Unique Device Identification – UDI
What is the Unique Device Identification system?
The unique device identification (UDI) system is a global initiative of the International Medical Device Regulators Forum (IMDRF) that aims to provide a single, globally harmonized positive identification system for medical devices. To facilitate this identification, the system requires a globally unique device identifier in a standardised format together with a database.
What is the Unique Device Identification – UDI?
The unique device identification, as described in the IMDRF guidance documents, is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows for the unique identification of a specific medical device.
What makes up the UDI?
The UDI is comprised of two parts:
- the Device Identifier (UDI-DI)
- the Production Identifier (UDI-PI)
The UDI-DI is a fixed element that identifies a manufacturer’s specific product and package configuration. It is also used to identify the specific device in a UDI database.
The UDI-PI identifies the unit of device production when any of the following are included on the package label of the device:
- lot/batch number
- serial number
- expiration date
- manufacturing date
- software version
- Distinct Identification Code (for human origin products).
Where does the UDI appear?
The UDI must be included on the labelling of the medical device. For ease of use, the label of most devices will include a UDI in human and machine-readable forms.
The UDI-DI part of the UDI, which identifies a manufacturer’s specific product and package configuration, is used to register the device in databases that are specific to the market on which the device is available.
Each country specifies the details of the device that a manufacturer or distributor must provide when registering the device in the database. Thereafter, it is the manufacturer’s/distributor’s responsibility to keep the information in the database up to date.
Examples of Databases
Each medical device on the market in a specific region must be registered in the relevant regional database for the market on which the device is available. These databases are usually accessible to the public. We list examples of these databases in the EU, the US and China.
EUDAMED will be a multipurpose system, functioning as a registration system, a collaborative system, a notification system and a dissemination system (also open to the public) and will be interoperable. The aim for EUDAMED is that there will be more transparency about medical devices that are available on the EU market during the entire lifecycle of the device.
AccessGUDID is a searchable database of device identification information, such as the device identifier on the label, the device name, the manufacturer’s name, the MR safety status, and premarket submission numbers. AccessGUDID is accessible to anyone, including patients, caregivers, health care providers, hospitals, and industry.
China (UDI Database)
In China, UDI Database was launched on 10 December 2019. The UDI-DI information on the UDI database will be accessible to the medical device distributor, medical institutions, authorities and the public. The UDI database will allow any party to identify and track a medical device according to its UDI throughout its entire life cycle.
What is the UDI used for?
The UDI is needed for registration of the company and the product in databases of medical devices, required before placing a device on the market. Besides for registration purposes, the UDI is meant to provide traceability in the databases for reporting serious incidents and for describing field safety corrective actions concerning specific medical devices.
Where can I get a UDI?
The UDI is obtained by registering with the official designated entity for the market on which the device will be placed. The designation of the official entities is done by the regulatory authority controlling the market (e.g. European Commission in EU, FDA in the US, NMPA in China).