by Innovit Corporate Affairs | Sep 4, 2021 | Blog, Eudamed
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...
by Innovit Corporate Affairs | Oct 28, 2020 | Blog, Eudamed
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...
by Innovit Corporate Affairs | Sep 23, 2020 | News
San Francisco, CA (September 23, 2020) Innovit, a global software company specializing in UDI compliance, Global Data Synchronization (GDSN), Master Data Management (MDM) and Product Information Management (PIM) solutions, has announced today that B. Braun Medical...
by Innovit Corporate Affairs | Sep 8, 2020 | Blog, Eudamed, GUDID
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...
by Innovit Corporate Affairs | Mar 10, 2020 | Blog, Eudamed
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...