Regulation 2024/1860 brings fresh momentum to the implementation of EUDAMED. Learn what’s changing, which modules are affected, and how MedTech companies should prepare for the upcoming deadlines.

In-house IVD: in-house laboratory tests for safe and reliable diagnostics. Find out more about requirements and regulatory specifications!

In vitro diagnostics (IVDs) enable early disease detection & precision treatment. Learn how PCR, AI & lab tests improve healthcare & patient outcomes!

The Medical Device Coordination Group (MDCG) requested scientific advice from the European Medicines Agency (EMA) to re-evaluate the classification of SARS-CoV-2 in the context of in vitro diagnostic medical devices (IVDs).