Australian Unique Device Identification (UDI) Framework: Medical Device UDI Implementation, Essential Principles Guidance

Australia is establishing a unique identification system for medical devices and its regulator, the Therapeutic Goods Administration (TGA) issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles for compliance requirements and guidelines for active medical devices.

The Australian Therapeutic Goods Administration (TGA) has set up a technical working group to help define the specific UDI labeling and data submission requirements, which is expected to take effect in January 2023.  Mandatory compliance, however, will likely not go into effect until the following year.

Last week the TGA published a third consultation paper seeking stakeholder feedback on the regulator’s proposed UDI framework.  TGA proposals include:

• Accepting device labels already compliant with US FDA as well as EU Commission labelling requirements;
• Phased UDI implementation approaches according to the risk classification of devices;
• Regulatory scope and exemptions;
• Data submissions and maintenance;
• Labeling and documentation requirements;
• UDI Adoption and application in healthcare system settings

Background

In October 2020, the Australian Government announced that it would strengthen patient safety through the establishment of an Australian UDI system for medical devices.  In February 2021, changes were made to the Therapeutic Goods Act to provide for collection of UDI data in an Australian UDI database (AusUDID), the creation of regulations to support collection of UDI data, and changes required to device labelling.  The Therapeutic Goods Administration will establish and maintain supporting infrastructure (the UDI database, data collection, and regulations around labelling requirements).

The potential benefits of adopting unique device identification for patients, healthcare providers & hospitals, industry and regulators include:

• Easier identification of medical device models
• More accurate recording and analysis of adverse events
• Faster and more accurate identification of device problems and more effective management of device recalls
• Standardized recording of devices in electronic health records, clinical information systems, registries, supply chains and reimbursement processes
• Better international device information sharing and management of global distribution chains.

The TGA has created a hub for Unique Device Identification (UDI) system for medical devices. 

This hub brings together information about the Australian Unique Device Identification system under the following headings and will be updated on a regular basis to ensure that all content is current and relevant:

• Strengthening patient safety
• Benefits to consumers and industry
• Progress to date
• Communications and stakeholder engagement
• News and updates

What is the UDI system for medical devices?

It is:

• a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard, which is applied to a specific model of medical device.
• comprised of both device information and production information.
• applied to the device label and all levels of packaging for that device in both machine-readable format (such as a barcode) and human-readable formats (such as a GTIN or HIBC code).  It allows for unambiguous identification of a specific model of each medical device on the market. 
• used as the ‘access key’ to information stored in the Australian UDI Database (AusUDID) and is the data that allows for linking of device information across other systems such as registries, and in a patient’s My Health Record.

When the UDI system is fully implemented, the label of most devices will include a UDI in both a human and machine readable form.  Globally harmonized, core data about medical devices will be made available to the public through the Australian UDI Database (AusUDID).

Why is the TGA establishing a UDI system for medical devices?

The TGA is establishing a UDI system for medical devices in order to strengthen patient safety.  This will be enabled by the UDI system to:

• Allow for tracking and tracing of medical devices including those that have been implanted in patients.  This will enhance the ability for doctors to notify patients quickly if there is a safety issue with a medical device. 
• Enable other reforms designed to improve the effectiveness of pre-market assessments of medical devices and management of post-market safety-related activities. 
• Become the unique identifier used in the context of business and clinical transactions e.g. in discharge summaries, patients’ records, registries, clinical notes and records, purchase orders, invoices, inventory maintenance/ management. 

What is the implementation timeframe for the UDI?

The TGA is in its early planning stages for UDI implementation and has not yet defined new regulations, regulatory dates or the transition approach.

On the basis that many device manufacturers supply to multiple markets and are in the process of preparing to meet the new European Union (EU) regulations, Australia does not plan to implement before the EU dates.

What guidance was issued on TGA Essential Principles compliance?

Australian regulators have issued new guidance on Essential Principles, which are legislative requirements regarding medical device (MD) and In Vitro Diagnostic (IVD) safety and performance.  Although online content related to Essential Principles remains under development, the TGA has published information on the following:

• Principle 1 on medical device use that does not compromise health and safety;
• Principle 2 on conformance of device design and construction to safety principles;
• Principle 9 on device construction and environmental properties;
• Guidance on demonstrating compliance with Essential Principles

More information can be found here.