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The US requirements for Unique Device Identification (UDI)

Date: May 19, 2021

Category: Industry news


An update and short FAQ guide for members in relation to the new US requirements for UDI.

In 2013, GS1 became an authorised issuing agency for unique device identifiers (UDIs) by the US regulator, the Food and Drug Administration (FDA). This means that GS1 members can use GS1 Global Trade Item Numbers (GTINs) on their products (in this case medical devices), to uniquely identify, track, and trace, medical devices through every step of the product lifecycle, supply chain and patient pathway.

GS1 UK, as one of 115 GS1 Member Organisations, have a requirement to ensure that we have accurate information of members that are using GTINs to identify medical devices being supplied to the US for sale and use. 

Between now and 30 September 2021, we are required to contact each of our 50,000+ GS1 UK members to confirm whether they are using GTINs on any medical devices supplied to the US market.

Why?

In order to ensure the US UDI database – the Global UDI Database (GUDID) – is up to date, all issuing agencies need to ensure the corresponding device information provided is accurate. This will help to ensure traceability and safety of registered devices available in the US.

What does this mean for me?

This means that you will need to declare your organisation as either “a medical device supplier to the US market” or “not a supplier of a medical device to the US market”.

I am supplying my products into the retail market/to retailers, not to healthcare providers, is this relevant to me? And if so, how do I know?

If you are supplying medical devices to the US this will apply to you. 

Since a medical device can include anything from a pacemaker or a hip implant, to a home blood pressure monitor or glucose machine, it is important to have all bases covered. Your product may be classified as a medical device without you expressly knowing that it is.

To find out if your product could be a medical device, the World Health Organisation definition may help.

What do I need to do?

First things first, you need to log into your MyGS1 area in order to update your status.

MyGS1 log in screenshot

Once you have logged in you will be able to find details under your account summary and then account details. Please note, this option will only be visible if you are listed as the account admin.

MyGS1 account summary screenshot

FDA question screenshot

Even if you do not supply medical devices to the US, you need to update your status to “No”.

If the answer is “Yes” and the information we hold for you is up to date and complete, you do not need to do anything. We will share the relevant device information with the corresponding GS1 Company Prefix (GCP) to our GS1 Global Office to share with the US FDA for the GUDID.

If the answer is “Yes” but we are notified of any incomplete product information or inconsistencies held by our GS1 Global Office versus the information we hold, a member of the GS1 UK healthcare team will contact you.

Please ensure your contact details are up to date in your MyGS1 account to allow us to process any discrepancies promptly. If you are not the correct contact to discuss this matter, please let the team know when we get in touch and provide an alternative contact for us to follow up with.

If I update this once, is this enough?

Details of medical devices available on the market can frequently change at any given time. As such, we need to provide regular updates annually to ensure the integrity of the GUDID is maintained. 

The good news is you will not need to remember to do this each year. We will contact you when the time is right to give you the opportunity to update your status in your MyGS1 account. All you need to do is keep an eye out for an email from us closer to the time towards the end of each year.

What happens if I am supplying medical devices to the US and I do not update my status?

If you do not do this, there is a risk that you will not be able to continue supplying your medical device(s) to the US market.

Further information

If you would like any further information, you can read more on the member declaration page or email us at healthcare@gs1uk.org to find out more.