What is a Unique Device Identifier (UDI)?
Unique Device Identifier (UDI) is a globally unique series of characters for each medical device on the market to:
- Unambiguously identify a device for patient safety
- Improve medical device traceability in the supply chains
The Unique Device Identifier of a medical device typically includes two parts:
- Device Identifier (DI): a code specific to the model of the device that is used as the access key to data stored in the UDI repository/database.
- Production Information (PI): a code that identifies the unit of device production including serial number, lot/batch number, Software as a Medical Device (SaMD) version, and manufacturing and/or expiration date.
History of UDI
The first concept of UDI was signed into US law and added as part of the FDA Amendments Act of 2007 to establish a unique device identification system and implementation timeframes for medical devices. The UDI Proposed Rule, published in 2012, was developed based on input from manufacturers and global regulatory bodies, as well as patient advocates and the clinical community.
2013 was a milestone year for UDI of medical devices – the European Commission released a framework for a UDI system in April, the FDA published the UDI Final Rule in September, and the International Medical Device Regulators Forum (IMDRF) published a guidance document on UDI in December. The IMDRF guidance document provides a framework for regulatory authorities to develop UDI Systems with a globally harmonized approach.
In 2014, the US FDA published a guidance document on the use of their Global Unique Device Identification Database (GUDID).
The EU adopted the UDI in 2017 under the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR), implemented in 2021. The European Databank on Medical Devices (EUDAMED) is the repository of information on the lifecycle of medical devices that are made available in the European Union (EU).
In late 2020, the Australian Government announced it will establish a UDI system to better protect patient safety by allowing for tracking and tracing of especially implanted medical devices in order to quickly respond to any safety issues, and to strengthen Australia’s post-market medical device adverse event system.
In February 2021, the TGA issued an amendment to the Therapeutic Goods Act 1989 regarding the establishment of the Australian Unique Device Identification Database (AusUDID).
Proposed UDI System in Australia
Australia plans to adopt the fundamental concepts of a globally harmonised UDI system as outlined by the IMDRF while also taking into consideration UDI systems currently in use globally. There have been two consultations to date on Australia’s UDI System and the following has been proposed:
The Australian UDI database (AusUDID) will be administered by the Therapeutics Goods Administration (TGA). The TGA is proposing to store only static information in their database such as:
- Device information
- Global Medical Device Nomenclature (GMDN)
- Brand name
- Software version (for SaMD)
- Reference/Catalogue number
- How the device is controlled i.e., indication of the information on the device label
- Date of discontinuance
- Clinical characteristics
- Clinical size e.g., volume, length, gauge, diameter
- Storage and handling conditions
- Critical warnings or contraindications
- Number of reuses
- Packaged as sterile/non-sterile
- Need for sterilisation before use, and method of sterilisation if applicable
- Manufacturer information
- Manufacturer’s name and address
- Manufacturer’s customer service contact
- Sponsor’s name, address, contact phone and email
- Supply chain information
- Package type
- Quantity per package
Dynamic production information, and patient information, will only be held by hospitals, registries, etc. and will not be stored in the TGA database.
The UDI will be issued to the manufacturer by an issuing agency, such as GS1, the Health Industry Business Communications Council (HIBCC) or the International Council for Commonality in Blood Banking Automation (ICCBBA).
The manufacturer will be responsible for placing the UDI labelling on all levels of medical device packaging, and for providing UDI information to the Australian Sponsor. It is not yet confirmed whether the Manufacturer or the Sponsor will be responsible for submitting the UDI data into the database.
There will be a publicly accessible version of the UDI database that can be downloaded and used by anyone requiring to identify a medical device e.g., consumers, healthcare organisations, research organisations etc.
What about the existing Global Medical Device Nomenclature (GMDN)?
The Global Medical Device Nomenclature or GMDN is used by other regulators and has been a part of the Australian regulatory framework since 2002. It is a standard for naming and grouping medical devices, which includes a term name, a 5-digit code and a definition.
There are plans to incorporate GMDN into the UDI system as the former is included in the IMDRF UDI Guidance and is also currently included in the Australian Register of Therapeutic Goods (ARTG).
What’s next for the Australian UDI System?
The TGA is still in the planning stages for the Australian implementation and has not yet defined the new regulations, regulatory dates, or the transition approach. The following areas are still under consideration:
- Global alignment (US or EU), including what changes in data elements would trigger new device identifiers
- Global medical device nomenclature (GMDN) and alignment with the ARTG
- UDI data to be stored on the database
- Data submission responsibilities
In September 2021, the TGA will be presenting their progress on the AusUDID to the IMDRF and Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association (DITTA).
For more information on the consultations on the Australian UDI System, check out the TGA website.