An important update has been introduced for medical device manufacturers and regulatory professionals with the release of an amendment to ISO 15223-1:2021, the international standard for labeling medical devices.
Key Updates in the Amendment
- Definition for Authorized Representative Added: The update includes a defined term for “authorized representative,” providing more clarity to assist in global compliance efforts.
- Modification of EC REP Symbol: The EC REP symbol, used to denote authorized representatives in the EU market, has been updated to no longer be country or region-specific. With this change, the intention is to transition towards an “EU REP” symbol to harmonize across the European market.
Implications for the EU Market
- Transition Period Unclear: Though the amendment has been published, it has not yet been harmonized by the EU, and the duration of the transition period allowing the use of both the EC REP and EU REP symbols remains undefined.
- Effect on Industry Stakeholders: This development impacts medical device manufacturers, regulatory professionals, and stakeholders navigating the EU market. Clear communication and strategic planning will be needed to ensure compliance during this transition.
Next steps
Stakeholders are advised to monitor updates from the European Commission for the official transition guidelines. These changes underscore the importance of staying informed on developments within regulatory standards to maintain smooth market operations.
For further details on the amendment, visit the official ISO website at ISO 15223-1 amendment.
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