- The European Commission has designated four supply chain standards organizations as issuing entities for unique device identifiers.
- Three of the organizations — GS1, the Health Industry Business Communications Council (HIBCC), and the International Council for Commonality in Blood Banking Automation (ICCBBA) — are also FDA-accredited to operate a system for assigning UDIs. A fourth agency, Informationsstelle für Arzneispezialitäten, was selected as a UDI-issuing entity in Europe.
- The four organizations will support implementation of unique device identification systems under the new EU Medical Device Regulation and In Vitro Diagnostics Regulation.
The European Union overhauled its regulations for medical devices and in vitro diagnostics in 2017 to tighten controls for safety and performance and establish new standards to reflect the technological and scientific advancements of the past two decades. After a transition period, the overhaul is set to go into effect in 2020 for medical devices and 2022 for IVDs.
A key component of the new rules is creation of an identification system based on unique device identifiers to improve product traceability.
Similarly, FDA released a final rule in 2013 requiring that medical devices distributed in the U.S. carry unique device identifiers. The system, which is being phased in over seven years, establishes a way to identify and trace a device from manufacturing through distribution to patient use.
Late last year, the agency issued a guidance document updating its policy for Class 1 and unclassified devices. The agency said it does not intend to enforce UDI direct mark requirements until Sept. 24, 2022, for devices whose compliance date is Sept. 24, 2020, with the exception of life-supporting or life-sustaining devices.
By enabling quick and definitive identification of a device, UDIs are expected to help reduce medical errors and facilitate accurate reporting of adverse events. In the U.S., product information must be submitted to the FDA’s Global Unique Device Identification Database (GUDID). The rule also requires that dates on medical device labels conform to a standard format.
FDA in April issued guidance on the use of UDIs by products that package two or more devices together and draft guidance on the form and content of UDIs. President Donald Trump's 2020 proposed budget includes the FDA's backing for adding unique device identification in claims data, a move some argue will improve patient safety.
The new EU regulations call for the UDI number to be applied to the medical device label, packaging or the device itself. Required product data must be submitted to Eudamed, the European Database on Medical Devices that will aid enforcement of the safety and performance requirements of the regulations.