Premarket Evaluation of High Risk Medical Devices in the EU
Recently the EU has come under heavy scrutiny for failing to produce adequate premarket clinical evidence that demonstrates efficacy and safety of innovative, higher – risk medic
Some IVDs and Radiology devices to be exempt from FDA 510(k)
The FDA (US Food and Drug Administration) has announced plans to ease the pre-market notification, or 510(k), requirements for certain in-vitro diagnostic (IVD) and radiology devic
EU publish much awaited draft regulation for e-labelling of medical devices
The European Commission has finally issued it’s much awaited draft regulation on e-labelling, the final version of which is expected to be adopted by 14 December and come into fo
TGA Release Update Regarding Proposed Regulatory Framework Reforms
The European Commission has finally issued it’s much awaited draft regulation on e-labelling, the final version of which is expected to be adopted by 14 December and come into fo
