Medical device CE marking

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


MDCG issues 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 until 26 May 2022.

The document can be downloaded in our library

Source: European Commission