MDCG Issues Guidance on Transition from ‘EC REP’ to ‘EU REP’ Symbol on Medical Device Labeling

The European Commission has published the reference of amendment EN ISO 15223-1:2021/A1:2025 in the Official Journal of the European Union (OJEU), formalizing the transition from the ‘EC REP’ symbol to ‘EU REP’ on medical device labeling. The Medical Device Coordination Group (MDCG) has issued accompanying guidance MDCG 2021-5 Rev. 1 Appendix to clarify how and when the change applies under the MDR and IVDR. Manufacturers have until 15 June 2031 (MDR) and 17 June 2031 (IVDR) to complete the transition. MedEnvoy reported on this amendment when it was first published in April 2025 — read that update here. 

Background 

The harmonized standard EN ISO 15223-1:2021 has long included the symbol ‘EC REP’ to identify the authorized representative in the European Union. The ‘EC’ designation refers to the European Community, which was replaced by the European Union under the Treaty of Lisbon in 2009. The symbol has been outdated in terminology since that date. 

In May 2024, the European Commission formally requested CEN and CENELEC to revise the standard to replace ‘EC REP’ with ‘EU REP’. The resulting amendment, EN ISO 15223-1:2021/A1:2025, was adopted by ISO in March 2025, published by CEN/CENELEC in November 2025, and its reference cited in the OJEU on 17 June 2026. The amendment also introduces a generic ‘XX REP’ symbol framework, where ‘XX’ is replaced by the applicable country or jurisdiction code. For the EU, ‘XX’ becomes ‘EU’, giving the symbol ‘EU REP’. 

The OJEU publication was implemented through two separate Commission Implementing Decisions: Decision (EU) 2026/1231 of 11 June 2026, which amends Implementing Decision (EU) 2021/1182 in support of the MDR, and Decision (EU) 2026/1313 of 15 June 2026, which amends Implementing Decision (EU) 2021/1195 in support of the IVDR. Both decisions entered into force immediately on the date of publication, 17 June 2026, meaning the amended standard EN ISO 15223-1:2021/A1:2025 can already be used to demonstrate conformity. 

The 5-year transition period was not arbitrarily set. Both decisions explicitly acknowledge the significant impact on economic operators in terms of costs and timing to implement labelling changes across manufacturing and distribution processes, at both EU and international levels. This was supported by evidence from industry stakeholders through the MDCG Subgroup on Standards, which met on 4 February 2026 specifically to address this topic. 

Key Points 

• What changed: The authorized representative symbol moves from ‘EC REP’ to ‘EU REP’. The change is purely editorial, reflecting a terminology update only, and has no impact on device safety, performance, or the role and responsibilities of the authorized representative. 

• Regulatory basis: The change is formalized through two Commission Implementing Decisions — 2026/1231 (MDR) and 2026/1313 (IVDR) — both published in the OJEU on 17 June 2026. 

• Transition period: Both ‘EC REP’ and ‘EU REP’ are acceptable during the coexistence period. The withdrawal of the old EN ISO 15223-1:2021 reference takes effect on 15 June 2031 under the MDR and 17 June 2031 under the IVDR. After those dates, only ‘EU REP’ confers a presumption of conformity under the respective regulation. 

• Staggered implementation permitted: During the transition, manufacturers may use either or both symbols across different packaging levels, including through re-labeling or over-labeling, provided the authorized representative information remains clear and intelligible. 

• Devices already on the market: Products bearing ‘EC REP’ placed on the EU market before the applicable withdrawal date may continue to be made available after that date. The change does not affect health, safety, or performance requirements. 

• No notified body approval required: Because this is a terminology update with no impact on device safety or performance, manufacturers do not need prior notified body approval to update labeling. 

Broader Implications 

The amendment to EN ISO 15223-1 introduces the generic ‘XX REP’ framework, which is designed for global use across multiple jurisdictions. Markets such as the UK, Switzerland, and others that reference ISO 15223-1 or maintain their own authorized or responsible representative requirements may adopt similar symbol updates. Manufacturers with multi-market labeling strategies should monitor regulatory developments in their relevant jurisdictions and consider addressing symbol updates holistically rather than market by market. 

What This Means for Manufacturers 

The transition period is sufficient, but it is not a reason to delay. Labeling updates across product lines, including packaging artwork, instructions for use, and documentation filed in regulatory submissions, require planning and resourcing. Manufacturers with large portfolios are best served by integrating ‘EU REP’ into labeling as part of natural product or packaging lifecycle changes, supported by a documented transition plan. 

• Review your current labeling across all packaging levels and IFU documents to identify where ‘EC REP’ appears and prioritize updates. 

• Incorporate ‘EU REP’ into new labeling artwork now, ahead of packaging reprints or regulatory submissions. 

• Document your transition plan to demonstrate a structured approach to compliance within the applicable withdrawal deadline under the MDR and IVDR. 

• Assess multi-market labeling strategies if your products are sold in jurisdictions beyond the EU that may introduce comparable symbol updates. 

How MedEnvoy Can Support 

MedEnvoy monitors regulatory developments across global medical device markets as part of our ongoing regulatory intelligence service. We share updates of this nature because labeling non-compliance is one of the most common sources of registration delays and post-market enforcement actions, and transitions of this scale require early planning. 

As a specialized EU Authorized Representative, MedEnvoy supports non-EU manufacturers with the full scope of MDR and IVDR obligations — including labeling compliance, regulatory submissions, and post-market requirements. If you have questions about how this transition applies to your products or your EU representation arrangements, contact us here.