EUDAMED Implementation and Roll-Out Timeline Update

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

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...

EUDAMED: Regulation News & Updates

The European Commission recently announced last November that the new EUDAMED will not launch until May 2022, even as the MDR takes effect in May 2020.  While the delay in EUDAMED certainly give us more time before we must submit information to the database including...