Medical Devices

If you manufacture or distribute any product that is exported to the United States and that is classified as a “medical device” you are now required to declare to the FDA if you use your GS1 prefix to “unique device identifiers” or UDIs.

Unique identification of medical devices (UDI): Agreed terms

Medical Device UDI Data Sharing with GS1 GDSN

A short introductory guide to Medical Device UDI Data Sharing with GS1 Data Synchronisation Standards and the GDSN

GS1 UDI Training and Advice

Advice and training from GS1 experts on implementing GS1 identification standards such as GTINs and barcodes for compliance with UDI requirements.

GS1 designated as Issuing Entity for UDI in EU

GS1 designated as Issuing Entity for Unique Device Identification (UDI) by the European Commission (07 June 2019)

Compliance Dates for FDA UDI Requirements

The table below outlines key compliance dates in the UDI final rule.

Scan4Safety at Tallaght University Hospital (TUH) Case Study

Giving time back to patient care

The initiative provides traceability of items used during surgery and procedures, improving the standard of care provided to patients and the Hospital's efficiency.

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Medical Devices

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