This document presents questions and answers on the Unique Device Identification system (UDI system) established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices
(IVDR). The questions covered by the document aim to provide further detail to operators on the application and practical implementation of the UDI requirements.
Note: This document is non-exhaustive and should be read in conjunction with the MDR/IVDR.
Of additional relevance are the UDI FAQ ‘Introduction to the new UDI system and the obligations of operators’, MDCG guidance and other documents covering the UDI requirements
MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746