EU selects unique identifier issuers for medical devices

Phil Taylor, 12-Jun-2019

Four organisations have been accredited as issuing agencies for the unique device identifiers (UDIs) that will be used to track medical devices through the supply chain in Europe.

Standards group GS1, the Health Industry Business Communications Council (HIBCC), blood banking association ICCBBA and IFA GmbH – an information service provider for the pharmaceutical market – have been listed as the approved issuing entities in the Official Journal of the EU.

The UDI provisions are part of the EU Medical Device Regulation (MDR), a new set of regulations that covers the production and distribution of certain medical devices in Europe, and is mandatory for companies that want to sell their products in the European marketplace.

The MDR mandates UDIs to give devices a unit-level identity that will facilitate the traceability of product sold in the EU, making it easier to carry out recalls, reduce medical errors, increase the visibility of inventory and improve the security of the supply chain from infiltration by counterfeit, diverted or stolen products.

As a reminder, manufacturers selling devices into the EU will have to ensure that a UDI is assigned and registered in the European Database on Medical Devices (EUDAMED) for every item introduced into the market by May, 26, 2020.

From 26 May, 2021, mandatory UDI coding onto devices starts, initially for class III products (e.g. implantable pacemakers, pulse generators, HIV diagnostic tests, automated external defibrillators, dental implants and extended-wear contact), with a progressive roll-out in other product categories until 26 May, 2027.

The four entities are “designated to operate a system for assignment of UDIs” in accordance with the MDR and for a period of five years from June 27, 2019, which can be renewed.

GS1 said in a statement that it has been accredited as UDI issuing agency by the US FDA since 2013, adding that other regulators are also planning to allow the use of GS1 standards as the basis of their national UDI system.