In June 2021, we held a half-day UDI forum for healthcare suppliers, with a follow up Q&A panel session, to update members on the latest regulatory requirements for compliance. Visit our webpage to access the sessions.
Do you comply with UDI?
If you supply medical devices anywhere in the world, chances are you have to comply with strict regulations – and some are pretty daunting to say the least
Here we talk about Unique Device Identification (UDI) regulations in Europe and in the US.
If you supply medical devices into other global markets, get in touch with us and talk to one of our standards experts. After all, one of the many advantages of being a global standards organisation means we can draw on local knowledge – the world over.
What is UDI?
Essentially, it’s the ability to uniquely identify, track and trace individual medical devices through the supply chain and, importantly, into a patient pathway. It goes without question this can fundamentally improve patient safety and it even enables the ability to remove an unsafe or recalled product from harm’s way before it reaches a patient.
To help achieve this industry ambition, the EU and the US have both published UDI regulations for medical devices. These regulations join a globally harmonised framework for identification of medical devices – enhancing quality of care, patient safety and business processes. Although, they do take similar but different regulatory approaches, with different compliance timescales and different databases for manufacturers to update. This means added complexity and lots of hard work for all involved.
Implementing GS1 standards will enable you to meet these regulatory requirements in addition to making cost savings, harnessing better quality data and improving efficiency throughout your business.
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.
|UDI assignment||Submission of UDI core data elements to the database||Placement of the UDI carrier
e.g. barcodes on products
|Implantable devices and Class III devices||26 May 2021||26 Nov 2022||26 May 2021|
|Class Ila and Class llb devices||26 May 2021||26 Nov 2022||26 May 2023|
|Class I devices||26 May 2021||26 Nov 2022||26 May 2025|
|Reusable devices that shall bear the UDI Carrier on the device itself||26 May 2021||26 Nov 2022||2 years after the date applicable for its respective class of devices|
|Class D IVDs||26 May 2022||26 Nov 2023||26 May 2023|
|Class C and B IVDs||26 May 2022||26 Nov 2023||26 May 2025|
|Class A IVDs||26 May 2022||26 Nov 2023||26 May 2027|
*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).
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:
|24 September 2014||Class III – do you comply?
Labels and packages of all Class III medical devices and devices listed under the Public Health Service Act must have a UDI. Data for these devices must be submitted to the Global UDI Database (GUDID).
|25 September 2015||Labels and packages of implantable, life-supporting and life-sustaining devices must have a UDI. Data for these devices must be submitted to the GUDID.|
|24 September 2016||Class II
Labels and packages of Class II medical devices must have a UDI. Data for these devices must be submitted to the GUDID.
|24 September 2018||Class I
Labels and packages of Class I medical devices that have not been classified as Class I, II or III must have a UDI. Data for these devices must be submitted to the GUDID.
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 :
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.
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.
We offer regular free healthcare webinars that explain more about the use of GS1 standards across the sector. They are great if you are new to the industry, new to GS1 standards, or would just like a refresher.
Our training provides greater understanding on how you can use GS1 standards to identify devices, encode the correct production information, follow barcode best practice, and manage your data to ensure compliance with regulatory databases.
All of our on-site training sessions can also be provided virtually. You can find out more using the link below or enquire at firstname.lastname@example.org.
If your organisation requires a deeper level of support to truly understand the impact of global regulations or even local NHS requirements, our team of professional standards consultants can work with you to explore your organisation and build an actionable plan to deliver what’s required for you.
We offer a one day consultancy service or a full bespoke discovery of your business.