Print UDI codes on Tyvek® and measure them in compliance with standards using REA VERIFIER
Medical device manufacturers have to apply UDI codes to Tyvek® packaging in a manner that is permanently readable, auditable, and compliant with standards. REA, in collaboration with DuPont, demonstrates how inkjet printing, optimized inks, and code verification in accordance with ISO/IEC 15415—using the ISO/IEC 15426-compliant REA VERIFIER—lead to sturdy marking processes.
Why is Tyvek® challenging for UDI printing?
Many medical device manufacturers are familiar with these challenges when marking Tyvek® packaging:
- Inconsistent print quality
- Illegible UDI codes
- Risks during audits and compliance inspections
- Scrap due to failed measurement results
We offer solutions for permanently readable UDI codes on Tyvek®
REA and DuPont
Why is Tyvek® so challenging to mark?
The unique properties of Tyvek® are both its greatest strength and the central challenge in the printing process.
- Fibrous, irregular surface:
makes it difficult to achieve precise code structures - Hydrophobic properties:
affect ink adhesion and drying - Low ink absorption:
may result in uneven print quality - Strict regulatory requirements (UDI):
require consistently high code quality
Even the slightest deviations can compromise the readability and regulatory compliance of codes.
Comprehensive Solution for Marking and Verification on Tyvek®
Download the white paperReliable marking on Tyvek® requires an integrated approach.
REA and DuPont combine material expertise with state-of-the-art coding and marking technologies and measurement techniques.
Material + Printing Technology + Print Quality Measurement = Process-Reliable
- Direct printing on Tyvek® using optimized inkjet systems
- Optimized inks for challenging material surfaces
- Code verification compliant with ISO/IEC standards
- True inline measurement technology = quality controlfor stable processes
The results achieved together demonstrate:
Even on challenging materials such as Tyvek®, consistently high print quality can be process-reliably achieved using measurement technology verifiable in accordance with ISO/IEC 15426.
This produces reproducible, auditable marking processes, even on complex materials.
Learn in detail about the challenges involved in printing on Tyvek® and how these can be addressed in practice.
White Paper on UDI Marking on Tyvek® in Practice
Your benefits:
- Understanding material properties
- Knowing suitable printing processes
- Meeting UDI quality requirements
- Real-world examples from the medical technology sector
Your Results:
- Improved readability of UDI codes
- Less scrap
- Standard-compliant measurement
- Reproducible printing processes
- Greater confidence during audits
- Phone +49 6154 638-0
- Mobile +49 151 40764551
- E-mail tthiel@rea.de
Tobias Thiel is the Business Development Manager for Pharmaceuticals and Medical Care at REA Elektronik GmbH and is responsible for the international expansion of the medical technology division. He supports medical device manufacturers worldwide in implementing standards-compliant marking and identification solutions, as well as international key accounts and OEM partners in executing complex UDI projects.
With over twelve years of experience in the packaging industry and more than fifteen years in technical sales, he possesses in-depth expertise in the areas of product marking, packaging processes, and regulatory requirements. His focus is on cost-effective and future-proof coding and marking solutions for sterile packaging, medical devices, and pharmaceutical applications.
Key areas of focus include reliable UDI marking of challenging materials such as Tyvek®, the selection of suitable printing technologies, and the integration of standards-compliant verification systems into existing production lines. Through close collaboration with customers, partners, and material manufacturers such as DuPont, Tobias Thiel develops innovative marking concepts to enhance traceability, digitalization, quality assurance, and compliance in the medical technology sector.
Key Areas
- UDI marking for medical devices
- Marking on Tyvek® and sterile packaging
- Inkjet, laser, and labeling solutions
- Ensuring code quality, either inline or via spot checks, using ISO/IEC 15426-compliant verifiers
- International regulatory requirements (MDR, FDA)
- OEM and production integration
As of August 2026
Regulates the UDI requirement for medical devices in the EU. For packaging made of Tyvek®, this means that the UDI code has to be affixed in a way that is unique, permanently readable, and traceable. UDI and product information are also recorded in the European database EUDAMED and used for the identification and traceability of medical devices (Regulations 2017/745 and 2017/746).
Defines the UDI requirements for medical devices in the U.S. market. Relevant requirements include, among others, unique product identification, machine-readable marking, and database registration. The regulatory requirements are set forth in 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830.
A method for measuring the print quality of 2D codes such as GS1 DataMatrix or QR codes. For Tyvek®, it is particularly important that contrast, modulation, and code geometry remain sturdy despite the challenging surface.
Defines requirements for measuring instruments used to monitor print quality (measurement accuracy, calibration, adjustment). Only standard-compliant measuring devices (verifiers) ensure that the quality of GS1 DataMatrix and HIBC codes—for UDL, among other applications—can be reliably and reproducibly measured and evaluated.
Define how UDI-compliant codes are structured in accordance with the specifications of the issuing entities. This includes standard-compliant print quality, the code type and size, as well as the data structure that correctly incorporates article numbers, lot numbers, serial numbers, and, where applicable, date information into the code. A prominent example is the GS1 General Specification Standard, which uses the GTIN as the article number.
Download the free white paper
Joint white paper from DuPont and REA
Frequently Asked Questions About UDI Marking on Tyvek®
Marking Tyvek® poses unique challenges for medical device manufacturers. The material has to retain its sterilization and protective properties, while UDI codes have to be permanent, high-contrast, and reliably readable. In our FAQ, we answer the most common questions about marking, suitable printing technologies, and measuring code verification in accordance with standards.
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Due to its fibrous structure and low ink absorption, Tyvek® is one of the most challenging materials for UDI marking. Only a carefully optimized combination of printing technology, ink, and code measurement ensures that UDI codes are permanent and readable over time and comply with standards.
Tyvek® is used worldwide as a sterile barrier material for medical devices and places special demands on the printing process. Its irregular, fibrous surface and hydrophobic properties affect how the ink behaves and can significantly impair the quality of Data Matrix codes.
Even minor deviations in print resolution, ink volume, or drying can reduce the readability of a UDI code. Therefore, the material, printing system, ink, and the process for metrological quality control (verification) have to be optimally coordinated. Only in this way can permanent, consistently reproducible, and standards-compliant marking results be achieved. -
High-resolution inkjet systems are particularly well-suited for UDI marking on Tyvek®. However, it is not only the printing system that is crucial, but also the use of the correct ink and subsequent verification of the code quality.
The best printing technology depends on the specific packaging, the production process, and regulatory requirements.
For many applications, high resolution direct inkjet printing offers a precise and cost-effective solution. With especially formulated inks, permanent, readable GS1 DataMatrix codes can be produced even on challenging Tyvek® surfaces.
Regardless of the printing method, the code quality should subsequently be metrologically verified in accordance with the relevant ISO/IEC standards to ensure that UDI marking remains permanent and compliant with standards over time. -
A printed UDI code is only reliable if its quality has been verified through metrological testing. Code verification ensures that the Data Matrix code meets the requirements of ISO/IEC standards and can be reliably read throughout the entire supply chain.
Not every Data Matrix code that looks good visually automatically meets regulatory requirements.
During each code measurement (verification), parameters such as symbol contrast, modulation, grid deviation, error correction, and print quality are evaluated in accordance with ISO/IEC 15415.
Standard-compliant verification reduces scrap, increases process-reliability, and helps companies reliably comply with the requirements of the Medical Device Regulation (MDR), the FDA, and other international UDI regulations. -
Medical devices are subject to various UDI regulations worldwide, most of which are mandated by law. These regulations incorporate user specifications from issuing entities and ISO/IEC standards. The standards define the methods for code measurement, specify the code properties, and form the basis for the data structures upon which the issuing entities rely.
Medical device manufacturers have to ensure that their UDI marking complies with the legal requirements of their respective markets. These include, among others:
- EU Medical Device Regulation (MDR) & In Vitro Diagnostic Medical Devices Regulation (IVDR) — regulatory UDI requirements for medical devices and in vitro diagnostic medical devices in the EU
- FDA UDI Rule (U.S.) —UDI requirements for medical devices in the U.S.
- ISO/IEC 15415 – Method for the qualitative evaluation of matrix codes (Data Matrix code, QR code, etc.)
- ISO/IEC 15426-1 & ISO/IEC 15426-2 (conformity of code measurement systems)
- GS1 General Specifications Standard —Specifications for GS1-compliant identification, data structure, and coding
In addition to the actual printing of the UDI code, verifiable code quality is particularly crucial for successfully passing audits and ensuring reliable traceability.
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Permanent high print quality is produced through the combination of suitable materials, optimized printing technology, optimal ink, and continuous inline verification.
The print quality of a UDI code depends on numerous factors. In addition to material properties, print resolution, ink selection, print parameters, and production speed play a decisive role.
Through the use of inline code verification, every single Data Matrix code is verified immediately after printing. Errors are detected immediately and can be automatically rejected or corrected.
This allows process variations to be detected early, reduces scrap, and ensures consistently high code quality. -
REA and DuPont are combining their expertise in material development, coding and marking technologies, and code measurement to help companies achieve secure and compliant UDI marking on Tyvek®.
Tyvek® poses unique challenges for marking. That is why REA and DuPont have been working closely together for many years to develop suitable solutions for the medical technology industry.
While DuPont contributes its extensive expertise on the material properties of Tyvek®, REA assists in selecting suitable printing technologies, inks, and code verification systems.
The results achieved through this collaboration demonstrate that high-quality, standards-compliant UDI markings can be permanently applied even to challenging Tyvek® surfaces. -
Yes. Modern marking and verification systems can often be integrated into existing production lines without having to replace the entire machine.
Many manufacturers want to continue using their existing packaging equipment while also meeting current UDI requirements.
In many cases, modern inkjet, laser, labeler, and verification systems can be integrated into existing production processes as retrofit solutions. This reduces investment costs while meeting requirements for traceability, process reliability, and print quality. -
Yes. REA helps companies evaluate individual applications and works with them to develop the appropriate marking and verification solution.
Every package and every production process has different requirements in terms of material, print image, and code quality.
Working closely with you, our experts will analyze your application and verify which printing technology, ink, and verification solution are best suited for your Tyvek® packaging. Upon request, we’ll conduct feasibility and print tests using actual materials and assist you with integration into existing production lines.