Do you comply with UDI?

Compliance timelines in the EU

The European Union published the regulations on medical devices and in-vitro diagnostics in April 2017. Original dates listed have since been updated to the timelines outlined below as highlighted in the European Commission's Unique Device Identification (UDI) System – FAQs document.

Update as of March 2021

The European Commission (EC) has officially confirmed that: “The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available by September 2021. Afterwards, the remaining modules will be displayed as soon as they are functional”. Further information is available online on the EC web page for Medical Devices – EUDAMED.

*Please note, in the UK, the timelines will only apply in Northern Ireland. 

Launch of European Commission’s UDI Helpdesk

On 17 May, the European Commission launched a dedicated UDI helpdesk to support organisations with implementing the obligations and requirements of the new UDI system under regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

It has been developed to provide additional support with regards to UDI assignment, labelling and registration of devices, as well as guidance on the use of the European Medical Devices Nomenclature (EMDN).

Access the helpdesk

Compliance timelines in the US

The US Food and Drug Administration (FDA) has had a Unique Device Identification (UDI) system for medical devices sold into the US since 2013. The compliance timelines are as follows:

New FDA update: FDA Extends Alternatives UDI-A160001 and UDI-A160002

The U.S. Food and Drug Administration (FDA) has extended the following unique device identifier (UDI) alternatives :  

• UDI-A160001
• UDI-A160002

This extension means certain nonprescription, over-the-counter devices intended to be sold exclusively through retail establishments may continue to bear a Universal Product Code (UPC) as their device identifier.

These two alternatives expire on 24 September 2023. 

For more information on the alternatives and a list of the FDA product codes to which the alternatives apply, click "learn more" below, to go to the FDA Decisions section of the UDI Exceptions, Alternatives, and Time Extensions page on FDA.gov.

Learn more

If you have questions, contact the FDA UDI Help Desk at GUDIDSupport@fda.hhs.gov

What does this mean for me?

Essentially, as a medical device manufacturer you have to apply a unique identification number to each medical device label, its packaging and, in some cases, the device itself. You must then share information about each device with regulatory databases in the US and in the EU – in addition your customers requesting this extra rich information about your products too.

If you are a new manufacturer and you intend to sell into the US, you will need to ensure you have a unique identification number for your products. You can contact us using the details below for support.

Getting the help and support you need

As the experts on GS1 standards, we can help you comply with meeting medical device requirements in the EU, in the US or in any of the markets you serve. Our range of training and consultancy services is helping medical device manufacturers of all sizes to understand the impact on them, develop a rigorous adoption plan and implement it across their organisation.

Remember, implementing GS1 standards not only enable your business’ compliance with UDI regulations – they are a catalyst for your business to operate more efficiently, save money and better meet the needs of your customers too. You can contact a member of the healthcare team for support via email at healthcare.gs1uk.org.