Europe – MDCG 2018-3 Rev.1 (June 2020) Guidance on UDI for systems and procedure packs.

This guidance should be read in conjunction with the Guidance on « Basic UDI-DI and
changes to UDI-DI »1 and the Guidance on « UDI database. Definitions, descriptions
and formats of the UDI core elements »2. The guidance is not intended to be
exhaustive in relation to all UDI obligations associated with systems and procedure
packs. The scope of this guidance is therefore limited to the aspects specifically
addressed below. For UDI-related aspects that are not specifically mentioned in this
guidance, the reader should make reference to the relevant provisions of Medical
Device Regulation (EU) 2017/745 (MDR)…