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 […]
MDCG 2022-12: “Alternative Solutions” Document. Interim Guidance for IVD Manufacturers
Author: Criterion Edge Writers What You Need to Know The Medical Device Coordination Group (MDCG) released a new document (MDCG 2022-12) to establish guidelines for in vitro diagnostic medical device […]
