{"id":706,"date":"2025-07-30T08:08:58","date_gmt":"2025-07-30T08:08:58","guid":{"rendered":"http:\/\/mdx.local\/?post_type=sector&#038;p=706"},"modified":"2026-02-24T12:41:27","modified_gmt":"2026-02-24T12:41:27","slug":"laboratories","status":"publish","type":"sector","link":"https:\/\/mdxcro.com\/fr\/sectors\/laboratories\/","title":{"rendered":"Laboratories"},"content":{"rendered":"\n<section id=\"block_afb7652a7465893b9c18bba766138ad0\" 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\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Expert Lab Compliance for EU IVDR and Global Diagnostics<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">Master in-house IVD validation under Article 5.5, enable cross-border testing via Article 6, and align clinical trial assays with EU CTR and IVDR.<\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/contact\/?utm_source=sector_laboratories\" class=\"button button--default\" target=\"_self\">\n                            Book a Lab Compliance Assessment                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/ivdr-lab-readiness-step-by-step-transition-checklist\/\" class=\"button button--secondary\" target=\"_self\">\n                            Read Our IVDR Lab Transition Guide                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n\n<section id=\"block_40dcc79e3238ce9d50360fbf29c43f50\" 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\">Core Laboratory Expertise<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">EU IVDR Article 5.5 \u2013 In-House Testing<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><b>Article 5.5 Compliance: <\/b><span style=\"font-weight: 400\">GSPR-based documentation, justification of unmet need, and public declarations per MDCG 2023-1<\/span><\/li>\n<\/ul>\n<ul>\n<li><b>ISO 15189:2022 QMS: <\/b><span style=\"font-weight: 400\">Laboratory QMS setup and enhancements beyond ISO scope (risk, traceability, PMS according to ISO 13485)<\/span><\/li>\n<li><b>RUO to IVD Transition: <\/b><span>Regulatory classification, technical documentation development, and support with Notified Body assessment &amp; CE mark.<\/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\">Non-EU Lab Compliance \u2013 IVDR Article 6<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><b>Cross-Border Testing: <\/b><span style=\"font-weight: 400\">CLIA\/CAP labs serving EU patients must comply with Article 6 obligations and therefore achieve compliance with IVDR.<\/span><\/li>\n<\/ul>\n<ul>\n<li><b>EU Market Entry: <\/b><span style=\"font-weight: 400\">Technical documentation, PRRC designation, Authorised Representative services (EU Rep) and conformity assessment with Notified Bodies<\/span><\/li>\n<li><b>UDI &amp; Labeling: <\/b><span style=\"font-weight: 400\">EUDAMED registration, UDI systems, and development of product labelling and instructions for use<\/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\">Assay Use in Clinical Trials (CTR\/IVDR)<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><b>In-House Testing (Article 5(5)): <\/b><span style=\"font-weight: 400\">Support for EU labs using local, non-CE marked tests in clinical trials under Article 5(5), including justification, GSPR compliance, and ISO 15189-aligned QMS.<\/span><\/li>\n<\/ul>\n<ul>\n<li><b>Performance Study Support (Article 58): <\/b><span style=\"font-weight: 400\">For non-EU labs or non-CE assays used in patient management, we prepare performance study applications or notifications per IVDR Article 58 and Annex XIV.<\/span><\/li>\n<li><b>Combined Trials (CTR + IVDR): <\/b><span style=\"font-weight: 400\">Regulatory strategy and documentation for trials involving both medicinal products and IVDs, ensuring full alignment with CTR and IVDR requirements.<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n\n<section class=\"table\"><div class=\"container\"><div class=\"headline\">Regulatory &amp; Quality Systems<\/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>IVDR Technical Documentation<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>ISO 15189 Accreditation<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Hybrid QMS Development<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Clinical Trial Assays &amp; local tests<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">Key Deliverables<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\">Annex I GSPR checklists + performance evaluation +\u00a0 public declarations<\/td><\/tr><tr><td class=\"cell highlight\">Gap assessments + documentation templates + internal audits<\/td><\/tr><tr><td class=\"cell highlight\">Combined ISO 15189 + ISO 13485 frameworks<\/td><\/tr><tr><td class=\"cell highlight\">Due-diligence to ensure regulatory readiness<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n\n\n<section id=\"block_e0bc818561edd5561869795db9edd8bd\" class=\"tabs\" style=\"padding-top: var(--wp--preset--spacing--medium);\">\n        <div class=\"container\">\n                    <div class=\"title\">Laboratory Compliance Roadmap<\/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-immediate-actions-from-may-2022\">\n                    Phase 1: Immediate Actions (From May 2022)                <\/button>\n                            <button class=\"tab-button\" data-tab=\"phase-2-compliance-implementation-from-may-2024\">\n                    Phase 2: Compliance Implementation (From May 2024)                <\/button>\n                            <button class=\"tab-button\" data-tab=\"phase-3-advanced-documentation-and-strategic-compliance-by-december-2030\">\n                    Phase 3: Advanced Documentation and Strategic Compliance (By December 2030)                <\/button>\n                    <\/div>\n\n        <!-- Tab Content -->\n        <div class=\"tab-content-wrapper\">\n                            <div class=\"tab-content active\" id=\"phase-1-immediate-actions-from-may-2022\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Phase 1: Immediate Actions (From May 2022)<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li><b>No Transfer to Other Legal Entities:\u00a0<\/b>Ensure that in-house IVDs are used and manufactured strictly within the same health institution.<\/li>\n<li><b>In-House vs CE-IVD Portfolio Review: <\/b>Identify which tests qualify as in-house IVDs, especially Class D, and confirm non-industrial scale manufacturing.<\/li>\n<li><b>Initial Classification Review: <\/b>Apply IVDR Annex VIII classification rules to all in-house IVDs.<\/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: Immediate Actions (From May 2022)                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"phase-2-compliance-implementation-from-may-2024\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Phase 2: Compliance Implementation (From May 2024)<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li><b>ISO 15189:2022 QMS Upgrade:\u00a0<\/b>Deploy an updated quality management system with extended scope to include risk management (ISO 14971) and manufacturing controls (ISO 13485), in alignment with MDCG 2023-1.<\/li>\n<li><b>GSPR Checklist Completion: <\/b>Evaluate all in-house devices against Annex I GSPRs. Document full or partial compliance, and justify any exemptions.<\/li>\n<li><b>Public Declaration: <\/b>Prepare and publish declarations including device identifiers and GSPR conformity confirmation (use MDCG Annex A template).<\/li>\n<li><b>Post-Market Experience Plan: <\/b>Implement procedures to review clinical use outcomes, aligned with post-market surveillance principles.<\/li>\n<li><b>Prepare for Competent Authority Review: <\/b>Ensure that all documentation\u2014including QMS records, technical documentation, GSPR justifications, and public declarations\u2014is inspection-ready as of May 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: Compliance Implementation (From May 2024)                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"phase-3-advanced-documentation-and-strategic-compliance-by-december-2030\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Phase 3: Advanced Documentation and Strategic Compliance (By December 2030)<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li><b>Written Justification for Use: <\/b>Finalize justification that no equivalent CE-marked IVD exists or cannot meet performance needs. Justifications must be based on technical, biological, or clinical criteria and reviewed regularly.<\/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: Advanced Documentation and Strategic Compliance (By December 2030)                        <\/button>\n                    <\/div>\n                <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n\n<section class=\"table\"><div class=\"container\"><div class=\"headline\">Why Choose MDx for Laboratory Compliance? Differentiated Expertise<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Capability<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>IVDR Lab Specialization<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Dual ISO Implementation<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Clinical Trial Integration<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Distance Sales<\/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\">Typical Consultants<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\"><img loading=\"lazy\" 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=\"\">10+ lab transitions completed<\/td><td class=\"cell\"><img loading=\"lazy\" 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=\"\">Non-IVD focus<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" 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=\"\">Integrated 15189+13485 solutions<\/td><td class=\"cell\"><img loading=\"lazy\" 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=\"\">Separate approaches<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" 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 of all assays used in clinical trials<\/td><td class=\"cell\"><img loading=\"lazy\" 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=\"\">Limited trial experience<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" 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=\"\">Article 6 compliance packages<\/td><td class=\"cell\"><img loading=\"lazy\" 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=\"\">EU-only focus<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n\n\n<section id=\"block_5ca9adadf03eb976b80fc0a0859471be\" 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\">Case Studies<\/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\n\n<section id=\"block_f0b443d8db145427487cc95f60ef7bcf\" class=\"faqs\" style=\"\">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Frequently Asked Questions<\/h2>\n                          <a class=\"button button--default\" href=\"https:\/\/mdxcro.com\/contact\/?utm_source=sector_laboratories\" target=\"\">\n            Ask us a Question          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Can our laboratory continue using LDTs after the IVDR deadlines?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Yes\u2014if you are an EU health institution and meet all six conditions of Article 5(5), including justification of unmet need, ISO 15189 compliance, GSPR alignment, and publication of a declaration. MDx provides full support across documentation, QMS updates, and regulatory strategy.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">What\u2019s the difference between an in-house IVD and a CE-marked test?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">An in-house IVD is manufactured and used solely within a single health institution and not placed on the market. CE-marked devices are commercial products approved for wider distribution under IVDR. MDx helps labs define and classify their assay portfolio and determine eligibility under Article 5(5).<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">What are the IVDR requirements for US labs (CLIA\/CAP) testing EU patient samples?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">US labs offering diagnostic services to EU citizens must comply with Article 6 of the IVDR. This includes full technical documentation, GSPR conformity, PRRC designation, and CE-marking via a Notified Body. MDx helps non-EU labs establish regulatory pathways and retain EU access.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Is ISO 15189:2022 sufficient for IVDR compliance?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Not by itself. While ISO 15189 is mandatory, MDCG 2023-1 confirms that a complete QMS must also address risk management (ISO 14971), manufacturing controls (ISO 13485), and post-market monitoring. MDx delivers integrated QMS frameworks tailored to IVDR expectations.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">How do I justify that no equivalent CE-IVD exists for our in-house test?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">The justification must be based on clinical, technical, or biological criteria and supported by a structured market assessment (e.g., EUDAMED review). MDx builds your justification files and GSPR checklist in line with Article 5(5)(d) and Annex I.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">What do I need to do if our in-house test falls under Class D?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Class D in-house IVDs require enhanced technical documentation similar to CE-IVD Annex II requirements, including detailed performance data. MDx provides support with performance evaluation plans, analytical\/clinical data, and PMS strategies.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Can non-CE marked assays be used in clinical trials?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Yes\u2014EU labs may use local tests under Article 5(5), while non-EU labs or sponsors using unapproved IVDs must apply for a performance study authorization under Article 58. MDx supports both routes and develops harmonized protocols for combined CTR + IVDR studies.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">What happens if our public declaration or GSPR file isn\u2019t ready by the 2024 deadline?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">You risk non-compliance, which could result in removal of your test or inspection findings. MDx ensures your declaration, justification, and GSPR documentation are complete, published, and ready for competent authority review.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Are there differences in how Article 5(5) is enforced across EU member states?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Yes. While the core IVDR requirements are EU-wide, enforcement and interpretation can vary. MDx helps navigate local competent authority expectations and national requirements to ensure consistent compliance.<\/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\":\"Can our laboratory continue using LDTs after the IVDR deadlines?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes\u2014if you are an EU health institution and meet all six conditions of Article 5(5), including justification of unmet need, ISO 15189 compliance, GSPR alignment, and publication of a declaration. 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MDx builds your justification files and GSPR checklist in line with Article 5(5)(d) and Annex I.\"}},{\"@type\":\"Question\",\"name\":\"What do I need to do if our in-house test falls under Class D?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Class D in-house IVDs require enhanced technical documentation similar to CE-IVD Annex II requirements, including detailed performance data. MDx provides support with performance evaluation plans, analytical\/clinical data, and PMS strategies.\"}},{\"@type\":\"Question\",\"name\":\"Can non-CE marked assays be used in clinical trials?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes\u2014EU labs may use local tests under Article 5(5), while non-EU labs or sponsors using unapproved IVDs must apply for a performance study authorization under Article 58. MDx supports both routes and develops harmonized protocols for combined CTR + IVDR studies.\"}},{\"@type\":\"Question\",\"name\":\"What happens if our public declaration or GSPR file isn\u2019t ready by the 2024 deadline?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"You risk non-compliance, which could result in removal of your test or inspection findings. MDx ensures your declaration, justification, and GSPR documentation are complete, published, and ready for competent authority review.\"}},{\"@type\":\"Question\",\"name\":\"Are there differences in how Article 5(5) is enforced across EU member states?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes. While the core IVDR requirements are EU-wide, enforcement and interpretation can vary. MDx helps navigate local competent authority expectations and national requirements to ensure consistent compliance.\"}}]}  <\/script>\n\n\n\n<section id=\"block_44f724d4fe95105508d9edd49de8ab58\" class=\"call-to-action\" style=\"\">\n        <div class=\"call-to-action--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/mdx-cta-bg.png\" \/>\n    <\/div>\n    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"content\">\n                                    <h2 class=\"title\">Secure your Laboratorie&#039;s future in Precision Diagnostics<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p><span style=\"font-weight: 400;\">Whether maintaining critical LDTs or expanding global testing services, MDx delivers specialized expertise for compliance without operational disruption.<\/span><\/p>\n<p><b>Compliance That Empowers. Diagnostics That Deliver.<\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/contact\/?utm_source=sector_laboratories\" class=\"button button--default\" target=\"\">\n                                Schedule a Lab Consultation                            <\/a>\n                                                                                                <a href=\"https:\/\/mdxcro.com\/ivdr-lab-readiness-step-by-step-transition-checklist\/\" class=\"button button--default\" target=\"\">\n                                Read IVDR Lab Survival guide                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<p><\/p>\n","protected":false},"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":true},"class_list":["post-706","sector","type-sector","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IVDR Lab Compliance | ISO 15189 &amp; LDT Transition Experts<\/title>\n<meta name=\"description\" content=\"Expert support for EU IVDR Article 5.5 compliance, ISO 15189 implementation, and LDT validation. 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