The UDI System
The unique device identification, UDI, is used to ensure identification and traceability of medical devices, including in vitro diagnostic medical devices, throughout the supply chain and their life cycle.
This excludes custom-made and investigational devices.
UDIs are generated according to global standards. Issuing entities operate systems which allow UDIs to be created in accordance with these standards.
Assignment and Labeling
Responsibility for assigning UDIs lies with manufacturers or the persons assembling systems or 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 labeling, as well as to all higher packaging levels.
The requirements concerning assigning, labeling, and registration of UDIs for medical devices, including in-vitro diagnostics are laid down in Articles 17, 53, 54, 65, and 104 of the Medical Devices Ordinance (MepV), and Articles 16, 46, 47, 58, and 85 of the In Vitro Diagnostic Devices Ordinance (IvDV).
UDI Database
UDIs are used for product registration in central UDI databases. In Switzerland, this is the Swiss database for medical devices, swissdamed. Manufacturers, authorized representatives, and persons who assemble systems or 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 individualized devices, allows to avoid unnecessary complexity of the data entered into swissdamed without compromising identification and traceability of these devices. - Direct Marking DI or Unit of Use DI
If a UDI-DI is directly marked on the device (Direct Marking DI), it must also be registered in swissdamed.
To denote the unit of use, a Unit of Use DI can be registered in swissdamed if the UDI is not labeled at the level of its unit of use. - UDI-PI
The UDI-PI (UDI production identifier) of a device is not registered in swissdamed. Only the type of UDI-PI is indicated (for example, whether a serial number, batch number, manufacturing date, or expiry date is used).
Triggers for Assigning New UDIs
Certain data elements of a UDI-DI cannot be modified after registration in swissdamed (non-updatable fields). In order to change these data elements, a new UDI-DI or Basic UDI-DI must be assigned and registered in swissdamed. swissdamed follows the EUDAMED approach and does not introduce any additional non-updatable fields.
UDI Issuing Entities
UDIs from the following issuing entities can be uploaded to swissdamed:
- GS1 AISBL
- Health Industry Business Communications Council (HIBCC)
- ICCBBA (International Council for Commonality in Blood Banking Automation)
- Informationsstelle für Arzneispezialitäten – IFA GmbH
These are the same issuing entities designated for EUDAMED. In addition, EUDAMED DI and EUDAMED ID assigned according EUDAMED requirements can be uploaded to swissdamed when the functionality for registering legacy products is operational.
Registration of Systems and Procedure Packs
Basic UDI-DIs and UDI-DIs for systems and procedure packs in accordance with Article 11 MedDO can only be uploaded to swissdamed by actors registered as persons who assemble systems and procedure packs (PR) or their mandates.
An exception applies to systems and procedure packs considered devices in their own right, according to Article 11, paragraph 3 MedDO. These must be uploaded to swissdamed by actors registered as manufacturers (MF) or their mandates.