The latest amendment to ISO 15223-1:2021 (Amd 1:2025) has been published, introducing crucial updates to enhance global compliance, clarity, and consistency in medical device labelling. As regulatory requirements evolve, these changes are essential for manufacturers, authorised representatives, and other stakeholders to ensure seamless international acceptance of their products. The key updates include:
- Definition of “Authorised Representative”: A clearer definition helps align with global regulatory frameworks, reducing ambiguity for manufacturers operating in multiple markets.
- Updated EC REP Symbol: The European Authorised Representative symbol has been revised to be universally applicable across different regions, promoting better recognition and compliance.
- Enhanced Labelling Consistency: Standardized labelling requirements help ensure medical devices meet international regulatory expectations
The updated standard can be accessed using the following link
