Following today’s publication in the Official Journal of the EU, EN ISO 15223-1:2021/A1:2025 is officially harmonised. ISO 15223-1:2021 (Amd. 1:2025) was updated by the International Organization for Standardization (ISO) in March 2025.
Modified EC-REP symbol and use in different countries
The 2025 update brought the following changes:
- Examples of use for an authorised representative in different countries or jurisdictions. Importantly, the authorised representative in the European Union will no longer be identified by the wording “EC-REP”, but “EU-REP”.
- Addition of defined term for authorised representative
Manufacturers have 5 years to adapt their IFUs and labels. The deadline to comply with the adjusted symbol is 17 June 2031.
For any questions, contact us here or at mdlaw@obelis.net.
References:
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.
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