The European Medical Device Regulation (EU) 2017/745 (MDR) requires medical device manufacturers to apply a product identifier, the Unique Device Identification (UDI) (Art. 10 (7) MDR). The UDI is a string of characters that enables unique identification of individual products on the market. The aim of the EU is to make medical devices traceable, to improve market surveillance and to increase the safety of medical devices in this way.
What is the UDI system for?
The UDI system makes it easier to identify and report abnormal medical devices and, if necessary, to initiate safety corrective measures. In this way, post-market surveillance, which a manufacturer is obliged to do according to the MDR, should become easier. Product recalls can be carried out more quickly and efficiently.
Improved traceability of medical devices will allow manufacturers to better record and analyze use errors. This will lead to a better data basis, increase the quality of medical devices and help reduce incorrect treatments.
The UDI system standardizes documentation throughout the supply chain. This should prove beneficial with regard to data transfer into administrative systems, especially health records and clinical information systems. Here, too, manufacturers can count on new insights into the use of their products and derive appropriate decisions from them.
The UDI system will put all logistics, ordering and delivery processes on a different footing. This should not only make the distribution chain more efficient, but also counteract the growing problem of product counterfeiting and misuse.
How is the UDI system structured?
The UDI code is a unique (alpha)numeric string (Art. 2 (15) MDR). There are 3 different UDI codes:
Basic UDI-Device Identification (Basic UDI-DI).
UDI-Device Identification (UDI-DI)
UDI-Production Identification (UDI-PI)
The Basic UDI-DI is a registration number for a group of products with the same intended purpose, same risk class and comparable design and manufacturing characteristics. It can be understood as an identifier of a product model.
The base UDI-DI does not appear on the label or packaging of a product. It does, however, appear on the:
- Manufacturer's Declaration of Conformity,
- technical documentation,
- product registration in EUDAMED,
- preparation of the summary report on safety and clinical performance and the
- preparation of certificates of free sale.
The main purpose of the base UDI-DI is to summarize information about a specific medical device model within the UDI database. The UDI database is part of the European medical device database EUDAMED (Art. 28 MDR). Manufacturers must enter all UDI-related data into the UDI database.
A basic UDI-DI can combine multiple UDI-DIs. A UDI-DI can only be assigned to one base UDI-DI.
The UDI-DI is then used to uniquely identify a respective product. The UDI-PI contains information on the manufacture of a respective product. These are, for example, batch and serial numbers or manufacturing and expiry dates.
How does a manufacturer implement UDI?
The manufacturer groups its product portfolio according to intended purpose, risk class and basic design and manufacturing characteristics. This information is the basis for the allocation of UDI codes by an allocation body. The allocation bodies are currently GS1, IFA, HIBCC and ICCBBA.
The allocation of UDI codes by the allocation bodies is for:
- marketed products including software and components
- Packaging levels
- Product configurations
- Product systems
- Treatment units
Changes to the medical device, such as a different trade name, a different product version, or a different product model, may require a new UDI-DI.
The UDI-PI is assigned by the manufacturer.
The manufacturer applies the UDI code in both machine-readable and human-readable form to the product label and packaging. The design of a product label is precisely defined. For example, there are specifications on the barcode, its colors and dimensions.
In addition, the manufacturer submits the relevant data to the UDI database. Otherwise, he is not allowed to market the medical device.
Are there special provisions for medical software regarding UDI?
Part C of Annex VI MDR contains special provisions for software:
- the UDI is assigned at the system level of the software,
- the software identification is considered as 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 base UDI-DI,
- any change that affects the original performance, safety, or interpretation of data; and
- a change in name or trade name, version or model number, critical warnings, contraindications, or user interface language.
Minor software changes, such as bug fixes unrelated to security, require a new UDI-PI and not a new UDI-DI. Even these minor changes shall be documented with respect to the UDI system.
The human-readable form of the UDI can be stored in software menus. If there is no user interface, other ways have to be used, e.g. an Application Programming Interface (API).
What are the deadlines for UDI?
UDI carriers are placed on the product's labeling and on all higher levels of packaging. Shipping containers are not considered a higher level of packaging. As part of the MDR transition deadlines, the following deadlines apply:
- Class III and implantable devices: May 26, 2021.
- Class IIa and IIb devices: May 26, 2023
- Class I devices: 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. Thus, the following deadlines apply here:
- Class III and implantable devices: May 26, 2023.
- Class IIa and IIb devices: May 26, 2025
- Class I devices: May 26, 2027
Where can I find help for UDI?
The Medical Devices Coordination Group (MDCG) of the EU Commission has written a number of guides related to UDI. Furthermore, the EU Commission offers a UDI Helpdesk and the allocation bodies provide comprehensive further information on their respective standards on their websites.
Conclusion
The changeover to UDI is a challenge, especially for manufacturers with large product ranges, and involves a lot of effort. It is therefore advisable to focus not only on the pure fulfillment of regulatory requirements, but to increase the overall quality, safety and efficiency of the product portfolio by optimizing the logistics and distribution chain.
