DOC for Self certified Class A (IVDD) and Class C (IVDR) waiting for Notified Body Certification for the first time.....

halosenthil

Registered
Dear All,

If i get answer for the below conditions, would be helpful at this moment.

1)During this transition Period, shall we issue the Declaration of Conformity for IVDR , which were self certified before (class A) as per IVDD and not yet CE certified for Class C by Notified body?

2)During this transition period, Shall we sell the new products released after 26 May 2022 in EU? If yes Self Certified for class A? per IVDD or Class C as per IVDR?

3.How to handle the Grandfather products (Released 20 years before and DMF is not available and Product release dates are Unknown?
 
Top Bottom