Read time: 2 minutes

Background

The European harmonized symbol for EU Authorized Representative has long been ‘EC REP’.

In March 2025, ISO 15223-1 (on medical device symbols) was updated to 1) add a new definition for “authorized representative” and 2) establish a symbol naming convention of “XX REP”. This was at the request of the European Commission, as “EC” for “European Community” has been out-of-date for nearly 30 years (since 2007).

Authorized representative is defined as a “natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation”.

“XX” is a placeholder for the applicable two-letter country code, e.g., EU REP for European Authorized Representative, CH REP for Swiss Authorized Representative.

In March 2026, the Commission and stakeholders discussed the transition period for this labeling change, with MedTech Europe lobbying for an extensive transition period to ensure manufacturers have sufficient time to comply.

Earlier this month, this amendment to ISO 15223-1 was adopted in Europe. EN ISO 15223-1:2021/A1:2025 has been harmonized under both the MDR and IVDR. In parallel, the MDCG published a guidance document on transitioning to the new symbol.

The Update

This change of the EC REP symbol has labeling consequences for every non-EU manufacturer marketing their devices in Europe. The MDCG has therefore published guidance on the transition via MDCG 2021-5 rev.1 – Appendix: HERE

The Commission is providing manufacturers with 5 years to implement this change, i.e., until 17 June 2031. After 17 June 2031, full transition to use of the EU REP symbol is mandatory.

Devices already placed on the EU market before this date do not need to be updated, and can continue to be made available with the EC REP symbol.

The guidance further notes that: