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Quick Insights from our experts on the EC Proposal concerning the IVDR transition and proposed MDR/IVDR amendment, possibly affecting the EUDAMED rollout. These are short segments created from our latest presentation, prepared exclusively for UDI customers.
Start the year with clean data and a firm understanding of what you must do for EUDAMED UDI compliance in 2024. UDI compliance readiness can be confusing. To help, we’ve gathered top tips from expert Gary Saner regarding upcoming milestones in the EUDAMED roadmap.
In recent news, Reed Tech became the first company to submit a device record (machine-to-machine) to the AusUDID Pre-Production system successfully.
By submitting product data to health authority databases, the medical device industry can help ensure the safety and traceability of devices. One crucial element is the European Commission/EUDAMED-specific concept of Basic UDI-DI.
The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project.
Explore the significance of the AusUDID rollout, its objectives, and how the TGA requirements for UDI differ from FDA regulations.
EUDAMED UDI Compliance is a critical aspect of the European Medical Device Regulation (MDR) that requires...
The Food and Drug Administration (FDA) has implemented the Unique Device Identification (UDI) system to enhance...
What are the potential consequences for medical device manufacturers not following through with product data...