IVD Regulation

Why is the new EU IVD Regulation creating a storm?

Why is the new EU IVD Regulation creating a storm?

Just last week, we have discussed on the publication of the new European Medical Device Regulations (MDR), 2017/745. The Regulations has come into force on 25th May 2017, marking the start of the transition period for companies selling medical devices into Europe.  Similarly, the in-vitro diagnostic devices (IVD) has gone from a Directive to an enforced Regulation – 2017/746.