Transition from IVD to IVDR

shimonv

Trusted Information Resource
Hi folks,
A colleague of mine has a CE certificate for a class B devices which expiring on March 24.
Their NB just recently contacted them and said they will not be able to renew or extend their CE certificate. This, of course, raises a concern on whether they are able to complete the transition to IVDR before the certificate expires.

It's not clear to me why can't they extend their CE certificate until 2025 while they work on their transition to IVDR.

Any thoughts?

Thanks,
Shimon
 
Top Bottom