MDCG 2021-5 Rev.1 – Labelling symbols update (EU REP)

The MDCG 2021-5 Rev.1 guidance provides important clarifications on the use of symbols applicable to medical devices under the MDR and IVDR.

Key point: transition from the “EC REP” symbol to “EU REP”

This evolution stems from the update of the harmonized standard EN ISO 15223-1 (Amendment 2025), introducing the EU REP symbol to designate the authorized representative established within the European Union.

Key takeaways:
• Editorial change only (no impact on safety or device performance)
• No prior Notified Body approval required for this labelling update
• 5-year transition period (until 17 June 2031)
• Possible coexistence of EC REP and EU REP symbols during this period

As of 17 June 2031, only the EU REP symbol will demonstrate compliance with MDR/IVDR requirements.

DOWNLOAD THE MDCG 2021-5 REV.1 GUIDE