MDCG 2021-19 : Guidance note integration of the UDI within an organisation’s quality management system 📰
The #MDCG has released a new guidance regarding integration of UDI within the company’s QMS. This indicates the manufacturer must create and establish UDI-complaince related processes, considering UDI assignment, product traceability, UDI links to quality records, and how to add UDI information to EUDAMED.
đź”— Source Document : https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-19_en.pdf
#MDRG #mdrguide #IVDR #MDR #medicaldevices #ec