MDCG 2021 Rev.1 – Guidance before EUDAMED fully functional ⏳

The #MDCG has released and updated “Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional”.  It provides direction to relevant parties on the application of MDR provisions during the absence of EUDAMED, and describes harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED is fully functional.

🔗 https://ec.europa.eu/health/sites/default/files/md_sector/docs/2021-1_guidance-administrative-practices_en.pdf

#EUDAMED #MDRG #mdrguide #IVDR #MDR #medicaldevices #ec