No longer a sandbox, device manufacturers can enter Basic Unique Device Identification Device Identifier (Basic UDI-DI) and UDI-DI information into EUDAMED using real data.
According to the European Commission, this is a Minimum Viable Product (MVP), so additional functionality will be added later, but it does allow full registration of devices. Still, there are issues to be aware of and concerns about how this module will (or will not) evolve as we advance toward a fully functional EUDAMED.
Lionel is leading the global healthcare strategy at the product content solution provider atrify, a company enabling UDI registrations into regulatory databases (such as EUDAMED) and GDSN connections between manufacturers, wholesalers, GPOs, and hospitals. He represents atrify in MedTech Europe (chairman of the EUDAMED IT Expert group), is an observer in the EUDAMED MDCG working group, and is a member of the GS1 Global Healthcare Leadership Team.
Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.