Medical device CE marking

MDCG 2021-27 and MDCG 2021-28 published by European Commission


On December 9, 2021, the European Commission published 2 new documents:

The MDCG 2021-27: on “Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746” (can be downloaded in our library)

The MDCG 2021-28: on “Substantial modification of clinical investigation under Medical Device Regulation” (can be downloaded in our library)

Source: European Commission