TypeAllBlog & InsightsCase studiesEvents & ConferencesIVD NewsRegulatory Updates
SectorAllDigital Health & AIIVDsLaboratoriesMedical DevicesPrecision 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
COMBINE Programme: Streamlining EU Combined Studies for Medicines, Devices, and Diagnostics

COMBINE Programme: Streamlining EU Combined Studies for Medicines, Devices, and Diagnostics
17.12.2024
Blog & Insights, IVD News, Regulatory Updates | Precision Medicine & CDx
MDCG 2020-16 Rev.3: IVDR Classification Rules

MDCG 2020-16 Rev.3: IVDR Classification Rules
09.07.2024
Regulatory Updates | IVDs, Precision Medicine & CDx
IVDR Performance Studies and the ISO 20916:2024 Revision

IVDR Performance Studies and the ISO 20916:2024 Revision
02.04.2024
IVD News, Regulatory Updates | IVDs, Precision Medicine & CDx
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