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Team-NB have published the position paper Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Device Regulation (EU) 2017/746. This is listed as “Team-NB PositionPaper BPG-IVDR V1” on the Team-NB website.

Please note that although this is a guidance document published by a collective group of Notified Bodies, it is possible that individual Notified Bodies may have their own requirements.