EU In Vitro Diagnostics Regulation (2017/746)

Dec 04, 2023

Which EU Notified Bodies Are Designated Under the MDR 2017/745 and IVDR 2017/746?

Oct 04, 2023

FDA to Regulate Lab Developed Tests (LDTs) as Early as 2025

Jul 23, 2023

Understanding FDA and EU Medical Device Labeling Requirements

Jun 20, 2022

Still Maintaining Duplicate MDD/IVDD- and MDR/IVDR-Compliant Documentation?

May 22, 2022

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

Feb 07, 2022

The New IVDR Compliance Deadline Extension Explained