Fundamental to the use of UDI is to understand the basic terminology and acronyms used.
UDI is Unique Device Identification.
- UDI-DI relates to Device Identifier
- UDI-PI relates to Production Identifier
But what does all this mean and what are the implications to manufacturers?
Provide Traceability of Device
The UDI system attempts to provide traceability of device from point of manufacture and through the supply chain such that any device placed on the market can be interrogated via the UDI database and be fully traced back to point of origin.
To that end, information related to its production, labeling, packaging and storage has to be fully transparent.
Designate Responsibility
To facilitate these requirements, the Commission will designate responsibility to selected “entities”, (an organization with legal rights and duties), to manage and assign UDIs within the design criteria stipulated by the regulations.
Throughout its Life Cycle
The system put in place for assignment of UDIs must be capable of identifying and tracking all devices throughout its life from manufacture to distribution to use. The system must be made accessible for review by interested parties (users).
There are key obligations in managing the system:
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- The system must be operational for a period of at least 10-years
the manufacturer shall keep an up-to-date list of all UDIs that have been assigned
- Both economic operators and health institutions must maintain a register of UDIs for devices they have supplied or received – at the very minimum for class III implantable devices, but ideally all
- The information related to UDI assignment must be made available to the Commission and Member States upon request
- The system must be compliant and remain in compliance with the criteria for designation
The UDI Carrier [Automated Identification for Data Capture (AIDC) and human readable interpretation (HRI) representation of the UDI] shall be on the label or on the device itself and on all higher levels of device packaging. This excludes shipping containers.
The US system allows the manufacturer to affix either the AIDC or the HRI, but the European Commission require that both readable systems are applied to devices and packaging.
Exception if Device Too Small
The only exception to the rule is if the device is too small in which case only one shall be applied to the device but both applied to the packaging.
Basic UDI-DI shall appear on the EU Declaration of Conformity.
The UDI will be used to report serious incidents and field safety corrective actions.
The Commission may, from time-to-time, make amendments to classifications and procedures related to the use of UDI.