MDCG 2022-3 updated
The Medical Device Coordination Group (MDCG) updated its guidance document on Verification of manufactured class D IVDs by notified bodies. The overall purpose of the document was to provide “[…] best practices for notified bodies in performing conformity assessment procedures relating to the verification of manufactured class D IVDs.” The latter is required in the context of batch testing for class D IVD medical devices under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
Revision 1 now includes a number of editorial and clarification changes that are listed on page 2 of the document.
MDG 2022-3 can be accessed here: Click