Even though the EU MDR was postponed until May 2021, the dwindled-down list of Notified Bodies suggests Regulatory Affairs professionals might not want to kick the can too far down the road.
For those looking at the upcoming IVDR, the situation is even bleaker. The IVDR has not yet been postponed, still facing a May 2022 effective date.
“…with only three notified bodies designated against the IVDR so far, potential delays in further designations because of COVID-19 and social distancing could be a real problem for a diagnostics industry that has been preventing from moving towards compliance when there are so many unfinished structures and documents”
To search the database of designated NBs on NANDO’s website, click here.
Read our updates on EU MDR by clicking here.