Med Device Link Newsletter - Dec 2023
LexisNexis Reed Tech
Regulatory compliance and product data management solutions for medical device manufacturers and pharmaceutical labelers
Seasons greetings! With the holiday season in full swing, things can get hectic. We want to remind you that we are here to help you stay up-to-date with the latest UDI requirements. If you require assistance updating your FDA GUDID records or preparing for UDI submissions to global health authorities, please do not hesitate to contact us via email at [email protected].
Industry News & Blogs
Reed Tech Submits First M2M UDI Submission to the AusUDID Pre-Production System
In recent news, Reed Tech successfully submitted a device record (machine-to-machine) to the AusUDID Pre-Production system.
Update on EUDAMED Timeline
The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project. This blog covers the most recent updates to the EUDAMED timeline.?
Understanding Basic UDI-DI in EUDAMED EUDAMED
Unique to the European Commission and EUDAMED, Basic UDI-DI is a product group identifier for related medical devices, like a ‘family’ of devices.
Reed Tech Insights
Intro to EUDAMED Basic UDI DI
Get a definition of EUDAMED Basic UDI-DI and how it differs from EUDAMED ID.
Basic UDI GS1 Implementation Example
See an example of a EUDAMED Basic UDI-DI implemented per GS1 standard. Basic UDI-DI must be assigned by May 26, 2024, in order to engage with a Notified Body.
Questions? Ask the Experts
If your team has questions about health authority requirements, device classes, Unique Device Identification (UDI) data attributes, or related topics, get in touch! Our elves are ready and happy to help.