TS EN ISO 15223-1/A1

TS EN ISO 15223-1/A1 is an amendment to the main standard on symbols used with information supplied by the manufacturer for medical devices. In this specific amendment, the focus is on adding a defined term for an authorized representative and revising the EC REP symbol so it is not country- or region-specific. In medical device labelling and instructions for use, symbols help reduce text burden, support multilingual use, and present information in a more consistent way.

How medical device symbols are used

Symbols used on medical device labels and accompanying documentation are intended to communicate product identity, manufacturer details, authorized representative information, conditions of use, storage, and traceability in a concise and standardized form. This supports clearer and more consistent presentation of the same device across different markets. The authorized representative is an important regulatory contact point and local interface acting on behalf of the manufacturer in the relevant market.

Why this amendment matters

An amendment of this kind updates selected terms or symbol meanings while preserving the structure of the parent standard. Here, the technical purpose is to make the EC REP symbol less tied to a specific country or region and to formalize the term authorized representative. From a general technical perspective, that means clearer labelling terminology, better international usability, and less ambiguity for users. It is still an amendment to the parent standard rather than a standalone document defining all medical device labelling rules.