MDCG publishes guidance on the transition from the ‘EC REP’ to the ‘EU REP’ symbol
The Medical Device Coordination Group (MDCG) has published MDCG 2021-5 Rev. 1 – Appendix, providing guidance on the transition from the "EC REP" symbol to the "EU REP" symbol introduced through EN ISO 15223-1:2021/A1:2025.
The document explains the reason for the terminology update, clarifies its regulatory implications, and outlines the transition period that will allow manufacturers to progressively implement the new symbol.
Why is the symbol changing?
The guidance explains that the current harmonised standard EN ISO 15223-1:2021 uses the symbol "EC REP" to identify the authorised representative.
Following the revision of the standard, the symbol has been updated to "EU REP", reflecting the fact that the European Union replaced the former European Community. The amended standard introduces the generic "XX REP" symbol, where "XX" is replaced by the relevant country or jurisdiction. For authorised representatives established in the European Union, the correct symbol is therefore "EU REP".
Editorial update only
The MDCG emphasises that replacing "EC REP" with "EU REP" is purely editorial.
According to the guidance, the change:
Does not affect the health, safety or performance of the device;
Does not modify the role or responsibilities of the authorised representative;
Does not change the legal obligations established under the MDR or IVDR.
The document also states that manufacturers do not require prior approval from their notified body, where applicable, solely to implement this labelling change.
Transition arrangements
To allow manufacturers sufficient time to adapt, the European Commission has established a five-year transition period.
During this period:
Both EC REP and EU REP symbols may be used;
Manufacturers may use one or both symbols on different packaging levels;
Relabelling or over-labelling solutions are considered acceptable, provided the authorised representative information remains clear and understandable.
The coexistence period runs until 17 June 2031. After this date, only the amended harmonised standard containing the EU REP symbol will confer a presumption of conformity under the MDR and IVDR. Devices already placed on the EU market before that date using the EC REP symbol may continue to be made available.
What manufacturers should know
For manufacturers of medical devices and IVDs, the guidance confirms that the transition from EC REP to EU REP is intended to be implemented gradually rather than immediately.
The document provides flexibility for updating labels and packaging during the five-year coexistence period and confirms that notified body approval is not required solely because of this terminology change. Manufacturers can therefore incorporate the new symbol into their normal labelling update processes while continuing to comply with the MDR and IVDR during the transition period.
