The Unique Device Identification (UDI) system is already applicable in the Unites States as well as in South Korea and has also come into effect as part of the European Medical Device Regulation (MDR) since May 2021. Many more countries (e.g. Saudi Arabia, Australia) around the globe are to follow and your UDI-project will extend to an ongoing UDI-program.
In case you are active in more than one market, your UDI setup must be able to cover the requirements of various regulatory authorities in order to submit Product Master Data to UDI databases worldwide. Master your UDI challenge with one single platform – start to ensure compliance with FDA and EU MDR with our pre-configured Content Packages for UDI Platform and extend to other countries/regions at any time!
