ISO 15223-1 First Amendment Published
Symbols for medical devices to be used with information to be supplied by the manufacturer
18 March 2025
The harmonized standard ISO 15223-1 defines the symbols used by medical device manufacturers to label and communicate important information. The MDR requires manufacturers to provide information on the labelling, including the batch number, shelf life and authorized representative. Symbols ensure that the information is understandable in all languages.
ISO 15223-1, last revised in 2021, specifies the size of the symbols and their placement on the packaging, product and IFU, and lists the symbols and their meaning as well as examples. ISO 15223-1:2021/Amd 1:2025 was updated again in March 2025; this time concerning the use of the authorized representative symbol.
The first change is the addition of a new section 3.20 so that the standard includes a definition of ‘authorized representative’ to ensure consistent application of this term. In addition, the symbol for the authorized representative under 5.1.2 and in the associated example under A.4 is changed to ‘XX-REP’, whereby ‘XX’ is to be replaced by the country or region-specific code. As a result, the EU Authorized Representative is now marked as ‘EU-REP’ and no longer as ‘EC-REP’ (European Community Representative), which had led to potential confusion with the country code of Ecuador.
If you have any further questions regarding the labelling of your medical devices, our experts will be happy to assist you.
