Mid-June 2016, the negotiated texts on the EU Medical Device Regulation and the IVD Regulations have been released. The final text should be published in the Official Journal of the European Union in January 2017 at the latest. The provision on the UDI system in Europe are included in these Regulations. GS1 is mentioned as one of the three assigning agencies for UDI in Europe. More detailed information will be shared within the GS1 Healthcare Public Policy Team.