The IVDR came into force in May 2017, but there are five years to adjust, until May 26, 2022. During the transition period, the Notified Bodies will be able to continue to issue the IVDD CE certificates, which will be valid for 5 years, provided that the date of application of the IVDR is not exceeded by two years.

Once the new IVDR CE certificate has been authorized for issue, only Notified Bodies can release it.