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ISO 20417

Standard for information to be supplied by the manufacturer of medical devices.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

ISO 20417 consolidates the labeling, IFU, and information-supplied requirements that historically lived across multiple device-specific standards. Aligns naturally with EU MDR Annex I labeling requirements.

What this means in practice

Useful single anchor for global labeling specifications; FDA recognizes specific clauses.

Primary references

3 sources

Link health: 3 verified· last checked 2026-05-09

ISO·2IEC·1

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On this term

Category: Standards
Sources: 3
Updated: 5/5/2026

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Standard for information to be supplied by the manufacturer of medical devices.

·Useful single anchor for global labeling specifications; FDA recognizes specific clauses.
·Aligns naturally with EU MDR Annex I labeling requirements.

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Standard for information to be supplied by the manufacturer of medical devices.

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