EUDAMED UDI Devices User Guide Update 📚

The June 2023 release of the EUDAMED User Guide UDI Devices included a new chapter on the registration of UDIs, updated information on the requirements for UDIs, improved clarity and readability, and a new section on the use of the UDI helpdesk.

The new chapter provides detailed instructions on how to register UDIs in EUDAMED, and the updated information reflects the latest changes to the MDR and IVDR. The user guide has also been improved to make it clearer and easier to read. Additionally, a new section was added to provide information on how to contact the UDI helpdesk for assistance with UDI registration.

🔗 Original Document:  https://webgate.ec.europa.eu/eudamed-help/en/files/UDI%20Devices%20-%20user%20guide.pdf