by Innovit Corporate Affairs | Jul 29, 2022 | Blog, Michelle Laurion
On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The guidance document, “Unique Device Identification: Policy Regarding...
by Innovit Corporate Affairs | 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...
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 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 | Nov 25, 2019 | Blog, Eudamed
The European Commission recently announced that the new EUDAMED will not launch until May 2022, even as the MDR takes effect in May 2020. Given this postponement, we now have the opportunity, and sufficient time, to properly prepare for implementing M2M data...
