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

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

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: Playground Testing Update

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...

EUDAMED and GUDID – What’s Changed?

The European Database for Medical Devices (EUDAMED) EU MDR, the European Union’s Medical Device Regulation is intended to support both pre-market product registration processes and post-market surveillance & vigilance activities by national regulators across the...