30 Aug UDI (Unique Device Identifier)
Introduction
This blog explains the concepts of UDI, UDI-DI, and UDI-PI according to the EU Medical Device Regulation (MDR) and EU In-Vitro Diagnostic (IVDR) in more detail to help understand the differences and how to deal with them.
UDI Definitions:
1. UDI (Unique Device Identifier)
The UDI is a series of numeric or alphanumeric characters created through a globally accepted device identification and coding standard like GS1, HIBCC, or ICCBBA. It allows for the unambiguous identification of a specific medical device on the market. The UDI is comprised of two parts: the UDI-DI and the UDI-PI.
2. Basic UDI-DI
The Basic UDI-DI is a new concept introduced by the EU MDR and IVDR. It’s important to understand its role:
1. Purpose: The Basic UDI-DI is the main key to access device-related information in regulatory documentation and EUDAMED. It groups devices with the same intended purpose, risk class, and essential design and manufacturing characteristics.
2. Format: It should be a string of 8 to 25 characters in length, composed exclusively of uppercase letters (A-Z) and numbers (0-9), without any spaces or hyphens.
3. Relationship to UDI-DI: Multiple UDI-DIs can be associated with a single Basic UDI-DI. This allows for the grouping of device variants or models that share fundamental characteristics.
4. Not on packaging: The Basic UDI-DI is not marked on the device or its packaging. It’s used in relevant documentation and databases only.
5. Regulatory use: It’s used in certificates (EU technical documentation assessment, EU type examination, EU product verification), declarations of conformity, and other regulatory documents.
6. Database entry: When submitting device information to EUDAMED, manufacturers must provide both the Basic UDI-DI and the associated UDI-DI(s).
3. UDI-DI (Unique Device Identifier – Device Identifier):
The UDI-DI is specific to a manufacturer and a device. It provides access to the information laid down in Part B of Annex VI of the MDR. Key points about UDI-DI:
– It’s unique to a specific device model.
– It’s the main key for device-related information in the UDI database (part of EUDAMED).
– It remains constant for the same device version/model.
– A new UDI-DI is required when there’s a change that could lead to misidentification of the device or ambiguity in its traceability.
4. UDI-PI (Unique Device Identifier – Production Identifier):
The UDI-PI identifies the unit of device production and, if applicable, the packaged devices. Key points about UDI-PI:
– It may include information such as the lot or serial number, expiration date, manufacturing date, or software version.
– It varies for each production unit, providing traceability for individual devices or batches.
– The type of UDI-PI used (e.g., serial number, lot number, expiry date) needs to be reported to EUDAMED, but the actual UDI-PI values are not stored in the database.
How to deal with UDI as a manufacturer:
1. Assignment: You must assign a UDI to your device and all higher levels of packaging before placing it on the market (except for custom-made and investigational devices).
2. UDI Carrier: Place the UDI carrier (containing both UDI-DI and UDI-PI) on the device label or packaging. For reusable devices, it should also be on the device itself.
3. Basic UDI-DI: Assign a Basic UDI-DI, which is a separate identifier used to group devices with the same intended purpose, risk class, and essential design and manufacturing characteristics. This is used in relevant documentation and as the main access key in EUDAMED.
4. Database submission: Ensure that the device information is correctly submitted to EUDAMED, including the UDI-DI and the types of UDI-PI used.
5. Changes requiring new UDI-DI: Be aware of changes that require a new UDI-DI, such as:
- Name or trade name changes
- Device version or model changes
- Labeling as single-use
- Packaged sterile
- Need for sterilization before use
- Quantity of devices in a package
- Critical warnings or contraindications
6. Maintain records: Keep up-to-date records of all UDIs assigned to your devices.
7. Comply with coding standards: Use only coding standards provided by issuing entities designated by the European Commission.
8. Reusable devices: Ensure the UDI carrier is permanent and readable after each reprocessing cycle for the device’s intended lifetime. A great technology can be laser marking where for example FOBA Laser is one of the leaders in this industry.
Example of a hypothetical UDI number based on GS1:
Basic UDI-DI: 796436712345ABCD9
UDI: (01)07964367123459(11)220315(17)250315(10)A373B2(21)1234
Let’s break this down:
1. Basic UDI-DI (GMN): 796436712345ABCD9
- 7964367 (GS1 Company Prefix)
- 12345ABCD (Model Reference)
- 9 (Check Character)
- This is a separate identifier, not physically marked on the device or its packaging
- It serves as the main key for device-related information in the UDI database (EUDAMED)
2. UDI-DI: (01)07964367123459
- (01) is the Application Identifier (AI) for GTIN
- 07964367123459 is the GTIN, identifying the specific device model
3. UDI-PI:
- (11)220315 – Production date (March 15, 2022)
- (17)250315 – Expiration date (March 15, 2025)
- (10)A373B2 – Batch/lot number
- (21)1234 – Serial number
It’s important to note that not all UDIs will contain all of these elements. The exact composition depends on the device type, its intended use, and applicable regulations. For instance, some devices might not have an expiration date, while others might not require a serial number.
As a manufacturer, you would need to determine which of these elements are necessary for your specific device based on its characteristics and the regulatory requirements it falls under. The UDI-DI is always required, while the elements of the UDI-PI may vary depending on the device type and applicable regulations.
Conclusion
The UDI system is essential for improving the traceability and safety of medical devices within the EU regulatory framework. It consists of the UDI-DI, which uniquely identifies a specific device model, and the UDI-PI, which tracks individual production units. The Basic UDI-DI serves as a key for accessing device-related information in regulatory documentation and is used to group devices with similar characteristics. Manufacturers are responsible for assigning UDIs, ensuring they are properly marked on devices and packaging, and submitting accurate information to EUDAMED. Compliance with these requirements enhances device identification, facilitates recalls, and ultimately contributes to patient safety.
Regulatory Intelligence Service:
We are helping companies with being up to date with medical device regulation globally. Learn more and join our exclusive service by clicking HERE.
No Comments