On June 18, 2025, the EU Medical Device Coordination Group (MDCG) released MDCG 2025-5, a detailed Q&A document clarifying the rules for in vitro diagnostic
A new paper titled “The AI Act: responsibilities and obligations for healthcare professionals and organizations,” published in Diagnostic and Interventional Radiology, offers a detailed analysis
Here’s a comprehensive overview of the Unique Device Identification (UDI) System as mandated by the EU’s MDR and IVDR regulations.
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