Draft EU MDR & IVDR Available

A draft of the EU’s Medical Device Regulation is available at item #13.

A draft of the EU’s In vitro Diagnostic Regulation is available at item #14.

http://www.emeeting.europarl.europa.eu/committees/agenda/201606/ENVI/ENVI%282016%290615_1/sitt-2571599

The EU must write them in the final form and translate them into the official languages before they can issue the regulations officially. That starts the transition period to bring the regulations into force.