Position Paper: Software Qualification under the IVDR (V2)

Position Paper Team NB 2025-06-27
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Summary

Guidance on qualification of software as an IVD under IVDR Regulation 2017/746, including software life cycle considerations.

Document Type: Position Paper

Source: Team NB (Team of Notified Bodies)

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Document Details

TypePosition Paper
AuthorityTeam NB
Publication Date2025-06-27

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TypePosition Paper
Published ByTeam NB
Date2025-06-27

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