Technical report · EUDAMED · UDI · MDR / IVDR
Master UDI-DI in EUDAMED: which products manufacturers must register now – and which ones not yet Since 28 May 2026, the first four EUDAMED modules have become mandatory. At the…
Category Technical article
Key Dates: UDI Requirements in Australia
New Schedules for Unique Device Identification (UDI) in Australia The Australian Therapeutic Goods Administration (TGA) has announced the binding timetables for the implementation of the UDI requirements. The UDI system…
Master UDI: The next level of medical device identification
The introduction of the Medical Device Regulation brought about a significant change: the assignment of Unique Device Identifiers (UDIs) for medical devices.This step has been taken to improve the identification,…
New EUDAMED FAQ
New EUDAMED FAQ: Comprehensive Answers to Your Questions About the EU Medical Device Database We are pleased to announce that we have expanded our website with a new, comprehensive FAQ…
Efficient transparency for safe medical devices: EUDAMED Packaging in the EU
The importance of the EUDAMED packaging system for the regulation of medical devices in the EU The EUDAMED packaging system is an indispensable part of the broader EUDAMED system, which…
UDI Compliance (Audit-Trail & Compliant Software)
UDI Compliance (Audit-Trail & Compliant Software) The implementation of the UDI system worldwide poses a challenge for manufacturers to comply with Unique Device Identification regulations. These obligations are multifaceted and…
UDI barcode & correct UDI labelling
UDI Barcode & Correct UDI Labeling Identification and traceability of medical devices are crucial factors for patient safety and efficiency in the medical device industry supply chain. In this context,…
“Maximum number of reuses of device” in EUDAMED
"Maximum number of reuses of device" in EUDAMED The implementation of Unique Device Identification (UDI) means that medical device manufacturers are obliged to provide health authorities such as the EUDAMED…
“Market Information”: Meaning and Integration in EUDAMED
"Market Information": Meaning and Integration in EUDAMED The implementation of Unique Device Identification (UDI) means that medical device manufacturers are obliged to provide health authorities such as the FDA or…
Significant EUDAMED Update: New Timeline
Significant EUDAMED Update: New Timeline Heads up, everyone! There's been a shift in plans. EUDAMED's full functionality is now slated for Q2 2027. In late October 2023, the European Commission…