Medical device CE marking

MDCG issues version 2 of MDCG 2020-16: Guidance on Classification Rules IVDR

2023-02

This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro
diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. 

The document can be downloaded in our library

Source: European Commission