Hi all
Exciting news! The new IVD Regulation, replacing the old IVD Directive, has just been published!
REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017 on in vitro diagnostic medical devices and repealing
Directive 98/79/EC and Commission Decision 2010/227/EU
Please go here to download a copy from the official EU site.
Enjoy!
JGM