2022-7

On July 13 the European Commission published MDCG 2022-12: Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)

This document provides guidance to Member States and other relevant parties on the application of certain IVDR 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