MDCG Publishes Appendix on Transition to EU REP Symbol

    On 17 June 2026, the Medical Device Coordination Group (MDCG) published a new Appendix — Transition to the "EU REP" symbol in EN ISO 15223-1 to MDCG 2021-5 Rev.1 Guidance on standardisation for medical devices. The appendix provides clear guidance on the transition from the "EC REP" symbol to the new "EU REP" symbol under EN ISO 15223-1.

    This update reflects the amendment of the harmonised standard EN ISO 15223-1:2021/A1:2025, which introduces an updated approach to identifying authorised representatives in medical device labelling under the MDR and IVDR.

    Key Points

    New "EU REP" symbol introduced

    The updated standard replaces the outdated "EC REP" symbol with "EU REP", reflecting current EU terminology and aligning the symbol with the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).

    Generic "XX REP" concept

    The amendment introduces a generic format ("XX REP") for authorised representatives, where "EU" is used for the European Union. This creates a scalable framework that can also accommodate other jurisdictions in the future.

    Purely editorial change

    The update is terminological only. It has no impact on device safety, performance, or the role of the authorised representative, and it does not require notified body approval for labelling updates.

    5-year transition period

    A transition and coexistence period runs until 17 June 2031, during which both "EC REP" and "EU REP" symbols may be used on labelling and packaging.

    Flexible implementation allowed

    During the transition, manufacturers may use both symbols — for example across different packaging levels or via relabelling — provided the information on the device remains clear and unambiguous to users.

    Mandatory use after transition

    From 17 June 2031, only the "EU REP" symbol will ensure compliance with MDR and IVDR labelling requirements.

    Why This Matters

    This appendix clarifies the practical implementation of the updated harmonised standard EN ISO 15223-1, ensuring a harmonised and resource-efficient transition for manufacturers across the EU. The extended transition period acknowledges the operational impact of labelling changes, while ensuring gradual alignment with the updated terminology across the entire EU regulatory framework for medical devices and in vitro diagnostics.

    What Does This Mean for You?

    Manufacturers of medical devices and IVDs should:

    • Plan the transition from "EC REP" to "EU REP" in all labelling, packaging, and Instructions for Use (IFU).
    • Take advantage of the 5-year transition window to integrate the change into existing label and artwork update cycles, minimising cost and disruption.
    • Review and update labelling activities — including primary packaging, secondary packaging, and IFUs — to ensure consistency with the amended harmonised standard over time.
    • Coordinate with your EU Authorised Representative to ensure all references on labelling are aligned with the new terminology before 17 June 2031.
    • Document the transition in your technical documentation and change-control records to evidence compliance with EN ISO 15223-1:2021/A1:2025.