Please see the update from Team NB, the Version 2 of the Position Paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
See also a useful comparison between version 1 and version 2.
Team-NB-PositionPaper-BPG-IVDR-V1-20230225.docx → Team-NB TechDoc IVDR.pdf – Draftable