Expert Lab Compliance for EU IVDR and Global Diagnostics
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.
Core Laboratory Expertise
EU IVDR Article 5.5 – In-House Testing
Non-EU Lab Compliance – IVDR Article 6
Assay Use in Clinical Trials (CTR/IVDR)
| Service |
|---|
| IVDR Technical Documentation |
| ISO 15189 Accreditation |
| Hybrid QMS Development |
| Clinical Trial Assays & local tests |
| Key Deliverables |
|---|
| Annex I GSPR checklists + performance evaluation + public declarations |
| Gap assessments + documentation templates + internal audits |
| Combined ISO 15189 + ISO 13485 frameworks |
| Due-diligence to ensure regulatory readiness |
Phase 1: Immediate Actions (From May 2022)
- No Transfer to Other Legal Entities: Ensure that in-house IVDs are used and manufactured strictly within the same health institution.
- In-House vs CE-IVD Portfolio Review: Identify which tests qualify as in-house IVDs, especially Class D, and confirm non-industrial scale manufacturing.
- Initial Classification Review: Apply IVDR Annex VIII classification rules to all in-house IVDs.
Phase 2: Compliance Implementation (From May 2024)
- ISO 15189:2022 QMS Upgrade: 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.
- GSPR Checklist Completion: Evaluate all in-house devices against Annex I GSPRs. Document full or partial compliance, and justify any exemptions.
- Public Declaration: Prepare and publish declarations including device identifiers and GSPR conformity confirmation (use MDCG Annex A template).
- Post-Market Experience Plan: Implement procedures to review clinical use outcomes, aligned with post-market surveillance principles.
- Prepare for Competent Authority Review: Ensure that all documentation—including QMS records, technical documentation, GSPR justifications, and public declarations—is inspection-ready as of May 2024.
Phase 3: Advanced Documentation and Strategic Compliance (By December 2030)
- Written Justification for Use: 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.
| Capability |
|---|
| IVDR Lab Specialization |
| Dual ISO Implementation |
| Clinical Trial Integration |
| Distance Sales |
| MDx CRO | Typical Consultants |
|---|---|
 10+ lab transitions completed |  Non-IVD focus |
| Integrated 15189+13485 solutions |  Separate approaches |
| Due-diligence of all assays used in clinical trials | Limited trial experience |
| Article 6 compliance packages | EU-only focus |
Major EU cancer center needed to maintain NGS-based LDTs under IVDR while continuing pharma trial partnerships
- Implemented Article 5(5) justification framework
- Developed GSPRs & technical documentation under IVDR
- Integrated ISO 15189 with 13485 and IVDR-compliant PMS
All tests maintained with zero service interruption. The laboratory was allowed to continue offering local tests in clinical trials.
CAP-accredited lab needed IVDR Article 6 compliance for EU patient testing.
- Technical documentation development alignment with Annex I
- Development of product Labelling and instructions for use
- Implementation of IVDR compliance PMS systems
- UDI implementation
- Notified Body selection and followed through CE certification
Continued EU market access with 100% regulatory compliance.
Frequently Asked Questions
Ask us a Question- Can our laboratory continue using LDTs after the IVDR deadlines?
Yes—if 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.
- What’s the difference between an in-house IVD and a CE-marked test?
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).
- What are the IVDR requirements for US labs (CLIA/CAP) testing EU patient samples?
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.
- Is ISO 15189:2022 sufficient for IVDR compliance?
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.
- How do I justify that no equivalent CE-IVD exists for our in-house test?
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.
- What do I need to do if our in-house test falls under Class D?
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.
- Can non-CE marked assays be used in clinical trials?
Yes—EU 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.
- What happens if our public declaration or GSPR file isn’t ready by the 2024 deadline?
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.
- Are there differences in how Article 5(5) is enforced across EU member states?
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.
Secure Your Lab’s Future in Precision Diagnostics
Whether maintaining critical LDTs or expanding global testing services, MDx delivers specialized expertise for compliance without operational disruption.
Compliance That Empowers. Diagnostics That Deliver.
