The new European Medical Device and In vitro Diagnostic Medical Device Regulations (MDR/IVDR) were signed into law on 5 April 2017 and entered into force on 25 May 2017. They apply from (Date of Application – DoA) 26 May 2020 (MDR) and 26 May 2022 (IVDR).
It is critical to understand that there is no “grand-fathering” of devices already allowed (that is, currently CE marked) to be placed onto the EU market. All devices will ultimately need to be made compliant.
Download this white paper to learn about the many remediation and implementation challenges and activities that must be undertaken to continue to distribute devices in the EU.
*This white paper was written prior to the European Commision MDR/IVDR deadline delays. Click here for the most recent updates.