MDCG 2021-5 Rev.1 on the Transition to the EU REP Symbol

MDCG 2021-5 Rev.1 clarifies the transition from the EC REP symbol to the EU REP symbol after the publication of EN ISO 15223-1:2021/A1:2025. The guidance gives manufacturers and Authorized Representatives a 60-month transition period, ending on 17 June 2031, to update labelling and related materials while keeping Authorized Representative information clear to users and authorities.

Background: EN ISO 15223-1 Amendment Introduces the EU REP Symbol

EN ISO 15223-1:2021/A1:2025 introduces an EU REP symbol to identify the European Authorized Representative on medical device labels and related information. The amendment reflects terminology used under the EU MDR and IVDR, while recognising that many products and packaging materials still use the EC REP symbol.

The European Commission guidance explains how manufacturers may transition from EC REP to EU REP without immediately replacing all labels, packaging, and instructions for use.

Five-Year Transition Period for the EU REP Symbol

MDCG 2021-5 Rev.1 confirms:

• Transition period: 60 months.
• Transition deadline: 17 June 2031.

During this period, manufacturers may continue placing devices on the EU market using the EC REP symbol, the EU REP symbol, or both, provided the Authorized Representative's identity and address remain clear and unambiguous.

What Is Acceptable During the Transition to the EU REP Symbol?

During the transition period, manufacturers may:

• Continue using the EC REP symbol on labels, packaging, and instructions for use.
• Use the EU REP symbol where labelling has already been updated.
• Use both EC REP and EU REP symbols at different packaging levels.
• Relabel or over-label existing packaging where needed, provided the Authorized Representative information remains clear and intelligible.

The guidance also recognises practical supply chain realities, including existing printed materials and packaging configurations across different product families.

What Device Manufacturers Should Do Now

Manufacturers should assess all materials that identify the EU Authorized Representative, including:

• Device labels.
• Packaging configurations.
• Instructions for use.
• Electronic labelling systems.
• Artwork and change-control procedures.

Manufacturers should also coordinate with their EU Authorized Representative to align implementation timing, label review workflows, and technical documentation updates.

Conclusion

MDCG 2021-5 Rev.1 provides a practical transition path for manufacturers moving from EC REP to EU REP labelling. Companies should use the transition period to update artwork, procedures, and documentation in a controlled way before the 17 June 2031 deadline.

Official Source

• MDCG 2021-5 Rev.1

Related Pure Global Resources

• EU Authorized Representative for Medical Device & IVD Companies
• EU Medical Device Classification & Regulation (MDR/IVDR)