EU Unique Device Identifier (UDI)
Both the EU Medical Device Regulation 2017/745 (MDR) and the EU IVD Regulation 2017/746 (IVDR) now require that all devices being placed on the market in accordance with these Regulations will need to be assigned a Unique Device Identifier (UDI) in order to facilitate product identification and traceability on the EU market. This will be a monumental task for many device manufacturers, especially those with a vast list of products and variants. The following article is intended to provide an extensive look into the requirements of the EU UDI system and provide guidance on how you may assign these codes
Definition and Anatomy
The Regulations define the UDI as “a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market” (MDR/IVDR Article 2(15)). The legislation goes on to clarify that the word ‘unique’ does not imply serialization of individual units, which means that it is possible for two products to be carrying the same UDI.
The UDI is made up of two parts:
- -DI: Device Identifier.
- -PI: Production Identifier.
UDI-DI: This portion of the UDI is both specific to the manufacturer and device-group. This is considered to be the “access-key” to the UDI database information. Each product variant will have a different UDI-DI, and can be thought of as the product or catalogue number. A unique UDI-DI shall be assigned to each level of device packaging i.e. the various levels of packaging containing a fixed quantity of devices (e.g. carton or case); this does not include the shipping container.
UDI-PI: This shall identify the unit of device production and may include the serial number, the lot number, software identification and manufacturing / expiry date. This tracks the specific production series. If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If the label indicates a date of manufacture, this does not need to appear on the UDI-PI unless the expiry date is not indicated.
How do I assign a UDI to my device?
The first step should be to make a list of all the devices, variants, and packaging levels for which you will require a UDI. Each list entry should have a description of that item.
hoose one of the UDI-issuing entities designated by the EU Commission. Currently, the following entities have been designated to issue UDI for the EU: GS1, HIBCC and ICCBBA. Each entity has specific standards which must be followed to generate the UDI; in fact, the format of each of these entities will differ.
Once you have signed up with one of these entities, you should be provided with your own specific unique prefix which will identify you as the owner of that UDI. Using the standards or instructions provided by one of the issuing entities, you may then generate the UDI-DI and -PI for your devices.
UDI Carrier
The UDI Carrier refers to the means by which the UDI is conveyed by using the Automatic Identification and Data Capture (AIDC) and Human Readable Interpretation (HRI), when applicable. The AIDC is the technology being used to automatically capture data e.g. barcodes, smart cards, biometrics, or RFID. On the other hand, the HRI is the legible characters encoded within the UDI Carrier. In the above example, the QR code is considered to be the AIDC, and the code beneath it the HRI. Together, they form the UDI Carrier.
The UDI Carrier shall be placed on the label or on the device itself and on all higher levels of device packaging. If there is a lack of space on the unit packaging, the Carrier may be shown on the higher packaging levels. In circumstances of limited space, the AIDC shall be shown in preference to the HRI for most cases. However, in the event the device is intended to be used in a care home setting or outside healthcare facilities, the HRI shall appear on the label even if there is no space for the AIDC.
Transitional Provisions
Article 123 of the MDR and Article 113 of the IVDR set transitional provisions for the inclusion of a UDI Carrier on the device labelling, as below. This means that by the dates indicated below the corresponding devices will need to show the UDI Carrier on the device labelling.
Device Changes
In some cases, changes made to the product may result in a new UDI-DI to ensure that the UDI is traceable to a specific product. If that product has changed, then it is reasonable to understand that the UDI-DI should also be changed. The Regulation is clear that in the event of the following changes to the product, the UDI-DI shall be updated (MDR Annex VI Part C (3.9)):
- (a) Name or trade name.
- (b) Device version or model.
- (c) Labelled as single use.
(d) Packaged sterile.
(e) Need for sterilization before use.
(f) Quantity of devices provided in a package.
(g) Critical warnings or contra-indications.
Failure to do so may lead to the misidentification of the device. It is also crucial that manufacturers which are repackaging or relabeling devices with their own label retain a record of the original UDI. The AIDC shall be clearly identified on the label using the UDI symbol, as display in ISO 15223-1.
Rules for Specific Types of Devices
| Single Use | For Class I and Class IIa single use devices packaged and labelled individually, the UDI Carrier does not need to be provided on the unit packaging label, but can be placed on the higher level e.g. carton. However, if the healthcare worker is not expected to have access to the higher packaging levels, then the UDI Carrier shall be placed on each individual product. Such as case would be in home healthcare settings. |
| Retail Point Products | For devices specifically intended to be provided for retail point of sale, the UDI-PI in AIDC does not need to be shown on the point of sale packaging. |
| Reusable | Such devices must indicate the UDI Carrier on the device itself and shall be permanent and legible after every process for their intended lifetime. This shall not apply in cases where: any type of direct marking would interfere with the safety or performance of the device. the device cannot be directly marked because it is not technologically feasible. |
| Assembled Devices | If a device needs to be assembled prior to being used, it is acceptable that the UDI Carrier be shown on one part of the device. |
| Implantable Devices | The UDI Carrier shall be shown on the unit packaging. For active implantable devices, the -PI portion shall contain the serial number. For other implantable devices, the serial number or lot number shall be indicated within the -PI. |
| Article 22 | The natural or legal person responsible for the Article 22 system or procedure pack shall identify the system with a UDI. All device contents shall have a UDI on the device or their packaging with the exception of widely used single use disposable devices or devices exempted elsewhere in the regulation. The system or procedure pack shall be affixed with a UDI Carrier on the outside of the packaging. |
| Configurable | A UDI shall be assigned to the configurable device in its entirety, rather than to each component, with each UDI-DI being provided for each group of configurations, rather than for all possible configurations. However, the -PI shall be assigned for each configurable device, and the UDI Carrier shall be affixed to that part which is most unlikely to change. |
| Device Components | For devices made up from multiple components which are made available for commercial sale on their own shall have their own UDI. |
| Custom-Made and Performance Study / Investigation Device | Custom-Made devices, and devices intended for performance study or clinical investigation shall not have a UDI assigned to them. |
Software
Software which is being commercially made available on its own and which is a device in itself will need to be assigned a UDI at the system level. The identification of software is considered to be a manufacturer control mechanism and is thus indicated within the -PI portion of the UDI. A new UDI-DI will be required whenever there are any of the following changes:
(a) the original performance;
(b) the safety or the intended use of the software;
(c) interpretation of data.
In the event of minor software updates, only the UDI-PI will need to be updated e.g. bug fixes, usability enhancements.
In cases where software is delivered by physical means, the UDI shall be displayed on each packaging level with AIDC and HRI. Furthermore, the UDI shall be displayed on the start-up/loading screen, about page, or other easily accessible page. If the software lacks a user interface, it must still be capable of transmitting the UDI through an API.
In electronic displays of the software, only the HRI will need to be shown. Furthermore, HRI format of the UDI for the software shall include the application identifiers (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI and determining which standard is being used to create the UDI.
How Advena Can Help You
Advena has extensive experience handling complex Medical Device Software projects including the following:
- Image processing.
- Computer Aided Diagnosis / Detection.
- Pharmacogenomics.
- Health apps.
- Artificial Intelligence modules.
We have helped many organisations build the required technical documentation and guide them through all their requirements to obtain their CE marking and place their products in the EU. Our team of consultants can guide you through the all the relevant EU requirements and can also help in building your Quality Management System.
