Product traceability from the point of manufacture to the point of care or use.
GS1 Global Trade Item Numbers (GTINs) are used to uniquely identify, track and trace products and devices as they are transferred through the supply chain and along the patient pathway.
Achieving this visibility means that products and devices can be effectively traced to the patient to better review outcomes and improve safety.
Items can also be closely monitored for post-market surveillance and in the event of a product recall, defective items can be quickly identified and removed from circulation.
GTINs also serve as an authentication measure to validate legitimacy. It is then easier to pinpoint any potential counterfeit or falsified products or devices that may have entered the supply chain.
How does it work?
Behind the barcode
Packaging for products and devices include a GS1 barcode – which is either linear or a 2D DataMatrix. This is encoded with essential product information such as batch/lot number, serial number, date of manufacture or expiry – production identifier (PI). In GS1 terms the PI is known as the Application Identifier (AI).
When scanned, this information is captured at the point of care or use in real time, where it can then be logged accordingly – either into an inventory management system or directly into the electronic patient record (EPR).
Benefits of product ID
Patient safety
Counterfeit and falsified products and devices can be identified to prevent harm and reduce the risk of Never Events.
Product recalls
Products can be easily traced, so in the event of a product recall, they can quickly be removed from circulation
Inventory management
Stock availability can be monitored in real time, eliminating the need for manual stocktaking.
Accurate records
Items used on, or in, a patient, can be captured at the point of use and recorded directly in the patient record.
Post-market surveillance
Products and devices can be widely surveilled while on the market to monitor patient outcomes and adverse events.
Patient-level information costings (PLICs)
Products used in a particular procedure or timeframe can be monitored to provide accurate PLICs.
Product identification
For procurement and inventory management, a single national Product Information Management (PIM) system for the NHS will help trusts easily access the right product information.
Suppliers will publish this standardised product information and a trust’s catalogue system will be automatically updated from this single source of information. Whenever any changes are made by the supplier, the trust’s catalogue will be update to ensure real-time accuracy of all product details.
This removes any ambiguity in the information and allows accurate comparisons to be made between suppliers and improves order accuracy and product availability respectively.
Unique device identification (UDI)
In the case of medical devices and in-vitro diagnostic medical devices, this is known as UDI which consists of the Device Identifier (labelling organisation ID and device model details (DI)) + PI information. In GS1 terms, the GTIN is the equivalent of the DI.
Individual medical devices can then be traced through the supply chain, and importantly, directly to the patient. Supporting information on UDI can be found on the GS1 website.
UDI regulations
To help achieve this, 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. Each regulation has similar requirements that differ in places, have different timescales and use different databases for manufacturers to update.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) are reviewing the UDI requirements for legislation in Great Britain.
Following the UK departure from Europe, the European Medical Device Regulation (EU MDR) and In-vitro Diagnostic Medical Device Regulations (IVDR) will not apply in Great Britain (GB). Legislation that will apply in GB will be the Medical Device Regulations 2002.
The MHRA will be using the recent Medicines and Medical Devices Act to improve the traceability of medicines and medical devices. By standardising the way in which devices are identified (using unique device identification – UDI), this will enable devices to be tracked and traced once on the market.
Device reference data will then be captured and held in a national medical device register to improve post-market surveillance. This includes: proactively monitoring device performance for re-certification, annual safety updates for higher-risk class devices, rapid reporting of safety incidents, and facilitation of efficient product recalls.
The register is intended to hold details of manufacturers and all relevant production information of devices placed on the GB market.
Registration of devices in GB are to be no later than 1 May 2021, 1 September 2021, and 1 January 2022 for relevant device classes.
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.
Compliance timelines in the EU
| Class of device | UDI assignment | Submission of UDI | Placement of the U |
|---|---|---|---|
| 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 |
The release of EUDAMED modules
The European Commission (EC) has officially confirmed that the EUDAMED UDI/Devices registration, and Notified Bodies and Certificates modules have been successfully deployed in the Production environment and are now available for use. The remaining modules will be displayed as soon as they are functional.
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).
The US Food and Drug Administration (FDA) has had a Unique Device Identification (UDI) system for medical devices sold into the US since 2013.
Compliance timelines in the US
| Deadline | Requirement |
|---|---|
| 24 September 2014 | Class III; 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. |
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 and UDI-A160002.
This extension means certain non-prescription, 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 any further questions, contact the FDA UDI Help Desk via the link below.
