Important Change in the European Authorized Representative Symbol (EC REP → EU REP): Manufacturers Must Update Documentation
The recent publication of Amendment 1 to the ISO 15223-1 standard brings a relevant change for all manufacturers of medical devices established outside the European Union: the symbol used to designate the European Authorized Representative is no longer EC REP but officially EU REP.
This change, although apparently simple, has direct implications for regulatory compliance and the traceability of devices on the European market.
What changes?
The old symbol "EC REP"(European Community Representative) has been replaced by "EU REP"(European Union Representative), bringing the terminology into line with the current post-Brexit European legal framework.
The change was formally adopted through ISO 15223-1:2021/Amd 1:2024, which deals with the symbols to be used on labels, packaging and instructions for use (IFU) of medical devices.
Where should the symbol be updated?
All materials in which this symbol appears should be reviewed and updated, including:
Product labels;
Packaging;
IFUs (instructions for use);
Technical documentation;
User manuals;
Catalogs and promotional materials (if applicable).
Why is this important?
The use of outdated symbols can result in non-conformities during audits, delays in entering the European market, or even corrective actions imposed by competent authorities during inspections or post-market surveillance.
In addition, the lack of consistency between the documents and the labeling elements can compromise the credibility of the manufacturer and generate doubts during the conformity assessment process.
How can Smart MDR support you?
Smart MDR supports manufacturers outside the EU in:
Identification of all documents and materials affected;
Updating labeling and documentation in accordance with the new standard;
Communication with the Authorized Representative and Notified Bodies;
Planning the transition in line with regulatory requirements and reasonable deadlines.
