Medical device CE marking

MDCG issues new revision of MDCG 2021-22 and MDCG 2019-6


The MDCG issued a new revision of the MDCG 2021-22 and the MDCG 2019-6:

MDCG 2021-22 Rev.1 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) 2017/74


MDCG 2019-6 Rev4 Questions and answers: Requirements relating to notified bodies

The documents can be downloaded in our library (click on the MDCG number)

Source: European Commission