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Apr 14, 2025

Navigating the Final Countdown: Key Deadlines and Compliance Requirements for IVDR Transition

EU MDR & IVDR Updates

Jan 12, 2024

Which EU Notified Bodies Have Been “Designated” Under the MDR 2017/745 and IVDR 2017/746?

Jan 12, 2024

MDCG 2022-6: Making Changes to Legacy Devices Without Triggering EU IVDR Compliance

may 26

Jan 12, 2024

The New IVDR Compliance Deadline Extension Explained

Jan 11, 2024

IVD Manufacturer Clinical Evidence Needed for IVDR Performance Evaluation Reports. Where to Begin?

IVD grouping

Jan 11, 2024

The Importance of Properly Grouping IVD Registrations Under the EU IVDR