How to assign UDI-DI and Basic UDI-DI to my device? Common pitfalls

The European Unique Device Identification system (UDI system) for medical devices was introduced with MDR (EU) 2017/745. In this hands-on session, we explain the regulatory requirements for implementing the UDI system and the Basic UDI-DI (BUDI) for tracing medical devices in Europe according to life cycle and quality management system. Furthermore, we demonstrate how BUDI for systems and procedure packs can be put into practice compliantly with MDR, Article 22, and describe why the Notified Body takes such an interest in BUDI.

Date and time: Wednesday, 26 October 2022, 8.00 pm (CEST) / 2.00 pm (EDT)

Your speakers: Daniel Rubisoier, Regulatory Affairs Specialist


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