Now that we know more about the what and why of UDI let’s understand the where, who, and “now what.”
Placement of a UDI carrier on a medical device: The UDI can be placed on the device package through multiple means, e.g. Printing, Marking, Radio Frequency Identification (RFID). On the device itself, direct marking is preferred for reusable devices to place the UDI. A variety of methods exist for applying direct marking including both intrusive methods (i.e., dot pin, etching, direct laser marking, etc.) and non-intrusive methods (i.e., cast/forge/mold, laser bonding, stencil, permanent adhesive label, etc).
Regardless of where the UDI is placed or which technology is being used, it’s important for device and packaging manufacturers to ensure that the UDI is readable for the expected service life. Placing the UDI on the label or the device itself does not create any negative impact on the benefit-risk ratio of the device, and there is no negative impact on the stability, biocompatibility, and effectiveness of the device.
Harmonization of UDI guidelines around the world: Multiple jurisdictions have established or are in the process of considering UDI system implementations for better traceability of medical devices. The EU (under the new EU MDR), the US FDA, Japan, China, Saudi Arabia, and South Korea have all already published UDI regulations. Similar regulatory requirements are under consideration in countries such as Australia, Canada, Singapore, and India.
The harmonization of UDI guidelines among different regulatory jurisdictions worldwide has been a challenge and significant variance has been introduced in the specifications of jurisdiction-specific UDIDs to meet health system requirements. There is a key role played by the International Medical Device Regulators Forum (IMDRF) in harmonizing the UDI regulations. IMDRF has organized multiple cross-jurisdiction workgroups and produced five UDI guidance documents since 2013 to promote more consistency in global labeling requirements.
The fundamental elements of a harmonized UDI system according to the ‘Unique Device Identification system application guide’ published by IMDRF includes:
Developing a standardized system of UDIs;
Placing UDIs in human- and machine-readable formats on package labels or the device;
Submitting core UDI data elements to a unique device identifier database (UDID); and
Setting up “transitional and implementation arrangements” to ensure smooth implementation of the UDI system.
Storing device information: A UDI database? According to the ‘Unique Device Identification system application guide’ of IMDRF, the Unique Device Identification Database (UDID) is a designated source for device identification information. The UDIDs, under different regulatory jurisdictions, are designed as a central medical device master database containing all essential information to devices in the jurisdiction, freely and effectively accessible to all stakeholders of the healthcare sector. The UDI databases include the entire package level hierarchy of a medical device (i.e., unit-of-use, base package, higher package levels), and the hierarchy should be linked to a specific device and provide a parent-child relationship structure. The device manufacturers are responsible for the initial submission and updates to the information in the UDID. (US FDA Medical Device UDI Database ) ( EU Medical Device Database)
UDI issuing entities: The globally accepted ISO/IEC UDI standards are implemented by global organizations, known as UDI issuing agencies/entities, such as GS1, HIBCC, and ICCBBA. These organizations have responsibility for maintaining the global uniqueness of their coding systems and the criteria of the UDI and manufacturers shall be permitted to choose which system to use.
Now what? Establishing the fundamental elements of a UDI system requires that all relevant parties have a clear understanding of their role to achieve the UDI system goals. Regulatory authorities that intend to establish a UDI system are responsible for establishing the basic regulatory requirements and vision for the UDI as a global standard. Issuing agencies/entities accredited or recognized by regulatory authorities are responsible for defining the general UDI specifications based on relevant international standards. Manufacturers are responsible for creating and maintaining globally unique UDIs for their medical devices by following the issuing agency’s specifications. Distributors, importers, retail pharmacies, healthcare providers and users significantly contribute to enhance the potential of the UDI as a key standard to facilitate adequate device identification through distribution and use with patients.