The European Commission (EU) announced its latest revisions to the proposed rule changes for unique device identification (UDI) requirements. The agreement has been in the development stage for the past year and the EU has now developed tighter rules for medical manufactures. These rules center on areas such as trace-ability and are designed to ensure that manufacturers produce devices with sufficient oversight. Manufactures should note the EU will now adopt a similar approach as to the FDA and employ a revised identification process, to ensure many varieties of medical technology are traceable through their life cycles.
With the agreement expected to be in place this year, it has been written to minimize disruptions in production, by allowing current devices with certificates to be valid until 2020 and an extra five (5) years (2022) for in vitro devices. All devices in production will have to follow the new national EU Law and comply by those dates.
Pragmatyxs has developed significant experience over the past years with customer roll outs. We aid in developing programs to identify and resolve all compliance requirements including the daunting task of converting labels for UDI compliance and now the EU UDI requirements.
We can work with your company to develop a consistent labeling solution as the EU roles out their rules.