Medical device CE marking

MDCG 2021-1 Guidance on administrative practices until EUDAMED is fully functional


The MDCG issued guidance 2021-1 in February 2021 and the document was updated with Rev 1. on May 4, 2021. The document provides guidance to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.

The document can be downloaded in our library

Source: European Commission