Position Paper: IVDR Significant Changes (V2)

Position Paper Team NB 2025-10-01
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Summary

Updated guidance on identifying and managing significant changes to IVDs under IVDR.

Document Type: Position Paper

Source: Team NB (Team of Notified Bodies)

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Document Details

TypePosition Paper
AuthorityTeam NB
Publication Date2025-10-01

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Quick Info

TypePosition Paper
Published ByTeam NB
Date2025-10-01

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