NEW YORK – The Dutch Ministry of Health this week notified BSI that its Netherland's notified body (NB) has been designated to the new IVDR, the company said.
As a result, BSI can provide conformity assessments to the full scope of the IVDR, which includes more than 80 codes. The IVDR takes effect in May 2022.
BSI said that this most recent announcement is the fourth and final designation for BSI and its two NBs in the UK and the Netherlands. They now have full scope designation to the IVDR, as well as the MDR, which takes effect in May 2020.
The lack of NBs to certify diagnostic tools and equipment as being in compliance with IVDRs had been a concern, and the first NB for IVDRs was named only in October.