EUDAMED is the IT system established by Regulation (EU) 2017/74) on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices and developed by the European Commission. A device identification system based on a unique device identifier (UDI) allows easier traceability of medical devices.
Really, EUDAMED and UDI are in essence quite straightforward concepts. But the grouping of devices into Basic UDI-DI device families is essential to make your registrations work, and also for organizing the technical documentation of your full portfolio. Companies that seek confirmation regarding their grouping, can reach out for a short check. This can best be setup by a limited ad hoc budget.
If you want to see how to group devices into device families, see here for a Tip of the Week about the importance of device groupings, here for the strategic considerations regarding the Basic UDI-DI groupings and here for information about UDI in relation to systems and procedure packs.
