Yesterday, the European Commission, as expected, issued a draft directive that includes creation of a unique device identification (UDI) system.
In a news release, the Commission announced two new proposals that, among other things, are designed to broaden the scope of regulated products, extend the database of publicly available information on medical products, and provide better traceability of devices throughout the supply chain. This last part includes creation of a unique device identification (UDI) system. The regulations are expected to be final in 2014, with the new rules gradually coming into effect from 2015 to 2019 (about a year behind the US UDI rule). Once the European Parliament finalizes the regulations, they will be in effect for all member states.
Watch for more on UDI in Europe, as well as additional aspects of the draft directive, in future posts.