{"id":12090,"date":"2025-07-30T08:08:58","date_gmt":"2025-07-30T08:08:58","guid":{"rendered":"https:\/\/mdxcro.com\/sectors\/laboratoires\/"},"modified":"2026-07-22T10:05:43","modified_gmt":"2026-07-22T10:05:43","slug":"laboratoires","status":"publish","type":"sector","link":"https:\/\/mdxcro.com\/fr\/sectors\/laboratoires\/","title":{"rendered":"Laboratoires"},"content":{"rendered":"\n<section id=\"block_98434581e359f18fa8630d589c937015\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/clinical-development.jpg\" fetchpriority=\"high\" class=\"no-lazy\" alt=\"\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Conformit\u00e9 experte des laboratoires \u00e0 l\u2019IVDR de l\u2019UE et aux diagnostics mondiaux<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">Ma\u00eetrisez la validation des DIV en interne au titre de l\u2019article 5.5, permettez les tests transfrontaliers via l\u2019article 6 et alignez les essais d\u2019essais cliniques sur le CTR de l\u2019UE et l\u2019IVDR.<\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=sector_laboratories\" class=\"button bouton--par d\u00e9faut\" target=\"_self\">\n                            R\u00e9server une \u00e9valuation de conformit\u00e9 du laboratoire                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/ivdr-lab-readiness-step-by-step-transition-checklist\/\" class=\"button bouton--secondaire\" target=\"_self\">\n                            Lire notre guide de transition IVDR pour les laboratoires                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_de1e8ad866cf9ec29fbc5f7d2b17caa3\" class=\"content-columns content-columns--three-columns \" style=\"padding-bottom: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Expertise cl\u00e9 en laboratoire<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">IVDR de l\u2019UE \u2013 Article 5.5 : tests en interne<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><b>Conformit\u00e9 \u00e0 l\u2019article 5.5 : <\/b><span style=\"font-weight: 400\">documentation bas\u00e9e sur les GSPR, justification d\u2019un besoin non satisfait et d\u00e9clarations publiques conform\u00e9ment au MDCG 2023-1<\/span><\/li>\n<\/ul>\n<ul>\n<li><b>SMQ ISO 15189:2022 : <\/b><span style=\"font-weight: 400\">mise en place et am\u00e9lioration du SMQ de laboratoire au-del\u00e0 du p\u00e9rim\u00e8tre ISO (risques, tra\u00e7abilit\u00e9, PMS selon l\u2019ISO 13485)<\/span><\/li>\n<li><b>Transition RUO vers IVD : <\/b><span>classification r\u00e9glementaire, d\u00e9veloppement de la documentation technique et accompagnement pour l\u2019\u00e9valuation par un organisme notifi\u00e9 &#038; le marquage CE.<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Conformit\u00e9 des laboratoires hors UE \u2013 IVDR Article 6<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><b>Tests transfrontaliers : <\/b><span style=\"font-weight: 400\">les laboratoires CLIA\/CAP au service de patients de l\u2019UE doivent respecter les obligations de l\u2019article 6 et, par cons\u00e9quent, se mettre en conformit\u00e9 avec l\u2019IVDR.<\/span><\/li>\n<\/ul>\n<ul>\n<li><b>Acc\u00e8s au march\u00e9 de l\u2019UE : <\/b><span style=\"font-weight: 400\">documentation technique, d\u00e9signation PRRC, services de repr\u00e9sentant autoris\u00e9 (EU Rep) et \u00e9valuation de conformit\u00e9 avec des organismes notifi\u00e9s<\/span><\/li>\n<li><b>UDI &#038; \u00e9tiquetage : <\/b><span style=\"font-weight: 400\">enregistrement EUDAMED, syst\u00e8mes UDI et d\u00e9veloppement de l\u2019\u00e9tiquetage produit et des instructions d\u2019utilisation<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Utilisation des essais dans les essais cliniques (CTR\/IVDR)<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><b>Tests en interne (article 5(5)) : <\/b><span style=\"font-weight: 400\">accompagnement des laboratoires de l\u2019UE utilisant, dans des essais cliniques, des tests locaux non marqu\u00e9s CE au titre de l\u2019article 5(5), incluant justification, conformit\u00e9 aux GSPR et SMQ align\u00e9 sur l\u2019ISO 15189.<\/span><\/li>\n<\/ul>\n<ul>\n<li><b>Soutien aux \u00e9tudes de performance (article 58) : <\/b><span style=\"font-weight: 400\">pour les laboratoires hors UE ou les essais non CE utilis\u00e9s dans la prise en charge des patients, nous pr\u00e9parons les demandes ou notifications d\u2019\u00e9tude de performance conform\u00e9ment \u00e0 l\u2019article 58 de l\u2019IVDR et \u00e0 l\u2019annexe XIV.<\/span><\/li>\n<li><b>Essais combin\u00e9s (CTR + IVDR) : <\/b><span style=\"font-weight: 400\">strat\u00e9gie r\u00e9glementaire et documentation pour les essais impliquant \u00e0 la fois des m\u00e9dicaments et des DIV, garantissant un alignement complet avec les exigences du CTR et de l\u2019IVDR.<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n<section class=\"table\"><div class=\"container\"><div class=\"headline\">Syst\u00e8mes r\u00e9glementaires &amp; qualit\u00e9<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Service<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>Documentation technique IVDR<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Accr\u00e9ditation ISO 15189<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>D\u00e9veloppement d\u2019un SMQ hybride<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Essais d\u2019essais cliniques &amp; tests locaux<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">Livrables cl\u00e9s<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\">Listes de contr\u00f4le GSPR de l\u2019annexe I + \u00e9valuation des performances + d\u00e9clarations publiques<\/td><\/tr><tr><td class=\"cell highlight\">Analyses d\u2019\u00e9carts + mod\u00e8les de documentation + audits internes<\/td><\/tr><tr><td class=\"cell highlight\">Cadres combin\u00e9s ISO 15189 + ISO 13485<\/td><\/tr><tr><td class=\"cell highlight\">Due diligence pour garantir la pr\u00e9paration r\u00e9glementaire<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section id=\"block_b1ed0ec6970c45a78ef0e9c156537ec5\" class=\"tabs\" style=\"padding-top: var(--wp--preset--spacing--medium);\">\n        <div class=\"container\">\n                    <div class=\"title\">Feuille de route de conformit\u00e9 du laboratoire<\/div>\n            <\/div>\n\n    <div class=\"tabs-wrapper\">\n        <!-- Tab Navigation -->\n        <div class=\"tab-navigation\">\n                            <button class=\"tab-button active\" data-tab=\"phase-1-actions-immediates-a-partir-de-mai-2022\">\n                    Phase 1 : actions imm\u00e9diates (\u00e0 partir de mai 2022)                <\/button>\n                            <button class=\"tab-button\" data-tab=\"phase-2-mise-en-oeuvre-de-la-conformite-a-partir-de-mai-2024\">\n                    Phase 2 : mise en \u0153uvre de la conformit\u00e9 (\u00e0 partir de mai 2024)                <\/button>\n                            <button class=\"tab-button\" data-tab=\"phase-3-documentation-avancee-et-conformite-strategique-dici-decembre-2030\">\n                    Phase 3 : documentation avanc\u00e9e et conformit\u00e9 strat\u00e9gique (d\u2019ici d\u00e9cembre 2030)                <\/button>\n                    <\/div>\n\n        <!-- Tab Content -->\n        <div class=\"tab-content-wrapper\">\n                            <div class=\"tab-content active\" id=\"phase-1-actions-immediates-a-partir-de-mai-2022\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Phase 1 : actions imm\u00e9diates (\u00e0 partir de mai 2022)<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li><b>Aucun transfert \u00e0 d\u2019autres entit\u00e9s juridiques : <\/b>Veiller \u00e0 ce que les DIV en interne soient utilis\u00e9s et fabriqu\u00e9s strictement au sein du m\u00eame \u00e9tablissement de sant\u00e9.<\/li>\n<li><b>Revue du portefeuille DIV en interne vs CE-IVD : <\/b>Identifier quels tests sont \u00e9ligibles en tant que DIV en interne, en particulier la classe D, et confirmer une fabrication \u00e0 une \u00e9chelle non industrielle.<\/li>\n<li><b>Revue initiale de classification : <\/b>Appliquer les r\u00e8gles de classification de l\u2019annexe VIII de l\u2019IVDR \u00e0 tous les DIV en interne.<\/li>\n<\/ul>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Untitled-61.jpg\" alt=\"Microscope research in a advanced medical technology lab, focusing on innovative healthcare solutions and MedTech development.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to Phase 1 : actions imm\u00e9diates (\u00e0 partir de mai 2022)                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"phase-2-mise-en-oeuvre-de-la-conformite-a-partir-de-mai-2024\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Phase 2 : mise en \u0153uvre de la conformit\u00e9 (\u00e0 partir de mai 2024)<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li><b>Mise \u00e0 niveau du SMQ ISO 15189:2022 : <\/b>D\u00e9ployer un syst\u00e8me de management de la qualit\u00e9 mis \u00e0 jour, avec un p\u00e9rim\u00e8tre \u00e9tendu incluant la gestion des risques (ISO 14971) et les contr\u00f4les de fabrication (ISO 13485), en alignement avec le MDCG 2023-1.<\/li>\n<li><b>Finalisation de la liste de contr\u00f4le GSPR : <\/b>\u00c9valuer tous les dispositifs en interne au regard des GSPR de l\u2019annexe I. Documenter la conformit\u00e9 totale ou partielle et justifier toute exemption. <\/li>\n<li><b>D\u00e9claration publique : <\/b>Pr\u00e9parer et publier des d\u00e9clarations incluant les identifiants des dispositifs et la confirmation de conformit\u00e9 aux GSPR (utiliser le mod\u00e8le MDCG annexe A).<\/li>\n<li><b>Plan d\u2019exp\u00e9rience post-commercialisation : <\/b>Mettre en \u0153uvre des proc\u00e9dures pour examiner les r\u00e9sultats d\u2019utilisation clinique, align\u00e9es sur les principes de surveillance apr\u00e8s commercialisation.<\/li>\n<li><b>Pr\u00e9paration \u00e0 l\u2019examen par l\u2019autorit\u00e9 comp\u00e9tente : <\/b>Veiller \u00e0 ce que toute la documentation \u2014 y compris les enregistrements du SMQ, la documentation technique, les justifications GSPR et les d\u00e9clarations publiques \u2014 soit pr\u00eate pour inspection \u00e0 partir de mai 2024.<\/li>\n<\/ul>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/regulatory-inteligence.jpg\" alt=\"ISO medical standards digital interface for MedTech innovation and quality assurance in healthcare technology.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to Phase 2 : mise en \u0153uvre de la conformit\u00e9 (\u00e0 partir de mai 2024)                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"phase-3-documentation-avancee-et-conformite-strategique-dici-decembre-2030\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Phase 3 : documentation avanc\u00e9e et conformit\u00e9 strat\u00e9gique (d\u2019ici d\u00e9cembre 2030)<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li><b>Justification \u00e9crite d\u2019utilisation : <\/b>Finaliser la justification qu\u2019aucun DIV \u00e9quivalent marqu\u00e9 CE n\u2019existe ou ne peut r\u00e9pondre aux besoins de performance. Les justifications doivent \u00eatre fond\u00e9es sur des crit\u00e8res techniques, biologiques ou cliniques et \u00eatre r\u00e9examin\u00e9es r\u00e9guli\u00e8rement. <\/li>\n<\/ul>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/compliance.jpg\" alt=\"Compliance in MedTech industry emphasizing regulation, policies, standards, and governance to accelerate medical device innovation and ensure safety and transparency.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to Phase 3 : documentation avanc\u00e9e et conformit\u00e9 strat\u00e9gique (d\u2019ici d\u00e9cembre 2030)                        <\/button>\n                    <\/div>\n                <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n<section class=\"table\"><div class=\"container\"><div class=\"headline\">Pourquoi choisir MDx pour la conformit\u00e9 des laboratoires ? Expertise diff\u00e9renciante<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Capacit\u00e9<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>Sp\u00e9cialisation IVDR pour les laboratoires<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Mise en \u0153uvre double ISO<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Int\u00e9gration des essais cliniques<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Vente \u00e0 distance<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">MDx CRO<\/th><th class=\"column\">Consultants typiques<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Plus de 10 transitions de laboratoires r\u00e9alis\u00e9es<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Sans focus IVD<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Solutions int\u00e9gr\u00e9es 15189+13485<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Approches s\u00e9par\u00e9es<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Due diligence de tous les essais utilis\u00e9s dans les essais cliniques<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Exp\u00e9rience limit\u00e9e des essais<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Packs de conformit\u00e9 \u00e0 l\u2019article 6<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Focus UE uniquement<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section id=\"block_ff46408f3e60e11aa12c382aa1bf7550\" class=\"case-study-details\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg&#039;);\">\n    \n    \n    <div class=\"container\">\n                    <div class=\"headline\">\u00c9tudes de Cas<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\" data-button-url=\"https:\/\/mdxcro.com\/fr\/case-studies\/genomic-lab-ivdr-transition\/\">\n                                                <div class=\"subtitle\">Genomic Lab IVDR Transition<\/div>\n                                            <div class=\"list\">\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/challenge.svg\" alt=\"Challenge\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Challenge <\/span>\n                                        <p><span style=\"font-weight: 400;\">Major EU cancer center needed to maintain NGS-based LDTs under IVDR while continuing pharma trial partnerships<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/solution.svg\" alt=\"Solution\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Solution <\/span>\n                                        <ul>\n<li><span style=\"font-weight: 400;\">Implemented Article 5(5) justification framework<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Developed GSPRs &amp; technical documentation under IVDR\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Integrated ISO 15189 with 13485 and IVDR-compliant PMS<\/span><\/li>\n<\/ul>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/result.svg\" alt=\"Result\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Result <\/span>\n                                        <p><span style=\"font-weight: 400;\">All tests maintained with zero service interruption. The laboratory was allowed to continue offering local tests in clinical trials.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                <\/div>\n                    <\/div>\n                                    <div class=\"slider-item\" data-button-url=\"https:\/\/mdxcro.com\/fr\/case-studies\/us-lab-distance-sales-compliance\/\">\n                                                <div class=\"subtitle\">US Lab Distance Sales Compliance<\/div>\n                                            <div class=\"list\">\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/challenge.svg\" alt=\"Challenge\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Challenge <\/span>\n                                        <p><span style=\"font-weight: 400;\">CAP-accredited lab needed IVDR Article 6 compliance for EU patient testing.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/solution.svg\" alt=\"Solution\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Solution <\/span>\n                                        <ul>\n<li><span style=\"font-weight: 400;\">Technical documentation development alignment with Annex I\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Development of product Labelling and instructions for use\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Implementation of IVDR compliance PMS systems<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">UDI implementation<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Notified Body selection and followed through CE certification<\/span><\/li>\n<\/ul>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/result.svg\" alt=\"Result\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Result <\/span>\n                                        <p><span style=\"font-weight: 400;\">Continued EU market access with 100% regulatory compliance.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                <\/div>\n                    <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                <a href=\"\/resources\/?category=case-studies\" class=\"button button--tertiary\">View Case Studies<\/a>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n<section id=\"block_459f866badf4fcbbd90e145ff1af2b51\" class=\"faqs\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Questions fr\u00e9quemment pos\u00e9es<\/h2>\n                          <a class=\"button button--default\" href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=sector_laboratories\" target=\"\">\n            Posez-nous une question          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Notre laboratoire peut-il continuer \u00e0 utiliser des LDT apr\u00e8s les \u00e9ch\u00e9ances IVDR ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Oui \u2014 si vous \u00eates un \u00e9tablissement de sant\u00e9 de l\u2019UE et respectez les six conditions de l\u2019article 5(5), notamment la justification d\u2019un besoin non satisfait, la conformit\u00e9 \u00e0 l\u2019ISO 15189, l\u2019alignement sur les GSPR et la publication d\u2019une d\u00e9claration. MDx apporte un soutien complet sur la documentation, les mises \u00e0 jour du SMQ et la strat\u00e9gie r\u00e9glementaire. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quelle est la diff\u00e9rence entre un DIV en interne et un test marqu\u00e9 CE ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Un DIV en interne est fabriqu\u00e9 et utilis\u00e9 uniquement au sein d\u2019un seul \u00e9tablissement de sant\u00e9 et n\u2019est pas mis sur le march\u00e9. Les dispositifs marqu\u00e9s CE sont des produits commerciaux approuv\u00e9s pour une distribution plus large au titre de l\u2019IVDR. MDx aide les laboratoires \u00e0 d\u00e9finir et classer leur portefeuille d\u2019essais et \u00e0 d\u00e9terminer l\u2019\u00e9ligibilit\u00e9 au titre de l\u2019article 5(5).  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quelles sont les exigences IVDR pour les laboratoires am\u00e9ricains (CLIA\/CAP) testant des \u00e9chantillons de patients de l\u2019UE ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Les laboratoires am\u00e9ricains proposant des services de diagnostic \u00e0 des citoyens de l\u2019UE doivent se conformer \u00e0 l\u2019article 6 de l\u2019IVDR. Cela inclut une documentation technique compl\u00e8te, la conformit\u00e9 aux GSPR, la d\u00e9signation d\u2019un PRRC et le marquage CE via un organisme notifi\u00e9. MDx aide les laboratoires hors UE \u00e0 \u00e9tablir des voies r\u00e9glementaires et \u00e0 conserver l\u2019acc\u00e8s \u00e0 l\u2019UE.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">L\u2019ISO 15189:2022 est-elle suffisante pour la conformit\u00e9 IVDR ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Pas \u00e0 elle seule. Bien que l\u2019ISO 15189 soit obligatoire, le MDCG 2023-1 confirme qu\u2019un SMQ complet doit aussi couvrir la gestion des risques (ISO 14971), les contr\u00f4les de fabrication (ISO 13485) et le suivi post-commercialisation. MDx fournit des cadres SMQ int\u00e9gr\u00e9s, adapt\u00e9s aux attentes de l\u2019IVDR.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Comment justifier qu\u2019il n\u2019existe pas de CE-IVD \u00e9quivalent pour notre test en interne ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">La justification doit \u00eatre fond\u00e9e sur des crit\u00e8res cliniques, techniques ou biologiques et \u00e9tay\u00e9e par une \u00e9valuation structur\u00e9e du march\u00e9 (p. ex., revue EUDAMED). MDx construit vos dossiers de justification et votre liste de contr\u00f4le GSPR conform\u00e9ment \u00e0 l\u2019article 5(5)(d) et \u00e0 l\u2019annexe I. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Que dois-je faire si notre test en interne rel\u00e8ve de la classe D ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Les DIV en interne de classe D exigent une documentation technique renforc\u00e9e, similaire aux exigences de l\u2019annexe II pour les CE-IVD, incluant des donn\u00e9es de performance d\u00e9taill\u00e9es. MDx accompagne les plans d\u2019\u00e9valuation des performances, les donn\u00e9es analytiques\/cliniques et les strat\u00e9gies de PMS. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Des essais non marqu\u00e9s CE peuvent-ils \u00eatre utilis\u00e9s dans des essais cliniques ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Oui \u2014 les laboratoires de l\u2019UE peuvent utiliser des tests locaux au titre de l\u2019article 5(5), tandis que les laboratoires hors UE ou les promoteurs utilisant des DIV non approuv\u00e9s doivent demander une autorisation d\u2019\u00e9tude de performance au titre de l\u2019article 58. MDx accompagne les deux voies et d\u00e9veloppe des protocoles harmonis\u00e9s pour des \u00e9tudes combin\u00e9es CTR + IVDR. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Que se passe-t-il si notre d\u00e9claration publique ou notre dossier GSPR n\u2019est pas pr\u00eat pour l\u2019\u00e9ch\u00e9ance 2024 ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Vous risquez une non-conformit\u00e9, pouvant entra\u00eener le retrait de votre test ou des constats lors d\u2019inspections. MDx veille \u00e0 ce que votre d\u00e9claration, votre justification et votre documentation GSPR soient compl\u00e8tes, publi\u00e9es et pr\u00eates pour l\u2019examen par l\u2019autorit\u00e9 comp\u00e9tente. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Existe-t-il des diff\u00e9rences dans l\u2019application de l\u2019article 5(5) selon les \u00c9tats membres de l\u2019UE ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Oui. Bien que les exigences IVDR de base soient communes \u00e0 l\u2019UE, l\u2019application et l\u2019interpr\u00e9tation peuvent varier. MDx aide \u00e0 naviguer les attentes des autorit\u00e9s comp\u00e9tentes locales et les exigences nationales afin d\u2019assurer une conformit\u00e9 coh\u00e9rente.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                      <\/ul>\n              <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n  <script type=\"application\/ld+json\">\n    {\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Notre laboratoire peut-il continuer \u00e0 utiliser des LDT apr\u00e8s les \u00e9ch\u00e9ances IVDR ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Oui \u2014 si vous \u00eates un \u00e9tablissement de sant\u00e9 de l\u2019UE et respectez les six conditions de l\u2019article 5(5), notamment la justification d\u2019un besoin non satisfait, la conformit\u00e9 \u00e0 l\u2019ISO 15189, l\u2019alignement sur les GSPR et la publication d\u2019une d\u00e9claration. MDx apporte un soutien complet sur la documentation, les mises \u00e0 jour du SMQ et la strat\u00e9gie r\u00e9glementaire.\"}},{\"@type\":\"Question\",\"name\":\"Quelle est la diff\u00e9rence entre un DIV en interne et un test marqu\u00e9 CE ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Un DIV en interne est fabriqu\u00e9 et utilis\u00e9 uniquement au sein d\u2019un seul \u00e9tablissement de sant\u00e9 et n\u2019est pas mis sur le march\u00e9. Les dispositifs marqu\u00e9s CE sont des produits commerciaux approuv\u00e9s pour une distribution plus large au titre de l\u2019IVDR. 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MDx aide les laboratoires hors UE \u00e0 \u00e9tablir des voies r\u00e9glementaires et \u00e0 conserver l\u2019acc\u00e8s \u00e0 l\u2019UE.\"}},{\"@type\":\"Question\",\"name\":\"L\u2019ISO 15189:2022 est-elle suffisante pour la conformit\u00e9 IVDR ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Pas \u00e0 elle seule. Bien que l\u2019ISO 15189 soit obligatoire, le MDCG 2023-1 confirme qu\u2019un SMQ complet doit aussi couvrir la gestion des risques (ISO 14971), les contr\u00f4les de fabrication (ISO 13485) et le suivi post-commercialisation. MDx fournit des cadres SMQ int\u00e9gr\u00e9s, adapt\u00e9s aux attentes de l\u2019IVDR.\"}},{\"@type\":\"Question\",\"name\":\"Comment justifier qu\u2019il n\u2019existe pas de CE-IVD \u00e9quivalent pour notre test en interne ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La justification doit \u00eatre fond\u00e9e sur des crit\u00e8res cliniques, techniques ou biologiques et \u00e9tay\u00e9e par une \u00e9valuation structur\u00e9e du march\u00e9 (p. ex., revue EUDAMED). MDx construit vos dossiers de justification et votre liste de contr\u00f4le GSPR conform\u00e9ment \u00e0 l\u2019article 5(5)(d) et \u00e0 l\u2019annexe I.\"}},{\"@type\":\"Question\",\"name\":\"Que dois-je faire si notre test en interne rel\u00e8ve de la classe D ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Les DIV en interne de classe D exigent une documentation technique renforc\u00e9e, similaire aux exigences de l\u2019annexe II pour les CE-IVD, incluant des donn\u00e9es de performance d\u00e9taill\u00e9es. MDx accompagne les plans d\u2019\u00e9valuation des performances, les donn\u00e9es analytiques\/cliniques et les strat\u00e9gies de PMS.\"}},{\"@type\":\"Question\",\"name\":\"Des essais non marqu\u00e9s CE peuvent-ils \u00eatre utilis\u00e9s dans des essais cliniques ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Oui \u2014 les laboratoires de l\u2019UE peuvent utiliser des tests locaux au titre de l\u2019article 5(5), tandis que les laboratoires hors UE ou les promoteurs utilisant des DIV non approuv\u00e9s doivent demander une autorisation d\u2019\u00e9tude de performance au titre de l\u2019article 58. MDx accompagne les deux voies et d\u00e9veloppe des protocoles harmonis\u00e9s pour des \u00e9tudes combin\u00e9es CTR + IVDR.\"}},{\"@type\":\"Question\",\"name\":\"Que se passe-t-il si notre d\u00e9claration publique ou notre dossier GSPR n\u2019est pas pr\u00eat pour l\u2019\u00e9ch\u00e9ance 2024 ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Vous risquez une non-conformit\u00e9, pouvant entra\u00eener le retrait de votre test ou des constats lors d\u2019inspections. MDx veille \u00e0 ce que votre d\u00e9claration, votre justification et votre documentation GSPR soient compl\u00e8tes, publi\u00e9es et pr\u00eates pour l\u2019examen par l\u2019autorit\u00e9 comp\u00e9tente.\"}},{\"@type\":\"Question\",\"name\":\"Existe-t-il des diff\u00e9rences dans l\u2019application de l\u2019article 5(5) selon les \u00c9tats membres de l\u2019UE ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Oui. Bien que les exigences IVDR de base soient communes \u00e0 l\u2019UE, l\u2019application et l\u2019interpr\u00e9tation peuvent varier. MDx aide \u00e0 naviguer les attentes des autorit\u00e9s comp\u00e9tentes locales et les exigences nationales afin d\u2019assurer une conformit\u00e9 coh\u00e9rente.\"}}]}  <\/script>\n\n<section id=\"block_171c55586697d2c89c52f04008378f9c\" class=\"call-to-action\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n        <div class=\"call-to-action--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/mdx-cta-bg.png\" alt=\"\" \/>\n    <\/div>\n    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"content\">\n                                    <h2 class=\"title\">S\u00e9curisez l\u2019avenir de votre laboratoire en diagnostic de pr\u00e9cision<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p><span style=\"font-weight: 400;\">Qu\u2019il s\u2019agisse de maintenir des LDT critiques ou d\u2019\u00e9tendre des services de tests mondiaux, MDx apporte une expertise sp\u00e9cialis\u00e9e pour une conformit\u00e9 sans perturbation op\u00e9rationnelle.<\/span><\/p>\n<p><b>Une conformit\u00e9 qui donne les moyens d\u2019agir. Des diagnostics qui tiennent leurs promesses. <\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=sector_laboratories\" class=\"button button--default\" target=\"\">\n                                Planifier une consultation de laboratoire                            <\/a>\n                                                                                                <a href=\"https:\/\/mdxcro.com\/ivdr-lab-readiness-step-by-step-transition-checklist\/\" class=\"button button--default\" target=\"\">\n                                Lire le guide de survie IVDR pour les laboratoires                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-12090","sector","type-sector","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Conformit\u00e9 des laboratoires \u00e0 l\u2019IVDR | Experts ISO 15189 et transition des LDT<\/title>\n<meta name=\"description\" content=\"Accompagnement expert pour la conformit\u00e9 \u00e0 l\u2019article 5.5 de l\u2019IVDR de l\u2019UE, la mise en \u0153uvre d\u2019ISO 15189 et la validation des LDT. 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