#32026D1313EU updates harmonised symbol standard for in vitro diagnostic medical devices
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This decision updates the EU list of harmonised standards for in vitro diagnostic medical devices by adding an amendment to EN ISO 15223-1:2021. The amendment changes the symbol and definition used for an authorised representative, so the symbol is no longer tied to a specific country or region. Manufacturers, authorised representatives, notified bodies, and compliance teams should check labelling, instructions, and technical documentation that rely on this standard. Using the updated standard can help show that products meet the relevant EU medical device rules.
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Key Changes
- Adds amendment EN ISO 15223-1:2021/A1:2025 to the EU list of harmonised standards for in vitro diagnostic medical devices
- Updates the defined term for authorised representative
- Changes the EC REP symbol so it is not country- or region-specific