Regulatory

Approvals, guidance and standards shaping diagnostics, including FDA, EMA, IVDR and laboratory-developed test oversight.

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Regulatory

Collaborative Framework Proposed to Streamline LDT Validation Across US Hospital Labs

Journal of clinical microbiology March 19, 2026

Significance 7/10 Regulatory

EU Notified Body Perspective on MDR and IVDR Conformity Assessment

Journal of market access & health policy January 8, 2026

Significance 5/10

Landmark studies

Regulatory

43 studies

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HER2 FISH Proficiency Testing in China Reveals Persistent Standardisation Gaps Diagnostic pathology 2024 Significance 6/10 Managing Measurement Bias in the Metrological Traceability Era: From IVD Surveillance to Laboratory Action Clinical chemistry and laboratory medicine 2024 Significance 6/10 Alinity m CMV Assay Delivers Precise, Rapid Viral Load Monitoring With Sub-3-Hour Turnaround Journal of clinical microbiology 2023 Significance 6/10 Diagnostic Management Teams: A Strategy to Reduce Diagnostic Errors and Laboratory Waste Worldwide Annals of laboratory medicine 2019 Significance 6/10 External Quality Assessment in the Traceability Era: Metrological Requirements for Post-Market Surveillance of IVDs Clinical biochemistry 2018 Significance 6/10 How Measurement Uncertainty Should Be Communicated to Clinicians on Laboratory Reports Clinical biochemistry 2018 Significance 6/10 European Multicenter Evaluation Validates Analytical Performance of Veris HIV-1 Molecular Assay Journal of clinical microbiology 2017 Significance 6/10 Reference Materials for Genetic Testing: The Get-RM Programme and Genome in a Bottle Consortium Annals of laboratory medicine 2016 Significance 6/10 Blood Collection Tubes as Unrecognised IVD Variables: A Framework for Laboratory Verification and Validation Clinical biochemistry 2016 Significance 6/10 Systematic Review of Preanalytical Error Collection Methods Recommends LIMS-Based Standardised Capture Annals of clinical biochemistry 2016 Significance 6/10 IHC4+C Breast Cancer Recurrence Score Robust to Staining and Scoring Variation Journal of clinical pathology 2015 Significance 6/10 Anatomy of an EQA Cycle: From Sample Distribution to Performance Assessment Clinical chemistry and laboratory medicine 2025 Significance 5/10 EQA Sample Design: Homogeneity, Stability and Clinically Relevant Targets Clinical chemistry and laboratory medicine 2025 Significance 5/10 Global EQA for Semen Analysis: 34 Years of Inconsistency and High Inter-Laboratory Variability Clinical chemistry and laboratory medicine 2024 Significance 5/10 EFLM Survey Reveals PFAS Dependency in IVD Technologies and Uncertain End-of-Life Pathways Clinical chemistry and laboratory medicine 2024 Significance 5/10 Top-Down Measurement Uncertainty for Tacrolimus by UHPLC-MS/MS: Two Approaches Converge Clinical biochemistry 2018 Significance 5/10 UK Guidelines for Post-Vasectomy Semen Analysis Under ISO 15189 Accreditation Journal of clinical pathology 2016 Significance 5/10 Venous Blood Draw Order Varies Widely Across Danish Laboratories Despite International Guidelines Clinical biochemistry 2018 Significance 4/10