EC REP to EU REP – What Does the Latest MDCG Guidance Mean for Manufacturers?

The MDCG has recently published an appendix to MDCG 2021-5 Rev. 1, providing clarification on the transition from the EC REP symbol to the EU REP symbol under EN ISO 15223-1.

Many manufacturers may wonder whether this change requires regulatory submissions, Notified Body approval, or immediate label updates. Fortunately, the guidance provides clear answers.

The change originates from the amendment EN ISO 15223-1:2021/A1:2025, which replaces the existing EC REP symbol with a more generic XX REP format. In this format, “XX” represents the applicable jurisdiction. For devices placed on the European Union market, the symbol becomes EU REP.

According to the MDCG, this is purely a terminology update. The change does not affect the safety, performance, intended purpose, or regulatory status of the device. It also does not change the role, responsibilities, or legal obligations of the Authorized Representative.

One important clarification is that manufacturers generally do not need prior Notified Body approval to update the symbol on labels or packaging, as this is not considered a significant regulatory change.

Recognizing the practical challenges associated with updating labels, packaging materials, IFUs, and artwork, the European Commission has provided a five-year transition period. Until 17 June 2031, manufacturers may continue to use the existing EC REP symbol or transition to EU REP. During this period, both symbols may coexist on different levels of packaging, and relabelling or over-labelling approaches are acceptable provided the information remains clear and understandable.

For manufacturers planning routine label updates or artwork revisions, it may be practical to incorporate the EU REP symbol during the normal change cycle rather than waiting until the end of the transition period.

While the update is relatively small, it serves as another reminder that standards and regulatory requirements continue to evolve, and manufacturers should ensure their labelling practices remain aligned with the latest harmonized standards and MDCG guidance.

Reference: MDCG 2021-5 Rev. 1 Appendix – Transition to the ‘EU REP’ Symbol in EN ISO 15223-1 (June 2026).