Let us have a brief intro on what is UDI?, In short, the Unique Device Identification (UDI) consists of a code on the label of a device. The first part of this code is unique and linked to all devices of that specific type; the second part of the code is linked to the homogeneous production of devices (e.g. batch, serial number, etc.). And it has come to the knowledge that the European regulator has published the UDI guidance for a medical device.
- The Basic UDI-DI is the key identifier of a device in Eudamed, on certificates and on the Declaration of Conformity.
- Multiple UDI-DIs can be linked to a single Basic UDI-DI, while a UDI-DI must be linked to only one Basic UDI-DI.
- The UDI-DI must unambiguously identify a device in the distribution chain; any change that may confuse identification should result in a new UDI-DI.
- Manufacturers can now identify the data elements and formats for developing their databases in preparation of the introduction of UDI Guidance in Europe.
At its March 2018 meeting, the European Medical Devices Coordination Group (MDCG) endorsed guidance documents covering UDI and related issues.
The endorsed guidances pertain to UD-DI
(https://ec.europa.eu/docsroom/documents/28667) , the European UDI database
(https://ec.europa.eu/docsroom/documents/28669) , and UDI architecture
(https://ec.europa.eu/docsroom/documents/28670) , in Eudamed.
The UDI Guidance on the database provides information on the data elements and their format, while the architecture guidance places these elements in context.
