European UDI Similar to U.S. Requirements and Challenges

The European Parliament recently voted to adopt its own version of the unique device identification regulation. The deadline for compliance toward these regulations is already in motion, and similar to U.S. FDA UDI regulations, the dates for compliance will be rolled out over several years for different classes of products – three years for medical devices, five years for in vitro diagnostics (IVDs). 

There are a number of similarities between the U.S. and European regulations:

• Assigning and labeling products with UDIs
• Publishing product data. Data will be published to the European Database of Medical Devices (EUDAMED) where in the U.S. it is published to the FDA Global UDI Database (GUDID). Both are made available to the public.
• UDIs for implantable devices are to be stored in patient records. The UDI regulation in Europe requires hospital and healthcare systems to store the UDIs for implantable devices in patient records much like the U.S. Meaningful Use Stage 3 requirement. In the U.S. EHR vendors must to be able to hold and manage UDIs and related data for implantable devices, and healthcare providers are required to share the UDIs as part of the Common Clinical Data set with other providers.

The other clear similarity is the complexity and challenge of UDI compliance for manufacturers regardless of geography. In the recent bylined article from Karen Conway, And Then There Were Two: UDI goes global, the story of one French-based IVD supplier illustrates many of the same challenges that U.S. manufacturers face.

The first classification of products required to meet compliance was quite limited and the “project” appeared to be mostly a labeling issue. But, when the deadline for the next class of products was addressed, a host of new problems surfaced. With decentralized data, technology systems and processes worldwide, what was thought to be a labeling and technology implementation project, turned out to be far more complex — centered around managing inter-company connectivity, data attributes and sustainable processes.  

As with many manufacturers, it is soon discovered that gathering the data elements for UDI is one of the most challenging aspects of UDI compliance and as pointed out in the article, customers are already asking for more data than the UDI requirements. Knowing that the plan for UDI is expansion, successful strategies will address UDI as a new business process that provides for change management, maintaining accuracy and an audit trail. Manufacturers that develop a sustainable master data management strategy that meets current compliance and customer needs but also considers future requirements will see the most return on investment.