European Commission Releases Harmonized UDI Framework

The European Commission (EC) has announced the release of its recommendation on a framework for a unique device identification (UDI) system for medical devices marketed in the EU, bringing the country in line with similar proposals since released by the US Food and Drug Administration (FDA) and under consideration by the International Medical Device Regulators' Forum.

Background

A UDI is essentially an identifying mark by which someone-particularly a regulatory authority-would be able to trace a device throughout its supply chain from the point of manufacture to the point of use. If a problem were to be discovered, regulators could then determine from which point the problem originated (the manufacturer, the distributor, a wholesaler, etc), and determine if a greater risk to the population necessitated remediation.

The system has much in common with pharmaceutical track and trace measures, but with a key difference: While pharmaceutical products are generally intended for quick use and are entirely consumed and disposed of in short order, medical devices are generally around for far longer, either due to their durability or because they are implanted into a person.

A UDI proposal has already been released in draft form in the US, and the IMDRF is working on a similar system as well. In updates to regulators, FDA's Kimberly Trautman, associate director of international affairs at the Center for Devices and Radiological Health (CDRH), has said that the US, IMDRF and EC are all working to make sure their proposals are harmonized.

"It really isn't going to help any particular regulator if we can't exchange that information with our regulatory counterparts throughout the world," she said. Right now, Trautman said, IMDRF is "honing in" on a handful of difficult issues that she said are holding up global implementation of a unified UDI system, including software kits and "four or five" other unspecified issues.

Several other countries and regions have been looking to implement a UDI proposal as well. In a statement to Regulatory Focus, 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 said.

FDA said a draft UDI guidance is due on or about 30 November 2013.

The EC UDI Proposal

The EC's proposal takes explicit note of those harmonization efforts, explaining that "Significant efforts are being made at international level towards a globally harmonized approach on traceability and to establish a globally accepted UDI system for medical devices."

But if it takes note of those efforts, it also notes that individual EU member states could create disharmonization within the system, and urges those states to follow its newly established framework to make sure all systems work together.

"In the meantime, should Member States decide to develop their own UDI mechanisms it is essential that these are made compatible with each other and with the future UDI system of the Union," EC implored. "This is important in order to avoid the risk of incompatible and divergent systems frustrating the objectives of the internal market and to facilitate the introduction of a harmonized UDI system of the Union."

Other issues are also critical to the implementation of UDI, EC said. Namely, interoperability and safety issues related to the integration of any UDI proposal with healthcare systems, and in particular their electronic health records (EHR) and e-Health systems.

EC's UDI Framework

EC's proposal would amend Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 to require manufacturers to meet device "traceability obligations."

And those obligations, it said, are still in the works. Specifically, the UDI proposal is under development by the IMDRF, and the EC said its recommendation is "aligned to the approach developed at the international level."

That said, the UDI framework proposed by the EC is premised on five primary objectives: the improvement of adverse event reporting, facilitating recalls and corrections, assisting post-market activity by regulators, enabling database queries and reducing medical errors by monitoring misuse. EC added that other vestigial benefits, such as the mitigation of counterfeiting and improved distribution networks, would also be supported by their UDI framework.

Covered under the UDI proposal will be traditional medical devices, as well as active implantable medical devices and in vitro diagnostic (IVD) devices.

EC also said that the UDI will be based on numeric or alphanumeric characters specific to a manufacturer, device model and the production of a device unit. That should allow the UDI to be readable by humans, as opposed to a barcode-only format that is machine-readable.

The specific information contained within the UDI will also depend on the risk of the medical device in question. For Class I (low risk) medical devices, the UDI's production identifier will need to include the expiration date and/or manufacturing date. Class II (a/b) devices will need to include lot and batch numbers. Class III (high-risk) devices will need to include batch/lot numbers or a serial number. Lower-risk devices can include more information than is necessary, such as that required for a Class III device, but high-risk devices cannot include less than is required. The same identifier must be affixed to "every packing level for all classes of devices."

All information should be provided to a EU-wide UDI database as well. EC said any databases should be created using the Extensible Markup Language (XML) format as a "common format for data exchange between UDI databases."

Importers and distributors will be required to confirm many of the above details and keep electronic records, thereby allowing a product to be traced through the system.