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A government shutdown forces the FDA to scale back operations, delaying new drug and device approvals and slowing healthcare innovation. Learn what continues, what pauses, and why prolonged disruptions matter for patients and providers
The European Commission (EC) has missed a key milestone in the rollout of EUDAMED, the central database for medical devices in the EU. According to the previously published timeline, EUDAMED was expected to be declared “fully functional” by July 1, 2025. However, with that date now passed and no notice published in the Official Journal of the European Union (OJEU), the official timeline remains unmet.
As part of ongoing enhancements to streamline data exchange and compliance processes, the ESG NextGen platform is preparing to go live this spring. We’re sharing a quick overview of the key milestones and what they mean for you especially as we approach the submission blackout period from April 12 to April 14, 2025.
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.
The Australia Therapeutic Goods Administration (TGA) has announced several updates to the go-forward plan for implementing UDI compliance News of note: • TGA has announced that they will have a similar model to the FDA, adopting some elements of the EUDAMED model• A...