Manufacturers who want to make continuous use of the extended transition period under the In Vitro Diagnostic Medical Devices Regulation (IVDR) must be able to provide a signed agreement for IVDR conformity assessment.
Of those, manufacturers who have a CE certificate issued by a notified body under the former IVD Directive (IVDD) and who want to change the notified body for IVDR certification, must also be able to provide evidence that surveillance activities for the IVDD CE certificate are appropriately addressed.
For this purpose, TEAM-NB has issued a draft agreement for the transfer of surveillance responsibilities.
You may access the document here. Please don’t hesitate to get in touch should you have any further questions.
Source: TEAM-NB
Accompanying this subject we recommend the following content on our website
- Draft manufacturer self-declaration and notified body confirmation letter for Regulation (EU) 2024/1860 available
- Extension of IVDR transition periods and early launch of Eudamed takes last hurdle