Unique Device Identification (UDI) in practice
Implementation for Dosing Pipettes
by Dr. Marvin Ferner, Head of Quality and PRRC
Implementing Unique Device Identification (UDI) under the EU MDR presents unique challenges for manufacturers of Class I medical devices, especially in the value product segment. The regulatory goals are clear – improved traceability, patient safety, and post-market surveillance. Yet, the economic feasibility of technical implementation is often less straightforward. See Article “Unique Device Identification (UDI) under EU MDR: Challenges and Implications for Class I Medical Devices“ to review the key set of requirements.
Unique Device Identification (UDI) under EU MDR
For products like dosing pipettes, where unit prices are low with tight profitability, the cost of UDI compliance - including marking technologies, packaging redesign, and verification - can quickly exceed current product value. This article outlines how elmplastic successfully addresses these challenges through practical, scalable solutions.
Translating MDR Requirements into Practical Solutions
While the EU MDR sets clear expectations for UDI implementation, the real challenge lies in translating these requirements into feasible, implementation strategies. For manufacturers of Class I medical devices like dosing pipettes, UDI implementation involves more than database entries - it’s about physical marking, packaging strategy, and technical feasibility.
Technical Components of UDI: Standards vs. Usability
The UDI system requires both AIDC and HRI formats. The term "AIDC format" typically refers to formats used in Automatic Identification and Data Capture (AIDC) technologies. These formats are used to encode data in various identification devices such as QR codes, and other data carriers [1].
HRI format generally refers to "Human Readable Interpretation" in the context of barcode formats and data encoding. It indicates the human-readable text that accompanies a QR code, allowing people to read the data without needing a scanner [1].
These formats follow very specific design pattern. For example, within a barcode label, the HRI is the text printed just below or beside the barcode, showing the encoded information in plain text [1].
GS1 Data Matrix is a specific implementation of the DataMatrix barcode symbology standardized by GS1, an organization that develops global standards for supply and traceability. It is designed to encode essential product information in a compact, two-dimensional barcode [2].
Modern barcode types follow standards, such as GS1, HIBCC Code 128 and ICCBBA ISBT 128 [3, 4, 5].
All three code standards focus on accurate identification and data management in sectors requiring high levels of safety, traceability, and interoperability, especially healthcare, medical devices and lab samples and pharmaceutical packaging for serialization and tracking.
- GS1 DataMatrix [2, 3]: Used across various industries (retail, healthcare, logistics) for encoding detailed data in a small, space-efficient 2D barcode, such as on medical devices, pharmaceuticals, and consumer products.
- HIBCC Code 128 [4, 6]: Primarily used in healthcare for labeling medical devices, pharmaceuticals, and laboratory samples to ensure accurate identification and inventory management.
- ICCBBA ISBT 128 [5, 7]: Specifically used in blood banking and transfusion medicine for labeling blood components, tissues, and related products to ensure safety, traceability, and compliance with international standards.
However, it is up to the issuing entity (GS1, HIBCC, ICCBBA) to determine format and specifications for UDI assignment [8, 9].
Bar code Verification: ISO Standards vs. User Practicability
While the MDR requires UDI bar codes to be machine-readable and durable, it does not define specific ISO standardized method for assessing the quality of 2D barcodes to help organizations verify that barcodes are printed correctly for accurate reading by scanners.
These standards are widely used in industry and help to ensure barcode readability and consistency, but they are not legally binding under MDR unless required by the issuing agency or a notified body.
- ISO/IEC 15459 (unique identification)
- ISO/IEC 15415 (2D barcode print quality)
- ISO/IEC 15426-1 (verifier conformance specification)
- ISO/IEC 29158 (direct part mark)
For users in daily need, this supports the practical approach of smartphone readability, as this is often more critical than a strict ISO compliance. Many users rely on built-in QR code readers with their devices, which can easily scan the codes, which eventually would fall short of ISO grading thresholds.
In particular for devices with small or curved surfaces, achieving high ISO grades turns out to be a technical challenge and may lead to an economical unfeasibility. The interpretation of the MDR requirements support implementation of the codes with a viable cost / benefit investment for Class I devices.
At elmplastic, we’ve taken a implementation-focused approach to UDI compliance, balancing regulatory demands with economic doability and production capabilities – for our customers and patients.
Our implementation options are:
Direct Printing
Direct printing on the pipette (barrel or plunger) - Our dosing pipettes are marked using an offset printing technology, that allows great individualization and print quality. This method offers:
- Full individualization of print design
- High print quality and readability of codes on small, curved surfaces
- Durable colors to ensure lasting visuals
- Cost efficient production for commercial viability
The implementation date set by MDR is May 2027. Yet, this technique allows elmplastic to meet the MDR’s direct marking requirement for reusable Class I devices (pipettes) already now, while maintaining production efficiency for our customers
Laser Marking: Technically Viable, Economically Challenging
While elmplastic is using laser marking in many other application, it is not yet an alternative for UDI marking. Technical benefits are:
- Permanent, abrasion resistant identification
- High contrast and precision
However, the economic impact is significant, as it may lead to a change control process for every single item, due to required additive in plastic raw material. Hence, the benefit of durability may be not as relevant.
Printed Individual Packaging (example OPP-Foils)
In addition to direct printing, pre-printed foils for single packaging of products could be used, when direct printing is not possible. The foil serves as an effective carrier material for the UDI information. This method supports MDR packaging hierarchy requirements and offers Batch-level flexibility for UDI-PI data and Compatibility with automated packaging systems.
Printed individual packaging (wrapping) is a viable solution for medical devices that cannot be directly marked due to size, shape, or cost constraints. While it requires longer lead times due to upstream printing, this is still very much a doable solution and favored.
Summary: UDI implementation is a Cross-Functional Challenge
Implementing Unique Device Identification (UDI) for low-cost Class I medical devices, like dosing pipettes, under the EU MDR presents challenges - chiefly, balancing regulatory requirements with economic feasibility.
The MDR mandates both machine-readable (AIDC) and human-readable (HRI) formats, without defining specific ISO standards for the barcode quality. For practical, cost-effective solutions for Class I oral dosing pipettes, elmplastic recommends methods like direct printing, which offers high print quality and durability, aligning with MDR deadlines and requirements. Pre-printed packaging like foils serves as an effective addition for dosing pipettes or alternative for products where direct printing is not possible, supporting MDR compliance and product identification needs.
Overall, elmplastic provides a scalable approach that balances regulatory demands with production realities, ensuring compliant and sustainable UDI implementation for Class I devices – for customers and patients.
Do you need expert guidance on UDI implementation for your medical devices?
Our team at elmplastic offers expert support for UDI implementation for pharma manufacturers - from technical feasibility studies to cost-optimized solutions for Class I devices.
For questions regarding implementation or support, the experts at elmplastic are always available to assist you. Visit our website at www.elmplastic.com to explore our full range of services and submit your UDI consultation request directly through our contact form.
References
[1] https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-190321-udi-sag.pdf
[2] https://www.gs1.org/industries/healthcare/udi
[4] https://www.hibcc.org/udi-labeling-standards/barcode-standards/
[5] https://health.ec.europa.eu/document/download/091726d9-1266-4f35-9171-67cd58f046c1_en
[6] https://www.hibcc.org/wp-content/uploads/SLS-2.6-Final.pdf
[8] https://www.fda.gov/media/96648/download
[9] https://webgate.ec.europa.eu/udi-helpdesk/en/udi-assignment/issuing-entities.html
