Are you tracking all the news about the latest developments for EUDAMED requirements? We are too! We continue to add insights concerning what to expect as EU UDI/EUDAMED requirements are published. For your quick reference and documentation, we have created a list of the current data elements for both US FDA GUDID and EUDAMED.
If your team is evaluating a EU UDI solution strategy (building, buying or renting a solution) or trying to figure out software development and resolve issues with data anomalies and business rules, keep Reed Tech in mind. For medical device manufacturers, we provide UDI specific solutions, services and expertise, reducing the internal burden in navigating the required business rules for validating, managing and submitting to regulatory agencies.
Reed Tech will roll out implementation and submission phases through 2019 in anticipation of the EU Medical Device Regulation (MDR) UDI submission deadline of May 2020.
Get in touch for an update on our progress and flexible options that may benefit your UDI product data management plan. Contact us by email: MedDevice@ReedTech.com
For your convenience, download the FDA and EU Data Element UDI Data Elements Lists.
Contained in this reference document:
- U.S. FDA UDI GUDID Data Elements
- EU MDR/IVDR EUDAMED Data Elements
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