FDA Issues Final Guidance on UDI Compliance Requirements and Extends Enforcement Deadline

Q&A: Is GDSN a Viable Option to Submit Data to EUDAMED?

by | Sep 4, 2021 | Blog

EUDAMED timelines are quickly approaching, and UDI data preparation is no easy task.   Preparing early with a master data strategy will make all the difference when mandates for EUDAMED and other health authorities come due.  A large component of that strategy centres...
EUDAMED Implementation and Roll-Out Timeline Update

EUDAMED Implementation and Roll-Out Timeline Update

by | Sep 4, 2021 | Blog

The European Commission recently sent out an update on the plan for implementation and roll-out of EUDAMED, as it stands today. Changes to the implementation timeline of different modules, and how they will affect the application of each aspect of MDR are outlined...

EUDAMED: Playground Testing Update

by | Oct 28, 2020 | Blog

EUDAMED go-live date is still scheduled for May 2022.  In order to ensure a smooth and effective implementation, the EU COM is providing a “EUDAMED playground” available for both manual web‑based user access and an automated M2M (machine‑to‑machine) Data Exchange for...