EU: Uncertain Regulatory Landscape

Formal decisions which will shape the future regulatory landscape of the EU are yet to be made by officials. Significant change is on the horizon however it is difficult to say when and how this will play out.  Information being released shows the EU remains indecisive however the concepts of a centralised regulatory body and two regulations to replace the Medical Device Directive, IVD Directive and Active Implantable Device Directive are well and truly looking likely.

Stay tuned for further updates as the EU grind slowly towards to a safe and efficient medical device regulatory system.