The European Medical Device Regulation (EU) 2017/745 (MDR) requires medical device manufacturers to assign their devices a device identifier, the Unique Device Identification (UDI) (Art. 10 (7) MDR). The UDI is a character string allowing for a clear and unambiguous identification of specific devices on the market. The new UDI system will make the traceability of medical devices easier, improve post-market surveillance and increase the safety of medical devices in this way.
What is the purpose of the UDI system?
The UDI system makes it easier to identify and report faulty medical devices and initiate safety corrective actions if necessary. This should simplify post-market surveillance, which a manufacturer is obliged to do under the MDR. Product recalls can be carried out more quickly and efficiently.
By improving the traceability of medical devices, manufacturers can better record and analyze application errors. This will lead to a better data basis, increase the quality of medical devices and help to reduce treatment errors.
How is the UDI system structured?
The UDI system consists of
- the UDI,
- the basis UDI-DI, and
- the UDI database
The UDI is a unique numeric or alphanumeric code (Art. 2 (15) MDR), which consists of two components, the UDI-DI and UDI-PI.
The UDI-DI (UDI-Device Identification) is used to identify a product model. The UDI-DI remains the same throughout the life cycle of the product model as long as no significant changes are made to the product. Changes, such as a different trade name, a different product version or a different product model, may require the assignment of a new UDI-DI.
The UDI-PI (UDI-Production Identification) is used to identify a production unit of device product. The different types of UDI-PI include the serial number, the batch number, the software identification and the manufacturing or expiry date or both.
The UDI therefore makes it possible to map both the product model and specific information on the production batch or individual unit of device production. Several production units of a product model therefore have the same UDI-DI but different UDI-PIs. This makes every medical device on the market clearly identifiable and traceable.
The Basic UDI-DI is a registration number for a group of devices with the same intended purpose, the same risk class and comparable design and manufacturing features. It can be understood as the identifier of a product family. A Basic UDI-DI can combine several UDI-DIs, whereas a UDI-DI can only be assigned to one Basic UDI-DI.
While the UDI appears on the device, label or packaging, the Basic UDI-DI does not appear on the device. The Basic UDI-DI is used for the administration and regulatory registration of medical devices at a higher level and is used in the:
- Declaration of conformity by the manufacturer,
- Technical documentation,
- Product registration in EUDAMED,
- Preparation of the summary report on safety and clinical performance,
- Creation of over-the-counter certificates
The UDI database is part of the European medical device database EUDAMED (Art. 28 MDR). Manufacturers must register all their medical devices in this database.
How do manufacturers obtain the UDI and Basic UDI-DI?
Manufacturers of medical devices receive the UDI-DIs and the Basic UDI-DIs via allocation offices designated by the Commission (Art. 27 MDR). The UDI-PI is assigned by the manufacturer themself.
There are currently four allocation offices whose standards can be used to implement the requirements of the MDR regarding UDI: GS1, IFA, HIBCC and ICCBBA. The actual generation of the UDI-DIs and Basic UDI-DIs differs between the various allocation offices. The allocation offices offer manufacturers corresponding instructions and guidelines that explain how to implement the UDI requirements using their standards. Manufacturers can also purchase code contingents of different sizes from the allocation offices in order to meet the specific requirements of their product range.
The allocation of UDI codes by the allocation bodies takes place for:
- Marketed products including software and components
- Packaging levels
- Product configurations
- Product systems
- Procedure pack
Where should the UDI be placed?
The UDI carrier is the medium on which the UDI is applied or stored in machine-readable form (AIDC - Automatic Identification and Data Capture) and human-readable form (HRI - Human Readable Interpretation) (Annex VI Part C 1. MDR). Options include linear 1D barcodes, 2D matrix barcodes and RFID (Radio Frequency Identification). The UDI carrier is placed on the label or to the device itself, as well as to all higher levels of the device packaging (Annex VI Part C 4. MDR). Shipping containers are not considered a higher level of packaging. Annex VI Part C point 4 MDR describes specific requirements for the design/property and placement of the UDI carrier. Information for special product types, such as implantable devices, is described in Annex VI Part C point 6 of the MDR.
The placement of the UDI is an additional requirement and does not replace any other marking or labeling requirements according to Annex I point 23 of the MDR.
How does registration in the UDI database work?
The UDI database is part of the European database on medical devices (EUDAMED). Manufacturers can register products in the UDI database via their EUDAMED access. In addition to the Basic UDI-DI and the associated UDI-DI, further product information, such as the risk class and the trade name, is queried. The UDI-PI is not entered directly, but by specifying the type of UDI-PI in the form of lot number, serial number, date of manufacture or expiry date. A user manual is available to support the product registration process.
How does a manufacturer implement the UDI in the QMS?
In accordance with Art. 10 (9) (h) MDR, the assignment of the UDI and ensuring the consistency and accuracy of the information provided in the UDI database during registration is part of the manufacturer's Quality Management System (QMS). The guideline MDCG 2021-19 exists to assist with the implementation of the UDI in the manufacturer QMS.
Accordingly, the manufacturer's QMS must describe or keep records of the following:
- Definition of responsibilities in relation to UDI implementation (including ensuring the necessary staff training)
- Selection of an allocation office
- Information on the structure of the UDI code
- Process of assigning UDI codes (incl. systematic identification of devices, parts, components, systems or procedure pack that require a Basic UDI-DI and a UDI-DI assignment)
- Grouping of UDI-DIs (incl. justification) and assignment to the Basic UDI-DI
- Definition of UDI-PI and applicability to the model of device
- Record of assigned Basic UDI-DIs and UDIs
- Registration process in the UDI database
- Transfer of the Basic UDI-DI into relevant documents (e.g. EU Declaration of Conformity)
- Referencing the UDI-DI in the corresponding technical documentation
- Processes regarding change management of the UDI system, including updating the UDI database
- Design and placement of the UDI carrier
- Validation and maintenance of the process for applying the UDI carrier (e.g. labeling process and maintenance of printing equipment)
- Procedures for linking the UDIs and the corresponding quality records (e.g. complaint records, trend reports, production records)
When is it necessary to assign a new UDI-DI?
The assignment of a new UDI-DI is always necessary if a change could lead to incorrect identification of the device and/or to ambiguities in its traceability. In particular, a new UDI-DI is required in the event of a change to the following elements:
- Basic UDI-DI,
- Name or trade name,
- Version or model of the product,
- Labeling as a single-use product,
- Sterile packaged,
- Necessity of sterilization before use,
- Quantity of products contained in a pack,
- Critical warnings or contraindications,
- CMR/hormone disrupting substances
Are there special regulations for medical software regarding UDI?
Part C of Annex VI Part C 6.5 MDR contains special provisions for software:
- the UDI is assigned at the system level of the software,
- the software identification is considered a manufacturing control mechanism and is specified in the UDI-PI,
- a new UDI-DI must be assigned after certain software changes, and
- the UDI is applied according to certain criteria.
Guideline MDCG 2018-5 "UDI Assignment to Medical Device Software" clarifies which changes to medical device software require a new UDI-DI:
- any change to the Basic UDI-DI,
- any change that affects the original performance, security or interpretation of data, and
- a change in the name or trade name, version or model number, critical warnings, contraindications or user interface language.
Minor software changes, e.g. bug fixes unrelated to security, require a new UDI-PI and not a new UDI-DI. These minor changes must also be documented regarding the UDI system.
For software distributed on a physical medium (e.g. CD or DVD), the entire UDI must be displayed in human readable format and machine readable format on each packaging level. The UDI must be made accessible to the user of the software in a readily accessible and easy-to-read form, e.g. in the info window with system information or in the start window. The UDI must only be provided in a human readable format. In cases where the software does not have a user interface, it must be able to transmit the UDI via an application programming interface (API).
What are the deadlines for UDI?
In the course of the MDR transition periods, the following deadlines apply for the obligation to place the UDI carrier:
- Class III and implantable devices: May 26, 2021
- Class IIa and IIb products: May 26, 2023
- Class I products: May 26, 2025
The MDR grants two additional years in the case of reusable devices where the UDI carrier is to be placed on the device itself. The following deadlines therefore apply here:
- Class III and implantable devices: May 26, 2023
- Class IIa and IIb products: May 26, 2025
- Class I products: May 26, 2027
Where can I find help for implementing the UDI?
The Medical Devices Coordination Group (MDCG) of the EU Commission has drawn up a series of guidelines relating to UDI. Furthermore, the EU Commission offers a UDI helpdesk and the allocation offices provide comprehensive further information on their respective standards on their websites.
Conclusion
The changeover to UDI is a challenge, particularly for manufacturers with large product ranges, and involves a great deal of effort. It is therefore advisable to focus not only on meeting regulatory requirements, but also on optimizing the logistics and distribution chain to increase the overall quality, safety and efficiency of the product portfolio.
