Medical device CE marking

MDCG 2021-4 Q&A on how to handle class D IVDs during transition to IVDR – revision 1

2024-09

MDCG issues revision 1 on Guidance 2021-4: a Q&A document on how certifications of the highest risk (class D) in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR) will be handled during the transition period.

The document can be downloaded in our library

Source: European Commission