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] European Commission Adds To Advice On High Risk Device Safety And Performance Requirements
The European Commission’s MDCG has issued revised guidance and advice on safety and clinical performance data required for implantable and class III devices under the MDR.
[FEATURED] Pharma, Device Groups Oppose FDA’s Planned Drug to Device Transition
Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging agents, currently regulated as drugs to […]
