How to Implement UDI (Unique Device Identification) using the GS1 Keys

If you supply medical devices to the USA you must comply with the new US FDA UDI regulations.









Being able to identify, track and trace medical devices at a global level is important for patient safety. To help achieve this, the US FDA (Food and Drug Administration) has established a Unique Device Identification (UDI) system for medical devices in the US.

The FDA has mandated that suppliers and manufacturers of medical devices must comply with new regulations. These state that all medical devices entering the US healthcare supply chain must be identified with a UDI.

KEY US FDA UDI compliance dates

GS1 standards conform to all US FDA requirements.

US UDI FDA key deadlines table

*Latest* September 24 2020: Rest of Class I (For Class I products that are not in compliance, but were produced/labeled before September 24 2018, extension given until September 24, 2021)


Compliance timelines in the EU 

The European Union published the Regulations on medical devices and in-vitro diagnostics in April 2017.

  UDI assignment and submission of UDI core data elements to the database Placement of the UDI carrier
e.g. barcodes on products
Implantable devices and Class 111 devices 25 May 2020 25 May 2021
Class Ila and Class llb devices 25 May 2020 25 May 2023
Class I devices 25 May 2020 25 May 2025
Reusable devices that shall bear the UDI Carrier on the device itself 25 May 2020 2 years after the date applicable for its respective class of devices
Class D IVDs 25 May 2022 5 May 2023
Class C and B IVDs 25 May 2022 25 May 2025
Class A IVDs 25 May 2022 25 May 2027

What does the US FDA UDI regulation mean for you?

Any medical device manufacturer or supplier trading with the US healthcare market must comply with this regulation.

This mandate is phased over a 6 year period – and it started on 24 September 2014. You must check the FDA website to see which class or classes the products you supply fall under. Then you must check which compliance date or dates apply to the products you supply.

Using GS1 standards to enable compliance

GS1 has been accredited by the FDA as an issuing agency for UDIs and our standards for identification and barcoding conform to all FDA UDI requirements, including:

  • Product identification at each level of the packaging hierarchy
  • The barcode symbols to use
  • The product data to be included in barcodes
  • The data that must be stored within the Global UDI Database (GUDID) specified by the US FDA

Similar regulations to the FDA mandate are expected to follow globally, but adapting to these changes will be easy through GS1 standards – the industry benchmark in healthcare.

And using GS1 standards will not only help you comply but bring efficiency savings to the way you do business.

How GS1 Malaysia can help

As the experts on GS1 standards, we are ideally placed to help you comply with the FDA mandate, and ensure you will comply with EU requirements that will follow. Our range of training and implementation services is helping medical device manufacturers of all sizes to comply, but also operate more efficiently and save money.



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