.com\/wp-content\/uploads\/2024\/09\/EN_fundedbyEU_VERTICAL_RGB_POS.png-768x778.webp 768w\" sizes=\"auto, (max-width: 867px) 100vw, 867px\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_450002455 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-964479487\" class=\"col medium-5 small-12 large-5\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1767667662\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1767667662 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div id=\"text-2423903280\" class=\"text\">\n\t\t\n<p><span style=\"font-size: 75%;\">Funded by the European Union. However, the views and opinions expressed are solely those of the author(s) and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.  <\/span><\/p>\n\t\t\n<style>\n#text-2423903280 {\n  line-height: 1.1;\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2038050595 > .col-inner {\n  padding: 5% 5% 0px 1%;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-439390267\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\" style=\"background-color:rgb(234, 240, 247);\" >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1814910777\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1814910777 {\n  padding-top: 18px;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div id=\"text-3314488515\" class=\"text\">\n\t\t\n<p><strong><span style=\"color: #a80c30;\">CQS is designated in two categories of Class D medical devices<em>:<\/em> <\/span><\/strong><\/p>\n<ul>\n<li><strong><span style=\"color: #a80c30;\">products intended for the detection or quantification of herpesvirus markers,\u00a0<\/span><\/strong><\/li>\n<li><strong><span style=\"color: #a80c30;\">products for the detection and quantification of bacterial infection markers,<\/span><\/strong><\/li>\n<li><strong>products for the detection or quantification of parasitic infection, and<\/strong><\/li>\n<li><strong>products for the detection or quantification of blood group markers.<\/strong><\/li>\n<\/ul>\n\t\t\n<style>\n#text-3314488515 {\n  font-size: 1rem;\n  color: rgb(168, 12, 48);\n}\n#text-3314488515 > * {\n  color: rgb(168, 12, 48);\n}\n<\/style>\n\t<\/div>\n\t\n<a href=\"https:\/\/www.cqssalud.com\/en\/cqs-designated-eurl-reference-laboratory\/\" class=\"button primary is-link\"  >\n    <span>+ info designation<\/span>\n  <\/a>\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-439390267 > .col-inner {\n  padding: 0px 9px 9px 9px;\n  margin: 0px 0px 0px 0px;\n  border-radius: 22px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n<style>\n#row-447773063 > .col > .col-inner {\n  padding: 0px 44px 0px 20px;\n}\n<\/style>\n<\/div>\n<div class=\"row\"  id=\"row-760595402\">\n\n\t<div id=\"col-2103965581\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t<div class=\"is-border\"\n\t\tstyle=\"border-width:0px 5px 0px 0px;\">\n\t<\/div>\n\t\t\t\n\t<div id=\"gap-186382568\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-186382568 {\n  padding-top: 18px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>EURL-IVDs for high-risk in vitro diagnostic medical devices (IVDs) have been designated in accordance with Article 100 of <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/746\/oj\" target=\"_blank\" rel=\"noopener\">Regulation (EU) 2017\/746<\/a> and by <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg_impl\/2023\/2713\/oj\" target=\"_blank\" rel=\"noopener\">Commission Implementing Regulation (EU) 2023\/2713 designating EU reference laboratories in the field of in vitro diagnostic medical devices.<\/a><\/p>\n<p>Las principales tareas de los EURL-IVD son las consultivas y las relacionadas con la evaluaci\u00f3n de la conformidad, en particular de los de mayor riesgo, es decir, los productos de la clase D. Los EURL-IVD se han designado con arreglo a los criterios establecidos en el <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg_impl\/2022\/944\/oj\" target=\"_blank\" rel=\"noopener\">Reglamento de Ejecuci\u00f3n (UE) n\u00ba 2022\/944 de la Comisi\u00f3n<\/a> y trabajar\u00e1n seg\u00fan las tareas encomendadas en el mismo.<\/p>\n<p>For the assessment of the conformity of class D devices, EURL-IVDs:<\/p>\n<ul>\n<li>verify the performance of class D devices and compliance with common specifications,<\/li>\n<li>perform batch testing of class D devices.<\/li>\n<\/ul>\n<h4><span style=\"color: #a80c30;\"><strong>CQS expands its role as an EU reference laboratory in two categories of in vitro diagnostic devices: parasitic infections and blood groups<\/strong><\/span><\/h4>\n<p><span style=\"font-weight: 400;\">In 2025, Consulting Qu\u00edmico Sanitario (CQS) was designated by the European Commission as a European Union Reference Laboratory (EURL) in two new categories of in vitro diagnostic medical devices. <\/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;\">class D. Specifically, the private laboratory CQS has been designated to verify medical devices intended for the detection or quantification of markers of parasitic infection and blood group markers, as set out in the Implementing Regulation (EU) No 1240\/2013. a17&gt;<span style=\"font-weight: 400;\">, 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;\">Implementing Regulation (EU) 2025\/2526, approved on 16 December<\/span><\/a><span style=\"font-weight: 400;\">. <\/span><\/span> <\/p>\n<h4><span style=\"color: #a80c30;\"><strong>Designated laboratories <\/strong><\/span><\/h4>\n<ol>\n<li><strong><span style=\"color: #a80c30;\">CQS<\/span>, Consulting Qu\u00edmico Sanitario SLU, <\/strong><em>Spain<\/em><\/li>\n<li><strong>RISE Research Institutes of Sweden, <\/strong><em>Sweden<\/em><\/li>\n<li>Carlos III Health Institute, Spain<\/li>\n<li><strong>EU Referenzlabor f\u00fcr In-vitro-Diagnostika am Paul-Ehrlich-Institut, <\/strong><em>Germany<\/em><\/li>\n<li>Consortium, Madrid Health Service (SERMAS), comprising three hospitals:\n<ol>\n<li>Hospital General Universitario Gregorio Mara\u00f1\u00f3n, <em>Spain<\/em><\/li>\n<li>Hospital Universitario la Paz, <em>Spain<\/em><\/li>\n<li>Hospital Universitario Ram\u00f3n y Cajal, <em>Spain<\/em><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<p><strong style=\"color: #a80c30;\">Scope of each EURL-IVD<\/strong><\/p>\n<table width=\"100%\">\n<tbody>\n<tr>\n<td width=\"31%\">\n<p><strong>EURL-IVD Technical Area<\/strong><\/p>\n<\/td>\n<td colspan=\"3\" width=\"68%\">\n<p>EURL-IVD designated<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"31%\">\n<p><strong>Detection or quantification of markers of hepatitis or retrovirus infection.<\/strong><\/p>\n<\/td>\n<td width=\"22%\">\n<p>Paul Ehrlich Inst.<\/p>\n<\/td>\n<td width=\"23%\">\n<p>Instituto de Salud Carlos III<\/p>\n<\/td>\n<td width=\"23%\">\n<\/td>\n<\/tr>\n<tr>\n<td width=\"31%\">\n<p><strong>Detection or quantification of markers of herpesvirus infection.<\/strong><\/p>\n<\/td>\n<td width=\"22%\">\n<p><span style=\"color: #a80c30;\"><strong>CQS<\/strong><\/span><\/p>\n<\/td>\n<td width=\"23%\">\n<p>SERMAS<\/p>\n<\/td>\n<td width=\"23%\">\n<p>Instituto de Salud Carlos III<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"31%\">\n<p><strong>Detection or quantification of markers of bacterial infections.<\/strong><\/p>\n<\/td>\n<td width=\"22%\">\n<p><span style=\"color: #a80c30;\"><strong>CQS<\/strong><\/span><\/p>\n<\/td>\n<td width=\"23%\">\n<p>SERMAS<\/p>\n<\/td>\n<td width=\"23%\">\n<p>Instituto de Salud Carlos III<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"31%\">\n<p><strong>Detection or quantification of markers of parasitic infections<\/strong><\/p>\n<\/td>\n<td width=\"22%\"><span style=\"color: #a80c30;\"><strong>CQS<\/strong><\/span><\/td>\n<td width=\"23%\">Instituto de Salud Carlos III<\/td>\n<td width=\"23%\">\n<\/td>\n<\/tr>\n<p><!-- NUEVAS FILAS --><\/p>\n<tr>\n<td width=\"31%\">\n<p><strong>Detection or quantification of blood group markers<\/strong><\/p>\n<\/td>\n<td width=\"22%\"><span style=\"color: #a80c30;\"><strong>CQS<\/strong><\/span><\/td>\n<td width=\"23%\">Paul Ehrlich Inst.<\/td>\n<td width=\"23%\">\n<p>RISE<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"31%\">\n<p><strong>Detection or quantification of markers of respiratory virus infection.<\/strong><\/p>\n<\/td>\n<td width=\"22%\">RISE<\/td>\n<td width=\"23%\">Paul Ehrlich Inst.<\/td>\n<td width=\"23%\">\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2103965581 > .col-inner {\n  padding: 0px 5% 0px 1%;\n  margin: -43px 0px 0px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-959819017\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\" style=\"background-color:rgb(234, 240, 247);\" >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1155498544\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1155498544 {\n  padding-top: 18px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>Contact us to access CQS EURL-IVD services or receive more information:<\/strong><\/p>\n<div class=\"wpforms-container wpforms-container-full\" id=\"wpforms-3032\"><form id=\"wpforms-form-3032\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"3032\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/en\/wp-json\/wp\/v2\/pages\/3063\" data-token=\"9d5b7a2ee59f8bcc02f3a676fb956931\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div class=\"wpforms-field-container\"><div id=\"wpforms-3032-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label\" for=\"wpforms-3032-field_1\">Name <span class=\"wpforms-required-label\">*<\/span><\/label><div class=\"wpforms-field-row wpforms-field-large\"><div 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style=\"max-width:400px;\"><\/div>\n\n\t\t<div class=\"tabbed-content\">\n\t\t\t<h4 class=\"uppercase text-left\">MORE INFORMATION<\/h4>\n\t\t\t<ul class=\"nav nav-line nav-vertical nav-uppercase nav-size-normal nav-left active-on-hover\" role=\"tablist\"><li id=\"tab-device-areas-and-scope\" class=\"tab active has-icon\" role=\"presentation\"><a href=\"#tab_device-areas-and-scope\" role=\"tab\" aria-selected=\"true\" aria-controls=\"tab_device-areas-and-scope\"><span>device areas and scope<\/span><\/a><\/li>\n<li id=\"tab-current-status-of-the-eurls\" class=\"tab has-icon\" role=\"presentation\"><a href=\"#tab_current-status-of-the-eurls\" tabindex=\"-1\" role=\"tab\" aria-selected=\"false\" aria-controls=\"tab_current-status-of-the-eurls\"><span>current status of the eurls<\/span><\/a><\/li>\n<li id=\"tab-fees-for-eurls\" class=\"tab has-icon\" role=\"presentation\"><a href=\"#tab_fees-for-eurls\" tabindex=\"-1\" role=\"tab\" aria-selected=\"false\" aria-controls=\"tab_fees-for-eurls\"><span>Fees for eurls<\/span><\/a><\/li>\n<li id=\"tab-work-methodology\" class=\"tab has-icon\" role=\"presentation\"><a href=\"#tab_work-methodology\" tabindex=\"-1\" role=\"tab\" aria-selected=\"false\" aria-controls=\"tab_work-methodology\"><span>work methodology<\/span><\/a><\/li>\n<li id=\"tab-recommendations-on-suitable-reference-materials-and-reference-measurement-procedures-of-higher-metrological-order\" class=\"tab has-icon\" role=\"presentation\"><a href=\"#tab_recommendations-on-suitable-reference-materials-and-reference-measurement-procedures-of-higher-metrological-order\" tabindex=\"-1\" role=\"tab\" aria-selected=\"false\" aria-controls=\"tab_recommendations-on-suitable-reference-materials-and-reference-measurement-procedures-of-higher-metrological-order\"><span>Recommendations on suitable reference materials and reference measurement procedures of higher metrological order<\/span><\/a><\/li>\n<li id=\"tab-establishment-and-management-of-a-network-of-national-reference-laboratories\" class=\"tab has-icon\" role=\"presentation\"><a href=\"#tab_establishment-and-management-of-a-network-of-national-reference-laboratories\" tabindex=\"-1\" role=\"tab\" aria-selected=\"false\" aria-controls=\"tab_establishment-and-management-of-a-network-of-national-reference-laboratories\"><span>Establishment and management of a network of national reference laboratories<\/span><\/a><\/li><\/ul><div class=\"tab-panels\"><div id=\"tab_device-areas-and-scope\" class=\"panel active entry-content\" role=\"tabpanel\" aria-labelledby=\"tab-device-areas-and-scope\">\n<span class=\"scroll-to\" data-label=\"Scroll to: #scope\" data-bullet=\"true\" data-link=\"#scope\" data-title=\"scope\" ><a name=\"scope\"><\/a><\/span>\n<p>Covered areas of Class D <em>in vitro<\/em> diagnostic medical devices<em>.<\/em><\/p>\n<ul>\n<li>Hepatitis and retrovirus<\/li>\n<li>Herpes virus<\/li>\n<li>Bacterial agents<\/li>\n<li>Respiratory viruses causing life-threatening diseases<\/li>\n<li>Parasitic infections<\/li>\n<li>Blood types<\/li>\n<\/ul>\n<p>Scope<\/p>\n<p>It may be consulted in the <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg_impl\/2023\/2713\/oj\" target=\"_blank\" rel=\"noopener\">Regulation of the (EU) 2023\/2713 of the Commission by which the designation of the laboratories referred to a15&gt; of reference of the EU in the field of the products a23&gt; healthcare products for in vitro diagnosis<\/a> and in the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/ES\/TXT\/HTML\/?uri=OJ:L_202502526\" target=\"_blank\" rel=\"noopener\">Regulation of Implementation (EU) 2025\/2526 of the Commission of 16 of December of 2025. <\/a> <\/p>\n<\/div>\n<div id=\"tab_current-status-of-the-eurls\" class=\"panel entry-content\" role=\"tabpanel\" aria-labelledby=\"tab-current-status-of-the-eurls\">\n<p>The designation act includes transitional provisions to allow EURL- IVDs to network and harmonise their working methods and for manufacturers and notified bodies to adapt their manufacturers and notified bodies to adapt their processes to include EURL-IVD testing.<\/p>\n<p>It is planned that the EURL-IVDs will assume their functions in the evaluation of a9&gt; the conformity of the products on 1 October 2024.<\/p>\n<p>At present, all EURL-IVDs are establishing a network to coordinate and harmonise their working methods. They are all working both within a general network involving all laboratories and within specific networks. The general network and sub-networks are working on the harmonisation of methods, procedures, processes, etc., in particular on common laboratory testing procedures for performance verification and batch testing of devices. The work will also adopt common rules of procedure.    <\/p>\n<\/div>\n<div id=\"tab_fees-for-eurls\" class=\"panel entry-content\" role=\"tabpanel\" aria-labelledby=\"tab-fees-for-eurls\">\n<span class=\"scroll-to\" data-label=\"Scroll to: #fees\" data-bullet=\"true\" data-link=\"#fees\" data-title=\"fees\" ><a name=\"fees\"><\/a><\/span>\n<p>The fees to be used by the EURL-IVD are in line with the Commission Implementing<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg_impl\/2022\/945\/oj\" target=\"_blank\" rel=\"noopener\"> Regulation ( EU) 2022\/945 .<\/a><\/p>\n<p><strong>Rules for the establishment of the rates of the laboratories of a8&gt; reference of the EU (EURL-IVD).<\/strong><\/p>\n<p class=\"parrafo\"><strong>Structure of fees<\/strong><\/p>\n<p class=\"parrafo\">1. The following categories of costs may be covered by the fees levied by the EU reference laboratories:<\/p>\n<p class=\"parrafo\"> a) staff costs, including travel costs and associated accommodation and subsistence costs;<\/p>\n<p class=\"parrafo\"> b) equipment costs, where the equipment is not provided by the manufacturer of the device to be tested;<\/p>\n<p class=\"parrafo\"> c) costs of consumables, test specimens and reference materials;<\/p>\n<p class=\"parrafo\"> d) shipping costs for samples;<\/p>\n<p class=\"parrafo\"> e) translation costs;<\/p>\n<p class=\"parrafo\"> f) general costs of the operation of the laboratory.<\/p>\n<p class=\"parrafo\">2. Without prejudice to paragraph 1, where the EU reference laboratory has a contract with another laboratory in accordance with Article 7(1) or (2) of Commission Implementing Regulation (EU) 2022\/944 (2), the fee levied by the EU reference laboratory may cover the amount it paid to that laboratory in accordance with that contract for the performance of the requested task.<\/p>\n<p class=\"parrafo\"><strong>Level of fees<\/strong><\/p>\n<p class=\"parrafo\">1. The fees levied by the EU reference laboratories shall be non-discriminatory, fair, reasonable and proportionate to the services rendered.<\/p>\n<p class=\"parrafo\">2. The EU reference laboratories shall set the fees based on incurred costs.<\/p>\n<p class=\"parrafo\">Where the calculation of incurred costs is unreasonably burdensome for a particular category of costs referred to in Article 1(1), points (a) to (e), the EU reference laboratories may estimate the incurred costs based on the average costs for that category.<\/p>\n<p class=\"parrafo\">The amount of the fee covering the costs referred to in Article 1(1), point (f), shall be determined by calculating a percentage of the combined costs referred to in Article 1(1), points (a) to (e), and shall not constitute more than 7 % of the those costs. <\/p>\n<p class=\"parrafo\"><strong>Rules for the calculation of fees<\/strong><\/p>\n<p class=\"parrafo\">1. The EU reference laboratories shall lay down the rules according to which they calculate the fees for carrying out the requested tasks, including the rules for the estimation of incurred costs based on average costs, and shall make them publicly available on their websites.<\/p>\n<p class=\"parrafo\">2. The EU reference laboratories shall review the rules referred to in paragraph 1 at least every 2 years and, if needed, adjust them.<\/p>\n<\/div>\n<div id=\"tab_work-methodology\" class=\"panel entry-content\" role=\"tabpanel\" aria-labelledby=\"tab-work-methodology\">\n<span class=\"scroll-to\" data-label=\"Scroll to: #methodology\" data-bullet=\"true\" data-link=\"#methodology\" data-title=\"methodology\" ><a name=\"methodology\"><\/a><\/span>\n<p><strong>How do notified bodies work with EURL-IVDs? <\/strong><\/p>\n<p><span style=\"font-weight: 400;\">All communications from manufacturers are made through the notified body chosen by the manufacturer. EURL-IVDs will liaise with notified bodies for the verification of medical devices for the  <\/span><\/p>\n<p><span style=\"font-weight: 400;\">There are two main types of verification: verification of the performance of the in vitro diagnostic medical device or IVD declared by the manufacturer, and the analysis of samples or IVD batches.<\/span><\/p>\n<p><strong>How do notified bodies function without EURL-IVD?<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">In vitro diagnostic medical devices have to be verified by the EU Reference Laboratory or EURL-IVD before they can be placed on the market, regardless of whether they are new or not. There are two main types of testing: performance verification and batch testing. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">With regard to conformity assessment of in vitro diagnostic medical devices, the following are concerned <\/span><i><span style=\"font-weight: 400;\">in vitro diagnostic<\/span><\/i><span style=\"font-weight: 400;\">without a designated EURL-IVD , these can still be certified by notified bodies and placed on the and placed on the EU market in accordance with Regulation ( EU) 2017\/746. <\/span><a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/746\/oj\"><span style=\"font-weight: 400;\">Regulation (EU) 2017\/746.<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">The elements of conformity assessment related to the EURL-IVD do not apply to them until a EURL-IVD is designated.IVD do not apply to them until a EURL-IVD is designated. See the  <\/span><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/9f23fca0-f407-4e45-a464-2d71b575d1fe_en\"><span style=\"font-weight: 400;\">MDCG 2021-4<\/span><\/a><span style=\"font-weight: 400;\">for guidance on how EURLs should be integrated into the conformity assessment process once designated. conformity assessment process once designated.<\/span><\/p>\n<p><strong>What if there is not yet a EURL-IVD for a Class D test area?<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">For the remaining 4 categories, namely arboviruses, hemorrhagic fever and other biosafety level 4 viruses, parasites and blood groups, either there were no laboratories meeting the criteria or their combined capacity was insufficient to cover the expected volume of requests.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A call for expression of interest has been published for the remaining areas, which is being processed by the EC. Expression of interest open &#8211; Possible second call for EU Reference Laboratories for high-risk in vitro diagnostic EU Reference Laboratories for high-risk in vitro diagnostic medical devices &#8211; Possible second call for EU Reference Laboratories for high-risk in vitro diagnostic medical devices <\/span> <a href=\"https:\/\/europa.eu\/\"><span style=\"font-weight: 400;\">European Commission<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<\/div>\n<div id=\"tab_recommendations-on-suitable-reference-materials-and-reference-measurement-procedures-of-higher-metrological-order\" class=\"panel entry-content\" role=\"tabpanel\" aria-labelledby=\"tab-recommendations-on-suitable-reference-materials-and-reference-measurement-procedures-of-higher-metrological-order\">\n<p>In accordance with <strong>Regulation 746, Article 100-2h, European reference laboratories (ERLs)<\/strong> must provide recommendations on (i) suitable reference materials and (ii) reference measurement procedures of higher metrological order for their specific areas. This applies only to devices whose intended use is related to <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2020-16-rev4-guidance-classification-rules-vitro-diagnostic-medical-devices-under-2025-03-18_en\" target=\"_blank\" rel=\"noopener\">class D.<\/a>   <\/p>\n<p>The purpose of sharing this information is to provide stakeholders in class D in vitro diagnostics (IVD) with access to references on standards and metrological traceability for IVD devices.<\/p>\n<p>This information is provided in the following table, which includes international standards:<\/p>\n<table width=\"672\">\n<tbody>\n<tr>\n<td colspan=\"4\" width=\"672\">\n<p><strong>Reference materials for scope 2 (herpesvirus) \u2013 IVD class D<\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"175\">\n<p><strong>Target pathogen<\/strong><\/p>\n<p><em>(EURL scope)<\/em><\/p>\n<\/td>\n<td width=\"137\">\n<p><strong>Scoreboard<\/strong><\/p>\n<\/td>\n<td width=\"179\">\n<div><strong>Reference material &#8211; RM<\/strong><\/div>\n<div><strong>(International standards)<\/strong><\/div>\n<\/td>\n<td width=\"181\">\n<p><strong>Reference and supplier<\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"175\">\n<p>Human cytomegalovirus (CMV)<\/p>\n<p><em>Scope 2: herpesviruses<\/em><\/p>\n<\/td>\n<td width=\"137\">\n<p>CMV antibodies<\/p>\n<\/td>\n<td width=\"179\">\n<p>WHO 1st international standard for CMV IgG <\/p>\n<\/td>\n<td width=\"181\">\n<p><a href=\"https:\/\/www.pei.de\/SharedDocs\/Downloads\/EN\/regulation-en\/referencematerial\/136616-17-ifu.pdf?__blob=publicationFile&amp;v=2\">136616\/17 (PEI)<\/a><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"175\">\n<p>Human cytomegalovirus (CMV)<\/p>\n<p><em>Scope 2: herpesviruses<\/em><\/p>\n<\/td>\n<td width=\"137\">\n<p>CMV DNA<\/p>\n<\/td>\n<td width=\"179\">\n<p>WHO 1st international standard for CMV for nucleic acid amplification techniques<\/p>\n<\/td>\n<td width=\"181\">\n<p><a href=\"https:\/\/nibsc.org\/documents\/ifu\/09-162.pdf\">09\/162 (NIBSC)<\/a><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"175\">\n<p>Virus de Epstein-Barr (VEB)<\/p>\n<p><em>\u00c1mbito 2: herpesviruses<\/em><\/p>\n<\/td>\n<td width=\"137\">\n<p>EBV antibodies<\/p>\n<\/td>\n<td width=\"179\">\n<p>N\/A<\/p>\n<\/td>\n<td width=\"181\">\n<p>N\/A<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"175\">\n<p>Virus de Epstein-Barr (VEB)<\/p>\n<p><em>Scope 2: herpesviruses<\/em><\/p>\n<\/td>\n<td width=\"137\">\n<p>ADN EBV<\/p>\n<\/td>\n<td width=\"179\">\n<p>1st international standard of the WHO on the VEB for techniques of amplification of nucleic acids<\/p>\n<\/td>\n<td width=\"181\">\n<p><a href=\"https:\/\/nibsc.org\/documents\/ifu\/09-260.pdf\">09\/260 (NIBSC)<\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<table width=\"671\">\n<tbody>\n<tr>\n<td colspan=\"4\" width=\"671\">\n<p><strong>Materiales de referencia para el \u00e1mbito 3 (agentes bacterianos) IVD clase D<\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"170\">\n<p><strong>Target pathogen<\/strong><\/p>\n<p><em>(EURL scope)<\/em><\/p>\n<\/td>\n<td width=\"144\">\n<p><strong>Scoreboard<\/strong><\/p>\n<\/td>\n<td width=\"177\">\n<div><strong>Reference material &#8211; RM<\/strong><\/div>\n<div><strong>(International standards)<\/strong><\/div>\n<\/td>\n<td width=\"180\">\n<p><strong>Reference and supplier<\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"170\">\n<p>Treponema pallidum (TP)<\/p>\n<p><em>\u00c1mbito 3: bacterial agents<\/em><\/p>\n<\/td>\n<td width=\"144\">\n<p>Anticuerpos TP<\/p>\n<\/td>\n<td width=\"177\">\n<div>1st WHO international standard for human syphilitic plasma IgG<\/div>\n<div> <\/div>\n<div>1er est\u00e1ndar internacional de la OMS para las IgG e IgM plasm\u00e1ticas sifil\u00edticas humanas<\/div>\n<\/td>\n<td width=\"180\">\n<p><a href=\"https:\/\/nibsc.org\/documents\/ifu\/05-122.pdf\">05\/122 (NIBSC)<\/a><\/p>\n<p>currently not available<\/p>\n<\/p>\n<p><a href=\"https:\/\/nibsc.org\/documents\/ifu\/05-132.pdf\">05\/132 (NIBSC)<\/a><\/p>\n<p>currently not available<\/p>\n<\/p>\n<p>NIBSC is preparing new material (likely to be available in October 2026).<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<div> <\/div>\n<div>With regard to higher-order metrological reference measurement procedures (ii), several databases are available for consultation. The<a href=\"https:\/\/www.jctlmdb.org\/\"> <strong><strong>JCTLM database<\/strong><\/strong> <\/a>lists the higher-order reference materials, measurement methods, and services that should be used in calibration hierarchies to assign values to calibrators and trueness control materials for quantities measured by in vitro diagnostic medical devices. The reference materials, measurement methods, and services listed, when applied following the models described in ISO 17511:2020, \u201cIn vitro diagnostic medical devices &#8211; Requirements for establishing the metrological traceability of values assigned to calibrators, trueness control materials, and human samples,\u201d can be used to establish metrological traceability. Submit your abstracts for the practical lessons  <\/div>\n<div> <\/div>\n<div>In addition to the JCTLM, other related publications have been selected with a10&gt; with<strong> metrological traceability as<\/strong> a possible source of recommended a18&gt; procedures recommended by higher metrological order and framework for this subject:<\/div>\n<ul>\n<li><a href=\"https:\/\/clsi.org\/standards\/products\/method-evaluation\/documents\/ep32\/\"><strong>CLSI EP32 &#8211; Metrological Traceability and Its Implementation<\/strong><\/a><\/li>\n<li><strong><a href=\"https:\/\/ilac.org\/publications-and-resources\/ilac-policy-series\/\">ILAC P10:07\/2020 ILAC Policy on Metrological Traceability of Measurement Results<\/a><\/strong><\/li>\n<li><a href=\"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2022-0995\/html?srsltid=AfmBOopW_xvInO3r3NvccmrENZJQJjcU5cwVMn5tRJgTUX1bRltl6UE6\"><strong>Establishing metrological traceability in laboratory medicine<\/strong><\/a><\/li>\n<li><a href=\"https:\/\/www.euramet.org\/european-metrology-networks\/laboratory-medicine\"><strong>European Metrology Network (EMN) for Traceability in Laboratory Medicine<\/strong><\/a><strong> (TraceLab Med)<\/strong><\/li>\n<li><strong><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/31202\" target=\"_blank\" rel=\"noopener\">Factsheet for manufacturers of in-vitro diagnostic medical devices<\/a><\/strong><\/li>\n<li><strong><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-2-guidance-general-principles-clinical-evidence-vitro-diagnostic-medical-devices-ivds-2022-01-27_en\" target=\"_blank\" rel=\"noopener\">MDCG 2022-2 &#8211; Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)<\/a><\/strong><\/li>\n<li><strong><a href=\"https:\/\/en.seamaty.com\/index.php?s=\/sys\/302.html\" target=\"_blank\" rel=\"noopener\">6 Indicators to Evaluate Clinical Diagnostic Performance Of IVD Reagents<\/a><\/strong><\/li>\n<li><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2020-16-rev4-guidance-classification-rules-vitro-diagnostic-medical-devices-under-2025-03-18_en\"><strong>MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017\/746. <\/strong><\/a><\/li>\n<\/ul>\n<\/div>\n<div id=\"tab_establishment-and-management-of-a-network-of-national-reference-laboratories\" class=\"panel entry-content\" role=\"tabpanel\" aria-labelledby=\"tab-establishment-and-management-of-a-network-of-national-reference-laboratories\">\n<p>According to <strong>IVD regulation 2017\/746<\/strong>, Article 100 (2h), and <strong>2022\/944 (art 15) EURLs<\/strong> have to set up and manage a network of national reference laboratories (NRLs) after consulting with the national authorities and publish a list of the participating NRLs and their respective tasks. The purpose of this interaction is among others to favor collaborations, sharing know-how and testing methods. <\/p>\n<p>For corresponding scopes, the NRLs that have been identified and with which there has been interaction for possible collaborations are:<\/p>\n<p><strong>Scope 2 (herpesvirus):<\/strong> Sahlgrenska Universitetssjukhuset (Sweeden)<\/p>\n<p><strong>Scope 3 (bacterial agents): <\/strong>Rijksinstituutvoor Volksgezondheid en Milieu (RIVM) (Netherland)<\/p>\n<p>The tasks with these NRLs are planned to be (i) networking and (ii) harmonization of methods  <\/p>\n<\/div><\/div><\/div>\n\t<div id=\"gap-1857764162\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1857764162 {\n  padding-top: 49px;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div id=\"text-292466568\" class=\"text\">\n\t\t\n<p><span style=\"font-size: 75%; color: #000000;\">Supports UN sustainability goals<\/span><\/p>\n\t\t\n<style>\n#text-292466568 {\n  font-size: 1rem;\n  color: #a80c30;\n}\n#text-292466568 > * {\n  color: #a80c30;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_1241529028\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" style=\"margin:15px 0px 0px 0px;\">\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"225\" height=\"225\" src=\"https:\/\/www.cqssalud.com\/wp-content\/uploads\/2024\/09\/descarga-8.png\" class=\"attachment-medium size-medium\" alt=\"\" srcset=\"https:\/\/www.cqssalud.com\/wp-content\/uploads\/2024\/09\/descarga-8.png 225w, https:\/\/www.cqssalud.com\/wp-content\/uploads\/2024\/09\/descarga-8-150x150.png 150w\" sizes=\"auto, (max-width: 225px) 100vw, 225px\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_1241529028 {\n  width: 12%;\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-814371862 > .col-inner {\n  padding: 0px 5% 0px 1%;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1525255433 {\n  padding-top: 0px;\n  padding-bottom: 0px;\n  background-color: rgb(255,255,255);\n}\n<\/style>\n\t<\/section>\n\t\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"class_list":["post-3063","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/pages\/3063","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/types\/page"}],"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=3063"}],"version-history":[{"count":43,"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/pages\/3063\/revisions"}],"predecessor-version":[{"id":3929,"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/pages\/3063\/revisions\/3929"}],"wp:attachment":[{"href":"https:\/\/www.cqssalud.com\/en\/wp-json\/wp\/v2\/media?parent=3063"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}