One More IVDR Notified Body In The Wings As Designation Progress Continues To Advance
Every designation of a notified body under the Medical Device and IVD Regulations has been greeted with fanfare given the historic pressure for more testing capacity. There may have been a shift in timelines, but IVD manufacturers still urgently need to engage with a certified testing body.
You may also be interested in...
The number of notified bodies designated under the IVD Regulation has now crept up to 11 as the first Finnish designation is announced.
The EU is now approaching 40 notified bodies under the Medical Device Regulation. The latest listing is the first in Cyprus.
The EU notified body association, TEAM-NB, is working hard to support industry with its MDR and IVDR compliance efforts. Its first technical documentation training session highlighted where help is likely to be most needed.