EUDAMED Mandatory Timelines for MDR and IVDR

EUDAMED Mandatory Timelines for MDR and IVDR

27.11.2025
Regulatory Updates | IVDs, Medical Devices
IVDR Lab Readiness: Step-by-Step Transition Checklist

IVDR Lab Readiness: Step-by-Step Transition Checklist

28.09.2025
Blog & Insights, Regulatory Updates | IVDs, Laboratories
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
FDA Laboratory Developed Tests (LDTs) Regulation

FDA Laboratory Developed Tests (LDTs) Regulation

04.10.2023
IVD News, Regulatory Updates | IVDs, Laboratories
Monkeypox Diagnostic Test Specifications: Navigating WHO’s TPPs

Monkeypox Diagnostic Test Specifications: Navigating WHO’s TPPs

24.08.2023
IVD News, Regulatory Updates | IVDs