In 2013, the European Commission recommended working toward a harmonized European standard for a unique device identification (UDI) system for medical devices. Since then, regulators and industry have been working toward a final directive on the system to provide identification and traceability of medical devices across the 28 member countries of the European Union.
That directive is expected to be released within the next year. Though much remains unknown about the specific shape the final directive will take, some aspects of the European UDI system are known, or at least able to be reasonably predicted. Here is what we know so far, and a few questions that have yet to be answered.
Timing: The European Union’s directive on UDI was tentatively expected to be released at the end of 2015, but is more likely to come early in 2016. The first compliance deadline is likely to follow one to two years after that.
Phases: Compliance deadlines are likely to be staggered according to the device risk class and type (medical device, active implantable medical device, and in vitro diagnostic medical device), similar to the timeline FDA is following for UDI in the United States. Under this phased system, higher-risk classes of devices are likely to be required to meet compliance deadlines first, with less-complex devices given more time to comply.
Database: While the United States has the Global Unique Device Identification Database (GUDID), the EU has its own repository of medical device data. EUDAMED – the European Database on Medical Devices – will be expanded to include medical device UDI information and opened to the public to access portions of the medical device data.
Data: The specifics of the data requirements for EUDAMED are of paramount concern to medical device manufacturers, especially to those that already have created solutions to comply with the U.S. UDI rule. The EC’s recommendation aligns the EU UDI system with the International Medical Device Regulators Forum (IDMRF) Guidance and encourages any Member State UDI system be harmonized with the EU UDI system. Industry is hoping for as much overlap in data standards as possible, to maximize efficiency and minimize costs related to compliance. You can click here or on the infographic above to access a chart showing current indications of the required data fields put forth by the EC, IMDRF and FDA.
The UDI experts at Reed Tech are working to make sure our UDI solutions enable our customers to make the most of their work to comply with U.S. regulations when complying in other markets around the world. Contact us today to see how we can help your company be ready to meet UDI mandates in the United States, Europe and beyond.