TypeAllBlog & InsightsCase studiesEvents & ConferencesIVD NewsRegulatory UpdatesWhitepapers
SectorAllDigital Health & AIIVDsLaboratoriesMedical DevicesPrecision Medicine & CDx
Navigating the IVDR CDx Certification Pathway

Navigating the IVDR CDx Certification Pathway
03.02.2026
Blog & Insights, IVD News, Regulatory Updates | IVDs, Precision Medicine & CDx
ISO 20916:2024 What You Need to Know for Clinical Performance Studies in 2026

ISO 20916:2024 What You Need to Know for Clinical Performance Studies in 2026
02.02.2026
IVD News, Regulatory Updates | IVDs, Precision Medicine & CDx
Impact of the Health Services Pack on IVD manufacturers, labs/health institutions and sponsors of combined studies

Impact of the Health Services Pack on IVD manufacturers, labs/health institutions and sponsors of combined studies
13.01.2026
Regulatory Updates | IVDs, Precision Medicine & CDx
FDA’s New CDx Pathway vs EU IVDR: Harmonised Science, Diverging Workload

FDA’s New CDx Pathway vs EU IVDR: Harmonised Science, Diverging Workload
27.11.2025
IVD News | Precision Medicine & CDx
FDA Proposes to Down‑Classify Key Oncology Companion Diagnostics to Class II: What CDx Sponsors Need to Know

FDA Proposes to Down‑Classify Key Oncology Companion Diagnostics to Class II: What CDx Sponsors Need to Know
27.11.2025
IVD News, Regulatory Updates | Precision Medicine & CDx
Team-NB clarifies CDx changes under IVDR Annex IX 5.2

Team-NB clarifies CDx changes under IVDR Annex IX 5.2
11.11.2025
Regulatory Updates | Precision Medicine & CDx
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