The in vitro diagnostic medical device regulation entered into force in May 2017 and becomes applicable on May 26,2022.The new rules contain a number of improvements.
The generous application date of regulation remains 26 May,2022. In particular, the IVD regulation will apply in full from 26 May 200 to CE marked in vitro diagnostic medical devices that do not require the involvement of notified body and to new in vitro diagnostics.
