The information on this page is from the European Commission website detailing the regulatory framework of the MDR & IVDR Regulations.
On 5 April 2017, 2 new Regulations on medical devices were adopted. These replace the existing Directives.
MDR – 3 years after entry into force for the Regulation on medical devices – Spring 2020
IVDR – 5 years after entry into force for the Regulation on in vitro diagnostic medical devices – Spring 2022
The new Regulations contain a series of extremely important improvements to modernise the current system. Among them are: