MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI
Posts published in “Unique Device Identification – UDI”
IFA UDI HRI & AIDC Formats IFA Basic UDI-DI ICCBBA Basic UDI-DI ICCBBA UDI HRI & AIDC Formats HIBCC Basic UDI-DI HIBCC UDI HRI &…
MDR EUDAMED-UDI- Data Dictionary V5.0
Unique Device Identification (UDI) System – FAQs
Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs)…
The FDA issued the first warning letter for UDI violations to help ensure compliance
MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI
Medical Devices: The EU will take steps to make use of single audit reports (an initiative of the International Medical Device Regulators Forum – IMDRF) in a…
MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI