EU: Initial guidance documents on UDI implementation published
The Medical Device Coordination Group (MDCG) and the UDI working group (UDIWG) of the EU have published initial documents on the implementation of the Unique Device Identifier (UDI) in accordance with the new European regulations on medical devices (2017/745) and in-vitro diagnostics (2017/756).
A document from the MDCG explains the concept of the Basic UDI-DI and the specifications for changes to the UDI-DI. Two documents from the UDIWG outline the planned structure of the database and the defined data elements.
The documents can be downloaded from the MDCG section of the EU's guidance pages.