The new EU Medical Device Regulations: Introduction to the future EU UDI System

On April 5, 2017, the In Vitro Diagnostic Medical Devices Regulation (IVDR) and Medical Devices Regulation (MDR) were approved by the European Parliament.

Salvatore Scalzo, from the European Commission’s DG Internal Market, Industry, Entrepreneurship and SMEs, spoke about the future of the EU UDI System and shared the main features of the new texts. He focused in particular on the establishment of a comprehensive EU database on medical devices (EUDAMED) where large part of the information will be made publicly available.

GS1 is provisionally listed in the final EU Regulations as one of the three assigning entities for unique device identifiers. According to the Regulations, a UDI number must be applied to the medical device label, its packaging and, in some cases, the device itself. Required product data must be submitted to EUDAMED, the central European database. GS1’s global identification and coding systems are compliant with relevant international ISO standards.