The Impact of MDCG 2024-10 on Internal Processes, Timelines, and Team Readiness
The introduction of the MDCG 2024-10 guideline in June 2024 marks a significant shift in how orphan medical devices are evaluated and brought to market in the European Union. This […]
The Impact of the IVDR on IVD Clinical Performance Studies
With the full implementation of the In Vitro Diagnostic Regulation (IVDR) in the European Union, the landscape for clinical performance studies involving in vitro diagnostic (IVD) devices has undergone significant […]
[FEATURED] Whole EU Medtech Industry Behind Latest Push To Have MDR Problems Tackled at Highest Levels
Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go […]
