The Medical Device Coordination Group (MDCG) has issued a Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional. The document provides guidance to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED.
The proposed practices and solutions aim to enable Member States and other relevant parties to meet their obligations under the MDR effectively while minimising any potential additional burden on the parties concerned.
To read the guidance, click here.