Potential impacts of the EU IVD-Regulation on clinical flow cytometry.

Maurizio Suppo provides an overview of the new EU IVD-Regulation and elaborates on how EU authorities will regulate the vast majority of the laboratory-developed tests currently performed across Europe on a daily basis.

As with many other ideas that are intended to improve existing products or procedures, the road to the new European IVD Regulation (IVD-R) 2017/746 is paved with good intentions. However, some of these intentions may render the daily life of clinical flow cytometry laboratories a lot more complex than they are now, due to the latest regulations covering laboratory-developed tests (LDTs).

Transition period for IVD-R

The legislative text currently used to regulate the distribution of all IVDs in Europe is the old IVD Directive 98/79/EC, which was drafted almost 25 years ago. As with anything old, it has started to show some severe limitations due to its age – particularly when compared with other IVD legislations in different parts of the world.

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