EC Rep To EU Rep: The Symbol Shift You Can't Ignore

By Gopiganesh Chandra Sekaran, Baxter International Inc.

What if a single symbol on your medical device label could determine market access — or trigger compliance gaps across jurisdictions? The recent update to ISO 15223-1 — formalized through Amendment 1:2025¹ — ushers in a critical shift from the legacy “EC REP” symbol to a more flexible, jurisdiction-specific format: “XX-REP.” This change is more than a visual refresh; it represents a strategic evolution toward regulatory clarity in a fragmented global market. As manufacturers, notified bodies, and regulatory authorities begin interpreting the implications, key questions are surfacing: What does this mean for legacy products? How will the EU MDR harmonization timeline shape transition planning? And most importantly, how can stakeholders proactively adapt to stay ahead of this industrywide transformation?

What Is New In ISO 15223-1:2021/Amd 1:2025?

ISO 15223-1:2021, titled Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements, provides a standardized set of symbols for medical device labeling. The 2025 amendment,¹ published on March 27, 2025, updates the symbol for the authorized representative from EC REP to XX-REP, a flexible designation indicating the authorized representative in a specific country or jurisdiction, such as EU REP for the European Union, CH REP for Switzerland, or NZ REP for New Zealand. It also mandates that the XX in the symbol be replaced by either the two-letter or three-letter country code from ISO 3166-1 (e.g., EU, CH, NZ) or other text as required by the relevant authority. This shift, driven by the European Commission’s standardization efforts under the EU Medical Device Regulation (MDR 2017/745²), has sparked disruption in the industry, as the intricate process of revising labels brings additional effort, costs, and burden of rework.

While ISO 15223-1:2021/Amd 1:2025 does not specify a transition period, implementation under the EU MDR depends on harmonization via the Official Journal of the European Union (OJEU). Transition periods are determined by the European Commission and vary based on device risk classification. Although a three-year transition is typical of harmonized standards,³ exact timelines are subject to amendment by the commission.

Regulatory Context: EU MDR And Harmonized Standards⁴

The EU MDR (Regulation (EU) 2017/745)² governs medical device requirements within the European Union. While it does not explicitly mandate the EU REP symbol, it establishes the need for an authorized representative for non-EU manufacturers under Article 11(3)(e). Annex I, Section 23.2(g) further requires that the representative’s name and contact details appear on the device label or packaging. The MDR’s full text is accessible here: EUR-Lex - 32017R0745.

ISO 15223-1 serves as a harmonized standard⁴ under the EU-MDR, providing symbols to meet these labeling obligations. The original 2021 version, harmonized on January 4, 2022, used EC REP. The 2025 amendment aligns the symbol with the MDR’s broader objectives, as requested by the European Commission in Implementing Decision C(2024)3371,⁴ dated May 27, 2024. This decision emphasized “consistency with current EU terminology,” reflecting the shift from the European Community (EC) to the European Union (EU) post-Lisbon Treaty (2009). Once the update is adopted by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) and cited in the OJEU, the amended standard will provide a presumption of conformity, with a transition period that is confirmed by the commission.

Reason For The Change

The transition from EC REP to EU REP addresses both symbolic and practical needs:

• Terminological Alignment: The term “European Community” became obsolete with the EU’s legal consolidation under the Lisbon Treaty. EU REP reflects the modern regulatory entity, enhancing clarity for stakeholders.
• Global Clarity: The EC designation risked confusion with Ecuador’s ISO 3166-1 two-letter country code, a potential issue in international trade. EU REP eliminates this ambiguity.
• Regulatory Consistency: The EU MDR, effective since May 26, 2021, emphasizes traceability and market surveillance. Updating the symbol ensures consistency with its harmonized standards⁴ ecosystem.

Why Didn’t This Symbol Change Roll Out In 2017?

When the EU MDR entered into force in 2017, the priority was tackling major structural challenges: setting up notified bodies, shifting from the old Medical Device Directive, and handling a flood of certification demands. Fine-tuning things like symbols and terminologies was not the top priority then.

By 2025, though, the regulatory framework has had time to settle. With the major groundwork done, the commission is in a much better position to focus on the smaller — but important — details, like making sure the terminology is clear and consistent.

Implications For Existing Labels

The shift from EC REP to EU REP introduced by ISO 15223-1:2021/Amd 1:2025 does not require immediate relabeling of medical devices already certified and labeled under the EU MDR (Regulation (EU) 2017/745) prior to March 27, 2025. For MDR-certified products bearing the EC REP symbol, manufacturers can continue to place these devices on the market and distribute existing stock without disruption, as the symbol remains widely recognized by regulators and users during the transitional phase. This flexibility applies to devices that have undergone conformity assessment under the MDR and are compliant with its requirements, including labeling obligations under Annex I, Chapter III, Section 23.2(d), which mandates the inclusion of the Authorized Representative’s name and address. To align with the MDR’s “state of the art” principle (Chapter I, Article 1), manufacturers may consider voluntarily adopting updated standards before harmonization to reflect the latest industry standards, though this is not mandatory and requires justification in technical documentation.

However, the formal integration of the EU REP symbol into the EU regulatory framework depends on the harmonization of ISO 15223-1:2021/Amd 1:2025 under the MDR, anticipated by mid-2025 (e.g., July 2025), when its reference is published in the OJEU. Following harmonization, a transition period will provide manufacturers with time to update labels on new MDR-certified products to reflect EU REP. During this window, existing MDR-certified inventory labeled with EC REP can remain in circulation, while new batches or updated product lines should adopt the revised symbol to align with the harmonized standard. Manufacturers are encouraged to track OJEU publications and collaborate with notified bodies to plan this transition, ensuring compliance without compromising market continuity.

Conclusion

The symbol change from EC REP to EU REP won’t force an instant label change; existing stock can remain on the market until the end of the transition period, which will begin once ISO 15223-1:2021/Amd 1:2025 is harmonized under the EU MDR. While the immediate impact on existing labels is minimal, manufacturers must prepare for upcoming compliance obligations. Proactively update labels to stay ahead, as the MDR’s “state of the art” principle encourages aligning with the latest standards to ensure best practices, though this is optional until harmonization. To reduce labeling revisions, manufacturers can strategically update to “EU REP” when submitting new labels for MDR certification to notified bodies or when implementing engineering changes to MDR-certified products. By staying informed and thinking ahead, manufacturers can ensure compliance with the evolving standard while maintaining regulatory and market continuity. The shift to EU REP not only aligns with modern EU terminology but also highlights the importance of consistent, clear labeling in the medical device industry.

References

1. ISO 15223-1:2021/Amd 1:2025
   https://www.iso.org/standard/86270.html
2. EU MDR Regulation (EU) 2017/745
   https://eur-lex.europa.eu/eli/reg/2017/745/oj
3. Harmonized Standards for EU MDR – Official List
   https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en
4. Implementing Decision C(2024)3371 of 27 May 2024
   https://eur-lex.europa.eu/eli/C/2024/3371/oj

About The Author:

Gopiganesh Chandra Sekaran is a senior project manager with over 18 years of experience in product design and regulatory compliance within the medical device industry. He has made notable contributions to the European Union Medical Device Regulation (EU MDR) labeling program and has successfully led compliance initiatives across various domains, including FDA’s Unique Device Identification (FDA-UDI), ISO Luer Standards, test method validation, xUDID, and non-conformance reports/corrective and preventive actions. He holds a Bachelor of Technology (B.Tech.) degree in polymer technology from Anna University, Chennai, India. For further inquiries, he can be reached at gopiganeshc@gmail.com.