Following its publication in the Official Journal of the European Union (OJEU) in June 2026, EN ISO 15223-1:2021/A1:2025 has become a harmonised standard under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
Key Changes in the Revised Harmonised Standard
The updated standard, published in March 2025, introduces important changes impacting manufacturers and authorised representatives:
- Transition from “EC-REP” to “EU-REP”. The most significant change is the transition from the previous “EC-REP” to “EU-REP” for authorised representatives within the European Union. This update reflects the current EU legal framework and improves regulatory clarity. The revised version introduces a flexible “XX-REP” concept, allowing the symbol to adapt to different jurisdictions and thereby, supporting global harmonisation.
- Definition for authorised representative. A formal definition of “authorised representative” has been introduced to ensure consistency across markets and regulatory frameworks.
Transition Period and Deadline to Use “EU-REP”
Manufacturers are granted a transition period of five years to implement the updated symbol. Final compliance deadline is 17 June 2031. After this date, compliance with MDR and IVDR requirements will rely on the use of the harmonised standard.
Manufacturers should begin planning implementation to ensure smooth transition. Key actions include:
- Verifying which version of the standard the manufacturer’s is declaring compliance with;
- Updating labels, IFUs, and packaging;
- Ensuring consistency across product portfolios;
- Aligning technical documentation.
Manufacturers are encouraged to proactively assess the impact and integrate these changes into their regulatory and quality processes in advance. In this context, having a system in place to monitor regulatory updates is crucial.
Sources
EUR-Lex (2026). Commission Implementing Decision (EU) 2026/1231 of 11 June 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, symbols to be used with information to be supplied by the manufacturer, medical electrical equipment, transfusion equipment for medical use, ophthalmic optics, non-active surgical implants, washer-disinfectors, prosthetics and sharps injury protection. Retrieved on 17/06/2026.
EUR-Lex (2026). Commission Implementing Decision (EU) 2026/1313 of 15 June 2026 amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for symbols to be used with information to be supplied by the manufacturer. Retrieved on 17/06/2026.
Regulatory Intelligence & Innovation
18/06/2026