ISO 15223-1 Amendment: EC-REP Symbol Changes to EU-REP

MedNet EC-REP GmbH is pleased to announce an important update to the symbol for European Authorized Representatives. The International Organization for Standardization (ISO) has recently amended ISO 15223-1:2021, introducing a change from "EC-REP" to "EU-REP" for the European Authorized Representative symbol.

This modification aims to eliminate potential confusion with Ecuador's country code (EC) and enhance clarity in medical device labeling. The amendment, ISO 15223-1:2021/Amd 1:2025, specifies that the authorized representative in the European Union will now be identified by "EU-REP" instead of "EC-REP".

Key Points for Manufacturers:

1. Gradual Transition: There is no immediate requirement to change your labels. We recommend implementing the new symbol when other label modifications become necessary
2. Updated Symbol Usage: When updating your labels, please use our contact details with the new EU-REP symbol
3. Notified Body Requirements: If a Notified Body is involved in your product's conformity assessment, they may have specific transition period requirements. We advise contacting them directly for guidance

This amendment reflects the ongoing efforts to streamline and clarify medical device regulations across the European Union. MedNet EC-REP GmbH remains committed to supporting our clients through this transition and ensuring compliance with the latest regulatory standards.

For any questions or concerns regarding this change, please don't hesitate to contact our team. We're here to assist you in navigating these updates and maintaining full compliance with EU regulations.