The UDI system
The unique device identification system (UDI system) is used to ensure identification and traceability of medical devices, including in vitro diagnostic medical devices, in the supply chain and during their life cycle. This excludes custom-made and investigational devices as well as devices manufactured and used in healthcare institutions.
UDIs are generated according to global standards. Issuing entities operate systems which allow UDIs to be created in accordance with these standards
Assignment and labelling
Responsibility for assigning UDIs lies with the manufacturers or persons assembling systems and procedure packs. They are required to assign a UDI to the device, system or procedure pack, as well as to each higher level of packaging, before it is placed on the market.
UDIs must be affixed directly to the devices or their labelling, as well as to all higher levels of packaging.
The requirements concerning assignment, labelling and registration of UDIs for medical devices, including in vitro diagnostic medical devices, are stipulated in Art. 17, 53, 54, 65 and 104 MedDO and Art. 16, 46, 47, 58 and 85 IvDO.
UDI database
UDIs are used for device registration in central UDI databases. Manufacturers, authorised representatives and persons who assemble systems and procedure packs are responsible for registering UDIs in swissdamed. The device information contained in UDI databases is publicly available.
UDI elements in swissdamed
- UDI-DI and Package UDI-DI
In swissdamed, each device is registered with its UDI-DI (UDI device identifier), as well as the UDI-DIs assigned to its packaging levels (package UDI-DIs). If a device has a secondary UDI-DI from another issuing entity, this can also be registered in swissdamed.
Each UDI-DI can only be registered once in swissdamed and must be associated with a single basic UDI-DI.
For legacy devices, an exception applies: the same UDI-DI may be assigned to a legacy device and its equivalent regulation device. - Basic UDI-DI
The Basic UDI-DI is the key element for linking devices in swissdamed. Each registered Basic UDI-DI must be associated with at least one UDI-DI, and each UDI-DI can only be associated with one Basic UDI-DI. - EUDAMED DI, EUDAMED ID
For legacy devices without a Basic UDI-DI or UDI-DI, the corresponding replacement identifiers EUDAMED ID and EUDAMED DI can be uploaded to swissdamed. - Master UDI-DI
The Master UDI-DI, used for certain highly individualised devices, enables entering excessive amounts of data in swissdamed to be avoided without compromising identification and traceability.