In March 2025, the International Organization for Standardization (ISO) updated ISO 15223-1:2021 (Amd. 1:2025). This standard describes the the use of symbols for medical devices.
This last update addresses the use of the authorised representative symbol for more countries and the use of country codes.
ISO 15223-1:2021/Amd 1:2025: updated authorised representative symbol
ISO 15223-1:2021/Amd 1:2025 was updated to specify that in the authorised representative’s symbol, the [XX] text is replaced by country codes or other text recognised the by country’s jurisdiction. Consequently, the authorized representative in the European Union will no longer be identified by the wording “EC-REP”, but “EU-REP”.
There is no need to duplicate the name and address if they identify the same responsible entity. All applicable symbols can be grouped together next to the single address. All applicable symbols can be grouped together.
More news on the possible harmonisation of this standard will follow.
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Do you have questions on compliance of medical devices and IVDs? Contact us here or at mdlaw@obelis.net.
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