The EU-REP Symbol: What Amendment 1:2025 Changes on Your Label

Aug 2

3 min read

Updated: Sep 29

If your label carries the EC REP symbol next to your authorised representative's name and address, that symbol has changed. ISO 15223-1 Amendment 1:2025 replaces it with a region-neutral EU-REP designation.

Why the EU-REP symbol replaced EC REP

The reason is narrower than it sounds. “EC” is the ISO 3166 alpha-2 country code for Ecuador. A symbol reading EC REP could therefore be read as identifying a representative in Ecuador rather than in the European Community. CEN and CENELEC revised the harmonised standard on the basis of the Commission’s standardisation request C(2021) 2406, and Amendment 1:2025 does so by removing the region-specific identifier from the symbol and defining the term “authorised representative” in its own right.

Where the symbol sits in EU law

EN ISO 15223-1:2021 is a harmonised standard. Its reference has been published in the Official Journal since January 2022, which confers a presumption of conformity in support of both the MDR and the IVDR. That is the mechanism by which a symbol on a label satisfies a regulatory labelling requirement.

A consequence worth knowing: because the standard is harmonised in the EU, symbols listed in it do not have to be separately explained in the information supplied with the device — provided that omitting the explanation does not itself create a risk. For devices intended for lay users, symbols are still explained.

The June 2026 Implementing Decisions and the 2031 dates

On 17 June 2026 the Commission published two Implementing Decisions in the Official Journal that cite the amendment as a harmonised standard. For medical devices, Commission Implementing Decision (EU) 2026/1231 of 11 June 2026 amends Implementing Decision (EU) 2021/1182 and inserts entry 12a, EN ISO 15223-1:2021 together with EN ISO 15223-1:2021/A1:2025. For in vitro diagnostic devices, Commission Implementing Decision (EU) 2026/1313 of 15 June 2026 amends Implementing Decision (EU) 2021/1195 and inserts entry 8a with the same two references.

Both Decisions describe the amendment in the same words: "addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific" (Implementing Decision (EU) 2026/1313, recital 4).

The reference to the unamended EN ISO 15223-1:2021 is not withdrawn at once. The Commission gives the reason in the IVD Decision: "it is necessary to defer the withdrawal of the reference of that harmonised standard, to allow for a period of 5 years" (Implementing Decision (EU) 2026/1313, recital 10). The deletion of the old entry applies from 15 June 2031 for medical devices (Implementing Decision (EU) 2026/1231, Article 2 and Annex point 5) and from 17 June 2031 for in vitro diagnostic devices (Implementing Decision (EU) 2026/1313, Article 2 and Annex point 1).

Medical devices (MDR): amended standard cited from 17 June 2026; unamended EN ISO 15223-1:2021 withdrawn from 15 June 2031.

In vitro diagnostic devices (IVDR): amended standard cited from 17 June 2026; unamended EN ISO 15223-1:2021 withdrawn from 17 June 2031.

Until those dates both versions of the symbol sit under a cited standard. After them, the unamended version no longer gives a presumption of conformity, and a label still showing the old symbol would have to be justified by other means. Five years covers several label revision cycles for most manufacturers, which is the point of the transition.

What this means in practice

Labels already printed and devices already placed on the market are not made non-compliant by an amendment to a standard. What changes is what you do at the next label revision.

Three practical points. Artwork files should be updated at the next planned revision rather than triggering an unplanned one. Instructions for use that describe the symbol need the description updated in the same cycle. And where labelling changes are assessed for significance, the assessment framework in MDCG 2020-3 applies as it would to any other labelling change.

A related point about your representative's details

Whatever the symbol reads, the name and registered address beside it must match the entity registered in EUDAMED. Where a manufacturer changes authorised representative under Article 12, the label changes with it — and the label change is often the slowest part of the transition.