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ISO 15223-1:2021/Amd 1:2025

Medical devices-Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific

Changes

1: Clearer definitions help to align with regulatory systems and reduce ambiguity in different markets

2: From the previous EC REP symbol to the EU REP symbol, the updated symbol improves identification and compliance.

3: The importance of labeling consistency is further strengthened

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