The International Medical Device Regulators' Forum (IMDRF), the regulators-only medical device harmonization group, has released a long-awaited major medical device proposal for industry comment regarding a Unique Device Identification (UDI) rule.
IMDRF launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), which disbanded in December 2012 after its device regulatory members decided to split off and form their own group without the involvement of industry.
At present, organizations involved in the IMDRF include the US Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), Brazil's National Health Surveillance Agency (ANVISA), Health Canada, the European Union (EU), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and the Asian Harmonization Working Party (AHWP). At IMDRF's 19-21 March 2013 meeting, it was also announced that China had become a full member, and that Mexico had been invited to participate as an official observer, potentially clearing the way to later join the organization.
Since its launch, IMDRF has been moving forward in a number of product areas, the most notable of which may be the UDI proposal.
A UDI is a labeling or marking standard by which regulators can keep track of a product-a sort of track-and-trace method for medical devices that allows anyone to determine from where a product originated and other information about a device. In addition, a UDI system is able to provide other benefits, such as allowing for the creation of a device registry to track the safety and efficacy of various products.
Several countries and regions, including the US and the EU, have been looking to implement a UDI proposal. In a separate statement to Regulatory Focus in early April 2013, FDA's Jay Crowley, senior adviser for patient safety at CDRH, noted that all countries involved in the UDI process are "well aligned."
"We continue to work in the IMDRF working group on UDI, which includes good representation from US, EC, China, Japan and others," Crowley added.
In an update last week, IMDRF said its "work on the revised Unique Device Identification Draft Guidance 2.0 on labeling specifications is progressing," and that it anticipates having a document available for public consultation at some time in the "near future."
IMDRF's UDI Guidance
That "near future" evidently meant next week, as the IMDRF has just announced the release of that proposal, which replaced the Guidance on a UDI System for Medical Devices document issued by the GHTF in September 2011.
The new UDI System for Medical Devices guidance provides "non-binding rules for use in the regulation of medical devices," IMDRF explained.
"This guidance provides a framework for those regulatory authorities that intend to develop their own UDI systems - such that, when implemented, it achieves a globally harmonized approach to UDI," the group continued. "It is expected that the regulatory authorities will follow the guidance when developing their own UDI requirements."
The hope, IMDRF said, is that UDI systems around the globe will be highly interoperable, allowing for the exchange of data on devices as they move throughout various regulatory systems and supply chains. "In order to reach the goal of a globally harmonized UDI System, it is critical that these systems are implemented without regional or national differences," it added.
IMDRF said the basic tenets of a harmonized UDI system should include eight components:
- The UDI and UDI Carrier are based on global standards.
- A UDI applied to a medical device anywhere in the world should be able to be used.
- It should meet the UDI requirements of any regulatory authority globally.
- National or local identification numbers should NOT be a substitute for UDI.
- Regulatory Authorities should not specify how to modify these standards.
- The UDI Database (UDID) core elements should not be modified.
- The UDID should use the Health Level 7 (HL7) Structured Product Labeling (SPL) for data submission.
- Each medical device needs to be identified by a UDI.
All stakeholders involved in the distribution and use of a device will be required to "capture and store" the UDI, though the guidance does not state for how long. IMDRF said this should assist in recalls and in preventing the proliferation of counterfeit medical device products.
The guidance also calls for the facilitation of adequate identification through the use of a "single global identifier that can be used to link and integrate existing government, clinical, hospital and industry databases."
That identifier should be globally unique to the particular device to which it is affixed or otherwise associated, and should not be changed unless the device is re-processed, re-manufactured or re-labeled as a new medical device.
Three Systems: GS1, HIBCC and ICCBBA
Three UDI systems were specifically identified by IMDRF as being acceptable for labeling use: the Global Standards One (GS1), Health Industry Business Communications Council (HIBCC) and the International Council for Commonality in Blood Banking Automation (ICCBBA) standards. All "meet the criteria of the UDI and manufacturers shall be permitted to choose which system to use," largely depending on which type of device they manufacture.
The standards' identifying identifications would need to be affixed to the device itself or the package, with higher levels of packaging also required to have a UDI. Shipping containers, however, would be exempted from the requirement.
The UDI is also composed of two parts: the Device Identifier (DI) and the Production Identifier (PI). The requirements for both are extensive and listed within the guidance, but mostly pertain to the information that must be included among the core data elements.
Specific requirements are also in place for various unique device types, including in vitro diagnostics, implantable devices, reusable devices, device software, kits and configurable medical device systems.
The guidance may be found here.