Medical device CE marking

MDCG 2021-22 Clarification on first certification – IVDR


On August 18, the European Commission published MDCG 2021-22: Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746.

The document can be downloaded in our library

Source: European Commission