The European regulatory landscape for medical devices continues to evolve. A key recent development is the formal transition from the long-established “EC REP” designation to the updated “EU REP” symbol, reflecting alignment with the current EU MDR (2017/745) and IVDR (2017/746) frameworks.
With the adoption of Commission Implementing Decision (EU) 2026/1313 and earlier Decision (EU) 2021/1182 and publication in the OJEU, the European Commission has harmonised the updated standard EN ISO 15223-1:2021/A1:2025.
The most visible change: ➡️ The traditional “EC REP” symbol is being replaced by ➡️ “EU REP”
⏳ Transition Period: 5-Year Co-Existence
Recognising the complexity of relabeling medical devices globally, the European Commission has introduced a 5-year transition (co-existence) period. During this time:
- Both “EC REP” and “EU REP” symbols may be used
- Manufacturers can transition gradually without immediate disruption
💡 Least Burdensome Approach: Smart Transition Planning
Rather than initiating costly, immediate relabeling projects, manufacturers can adopt a pragmatic, cost-neutral approach:
- Check the device cycle and most likely within a five-year period devices and device label are going to be updated anyway, and that would be the time to update the symbol. –> no additional cost!
- Identifying which devices may have longer device cycle.
- Plan accordingly:
a) Document which devices will not need an update since they will be updated within the time frame.
b) Plan the update only for the device which are in danger not to be updated within the time frame.
🏭 Key Actions for Manufacturers
✔ Review labeling, packaging, and IFUs
✔ Assess lifecycle-based update opportunities
✔ Apply a least burdensome transition strategy
✔ Update documentation and procedures where required
🌍 Strategic Considerations
While the transition period provides flexibility, early adoption of the “EU REP” symbol may offers advantages:
- Avoids future rework and dual labeling strategies
- Demonstrates proactive compliance to notified bodies and authorities
- Simplifies long-term supply chain management
📘 Additional Guidance from MDCG
In June 2026, the Medical Device Coordination Group (MDCG) published an update to MDCG 2021-5 Rev. 1, including an appendix specifically addressing the transition to the “EU REP” symbol.
This guidance provides further clarity on how manufacturers should approach implementation and planning.
💬 Have you started preparing for the transition to the “EU REP” symbol?
Early planning can significantly reduce costs and ensure compliance well before the deadline.
