Has the EU clarified the use of UDI as it relates to software-only devices? 1.37K viewsOctober 10, 2022Medical Device 0 Sam Smith11.38K October 19, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted October 19, 2020 0 Comments Spread the loveYes, the requirements are outlined in Annex VI Part C Section 6.5 of the Regulation. Spread the love Login