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Labelling

Articles Tagged: Labelling

Deadline of UDI Carrier on Labelling has Arrived for Certain Devices

By 26thMay 2025, manufacturers of certain medical devices must ensure that the UDI carrier is correctly affixed to the device, label or packaging. These include: This deadline is a critical step in the full implementation of the Unique Device Identification (UDI) system, aimed at enhancing the traceability, safety, and post-market surveillance of medical devices across ...

UPDATE: ISO 15223-1:2021

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: The updated standard ...