FDA and EU UDI Data Submission Mandates
The FDA released its UDI mandate in 2012, but other mandates are under development in Europe and around the world.
Download this chart (updated May 2019) to see what we know so far about EU UDI Data Element Requirements from:
- European Commission (EC)
- International Medical Device Regulators Forum (IMDRF)
Reed Tech approached the process by finding the best solution for my company—not the best solution for Reed Tech
Current customer, Information Services Project Manager at medical device manufacturer with over 100,000 Class III, II, and I submissions