Hamburg, 12th August 2020, Christoph Petershagen
On Monday (10/08/2020) the European Commission has released an update of their list of frequently asked questions (FAQs) related to the Unique Device Identification (UDI). This document covers not only the requirements of Regulation (EU) 2017/745 on medical devices, but also those of Regulation (EU) 2017/746 on in-vitro diagnostic medical devices. The updates are mainly editorial or related to the extent of the transition phase.
With it the European Commission answers the most frequent questions of this topic, for example “What is the Basic UDI-DI?”, “How should a UDI appear on the label or package of a device?” or “Who are the designated issuing agencies?”. In doing so they provide useful links to existing MDCG guidance and other sources, which allow a more detailed understanding of the topic.
Even if the updates are not that relevant, the document will give you a short and clear overview of the UDI topic. This will help you to implement the UDI in your organization.